Circular 15/2013/tt-Byt: Guidelines For Ensuring The Quality Of Implementation Of Hiv Testing Techniques

Original Language Title: Thông tư 15/2013/TT-BYT: Hướng dẫn bảo đảm chất lượng thực hiện kỹ thuật xét nghiệm HIV

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MINISTRY OF HEALTH
Number: 15 /2013/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, May 24, 2013

IT ' S SMART

GUIDE TO THE QUALITY OF HIV TECHNICAL EXECUTION OF HIV

________________________________________________________

The Prevention of Defense, Anti-Virus Infection, causes an HIV/AIDS syndrome on June 29, 2006;

Base of Protocol 63 /2012/NĐ-CP August 31, 2012 of the Government stipulated the function, mandate, jurisdiction and organizational structure of the Ministry of Health;

On the recommendation of the Office of the Bureau of Defense, Anti-HIV/AIDS, the Chief Legal Officer;

The Ministry of Health issued the Information Protection Guide to the Quality of Performing HIV Testing. .

Chapter I

GENERAL REGULATION

What? 1. The adjustment range

This message adjuts the following problems:

1. Human resources, facilities, equipment, trial quality management for HIV screening laboratories, HIV affirmants and national reference prevention for HIV testing (later known as HIV testing).

2. The procedure announced the HIV screening test room, which recognizes the HIV assertion clinic and designated the national reference room for HIV testing.

What? 2. Explain the word

In this Information, the words below are understood as follows:

1. The HIV screening test room is the test room for one or more HIV testing techniques specified in this Article 3, but is not confirmed for HIV positive cases.

2. The HIV affirmable test room is the HIV screening test room that has been identified by the Ministry of Health and recognized eligible for the test results of HIV claims.

3. The national reference room for HIV testing is that the HIV affirmable laboratory is designated by the Ministry of Health to carry out regulatory tasks at Article 28 of this message.

What? 3. Classification of HIV testing techniques

1. HIV testing with a serum technique, including:

a) The HIV test by simple technique does not require specialized test equipment (after this is called HIV testing by simple technique);

b) HIV testing with ELISA technique or optical emission or electrolumination (later abbreviated as HIV testing by the autoimmune technique).

2. HIV testing with molecular biology techniques.

Chapter II

CONDITIONS FOR HIV TESTING IN SERUM ENGINEERING.

Section 1. CONDITIONS FOR HIV SCREENING FOR HIV SCREENING.

What? 4. Conditions for HIV testing room by simple technique

1. Human conditions:

a) There are at least 02 test personnel who meet the following conditions:

-There is a professional degree from professional high school becoming one of the following majors: y, pharmacy, biology, chemistry;

-There is certification through the training of the HIV test of medical facilities appointed by the Minister of Health, or have a certificate of confirmation through training, training for HIV testing due to the competent authorities in the foreign country in accordance with the test technique that person is. to be delivered.

b) There are at least 1 employees who respond to regulatory conditions at Section 3 Article 26 Law Enforcement, Anti-Infection That Causes HIV/AIDS (later known as Law Enforcement, Anti-HIV/AIDS) in the case of blood and blood. to direct results directly to the person who is tested for HIV.

2. The condition of the facilities:

In addition to meeting the conditions of the prescribed facilities at Clause 1 Article 5 digital decree. 92 /2010/NĐ-CP August 30, 2010 The government regulates the implementation of some of the provisions of the Law, against the infectious disease of biological safety assurance at the laboratory (later called the Digital Protocol). 92 /2010/NĐ-CP), The HIV testing room with a simple technique must respond to the following conditions:

a) The area that performs HIV testing:

-separately from the other test areas in the lab;

-Make sure the clear, clean, avoid the dust.

-There's enough electricity and water.

b) The test table must be placed in a position of sufficient light and avoid the flow of wind;

c) The walls of the test area must use water-impermeaer materials, which withstand heat and corrodiated chemicals, and must have a high degree of high degree from the test table to at least 50 cm;

d) There was a washbasin arranged in the area near the door of the test room;

There ' s a waste disposal system before we ' ve poured into the common waste.

3. The condition of the device page:

In addition to meeting the conditions of the prescribed equipment at points b, c and d 2 Article 5 The number of arithmetic. 92 /2010/NĐ-CP, The HIV testing room with a simple technique must respond to the following conditions:

a) There are test equipment that are consistent with the testing technique that is performing at the laboratory;

b) There is a separate food and care device that is consistent with the test capacity;

c) There is pipeet in accordance with the test technique for test techniques that need to use pipet;

d) There ' s a time clock.

4. Conditions on the management of the test quality:

a) The apparatus of the laboratory must meet the following conditions:

-There's a file manager profile, including the device's receipt of equipment, machine scheduling, computer logs, and manual usage in Vietnamese;

-There is a summary of the manual using the device page being posted in a convenient location for the lookup during the use of the device page;

-Maintenance, maintenance and periodic calibration;

-Refrigerated refrigerators, the product must be monitored monitoring the daily temperature by the board or the temperature monitor and must have a backup power source.

b) Perform full of the test samples in the product set in the direction of the manufacturer; encourage the combination to perform with the internal examination;

c) Participation in the HIV test foreign program;

d) HIV testing must meet the following conditions:

-In accordance with the methods of testing prescribed at Annex 6 April 9 /2012/TT-BYT on 24 May 2012 by the Minister of Health for the monitoring of HIV/AIDS epidemiology and the monitoring of sexually transmitted infections (later known as SATT). No. 09 /2012/TT-BYT);

-In the right direction using the manufacturer's product.

The product used in HIV testing must have an effective number of registered registration or be used by the Ministry of Health and is still in use.

e) Time saving test results (record or print or reading) and test diagram: 05 years from the date of the test to all HIV testing techniques.

What? 5. Conditions for HIV testing room with a marked immune technique.

1. Human conditions:

In addition to meeting the stipulation conditions at the point b 1 Article 4 This information, the HIV test room with the immune technique marks at least 2 test personnel responding to the following conditions:

a) There is a professional degree from the professional high school that goes up to one of the following majors: y, pharmacy, biology, chemistry, in which employees are assigned in charge of the laboratory having to have degrees from college or higher;

b) There is certification through the training of the HIV test of medical facilities specified by the Minister of Health, or have a certificate of confirmation through training, training for HIV testing due to the competent authority in the foreign country in accordance with the test technique that person is. to be delivered.

2. The condition of the facilities:

In addition to meeting the regulatory conditions at Article 2 of this Smart 4, the HIV test room with the marking-based immune technique must respond to the following conditions:

a) There is a deep sink for the washing of test instruments made of waterproof materials, which are tolerant of corrodized chemicals;

b) There is a regulatory machine or a suction machine.

3. The condition of the device page:

In addition to responding to the conditions of the prescribed equipment at the Third Article 4 Article 4, the HIV test room with the marking-based immune technique must respond to the following conditions:

a) There is at least one of the following three device systems: the ELISA array or the optical system of emission or photovolcic systems;

b) There are at least 1 centrifugworks in accordance with the test technique;

c) There are at least 01 pipets that guarantee the volume consistent with the experimental testing technique.

4. Process Quality Management: Meet the regulatory conditions at paragraph 4 Article 4 This message.

Section 2. CONDITIONS FOR THE HEMATOLOGY LAB CLAIM HIV

What? 6. Human conditions

In addition to meeting the stipulation conditions at Article 1 Article 5 This information, the test room affirmed that HIV must respond to the following conditions:

1. The person who directly performs the test of the HIV test lab must also respond to the following conditions:

a) There is experience of HIV testing for at least 01 years;

b) There is a fundamental understanding of HIV and HIV testing techniques simultaneously with the ability to analyze and measure test results;

c) There is a understanding of the laws of law that are related to HIV testing.

2. The curator and staff of the test department affirmed that HIV must meet the regulatory conditions at Clause 3 Article 5 Digital Protocol 92 /2010/NĐ-CP.

What? 7. The condition of facilities

1. Responding to the conditions of level I-level biological safety by regulation at the Digital Protocol 92 /2010/NĐ-CP And the conditions are stipulated in paragraph 2 Article 5 of this. The case of testing for HIV is carrying out the culture, the distribution, the animal ' s experiment, and the conditions for the safety of grade III, under the regulation of the digital decree. 92 /2010/NĐ-CP.

2. There is a backup power source.

What? 8. Terms of Equipment

In addition to meeting the conditions of the prescribed equipment at points b, c and d 2 Article 5 The number of arithmetic. 92 /2010/NĐ-CP, The hematology laboratory confirms that HIV must respond to the following conditions:

1. There are devices that are consistent with HIV testing techniques that are performing at the prescribed laboratory at Section 1 Chapter II this message.

2. Have a deep-negative refrigerator with a negative temperature of at least 20 o C to file a positive or non-determinate sample.

What? 9. Quality Management Conditions

Meet the terms of the regulatory quality management at the Fourth Article 4.

What? 10. Conditions on the ability to carry out HIV testing

1. The condition of experience implementation of HIV testing:

a) There is a time for the implementation of HIV in a manner III prescribed at Annex 6 issued in accordance with the Information No. 09 /2012/TT-BYT at least 3 months prior to the filing of the filing of eligible recognition of HIV positive cases;

b) During the implementation of the HIV test specified at the point a 1 This must have detected at least 50 positive suspects. In the case of a test-based test, there must be a number of tests of that technique at least 20 times.

c) The test results of the test techniques are required.

2. Participate in full program of HIV tests, in which the latest examination of the 02 test results must be reached standard.

3. The sampling of HIV tested positive and suspected of ensuring scientific, reasonable, and complete medical samples during the prescribed trial period at the point of paragraph 1 This.

Section 3. CONDITIONS FOR THE NATIONAL REFERENCE ROOM FOR HIV BLOOD SERUM TESTING

What? 11. Human conditions

In addition to meeting the regulatory conditions at paragraph 3 Article 6 Digital Protocol 92 /2010/NĐ-CP And this Article 6 of this, the national reference test for HIV, has to have at least 8 employees, of which:

1. The employee in charge has a graduate degree in medicine or biology and has experience performing an HIV serum test from 05 years or more.

2. The employees are tasked with managing the quality of testing, building the standard set, ensuring that the biomedical safety should have a degree in medicine or biology, and have experience performing the HIV serum test from 3 years or more.

3. Other employees must have a professional degree in accordance with the job being delivered and have to be experienced at least 01 years of doing that work.

What? 12. Conditions on facilities

Meet the conditions of regulation at paragraph 1 Article 6 of the number of Protocol 92 /2010/NĐ-CP.

What? 13. Terms of Equipment

In addition to meeting the conditions of the prescribed equipment at paragraph 2 Article 6 of the Digital Protocol 92 /2010/NĐ-CP, the national reference room for HIV serum testing must respond to the following conditions:

1. There is a basic test device with the number of at least as follows:

a) 02 the ELISA series, which has an ELISA set of semi-automatic ELISA and 1 autonomous ELISA.

-A three-dimensional shaking in the Western Blot.

-1 high speed centrifugations (at least 15,000 rpm);

-02 stirred machines;

-02 mixers;

-02 sets of pipets in accordance with the test technique in which the test room is performing;

-01 deep refrigerators o C to store the sample of the disease and to contain chemicals that serve the production of the external test and internal examination;

-It's a 70-year-old refrigerator. o C to save the model for the construction of the HIV sample bank;

-03 refrigerators with warranty temperature from 04-08 o C, consisting of: 1 cabinet to save the product, 01 of the medicine cabinet; 01 cabinets serving a peripheral sample production;

-1 cupboard 37. o C.

-A fiberglass.

-A vacuum pump;

-A specialized printer printer.

b) The equipment, other consumable supplies in accordance with the testing techniques are being carried out at the laboratory.

What? 14. The condition of quality management and capacity implementation of HIV testing

1. Conditions on Quality Management: Reaching ISO 15189 standard or regulatory equivalent for the laboratory. In the case of the production and supply of the external test and internal examination must be the ISO 17043 standard.

2. The condition of the ability to carry out the HIV test:

a) There is the ability to manage the coordination and supply of a foreign exchange program, the internal examination for other HIV health care labs;

b) There is the possibility to support the construction of the standard processes for the testing of HIV serum testing techniques to provide for the prevention of HIV and implementation patients;

c) There is a possibility to build a way to test HIV and to train HIV testing with a serum technique;

d) There is a sample bank that serves to secure the quality of HIV testing;

There is the ability to coordinate or organize the deployment of scientific studies involving pathology, HIV immunology; research assessment of the methods of HIV anemia, the quality of HIV testing of HIV in the field, and HIV. other studies are relevant;

e) The implementation of all HIV testing methods in the same-time serum techniques must be able to test the validation of HIV infections of undefined responses;

g) Join the annual foreign exchange program on HIV testing of international agencies and organizations recognized by the Ministry of Health.

Chapter III

CONDITIONS FOR HIV TESTING LABORATORIES USING BIOENGINEERING.

What? 15. Conditions for HIV testing room with molecular biology techniques.

1. Human conditions:

In addition to meeting the regulatory conditions at paragraph 3 Article 6 of the Digital Protocol 92 /2010/NĐ-CP And this Article 4 Article 4, the HIV testing lab with molecular biology, must have at least two test workers who respond to the following conditions:

a) There is a professional degree from the professional high school that goes up to one of the following majors: y, pharmacy, biology, chemistry, where employees are assigned in charge of the laboratory to have a postgraduate degree in medicine, biology;

b) There is certification through the training of HIV testing by molecular biology of the medical facilities specified by the Minister of Health, or have a certificate of confirmation through training, training for HIV testing due to the competent authority in the foreign country. The test technique that the person is entrusted with;

c) There are at least 01 years of experience performing HIV testing using molecular biology techniques.

2. The condition of the facilities:

In addition to meeting the regulatory conditions at Clause 1 Article 6 Digital Protocol 92 /2010/NĐ-CP, HIV testing with molecular biology techniques must respond to the following conditions:

a) For the test room using an automatic and non-closed test system must have at least 3 separate units or regions designed in accordance with the one-dimensional principle with the following order:

-Chemical preparation.

-The room for the sample.

-Great room.

The laboratory case performs PCR testing techniques, in addition to the above-listed rooms with an additional 1 additional rooms or areas for the analysis of PCR products.

b) For the test room using a fully closed and closed test system: Must be designed in accordance with the system's requirements.

3. The condition of the device page:

In addition to meeting the regulatory conditions at paragraph 2 Article 6 Digital Protocol 92 /2010/NĐ-CP, HIV testing with molecular biology techniques must respond to the following conditions:

a) There are test pages that are consistent with the testing technique that are performing at the test facility and are distributed in the rooms as follows:

-The chemical preparation room:

+ Refrigerator 4ºC and negative 20ºC to preserve chemicals and products;

+ Biosecurity cabinets or PCR operations cabinets with UV lamps and lighting lights;

+ centrifugation machine for the type of vitro from 1.5-2 ml;

+ Pendulum mixer;

+ The pipeet uses its own to phase a reaction solution.

-A sample.

+ Biosecurity cabinet level II;

+ Refrigerator minus 80ºC;

+ Fridge 4oC;

+ Cold centrifugation machine for type 2 ml and 5 ml type tube;

+ Pendulum mixer;

+ The pipet is used separately for extraction;

+ Timer;

+ Rotating Mixer, thermal brew (optional of the technique);

+ The machine is the template for processing and extraction (if any).

-Great room.

+ The thermal machine for the case of using conventional molecular biological test machine or Real Time PCR;

+ Centrifunel for the 0.2-2ml; tube.

+ The pipet is consistent with each technique;

+ PCR template operations cabinets;

+ Refrigerator 4oC to store molecular biology products.

b) In the case of using the PCR test technique to add the following device pages at the PCR product analysis area:

-Ministry of electricity, microwave, gel tools, reading machine and gel analysis or ELISA array against the case of analysis of results using ELISA technique;

-The Pipet's own.

-The 4oC fridge.

c) There are consumable objects used for testing in accordance with the performing molecular biology technique.

4. Quality management conditions:

Meet the conditions of regulatory quality management at points a, b, c, e and e Section 4 Article 4 This Information.

5. The case of a test lab that performs HIV testing by molecular biology techniques for children under 18 months must also respond to the following conditions:

a) The condition of the ability to carry out the HIV test:

-There is a time for HIV testing by molecular biology, which is at least 6 months before the publication date of publication and must detect at least 20 positive suspects;

-The test results of test techniques are required.

b) The sampling of HIV tested positive and suspected of ensuring scientific, reasonable, and complete samples of the disease in the time of execution by regulation at this point of paragraph.

What? 16. Conditions for the National Chamber of reference for HIV testing by molecular biology techniques.

1. Human conditions:

In addition to meeting the regulatory conditions at paragraph 3 Article 6 Digital Protocol 92 /2010/NĐ-CP And the point is that this fourth Article 4 is required to have at least 05 employees, of which:

a) The employee in charge has a doctorate in medicine or biology and has an experience of performing a molecular biology test from 05 years or more;

b) The employees are tasked with quality management, biosafety, in charge of constructing a standard set of undergraduate degrees in medicine or biology, and having experience performing a molecular physiology of molecular biology from 3 years or more;

c) Other employees must have a professional degree in accordance with the experience of at least 01 years for the work delivered.

2. Conditions on the basis of matter: Meet the conditions specified at Clause 2 Article 15 This message.

3. The condition of the device page: Meeting the stipulation conditions at paragraph 3 Article 15 This message.

4. Conditions on Quality Management: Reaching ISO 15189 standard or regulatory equivalent for the laboratory. In the case of the production and supply of the external test, the test cabinet must reach an additional ISO 17043 standard.

5. The condition of the ability to carry out the HIV test:

a) There is the ability to manage coordination or to provide an external examination program, the internal examination for HIV molecular biology laboratories;

b) There is the ability to build standard processes on molecular biology testing techniques to provide for the laboratory of HIV molecular biology testing and implementation;

c) There is a possibility to train HIV molecular biological testing techniques;

d) With the ability to coordinate or organize the deployment of scientific studies involving pathology, molecular biology of HIV and other studies is relevant; and the development of HIV/AIDS.

We ' ve done all these HIV tests using molecular biology.

e) Participate in the annual foreign exchange program of prestigious international agencies and organizations.

Chapter IV

PROFILE, SEQUENCE, AUTHORITY PROCEDURE RECEPTION, RECOGNITION OF HIV TESTING ROOM

Section 1. PROCEDURE FOR HIV SCREENING TESTING

What? 17. The filing of the test room published qualified for HIV screening tests

1. Text publication of the test room qualified for an HIV screening test under the prescribed form at Annex 1 issued by this message.

2. The copy of the state agency ' s operational license has jurisdiction over the basis of an examination, private treatment or a copy of the established decision by the state agency to have jurisdiction over the health facilities of the state.

3. The personnel list of the prescribed laboratory at Annex 2 issued by this message. For the lab at the clinic, the treatment must be sent with a copy of the evidence that the lab personnel conduct the practice.

4. The basis of the physical base attached to the face diagram by the implementation of the HIV test technique of the stamped and signed base of the head of the facility.

5. The medical device's medical device for a prescribed sample of the three-issued Appendix 3.

What? 18. The procedure announced the test room qualified for the HIV screening test.

1. The procedure for publication of HIV testing is eligible for a test room belonging to the facilities of the disease, treating the disease: The procedure for publication of the HIV test is done at the same time that the proposed licensing of the facility's operating license.

2. The procedure for publication of HIV testing for the laboratory does not belong to the facilities of the disease, treating the disease:

a) Before the implementation of the HIV screening test, the facility where the HIV test room must submit 1 sets of prescribed records at Article 17 of this Notice to the Provincial Health Department, the central city (later called the province) where the facility is located;

b) After receiving the file, the Provincial Health Department sent the basis of the filing of a document filed under the prescribed pattern at Annex 4 issued by this Information;

c) After 15 working days, since the date of the record on the record, if the Department of Health does not offer a revised offer, the facility is allowed to deploy the HIV test operation;

d) The case case is not valid, during the 5-day period of work since the date received the case, the Provincial Health Service must have the text of the revised, complementary basis. The text of the revised offer, the addition must be specified as the addition of the documents, which content needs to be modified;

When receiving an amendment request text, additional, the basis of eligible for the implementation of the HIV test must proceed with the amendment, complemusing the stated content in the text and sending the revised case to the Department of Health;

e) After 15 days of work, since the date of writing on the additional filing papers, if the Department of Health Department does not offer a revised offer, the facility is allowed to deploy the HIV test operation.

Section 2. FILE, NEW LEVEL PROCEDURE, REISSUED AN HIV CONFIRMED LAB CERTIFICATE

What? 19. Records, new level procedure certificate office certification for HIV

1. The filing of a new level of acceptance of the certificate office confirms HIV: Implementation in accordance with Article 17 of this.

2. The procedure for receiving and processing the new issue of the new grant certificate office confirms HIV:

a) The facility where the test room offers to grant a new level of a certificate of HIV certification (later called a proposed facility) sends 1 Department of Public Affairs, anti-HIV/AIDS-Ministry of Health. The date of adoption of the filing is calculated according to the Office of the Bureau, against HIV/AIDS-the Ministry of Health;

b) During the 5-day period of work, since the date of receiving the file, if there is no modification requirement, the case adds the Bureau, the Prevention of HIV/AIDS-the Ministry of Health must have a document which defines the test basis, evaluating the ability to carry out the HIV test (after this is called off) The database of the proposed facility;

c) The case of filing a proposal to grant an unsigned trial of HIV is not valid in the time of the 5 working days, since the date of the filing, the Bureau, against HIV/AIDS-the Ministry of Health must have a notification text for the proposed facility to complete the pool. Sister, The text message must specify specifically about the documents that need to be modified and the content needs to be modified;

d) When a document is received, the proposed basis must be added, correct in accordance with the content that has been written in the text and sent back to the Bureau, against HIV/AIDS-the Ministry of Health. The date of receiving additional records, the amendment is calculated in accordance with the Office of the Bureau of Public Affairs, against HIV/AIDS-the Ministry of Health. After 5 working days, since the date of receiving additional records, if the case is valid, the Bureau, against HIV/AIDS-the Ministry of Health must carry out the designation of the inspection facility;

Case the proposed facility has added, modified the profile but not true to the request, the Bureau, against HIV/AIDS-the Ministry of Health will notify the facility to continue to complete the prescribed profile at the c, d of this clause.

3. Test capacity testing the HIV test of the recommended facility:

a) During a maximum period of 10 working days, since the date of receiving the designation of the Bureau designation, against HIV/AIDS-the Ministry of Health, the inspection facility must submit a sample review of the HIV test capacity and the report samples for the testing of the capacity assessment. HIV testing for the recommended basis;

b) In the maximum period of 20 days from the date of receiving the text and the sample assessment of HIV testing, the proposed facility must carry out and submit a report of the assessment of the HIV test capacity for the examination facility including:

-The test results and samples of the hospital are due to self-work on 30 samples of HIV-tested patients in a row (including 20 samples of positive reactions in a way III and 10 samples of the disease have negative reactions) for the trial basis. The serum.

-The results of the test on the HIV test force's HIV test force sent.

c) During the 10-day period of work, since the date received the report of the proposed facility, the test facility must conduct the test capacity assessment on:

-A recommended basis for a recommended basis;

-Results of HIV testing capacity for which the database sends;

After the completion of the evaluation, the audit facility is responsible for sending the results of the Bureau, against HIV/AIDS-the Ministry of Health under the prescribed form at Annex 5 issued by this Information;

d) During the 10-day period of work, since the date of receiving the report of the inspection facility (the date of the reported report is calculated according to the Bureau of Defense, anti-HIV/AIDS), the Department of Health, anti-HIV/AIDS-Ministry of Health must conduct the procedure. After:

-The case of test results: The Minister of Health review, decides the establishment of the actual appraisal team at the proposed facility;

-The case of the test results failed: There is a text message for the proposed facility to know.

4. The organization of the appraisal for granting new examination of the test room confirms HIV:

a) The Minister of Health to establish a proposed base appraisal delegation of the following components:

-Bureau leader, anti-HIV/AIDS leader;

-Representative of the French.

-National reference room representative for HIV anemia;

-Independent expert on HIV testing;

-Defense Specialist, anti-HIV/AIDS as a secretary.

b) The coordination component in the appraisal process:

-Representative one of the institutes: Central Institute of Epidemiology, Institut Pasteur city Ho Chi Minh City, Institut Pasteur Nha Trang, Institute of Institute of Sanitation (later called the Regional Institute) depending on the venue where the facility offers the certification of the clinic. HIV affirmable based on the headquarters;

-Representative of the Department of Health where the facility offers to be based.

c) The new level of appraisal procedure certification for the testing of HIV asserts:

-Forensic case appraise; examination of the conditions on the basis of matter, equipment, medical instruments, personnel organization of the proposed facility;

-Set the specified pattern by the specified pattern at Annex 6 issued by this message;

-The appraisal is made of 05 copies: 01 copies in the Bureau, anti-HIV/AIDS-Ministry of Health, 01 copies at the Department of Health Department where the proposed facility is based, 01 copies at the national reference room for HIV anemia, 01 save at the Institute of Medicine area and 01 copies at the facility specified;

-After a five-day period of work since the end of the appraisal, the Bureau, against HIV/AIDS leadership, decides to grant the certification of the test department to determine HIV according to the prescribed pattern at Annex 7 issued by this message. The non-level case has a written statement stating the reason.

5. Management certificate management certificate for HIV:

a) Every lab that insists HIV is given only a certificate of testing for HIV is valid for 5 years, since the date of the degree;

b) A copy of the HIV autopsy paper copy and the new level of proposed records, the granting of the HIV confirmation test paper filed in the body of the medical certificate office, confirmed HIV;

c) After the granting of the trial certificate for HIV, the Ministry of Health sent a notification text to the Provincial People ' s Committee and the Department of Health Department where the facility was granted a trial for an HIV confirmation test reservation based in the 30-day period. From the day, level.

What? 20. Records, procedures for a medical certificate of testing for HIV.

1. The granting of certificates is applied in the following cases:

a) The certificate is expired;

b) The certificate is missing or damaged;

c) Change the person in charge or staff directly implementing the HIV test technique;

d) Changes to the location of the test base;

In addition to HIV testing;

e) The certificate is revoked.

2. Records, the procedure of granting the test office certification for HIV confirmed for the case of a missing or damaged certificate:

a) The filing of the request for the acceptance of the laboratory certificate of HIV is:

-The proposed repetition text of the facility where there is an HIV-based test laboratory according to the prescribed pattern at Annex 8 issued by this message;

-The HIV certificate office certificate has been issued (if any).

b) The process of granting the examination to the trial of the test office affirmed HIV due to missing or damaged certificate:

-Check for the filing of a filing appraisal at the Ministry of Health or certificate department certification for the damaged HIV assertion (if any);

-During the five-day period of work, since the date of receiving the file, the Bureau, against HIV/AIDS, has to be reviewed by the Minister of Health, deciding on the granting of a trial certificate for the confirmed trial of HIV.

3. Records, the procedure of granting a lab certificate to the trial of HIV due to changes in the person or staff directly performing an HIV test or a change in the location of the test facility:

a) The record offers to grant the certification of the laboratory certificate for HIV: In accordance with the regulation at Point 2 This is:

b) The process of granting the examination to the trial of the test office of HIV is due to the change of the person in charge or the person directly performing an HIV test or a change in the location of the test facility:

-During the five-day period of work, since the date of receiving the filing, the Bureau, against HIV/AIDS-the Ministry of Health designated the inspection facility to conduct the actual examination at the recommended facility;

-During the 15-day period of work, the inspection facility must conduct examination of the conditions performing test techniques at the proposed facility and report the Department of Defense, anti-HIV/AIDS attached to the audit editor;

-Within a maximum of 10 working days, since the date of receipt of inspection of the inspection facility, the Bureau of Prevention, anti-HIV/AIDS required by the Minister of Health review, decides the granting of the trial certificate to confirm HIV according to the prescribed pattern. Appendix 7 issued this message.

4. For the specified cases at Point a, the Point and Point of Clause 1 Article, the sequence procedure is done by regulation at Article 19 of this.

Section 3. JURISDICTION, RECORDS, PROCEDURES FOR THE NATIONAL REFERENCE ROOM FOR HIV TESTING

What? 21. The authority to specify the national reference room for HIV testing

The Minister of Health appointed the HIV test room of the state health system as the national reference room for HIV testing.

What? 22. The procedure to specify a national reference room for HIV testing

1. The Department of Defense, anti-HIV/AIDS sent the basis of the facility where the test room is expected to be designated as a national reference room for HIV testing (the following designation is the designated basis) of a filing of specified documents at 2, 3, 4 and 5. Article 17 of this and send it back to the Ministry of Health.

2. The procedure, the procedure for receiving and processing the profile:

a) During the 10-day period of work, since the date of receiving the file, if there is no additional offer of records, the Bureau, the Anti-HIV/AIDS-Ministry of Health must have the Office of the Minister for Health review, deciding whether the establishment of the facility appraisal is specified;

b) The proposed case case is not valid, during the 5 working days, since the date of the filing, the Bureau, against HIV/AIDS-the Ministry of Health must have a notification text for the intended basis specified to complete the profile. The text message must specify specifically about the documents that need to be modified and the content needs to be modified;

c) Over the 20-day period, since the date of receiving the text of the request to complete the profile, the intended basis is required to complement, correct in accordance with the content that has been written in the text and sent to the Bureau, against HIV/AIDS-the Ministry of Health. The date of receiving additional records, the amendment is calculated in accordance with the Office of the Bureau of Public Affairs, against HIV/AIDS-the Ministry of Health.

After 5 working days, since the date of receiving additional records, if the case is valid, the Bureau, against HIV/AIDS-the Ministry of Health must carry out the proposed formation of the appointed appraisal at the Point of Point;

d) The proposed base case has added, modifying the profile but not true to the request, the Bureau, against HIV/AIDS-the Ministry of Health will notify the facility to continue to complete the prescribed profile at the b Point and Point.

3. The organization of the appraisal:

a) The Minister of Health to establish a proposed base appraisal delegation of the following components:

-Office of the head of the Bureau, against HIV/AIDS-the Ministry of Health.

-Independent experts on HIV testing; biological safety; management of the quality assurance of HIV testing;

-The French Ministry of Health.

-Representative of the Department of Health Services.

-Department of Health Services-Ministry of Health;

-Department Specialist, anti-HIV/AIDS-Ministry of Health as Secretary of State.

b) appraisal process: Implementation by paragraph c 4 Article 19 This message.

Section 4. SUSPENSION OF HIV TESTING, RECOVERY OF HIV CONFIRMED TESTING.

What? 23. The suspended cases are active.

HIV testing is suspended in the following cases:

1. Do not comply with the test processes or have the technical expertise of the test-based test technical expertise issued by the Minister of Health but has not yet affected the results of the test.

2. Not fully equipped with a test device or have a test site but those devices do not work or do not guarantee the quality.

3. Do not participate in the external examination program.

4. The facilities do not guarantee the conditions under the provisions of this Smart.

5. Do not perform the statistics, report the results of the HIV test results.

What? 24. The authority to suspend operations

1. The Minister of Health decides to suspend the operation of the HIV affirmable lab and the national reference room for HIV testing.

2. Director of the Department of Health Department decided to suspend the operation of the HIV screening clinic.

What? 25. Procedulation, duration of suspension

1. During the examination, the active inspector of the HIV laboratory if the HIV test room was detected in violation of one of the regulations at Article 23 of this information, the unit carried out the inspection, the inspector had to establish a temporary border. The prescribed form at Annex 9 issued by this message and sent back to the Bureau, against HIV/AIDS-the Ministry of Health or the Department of Health.

2. During the 5 working days, since the date of receipt of the temporary receipt only operates in Clause 1 Article:

a) Department of Defense, anti-HIV/AIDS Chief Minister for Health review, decides that the suspension works;

b) The medical department has to submit a review of the Provincial Health Department, deciding whether the suspension works.

3. The decision to suspend operations has a period of 6 months from the date of the signing, issued and submitted as follows:

a) For HIV asserts HIV and the national reference room for HIV testing: The facility where HIV testing is suspended, and the units that have joined the appraisal of the trial certificate confirm HIV or determine only HIV. the national reference room for HIV testing;

b) For the HIV screening test room: The facility where HIV testing is suspended and the prevention center, against HIV/AIDS.

4. The HIV test room case suspended has been conducted to rectify the violations, the slowest day being 30 days before the suspension of the suspension expires, the facility where HIV testing is suspended is required to send reports of remediation of the violations. So,

a) The Regulatory Facility stipulated at the Point 2 Article 2 Article 19 This message to the clinic affirmable HIV and the national reference room for HIV testing;

b) Central, anti-HIV/AIDS province where the basis of HIV testing is suspended based on the HIV screening laboratory;

c) The time of receiving a breach of the breach is calculated as the recognition of the work of the prescribed facilities at the points a, b This paragraph.

5. During the 20-day period of work, since the date received reports of rectify the violations of the suspended facility, the regulatory units at points a, b Section 3 This must conduct examination and report the results of the inspection of the Bureau, against the government. HIV/AIDS-Ministry of Health or Health Services-Department of Health. The time of receiving an infringement of the breach was calculated according to the Bureau of Public Affairs, anti-HIV/AIDS-Ministry of Health or Department of Health.

6. The suspension of the suspended facility has performed the correcing of the violations and the regulation response of this Information, then during the 5-day period of work, since the date of receiving the report of the designated units at paragraph 3 This Article:

a) Department of Health, HIV/AIDS-Ministry of Health is required to submit to the Minister of Health, to decide whether the termination of the suspension works. The decision to end the suspension of the operation was sent to the facility where the HIV test room was suspended and the units joined the appraisal appraisal of the test room affirmable HIV or decided to specify the national reference room for treatment. HIV test;

b) The Chamber of Health Services-The Department of Health Department has to submit a review of the Department of Health Department review, deciding the termination of the suspension. The decision to end the suspension of the operation was sent to the facility where the HIV test room was suspended operations and the Center for Prevention, anti-HIV/AIDS department.

7. The case expires at the time of the suspension of the operation that the suspended facility does not carry out to rectify the violations or have performed the remediation of the violations but still does not meet the regulation of this Information, then during the 5-day work. from the expiration date of the suspension decision or since the date of receiving the report of the specified unit at paragraph 3 This Article:

a) Department of Health, HIV/AIDS-Ministry of Health must present the Minister of Health review, decide whether the recall of the trial of the trial is HIV or the decision to specify a national reference to the HIV test of that facility;

b) The Chamber of Health Services-The Department of Health Department is required to submit a review of the Department of Health, which decides to end the HIV screening test of that facility.

What? 26. Recover the HIV autopsy lab, the decision to specify the national reference room for HIV testing.

1. The trial certificate for HIV affirmable, the decision to specify the national reference room for HIV testing is revoked in the following case:

a) The case stipulated at the Article 7 Article 25 of this Information;

b) The trial certificate for HIV affirmables, the decision to specify the national reference room for HIV testing is granted not the right authority or that there is a law of the law;

c) The test facility is no longer active, destroyed or dissolved or merged;

d) The test facility was revoked operating under the regulation of the competent state governing body.

The use of an HIV test product does not have a subscription number or is not permitted by the Ministry of Health or expired use.

2. The Minister of Health decides to revoking the certification of the HIV certificate office, which decides to specify the national reference room for HIV testing.

3. The procedure to revoking the trial certificate office confirms HIV, the decision to specify the national reference room for HIV testing:

a) During the examination, the HIV laboratory operation inspector was granted a laboratory certification for HIV or decided to specify a national reference room for HIV testing if the facility was detected in violation of one of the rules. In this case, the unit is in charge of the inspection, the inspector must compile the suspension of the operating system in accordance with the provisions of the Exhibit 9 issued by this message and send it to the Bureau, against HIV/AIDS-the Ministry of Health;

b) During a 5-day period of work since the date of receipt of the suspension of the operation specified in Clause 1 Article, the Bureau, the Anti-HIV/AIDS-Ministry of Health, was reviewed by the Minister of Health, which decided to revoking the certificate of laboratory certification. HIV or the decision to specify a national reference room for HIV testing;

c) The decision to revoking the HIV certificate office certification, the decision to specify the national reference room for HIV testing is sent as follows:

-The facility where the HIV test room is recovered from a trial certificate for HIV affirmation or decision to specify a national reference room for HIV testing;

-Units that have entered the appraisal of the trial certificate for HIV or determine the national reference room for HIV testing.

Chapter V.

EXECUTE RESPONSIBILITY

What? 27. Responsible for HIV testing

1. The responsibility of the HIV screening laboratory:

a) proceed with the taking or receiving of the sample of the disease to perform HIV detection testing techniques but is not confirmed cases of HIV positive;

b) Participate in the HIV test foreign program conducted by the Ministry of Health or designated;

c) The organization carried out the consultation of HIV testing, announcing the results of HIV testing under the regulations of the Law of Prevention, Anti-HIV/AIDs;

d) Implemonation of the data report by regulations at Digital Information No. 09 /2012/TT-BYT and records, stored the fully qualified test book chart at Decision 868 /QĐ-BYT on 29 March 2005 by the Minister of Health for the Board of Health. 07 for HIV testing.

2. The responsibility of the testing office confirms HIV:

In addition to the implementation of the provisions at Clause 1 Article, the test room asserts that HIV must carry out the following responsibilities:

a) Take on samples of suspected positive medical tests of HIV screening laboratories on the site or neighborhood to conduct tests of HIV positive. A positive or suspected 2-year suspicion from the day of the trial confirmed in the laboratory;

b) Training, monitoring of technical support and participation in testing pursuits to 1-year-per-/time trial activity at HIV screening testing facilities on the site of charge.

What? 28. The responsibility of the national reference room for HIV testing

In addition to the implementation of the provisions at Article 2 Article 27 This message, the national reference room for HIV testing is also required to perform the following responsibilities:

1. Take on tested positive test samples due to HIV-sent tests.

2. Training, technical support, monitoring, periodic examination of 1-year-time on the basis of testing of HIV according to the Department of Health ' s analysis.

3. Organization for the deployment and management of quality assurance for the HIV test prevention system.

What? 29. Office of the Bureau, Anti-HIV/AIDS-Ministry of Health

1. Directed, inspect, monitor, evaluate the activity and aggregate the number of HIV test activity on the nationwide range.

2. The director of facilities with a national reference room for HIV testing builds documents and organizes training for HIV testing for units, localities.

3. Every year, presiding, co-ordination organization organization evaluation and implementation of the work implementation guarantee the quality of HIV testing.

What? 30. Department of Health Services

1. Directed by, check out the HIV test work on the province.

2. The revised, complementary initiative aims to rectify the inadequate related to the implementation of the quality assurance of HIV testing in the process of implementing the provisions of this Smart.

3. Coordinate with the departments, the relevant sector that supports and organizes the monitoring of the deployment of HIV testing.

4. The annual, report of the Health Ministry lists the HIV affirmable tests, the HIV screening laboratory on the site.

Chapter VI

EXECUTION CLAUSE

What? 31. The transition clause

1. The new building or renovation of HIV tests after this date is valid to meet the correct conditions in this Information.

2. The HIV testing departments that have been active prior to this date of the announcement are valid for a renovation plan to arrive on December 31, 2014 to meet the eligitherapy conditions at this level.

3. For the HIV screening test room of the pathology facility, the treatment was established before the date of this date that the effect is continued to operate but the delay until 1 December 2013 must carry out the procedure to publish enough test conditions. HIV is in accordance with the provisions of this Article 2 Article 18.

4. HIV testing departments have been recognized by the Ministry of Health to confirm the results of the HIV test positive prior to this date ' s effective date in effect, but the slog until August 30, 2014 must submit a prescribed record at Article 5. These 17 Parameters Accompany All Periodic Periodic Examination of the Regional Institute for the Bureau of Defense, Anti-AIDS-Ministry of Health, for appraisal.

The case for HIV testing meets regulatory conditions in this Smart, Department of Defense, Anti-AIDS Health Ministry, which is responsible for the leadership of the Health Ministry, deciding whether to issue a trial for an HIV test.

The case of HIV testing prevention does not meet regulatory conditions at this Smart, Department of Defense, Anti-AIDS Health Ministry, which is responsible for the leadership of the Ministry of Health review, deciding the recall decision to recognize the test room. HIV positive cases have been issued.

What? 32. Terms of reference

The case where the text that is shown in this text is replaced or modified, supplemated by an alternate text or text that has been modified, added.

What? 33.

1. This message came into effect on July 1, 2013.

2. Decision No. 3052 /2000/QE-BYT August 29, 2000, of the Minister of Health on the Board of Health's management of the standard of laboratory testing is allowed to confirm that HIV is out of force since this date is effective.

What? 34.

Chief of the Department, Director of the Bureau, Anti-HIV/AIDS, the Chief, the Director, the Director General of the Department, Bureau, Directorate of Health, Head of the Department of Health, Unit of the Department, Director of the Department of Health Provinces, Central City and Head of State. The Ministry of Health, the industry, is responsible for this operation.

In the course of execution, if there is difficulty in the problem, the units, the local report on the Ministry of Health to study, solve.

KT. MINISTER.
Chief.

(signed)

Nguyen Thanh Long