Thông tư 41/2015/TT-BYT sửa đổi Thông tư 41/2011/TT-BYT hướng dẫn cấp chứng chỉ hành nghề đối với người hành nghề và cấp giấy phép hoạt động đối với cơ sở khám bệnh, chữa bệnh do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

AMENDMENTS AND SUPPLEMENTATION TO A NUMBER OF ARTICLES OF THE CIRCULAR NO. 41/2011/TT-BYT OF THE MINISTRY OF HEALTH GUIDING THE GRANT OF PRACTICING CERTIFICATE TO MEDICAL EXAMINATION AND TREATMENT PRACTITIONERS AND OPERATION LICENSES TO MEDICAL EXAMINATION AND TREATMENT FACILITIES DATED NOVEMBER 14, 2011 OF THE MINISTER OF HEALTH

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

Pursuant to the Decree No. 87/2011/ND-CP detailing and guiding the implementation of some of articles of the Law on Medical Examination and Treatment dated September 27, 2011;

Pursuant to the Decree No. 63/2012/ND-CP on functions, responsibilities, power and the structural organization of the Ministry of Health;

At the request of the Director of the Department of Medical Service Administration,

The Minister of Health issues this Circular on amendments and supplementation to a number of articles of the Circular No. 41/2011/TT- BYT guiding the grant of practicing certificate to medical examination and treatment practitioners and operation licenses to medical examination and treatment facilities dated November 14, 2011 of the Minister of Health.

Article 1. Amendments and supplementation to a number of articles of the Circular No. 41/2011/TT-BYT

1. Clause 1 of Article 1 is amended as follows:

“1. Grant and re-grant of practicing certificates and adjustments to scope of practicing on the practicing certificate of the medical examination and treatment practitioners (hereinafter referred to as the practitioner):

a) Applications and procedures for grant and re-grant of practicing certificates and adjustments to scope of practicing on the practicing certificate (hereinafter referred to as the practicing certificate):

b) Certification of the practice period;

c) Criteria for accreditation of proficiency in Vietnamese or good command of another language or qualifications for interpreting in medical examination and treatment;

d) Application for practice of medical examination and treatment;

dd) Grant and re-grant of practicing certificates and adjustments to scope of practicing on the practicing certificate.”

2. Article 2 is amended as follows:

“Article 2. Regulated entities

1. This Circular applies to practitioners and medical examination and treatment facilities (hereinafter referred to as the medical facilities) nationwide, except those regulated in clause 2 of this Article.

2. Medical civil-military facilities and practitioners thereof, and practitioners and medical facilities under the administration of the Ministry of National Defense shall follow regulations of the Minister of National Defense.”

3. Article 3 is amended as follows:

“Article 3. Interpretation of terms

1. Medical examination and treatment period required for obtaining the practicing certificate means a period during which a person applying for a practicing certificate directly and continuously administers medical treatment and examination after receiving his/her professional qualifications (from the time of signing the employment contract or obtaining the decision on recruitment including the probation period stated in the employment contract or signing the agreement on practice period with a medical facility ) to the date of application for the practicing certificate including the period of specialty training or postgraduate courses ( resident physicians, medical specialists 1 and medical specialists 2) in specialties that he/she applies for the practicing certificate.

2. Medical examination and treatment period required for being appointed as a person in charge of technical expertise or head of a professional division (hereinafter referred to as the division) means a period during which he/she directly administers medical treatment and examination after receiving his/her professional degree (from the time of signing the employment contract or obtaining the decision on recruitment) to the date of appointment as the person in charge of technical expertise or head of the division, including the period of specialty training or postgraduate courses (resident physicians, medical specialists 1 and medical specialists 2) in specialties that he/she takes charge of).

3. Working time: the practitioner is entitled to make a choice between full-time and part-time job but his/her working time must comply with legislation on labor.

a) A full-time practitioner means the one who continuously works at least 8 hours/day during the working time registered by his/her medical facility, or the one who works during the whole medical facility’s working time if it is less than 8 hours/day. For example:

- If the working time of a medical facility is 24 hours/day and 07 days/week, its full-time practitioner shall continuously works at least 8 hours/day in accordance with legislation on labor.

- If the registered working time of a medical facility is from 09h00 - 16h00 and 07 days/week, its full-time practitioner shall works during the whole length of time mentioned above in accordance with legislation on labor.

b) A part-time practitioner means the one who works part of the whole working time of his/her medical facility and his/her working time is less than that regulated in point a of this clause.

4. Clause 2 and 3 of Article 4 are amended as follows:

“ 2. Besides the Law on Medical Examination and Treatment, Decree No. 87/2011/ND-CP and this Circular , practitioners and facilities shall follow laws on pharmaceuticals, trade, businesses , investment, advertising, environmental protection, radiation safety, fire protection and other relevant legal normative documents.

3. The collection and use of charge for grant, re-grant of the practicing certificate, and adjustment to the scope of practicing on the practicing certificate; grant, re-grant of the practicing certificate and adjustment to the scope of practicing on the operation license of facilities; grant of certificate of proficiency in Vietnamese or another languages or qualifications for interpreting in medical examination and treatment shall comply with regulations of the Minister of Finance.

5. Clause 1 of Article 5 is amended as follows:

“1. An application for a practicing certificate submitted by a Vietnamese applicant shall contain documents specified in clause, Article 27 of the Law on Medical Examination and Treatment. To be specific:

a) An application for a practicing certificate using form 01 in the Annex 01 hereof and 02 color photos with a white backdrop, 04 x 06 cm, taken within 06 months to the date of application;

b) A certified true copy of proper medical degrees corresponding to the scope of practicing covered by the practicing certificate that he/she applies. It is specified as follows:

- A medical degree.

- Degrees or certificates of professional qualifications ( for traditional medicine practitioners) or certificates of family remedies or family medicine granted by the Minister of Health or Director of the Department of Health of the province;

- Technician qualification: at least an associate degrees in medical technique; any bachelor of science in chemistry, biology and pharmacy graduating before the day on which this Circular takes effect must obtains a certificate of testing technique or certificate of completion of a testing technique course whose duration is at least 03 months and provided by training facilities that are granted training codes and have their training course evaluated under regulations of the Circular No. 22/2013/TT-BYT guiding on continuous training in health sector; any certificate obtained before the day on which the Circular No. 22/2013/TT-BYT takes effect shall be granted under the permission of the State competent authority.

- Doctor-level qualifications in preventive medicine;

- Bachelors of medicine from overseas universities including: bachelors of clinical medicine, surgery and internal medicine, general medicine, traditional medicine, oral and maxillofacial surgery and dentists must obtain the following degrees and certificates:

+ For those who graduated before February 01, 2012: a bachelor’s degree in medicine if the country that grants such degree is a signatory to the mutual recognition agreement signed with Vietnam or a bachelor’s degree in medicine and a certificate granted by the Department of Testing- Ministry of Training and Education if the country that grants such degree is not a signatory to mutual recognition agreement; degree(s) or certificate(s) of medicine of enhancement courses in respective majors or specialties in an accumulative period of at least 12 months educated by universities of medicine and pharmacy or central general or specialized hospitals of Vietnam.

+ For those who graduate after February 01, 2012: a bachelor’s degree in medicine if the country that grants such degree is a signatory to the mutual recognition agreement signed with Vietnam or a bachelor’s degree in medicine and a certificate granted by the Department of Testing- Ministry of Training and Education if the country that grants such degree is not a signatory to the mutual recognition agreement; certificates of completion of enhancement courses in respective majors or specialties in a period of at least 12 months educated by universities of medicine and pharmacy that are granted major codes corresponding to every major under the guidance of the Minister of Health.

- In case of loss of a degree, the applicant must present the certificate of graduation or a certified true copy of such degree granted by the training institution;

c) One of the following certificates of practice period:

- A Certificate of practice period under Article 18 hereof, certificate of completion of residency program, medical specialist I, medical specialist II and Certificate of completion of a specialty orientation course with the total convertible time of practice period equal to that in regulations in Article 24 of the Law on Medical Examination and Treatment;

In case the time of the specialty orientation course is less than that regulated in Article 24 of the Law on Medical Examination and Treatment, the applicant shall provide a certificate of practice period that meets the length of time regulated in Article 24 of the Law on Medical Examination and Treatment.

d) A Certificate of Health granted by the Minister of Health;

d) A criminal record;

e) A Curriculum vitae certified by the People’s Committee of the commune where the practitioner located. With respect to every practitioner working for medical facilities, their CV must be certified by their head of the medical facility. CVs are made using form 04 –Annex 01 enclosed with this Circular. A CV is valid within 06 months from the day on which this CV is made to the time of application for the practicing certificate.

6. Clause 4 is added to Articles 5 as follows:

“4. Applications for adjustments to the scope of practicing on the practicing certificate:

a) Documents requested in an application for expansion of the scope of practicing on the practicing certificate:

- An application form for expansion of the scope of practicing on the practicing certificate using form 03 – Annex 01 of this Circular:

- A certified true copy of professional qualifications appropriate for the expansion;

- A Certificate of practice period under point c, clause 1 of this Article;

b) Documents requested in an application for changes in the scope of practicing on the practicing certificate under point b, c, Article and e, clause 1, Article 5 hereof and:

- An application form for changes in the scope of practicing using form 03 a –Annex 02 enclosed with this Circular;

- 02 color photos with a white backdrop, 04 x 06 cm, valid within 06 months from the day on which such photos are taken to the date of application;

7. Point g is added to clause 1 of Article 6 as follows:

“g) A certificate of satisfactory health granted by a qualified medical facility prescribed by the Minister of Health;

8. Clause 4 and 5 are added to Article 6:

“4. An application for adjustments to the scope of practicing on the practicing certificate:

a) Documents requested in an application for expansion of the scope of practicing on the practicing certificate:

- An application form for supplementation to the scope of practicing using form 04 enclosed with this Circular;

- A certified true copy of professional qualifications appropriate for the expansion;

- A certificate of practice period in a respective field and the duration of the practice period satisfying Article 24 of the Law on Medical Examination and Treatment;

b) Documents requested in an application for changes in the scope of practicing under point b, c, Article and e, clause 1, Article 5 hereof, and:

- An application form for changes in the the scope of practicing;

- 02 color photos with a white backdrop, 04 x 06 cm, valid within 06 months from the day on which such photos are taken to the date of submission;

5. Certified true copies of documents requested in the application for grant, re-grant or adjustments to the scope of practicing on the practicing certificate may be presented in the following manners:

The certified true copies;

b) Copies enclosed with their original for comparison and the copies will be signed by the recipient (if the application is submitted directly).”

9. Article 7 is amended as follows:

“Article 7. Procedures for grant and re-grant of a practicing certificate and adjustments to the scope of practicing on the practicing certificate

1. The application for grant and re-grant of a practicing certificate and adjustments to the scope of practicing on the practicing certificate under Article 5 and Article 6 hereof shall be conducted as follows:

 a) The applicant for grant and re-grant of the practicing certificate and adjustments to the scope of practicing on his/her practicing certificate is regulated in clause 1, articles 26 of the Law on Medical Examination and Treatment shall submit 01 application to the Department of Medical Service Administration –Ministry of Health; the applicant that is a traditional medicine practitioner shall send 01 application to the Department of Traditional Medical Administration of Vietnam;

- If a practitioner who has been granted the practicing certificate by the Ministry of Health works for a medical facility under the administration of the Department of Health at the time of application for changes in the the scope of practicing, he/she shall submit the application to the Department of Health.

- If a practitioner who has been granted the practicing certificate by the Department of Health works for a medical facility under the administration of the Ministry of Health or another Department of Health at the time of application for changes in the scope of practicing, he/she shall submit the application to the the Ministry of Health or the supervisory Department of Health.

- If the applicant applying for grant and re-grant of the practicing certificate and adjustments to the scope of practicing on his/her practicing certificate does not work for any medical facility , he/she shall submit the application to the Department of Health located in his permanent province.

b) The applicant applying for grant and re-grant of the practicing certificate and adjustments to the scope of practicing on his/her practicing certificate in clause 1, articles 26 of the Law on Medical Examination and Treatment shall submit 01 application to the Department of Health of the province:

2. The procedures for grant and re-grant of practicing certificates and adjustments to scope of practicing on the practicing certificate:

a) After receipt of the application for grant and re-grant of a practicing certificate and adjustments to scope of practicing on the practicing certificate, the Department of Health of the province (hereinafter referred to as the application-receiving agency) shall send the applicant an application receipt using Annex 03 hereof;

b) The Secretariat in Article 9 hereof shall examine and evaluate such application within the time limit specified in clause 2 and 3, Article 28 of the Law on Medical Examination and Treatment. In case of a complete and valid application, the Secretariat shall submit it to the Director of application receiving agency to grant and re-grant a practicing certificate or approve for adjustments to scope of practicing on the practicing certificate; if the application is rejected, the application-receiving agency shall send the applicant a written notice on which reasons for rejection shall be specified;

In case of an incomplete or invalid application, within 10 working days from the date stated on the application receipt, the application-receiving agency shall send the applicant a written request for completion of the application in which the name of documents requested or items needing modifying shall be specified.

c) After receipt of such request, the applicant shall modify and/or complete his/her application according to the written request and submit it to the application-receiving agency. The date of receipt of the supplement application shall be specified on the application receipt. If there is no request for modification or supplementation, the application-receiving agency shall grant or re-grant or approve the adjustments to the scope of practicing on the practicing certificate within a time limit stipulated in point b of this clause;

d) In the event that the applicant has modified his/her application but such modification does not match the request of the application-receiving agency, this agency shall send the applicant a written request for re-modification until the application is complete and valid as stipulated in point c and d, clause 2 of this Article.

3. The decision on grant, re-grant or changes in the scope of practicing on the practicing certificate issued by the Minister of Health or Director of Department of Health using the form in Annex 4a and the code in Annex 05 hereof; one individual is granted only one practicing certificate. Blank practicing certificates are managed and granted by the Ministry of Health.

4. A duplicate of the practicing certificate, decision on re-grant of practicing certificate or approval for changes in scope of practicing and application for grant and re-grant of a practicing certificate or adjustments to scope of practicing on the practicing certificate shall be stored at the authority competent to grant practicing certificates.”

10. Article 7a is added to Article 7 as follows:

“Article 7a. The scope of practicing on the practicing certificate:

1. The scope of practicing stated on the practicing certificate according to its specialty group shall be specified in Annex 4b of this Circular.

2. The person in charge of technical expertise of the medical facility shall consider permitting a practitioner to perform his/her expertise at the medical facility based on the scope of practicing on practitioner’s practicing certificate, degree, certificate and capacity.

11. Clause 9 is added to Article 11 as follows:

“9. In case the person in charge of technical expertise of a medical facility is absent from his/her medical facility due to illness, on leave, on classes or other reasons, he/she must comply with the following procedures:

a) If the absence is 3 days or shorter, he/she shall make a power of attorney giving permission to another practitioner at his/her medical facility whose scope of practicing matches at least one of the specialties of the medical facility and the practice duration is at least 54 months.

b) If the absence is longer than 03 days, he/she shall follow point a, clause 9 of this Article;

c) Where the absence of from 30 to 180 days, he/she shall submit an application for leave to the Department of Health and follow point a, clause 9 of this Article;

d) If the absence is longer than 180 days, the medical facility shall submit an application for replacement of the person taking charge of technical expertise.”

12. Clause 3a is added to clause 3 of Article 16:

 “3a. The one who has the power to certify the practice period of a practitioner working for a medical center (preventive medical centers, medical centers of districts or medical centers of ministries or departments), medical authority or organization shall be an official who has a long-term employment contract:

a) In case of a medical center, authority or organization having their own medical facility: the working time of a practitioner is certified by the head of such center, authority or organization, and and this practitioner shall have a decision on medical facility enclosed;

b) In case of a medical center, authority or organization having no medical facilities: the practice period of a practitioner shall be certified by the head of certifying agency and have an document about work assignment enclosed;

c) With regard to a practitioner having obtained practicing certificate and perform medical examination and treatment from January 01, 2012 up to now, he/she shall follow regulations in clause 1 , Article 24 of the Law on Medical Examination and Treatment.”

13. Clause 4 of Article 16 is amended as follows:

“4. The Minister of Health, Directors of Ministries , Departments or Director of Department of Health of the province shall cooperate with medical facilities under its administration to instruct practitioners to get their practice period certified.

14. Article 25a is added to Article 25:

“Article 25a. Healthcare consultancy and medical preventive clinics

1. Facilities:
Facilities shall satisfy all requirements in clause 1, Article 25 hereof;

2. Required medical equipment:

a) Adequate medical equipment that serves the purposes in the scope of practicing;

b) Anti-shock medicines and specialty adequate first aid kits;

c) Vaccination and biologicals (is any) shall be given in accordance with the Circular No. 12/2014/TT-BYT guiding the implementation of management and use of vaccination dated March 20, 2014 of the Minister of Health.

3. Personnel:

a) The one in charge of technical expertise of a healthcare consultancy and medical preventive clinic must be a general practitioner who gets a practicing certificate and his/her length of period of medical examination and treatment shall be at least 54 months;

b) In addition to the one in charge of technical expertise of a healthcare consultancy and medical preventive clinic, every practitioner in such clinic who performs medical examination and treatment must obtain a practicing certificate corresponding to his/her assigned expertise.

4. Scope of practicing:

a) Perform medical examination of infectious diseases, school-related diseases, nutrition-related disease, non-communicable diseases and others;

b) Broadcast propaganda about healthcare, nutrition, vaccine injection and disease threat control to raise awareness on community healthcare;

c) Provide commercial biologicals and vaccine injection services;

d) Provide community healthcare and functional rehabilitation;

e) Manage, provide consultancy services and preventive treatment for infectious diseases, nutrition-related diseases, digestive disorder- related diseases, non-communicable diseases (goiter, basedow, diabetes, hypertension, gum diseases, occupational diseases, etc.)

According the actual capacity of the practitioner, and medical facilities, medical equipment of the clinics, the Director of the Department of Health shall consider approving the list of specialties specified in the Circular No. 43/2013/TT-BYT dated December 11, 2013 of the Minister of Health.”

15. Point c and point dd , clause 4 of Article 29 are amended as follows:

“c) Contrast media (contrast agents) shall not be used, except medical imaging clinics having intensive care physicians and emergency rooms.”

“d) X-ray technicians (graduating from universities) are permitted to read and analyze images but not allowed to draw diagnostic conclusions.”

16. Clause 3 of Article 36 is amended as follows:

“3. Personnel:

a) The one who takes change of technical expertise shall:

- Be a physician or physician assistant having practicing certificate.

- Have been giving medical examination and treatment for at least 54 months.

b) The number of practitioners of a medical station of a commune shall be at least equal to that in Section IV of the Joint Circular No. 08/2007/TTLT-BYT-BNV dated June 05, 2007 of inter-Ministries: the Ministry of Health –Ministry of Home Affairs shall release guidance on the payroll of the state medical medical facility .

c) Any physician not obtaining the practicing certificate works for medical stations of communes located at extremely disadvantageous regions is allowed to administer medical examination, give prescription and treatment for common illness according to the document about work assignment of the Director of the medical Center of the province. The Director shall be responsible for his assignment.

17. Clause 7 is added to Article 39 as follows:

“7. Documents requested in an application for replacement of the person taking charge of technical expertise of a medical facility :

a) A written request for replacement;

b) A decision on dismissal of the person taking charge of technical expertise;

c) A decision of appointment as the person in charge of technical expertise of a medical facility ;

d) A certified true copy of the practicing certificate of the new person taking charge of technical expertise;

dd) An employment contract or a decision on recruitment of the new person taking charge of technical expertise;

e) A certificate of the practice period or documents about the period of his/her practice period as evidence

g) An original of the operation license of the medical facility”.

18. Annex 4a and 4b are added to the Annex 4 and Annexes 01, 03, 04, 13 and 14 of the Circular No. 41/2011/TT-BYT are amended, hereof.

Article 2. Entry into force

This Circular comes into effect from January 01, 2016.

Article 3. Implementation and implementation organization

1. Directors of Department of Medical Service Administration, Department of Traditional Medicine and Pharmacy shall execute this circular, within their functions and responsibilities.

2. Directors of Department of Medical Service Administration, Department of Traditional Medicine and Pharmacy, Legal Departments and chief inspector of the Ministry of Health shall cooperate with general departments, relevant departments and sub-departments to inspect the grant of practicing certificates and operation licenses, and the execution of medical examination and treatment and the observance of laws by medical examination and treatment facilities.

3. Directors of Departments of Health shall take charge of inspecting the grant of practicing certificates, operation licenses, medical examination and treatment and the observance of laws by medical examination and treatment facilities within their provinces.

Any issues or concerns arising during the implementation of this Circular shall be promptly reported to the Department of Health (Department of Medical Service Administration or Traditional Medicine Administration of Vietnam)./.

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