Thông tư 12/2015/TT-BYT

CIRCULAR

PROVIDING GUIDANCE ON THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF DECREE No. 96/2012/NĐ-CP DATED NOVEMBER 15, 2012 BY THE GOVERNMENT PROVIDING FOR OPIOID REPLACEMENT THERAPY

Pursuant to the Decree No. 96/2012/NĐ-CP dated November 15, 2012 by the Government providing for opioid replacement therapy;

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

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

The Minister of Health promulgates the Circular providing guidance on the implementation of a number of articles of the Decree No. 96/2012/NĐ-CP dated November 15, 2012 by the Government providing for opioid replacement therapy.

Chapter I

GENERAL PROVISIONS

Article 1. Governing scope

This Circular provides for:

1. Requirements on ORT facilities and ORT dispensing facilities (hereinafter referred to as treatment facilities)

2. Documents, procedures for the issuance/reissuance of operating license to treatment facilities.

3. Procedures for suspension and withdrawal of operating license from treatment facilities.

4. Certification for the application for treatment and transfer between treatment facilities for opioid replacement therapy.

Article 2. Rules for opioid replacement therapy

1. Opioid replacement therapy (abbreviated to ORT) shall be provided only by treatment facilities satisfying the requirements specified in this Circular.

2. The professional guidelines for ORT provided by the Minister of Health shall be complied with.

Chapter II

REQUIREMENTS FOR TREATMENT FACILITIES

Section 1. REQUIREMENTS ON ORT PROVIDERS

Article 3. Requirements for material facilities

Apart from the requirements prescribed in Clause 1 Article 12 of the Decree No. 96/2012/NĐ-CP dated November 15, 2012 by the Government, treatment facilities shall fulfill the following requirements:

1. Rooms in treatment facilities shall be firm, bright and shall have ceiling that is proof against dust; wall and floor shall be easily cleaned with cleaning agent; windows shall be firm and doors shall be lockable.

2. Testing laboratories shall satisfy the following requirements:

a) Wall in testing areas and laboratory table shall be flat, watertight, resistant to heat and corrosive substances;

b) There shall be washbasin, emergency eye wash, first aid box in the laboratory.

Article 4. Requirements for equipment

1. Rooms for dispensing and preservation of medicine shall be equipped with:

a) Hygrometers;

b) Room thermometers;

c) Air conditioners;

d) 02 lockable cabinets, one of which is for storing daily dispensed medicines and the other is for medicine preservation;

dd) Medicine dispensers;

e) Cabinets or shelves for keeping files, records, papers;

g) Equipment prescribed in Points b and c Clause 2 Article 12 of the Decree No. 96/2012/NĐ-CP

2. Consulting rooms shall be equipped with:

a) Body temperature thermometers;

b) Stethoscope;

c) Emergency medical box (with antidote);

d) Blood pressure monitor;

dd) First aid kit;

e) Medical bed;

g) Body scales and height gauges;

h) Equipment prescribed in Point b Clause 2 Article 12 of the Decree No. 96/2012/NĐ-CP.

3. The laboratory shall be equipped with:

a) Equipment for urine test and blood draw;

b) Medical refrigerators;

c) Equipment prescribed in Point c Clause 2 Article 12 of the Decree No. 96/2012/NĐ-CP.

4. Place for sampling urine of patients shall be equipped with:

a) Toilet seats (with water supply pipes with valves located outside of the place for taking urine);

b) Wall stuck with one-way colored mirror enabling the staff of treatment facilities to observe the urine self-taking process of the patients.

5. Other equipment according to functions and tasks of each division.

Article 5. Requirements for staff

1. Apart from the requirements specified in Clause 3 Article 12 of the Decree No. 96/2012/NĐ-CP staff of treatment facilities shall satisfy the following conditions:

a) Physicians must have at least 18 months’ experience of medical examination and treatment;

b) Staff members in charge of assisting medical examination and treatment must have intermediate degrees in medicine or higher;

c) Staff members in charge of testing must have intermediate degrees in medicine, pharmacy, biology or chemistry or higher;

d) Staff members in charge of preserving and dispensing medicine must have intermediate degrees in pharmacy or higher;

dd) Staff members in charge of consultancy must have intermediate degrees in medicine, pharmacy or sociology or higher;

e) Staff members in charge of administrative business must have at least intermediate degrees;

g) On the basis of the real conditions, the treatment facility may hire security officers or cooperate with the local police department in ensuring the security for the treatment facility; if necessary, the treatment facility may hire not more than 02 private security officers.

2. The treatment facility may assign its employees to perform single task or various tasks if necessary in order to ensure fulfillment of the requirements specified in Clause 1 of this Article and suit the scale of the facility.

Section 2. OPERATION CONDITIONS OF ORT DISPENSING FACILITIES

Article 6. Infrastructure

Apart from the requirements specified in Clause 1 Article 13 of the Decree No. 96/2012/NĐ-CP ORT dispensing facilities shall satisfy the requirements specified in Clause 1 Article 3 of this Circular.

Article 7. Equipment

Equipment in such facilities shall satisfy the requirements specified in Clause 1 Article 4 of this Circular.

Article 8. Staff

Apart from the requirements specified in Clause 3 Article 13 of the Decree No. 96/2012/NĐ-CP ORT dispensing facilities shall satisfy the requirements specified in Points d and g Clause 1 Article 5 of this Circular.

Chapter III

DOCUMENTS, PROCEDURES FOR THE ISSUANCE/REISSUANCE OF OPERATING LICENSE TO TREATMENT FACILITIES

Article 9. Application for the issuance/reissuance of operating license to treatment facilities

1. An application for the issuance of a new operating license shall include:

a) An application form for operating license using the form in Appendix 1 enclosed with this Circular;

b) A certified true copy of the decision on the establishment granted by an authority body or a certified true copy of the certificate of business registration or a certified true copy of the certificate of investment;

c) A list of staff members of the treatment facility using the form in Appendix 2 enclosed herewith and enclose with a certified true copy of qualifications of each member;

d) The floor plan of the treatment facility;

dd) A list of equipment of the treatment facility using the form in Appendix 3 enclosed herewith.

2. The application for reissuance of operating license to the facility whose license is lost or damaged shall include:

a) An application from using the form in Appendix 1 enclosed with this Circular;

b) The original copy of the operating license that is damaged (if any);

c) The report on the operation in the latest 6 months up to the time the application is made.

3. The application for reissuance of operating license to the treatment facility that is relocated or have its operating license withdrawn shall include:

a) The papers specified in clause 1 of this Article;

b) The report on the operation over the latest 6 months up to the time the application is made.

Article 10. Procedures for the issuance/reissuance of operating licenses to treatment facilities

1. The application for issuance/reissuance of operating license shall be made in 01 set and sent to the Department of Health of provinces of the area where the facility is located.

2. Procedures for considering the issuance/reissuance of operating licenses to treatment facilities:

a) When the application is received, the Department of Health of provinces shall send the applicant facility the Document receipt using the form in Appendix 4 enclosed herewith;

b) Within 20 working days from the day on which the satisfactory application is received, the Director of the Department of Health of provinces shall conduct an appraisal to issue/reissue the operating license;

c) If the application is not satisfactory, within 10 working days from the day written on the Document receipt, the Department of Health of provinces shall send a written notification to the applicant for completion. The notification shall specify the contents and documents that are unconformable;

d) When the request is received, the applicant shall complete the application according to the notification and submit the application to the Department of Health of provinces. The date of receipt of the modified application shall be written on the Document receipt;

dd) If the application is still unsatisfactory after modification, the Department of Health of provinces shall send a written notification to the applicant for completion according to the provisions in Point c Clause 2 of this Article.

Article 11. Appraisal serving the issuance/reissuance of operating licenses to treatment facilities

The Director of the Department of Health of provinces shall establish an appraisal team to carry out the issuance/reissuance of operating licenses to treatment facilities including:

1. A representative of heads of the Department of health of provinces as Leader.

2. A representative of heads of HIV/AIDS centers of provinces as the standing Deputy leader.

3. A representative of heads of the Division in charge of managing the ORT of the Department of Health of provinces as the Deputy leader.

4. Representatives of Specialist Pharmaceutical Division of the Department of Health of provinces as Members.

5. Physicians with experience in ORT as Members.

6. Representatives of Police department as members.

7. Specialists of the Division in charge of managing the ORT of the Department of Health of provinces as the Secretary.

Article 12. Procedures for the issuance/reissuance of operating licenses to treatment facilities

1. The procedures for the issuance of operating licenses to treatment facilities or the reissuance of operating licenses to treatment facilities that are relocated or have operating license withdrawn:

a) Conduct appraisal of the legal record; inspect the conditions of material facilities, medical equipment, staff of the treatment facility;

b) Formulate appraisal record according to the form in Appendix 5 enclosed herewith. The record of appraisal of a treatment facility shall be made in 02 copies, 01 of which shall be retained at the Department of Health of provinces and the other shall be retained at the treatment facility undergoing appraisal;

c) Within 02 working days from the day of appraisal, the Appraisal team shall submit the Director of the Department of Health of provinces the appraisal record;

d) Within 03 working days from the day on which the appraisal record is received, the Director of Department of Health shall consider and give decision on the issuance/reissuance of operating license to the treatment facility. If the application is rejected, the applicant treatment facility shall be sent a writing containing the explanation.

2. Procedures for reissuance of operating license applicable to the treatment facility with the license being lost or damaged:

a) Within 05 working days from the day on which the application for the reissuance of the operating license is received (according to the to the date stamp on the dispatch sent by the Provincial Department of Health), the division in charge of managing the ORT of the Department of Health of provinces shall examine the appraisal documents according to which the operating license for such treatment facility is granted that are retained at the Department of Health;

b) Within 10 working days from the day on which the application for reissuance of operating license is received (according to the dated stamp on the dispatch sent by the Provincial Department of health), the Director of Department of Health of provinces shall consider and give decision on the reissuance of operating license. If the application is rejected, the applicant treatment facility shall be sent a writing containing the explanation.

Article 13. Management of operating licenses

1. A treatment facility shall be granted with only 1 operating license according to the form in Appendix 6 enclosed herewith.

2. A copy of the operating license and the application for issuance/reissuance of operating license shall be retained at the Department of Health of provinces.

Chapter IV

PROCEDURES FOR SUSPENSION AND WITHDRAWAL OF OPERATING LICENSE FROM TREATMENT FACILITIES

Article 14. Cases of suspension of the operating license

The operation of a treatment facility shall be suspended in any of the following cases:

1. The staff members of treatment facility fail to comply with the treatment procedures or do not conform to the specialist guidelines issued by the Minister of Health.

2. Infrastructure, equipment and staff fail to satisfy the requirements specified in this Circular.

3. The treatment facility fails to submit the report on the treatment and the compliance of the patients with the treatment according to the regulations to the authority body.

Article 15. Procedures for and duration of suspension

1. During the inspection of the operation of a treatment facility, if the facility is found violating any of the regulation in Article 14 of this Circular, the establishment in charge of the inspection shall make a record of suspension of operation using the form in Appendix 7 enclosed herewith and send it to the Department of Health of provinces.

2. Within 05 working days from the day on which the record of suspension of operation prescribed in Clause 1 of this Article is received, Director of Department of Health of provinces shall consider and give decision on the suspension of operation. The duration of the decision on suspension of operation shall not exceed 06 months from the day it is signed and shall be sent to the treatment facility that shall incur the suspension and HIV/AIDS centers of provinces.

3. If the treatment facility incurring the suspension have dealt with the violations, not more that 30 days before the day the suspension decision expires, the treatment facility incurring the suspension shall send a report on dealing with the violation to the Department of Health of provinces where the office of such facility is located. The date of receipt is based on the receipt seal of the incoming official dispatch of Department of Health of provinces.

4. Within 05 working days from the day on which the report on the dealing with the violations from the facility incurring suspension, Department of Health of provinces shall assign a unit to inspect the dealing with the violations of the treatment facility (hereinafter referred to as the assigned unit).

5. Within 10 working days from the day on which the written assignment from the Department of Health of provinces is received, the assigned unit shall conduct inspection and report the results to the Department of Health of provinces. The date of receipt is based on the receipt seal of the incoming official dispatch of the assigned unit.

6. If the treatment facility has eliminated the violations and satisfies regulations in this Circular, within 05 working days from the day on which the report from the assigned unit is received, the Director of the Department of Health shall consider and decide the suspension termination. The decision on suspension termination shall be sent to the treatment facility that incurs the suspension and HIV/AIDS centers of provinces.

7. When the suspension decision expires, if the treatment facility has not completed the dealing with the violations or the dealing with the violations is not conformable to the regulations in this Circular, within 05 working days from the day on which the suspension decision expires or from the day on which the report from the assigned unit is received, Director of Department of Health of provinces shall consider and decide the termination of treatment activities of such facility.

Article 16. Withdrawal of operating licenses of treatment facilities

The operating license shall be withdrawn in any of the following cases:

1. The operating license is issued ultra vires.

2. The treatment facility does not operate after 12 months from the day on which the operating license is issued.

3. The treatment facility has been suspended for 12 constant months or has been shut down.

4. The treatment facility is relocated.

5. The cases specified in Clause 7 Article 15 of this Circular.

Article 17. Procedures for the withdrawal of operating licenses of treatment facilities

1. During the inspection of the operation of a licensed treatment facility, if the facility is found violating any of the regulation in Article 16 of this Circular, the establishment in charge of the inspection shall make a record of suspension of operation using the form in Appendix 7 enclosed herewith and send it to the Department of Health of provinces.

2. Within 05 working days from the day on which the record of suspension of operation prescribed in Clause 1 of this Article is received, Director of Department of Health of provinces shall consider and give decision on the withdrawal of operation licensing. The decision on suspension termination shall be sent to the treatment facility that suffers the withdrawal of operating license and the HIV/AIDS centers of provinces.

Chapter V

GUIDELINES FOR APPLICATION FOR ORT AND TRANSFER BETWEEN ORT FACILITIES

Article 18. Application for ORT

1. Any people wishing to receive ORT shall complete the form in Appendix 8 enclosed herewith; take legal responsibilities for the declaration and commitment in the form.

2. When the satisfactory application for ORT is received, the treatment facility shall provide the ORT for eligible patients according to the regulations in Clause 1 Article 7 of Decree No. 96/2012/NĐ-CP and.

3. The treatment facility shall send the decision on the admission of eligible patient according to the regulations in Point b Clause 2 Article 7 of Decree No. 96/2012/NĐ-CP to the People’s Committee of the commune where the applicant lives.

Article 19. Procedures for transfer between ORT facilities

1. Procedures for transfer of ORT patients:

a) The patient shall submit an application form for transfer of ORT facility (using the form in Appendix 9 enclosed with this Circular) to heads of the treatment facility from which he/she is receiving treatment.

b) Within 02 working days from the day on which the application form for transfer of ORT facility is received, heads of the treatment facility from which he/she is receiving treatment shall make a copy of the treatment dossier and a Note of transfer of ORT receiver (hereinafter referred to as Transfer note) using the form in Appendix 10 enclosed herewith;

c) Within 02 working days from the day on which the Transfer note and the treatment dossier is received, the new treatment facility shall accept and carry the treatment for the patient applying for transfer of ORT facility.

2. Procedures for change of ORT facility:

a) The patient shall submit an application form for transfer of ORT facility (using the form in Appendix 9 enclosed with this Circular) to heads of the treatment facility where he/she is receiving treatment from;

b) Within 04 working days from the day on which the application form for transfer of ORT facility is received, heads of the treatment facility from which he/she is receiving treatment shall make a copy of the treatment dossier and a Transfer note using the form in Appendix 10 enclosed herewith;

c) Within 02 working days from the day on which the Transfer note and the treatment dossier is received, the new treatment facility shall accept and carry the treatment for the patient applying for transfer of ORT facility.

Chapter VI

RESPONSIBILITIES

Article 20. Responsibilities of the Ministry of Health

1. Preside over, provide guidance, conduct inspections of the implementation of this Circular nationwide.

2. Cooperate with relevant units in formulating programs/materials for training in ORT; research, apply science and technology in ORT.

3. Cooperate with experts, apply new techniques and treating methods, conduct international cooperation in terms of ORT.

Article 21. Responsibilities of the Department of Health of provinces

1. Preside over, cooperate with the departments, specialized regulatory bodies and relevant units in formulating and requesting the People’s Committees of provinces to approve the plan on ORT in local areas according to the law provisions.

2. Preside over, provide guidance, conduct inspections of the implementation of this Circular in administrative divisions.

3. Manage the issuance of operating license to treatment facilities in local areas; public on website of Services of Health of provinces the information relating to the issuance/reissuance of operating licenses, the list of treatment facilities that are granted issuance/reissuance of operating licenses and facilities that incur the suspension/withdrawal of operating licenses.

4. Inspect and supervise the operation of treatment facilities within the competence; conduct inspections and handle the violations relating to the ORT activities in administrative division according to the law provisions.

5. Report the issuance/reissuance and withdrawal of operating licenses from treatment facilities according to the law provisions.

Article 22. Responsibilities of HIV/AIDS centers of provinces.

1. Give advice to Departments of Health of provinces on master plan on ORT in local areas.

2. Provide guidance and technical assistance to the ORT activities of treatment facilities in the administrative division according to the law provisions.

3. Participate in the inspection and supervision of the operation of treatment facilities within the competence.

Article 23. Responsibilities of treatment facilities

1. Provide ORT according to the specialist guidelines regulated by the Ministry of Health.

2. Ensure the satisfaction of infrastructure, equipment and staff with the work and the quantity of patients at the facilities.

3. Monthly report to the authority body the list of patients receiving treatment, the treatment activities and the compliance of the patients with the treatment according to the regulations.

4. Facilitate the inspection and supervision of Services of Health of provinces and HIV/AIDS centers of provinces.

Chapter VII

IMPLEMENTARY CLAUSE

Article 24. Terms of reference

If a document mentioned in this Circular is replaced or amended, the new one shall prevail.

Article 25. Effect

1. This Circular comes into effect from August 01, 2015.

2. The Circular No. 12/2013/TT-BYT dated December 4, 2013 by the Minister of Health providing guidance on the implementation of a number of articles of the Decree No. 96/2012/NĐ-CP dated November 15, 2012 by the Government providing for opioid replacement therapy is annulled by the effect of this Circular.

Article 26. Responsibilities

Chiefs of the Ministerial offices, Directors of Departments of HIV/AIDS prevention and fighting, Heads of Departments, Director General affiliated to the Ministry of Health, Heads of agencies and units affiliated to the Ministry, Director of Services of Health of provinces and Heads of medical agencies affiliated to the Ministries and specialized regulatory bodies shall be responsible for implementing this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (the Department of HIV/AIDS prevention and fighting) for consideration and solution./.