Circular No. 35/2013/TT-BYT dated October 30, 2013 of the Ministry of Health on revocation of practicing certificates, operating licenses and suspension of medical practitioners and medical facilities from practice

THE MINISTRY OF HEALTH

Circular No. 35/2013/TT-BYT dated October 30, 2013 of the Ministry of Health on revocation of practicing certificates, operating licenses and suspension of medical practitioners and medical facilities from practice

Pursuant to the Law on Medical examination and treatment dated November 23, 2009;

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

At the request of the Director of the Department of Medical Services,

The Minister of Health promulgates a Circular on revocation of practicing certificates, operating licenses, suspension of medical practitioners and medical facilities frompractice.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular deals with:

1. The procedure for revoking practicing certificates and licenses to provide medical examination and treatment (hereinafter referred to as operating license).

2. The cases in which part of or the entirepracticeof medical practitioners (hereinafter referred to as practitioner) and medical facilities is suspended.

3. The procedure and duration of suspension of part of or the entirepracticeof practitioners and medical facilities.

Article 2. Regulated entities

1. This Circular is applicable to:

a) The practitioners and medical facilities under the management of the Ministry of Health and Services of Health.

b) The practitioners whose practicing certificates are issued by the Ministry of National Defense but working at the medical facilities that are not under the management of the Ministry of National Defense;

c) The medical facilities nationwide (except for the medical facilities mentioned in Point c Clause 2 of this Article).

2. This Circular is not applicable to:

a) Violations committed by practitioners and medical facilities whose practicing certificates or operating licenses are revoked, or whosepracticeis suspended as prescribed by legislation on handling administrative violations;

b) The practitioners whose practicing certificates are issued by the Ministry of National Defense and working at the medical facilities under the management of the Ministry of National Defense;

c) The medical facilities under the management of the Ministry of National Defense.

Article 3. Interpretation of terms

1. Suspension of part of thepracticeof a practitioner means the practitioner being prohibited from performing one or some of the medical procedures written in his practicing certificate.

2. Suspension of the entirepracticeof a practitioner means the practitioner being prohibited from performing all of the medical procedures written in his practicing certificate.

3.Suspension of part of the practice of a medical facility means the medical facility being prohibited from performing one or some of the medical procedures written in its operating license or having the entire operation of one or some of its departments or wards suspended.

4. Suspension of the entirepracticeof a medical facility means the medical facility being prohibited from performing all of the medical procedures written in its operating license.

Chapter II

PROCEDURE FOR REVOKING PRACTICE CERTIFICATES AND OPERATING LICENSES

Article 4. Procedure for revoking the practicing certificate

1. When one of the violations mentioned in Clause 1 Article 29 of the Law on Medical examination and treatment is discovered, the procedure for revocation shall be carried out as follows:

a) The competent authority mentioned in Clause 1 and Clause 2 Article 26 of the Law on Medical examination and treatment shall issue a decision to revoke the practicing certificate under the form in Appendix No. 1 of this Circular;

b) Within 05 working days from the day on which the decision to revoke the practicing certificate is received (according to the date stamp of the post office), the practitioner shall submit the original practicing certificate to the agency that issues the decision.

If the agency that issues the decision on revocation (hereinafter referred to as revoking agency) is not the issuer of the practicing certificate, a written notification shall be sent to the issuer of the practicing certificate.

c) The revoking agency shall post the information about the revocation of the practicing certificate on its website.

2. If Point d Clause 1 Article 29 of the Law on Medical examination and treatment is violated, it is required to obtain a conclusion of the Medical Council prescribed in Article 74 and Article 75 of the Law on Medical examination and treatment that the practitioner commits medical errors that cause serious harm to the health and life of the patient before initiating the procedure mentioned in Clause 1 of this Article.

3. The Minister of Health shall delegate the Director of the Service of Health to revoke the practicing certificate if the practicing certificate is issued by the Ministry of Health or the Service of Health of another province, and notify the issuer of that practicing certificate.

Article 5. Procedure for revoking the operating license of a medical facility 

1. When one of the violations mentioned in Clause 1 Article 48 of the Law on Medical examination and treatment is discovered, the procedure for revocation shall be carried out as follows:

a) The competent authority mentioned in Clause 1 and Clause 2 Article 45 of the Law on Medical examination and treatment shall issue a decision to revoke the operating license under the form in Appendix No. 2 of this Circular;

b) Within 05 working days from the day on which the decision to revoke the operating license is received (according to the date stamp of the post office), the medical facility shall submit the original operating license to the agency that issues the decision on revocation;

c) The revoking agency shall post the information about the revocation of the operating license on its website.

2. If Point b Clause 1 Article 29 of the Law on Medical examination and treatment is violated, it is required to obtain a conclusion from the inspectorate that the medical facility does not meet the conditions prescribed in Article 43 of the Law on Medical examination and treatment before initiating the procedure mentioned in Clause 1 of this Article.

Chapter III

CASES IN WHICH PART OF OR THE ENTIRE MEDICAL PRACTICE OF THE PRACTITIONER OR MEDICAL FACILITY IS SUSPENDED

Article 6. Cases in which the practitioner is suspended from part of or the entirepracticedue to medical errors

1. The practitioner that violates one of the regulations in Clause 1 Article 73 of the Law on Medical examination and treatment without causing serious harm to the health and life of the patient, which lead to the revocation of the practicing certificate according to Point d Clause 1 Article 29 of the Law on Medical examination and treatment, shall has part of or the entirepracticesuspended.

2. The extent of medical errors committed by the practitioner shall be determined by the Medical Council prescribed in Article 74 and Article 75 of the Law on Medical examination and treatment and is the basis for the competent authority to decide to suspend part of or the entirepracticeof the practitioner.

Article 7. Cases in which part of or the entirepracticeof a medical facility is suspended

1. When a medical facility commits medical errors or fails to satisfy one of the conditions prescribed in Article 43 of the Law on Medical examination and treatment, part of or its entirepracticeshall be suspended.

2. The extent of medical errors committed by the medical facility shall be determined by the Medical Council prescribed in Article 74 and Article 75 of the Law on Medical examination and treatment and is the basis for the competent authority to decide to suspend part of or the entirepracticeof the medical facility.

3. The medical facilities shall have part of or the entirepracticesuspended in the cases below:

a) The entirepracticeshall be suspended when one of the conditions pertaining to the scale, infrastructure, equipment, personnel prescribed in the Circular No. 41/2011/TT-BYT dated November 14, 2011 of the Minister of Health is not satisfied.

b) Part of the condition shall be suspended when one of the conditions prescribed in Article 43 of the Law on Medical examination and treatment is not satisfied, except for the cases mentioned in Point a of this Clause.

Chapter IV

PROCEDURE AND DURATION OF SUSPENSION OF PART OF OR THE ENTIRE PRACTICE OF PRACTITIONERS AND MEDICAL FACILITIES

Article 8. Procedure for suspending part of or the entirepracticeof a practitioner

1. When a violation mentioned in Article 6 of this Circular is discovered, the procedure for suspending part of or the entire thepracticeof a practitioner shall be carried out as follows:

a) The Minister of Health shall delegate the Director of the Department of Medical Services to issue the decision to suspend part of thepracticeof the practitioner working at a medical facility under the management of the Ministry of Health and other Ministries under the form in Appendix 3 to this Circular;

b) The Minister of Health shall delegate the Director of the Service of Health to suspend part of thepracticeof the practitioner whose practicing certificate is issued by the Ministry of Health or the Minister of National Defense or a Service of Health of another province, except for the case mentioned in Clause 3 of this Article, and notify the issuer of that practicing certificate under the form in Appendix 3 to this Circular.

c) If the agency that issues the decision on suspension is not the issuer of the practicing certificate, a written notification shall be sent to the issuer of the practicing certificate.

d) The agency that decides the suspension of part of or the entirepracticeof the practitioner shall post the information about such suspension on its website.

2. Before initiating the procedure mentioned in Clause 1 of this Article, it is required to have a conclusion of the Medical Council that the practitioner commits medical errors as prescribed in Article 74 and Article 75 of the Law on Medical examination and treatment.

Article 9. Procedure for suspending part of or the entire operation of a medical facility

1. When a violation mentioned in Article 7 of this Circular is discovered, the procedure for suspending part of or the entirepracticeof a facility shall be carried out as follows:

a) The Minister of Health shall delegate the Director of the Department of Medical Services to issue the decision to suspend part of thepracticeof the medical facility under the management of the Ministry of Health and other Ministries under the form in Appendix 4 to this Circular;

b) The Service of Health shall issue the decision to suspend thepracticeof the medical facility under the form in Appendix 4 to this Circular;

c) If the agency that issues the decision on suspension is not the issuer of the operating license of the medical facility, a written notification shall be sent to the issuer of the operating license.

d) The agency that issues the decision on revocation shall post the information about the suspension of the medical facility on its website.

2. Before initiating the procedure mentioned in Clause 1 of this Article, it is required to obtain a conclusion from the Medical Council (according to Article 74 and Article 75 of the Law on Medical examination and treatment) or Inspectorate that the medical facility does not meet the conditions prescribed in Article 43 of the Law on Medical examination and treatment.

Article 10. Duration of the suspension of part of or the entirepracticeof the practitioner or medical facility

1. Duration of suspension of part of or the entirepracticeof a practitioner:

a) The duration ofpracticesuspension is written in the decision to suspend the practitioner frompractice, depends on the nature and seriousness of the violations, the capacity for rectification of the practitioner, and shall not exceed 24 months.

b) If the is suspended frompracticefor fewer than 24 months: if the practitioner fails to rectify the medical errors, the competent authority shall consider extending the suspension, but the total suspension duration shall not exceed 24 months, or consider revoking the practicing certificate in accordance with Article 4 of this Circular.

b) If the practitioner is suspended frompracticefor 24 months: if the practitioner fails to rectify the medical errors after 24 months, the practitioner shall has his practicing certificate revoked in accordance with Article 4 of this Circular if his entirepracticeis suspended, or must apply for the re-issuance of the practicing certificate to change the scope ofpracticeif part of hispracticeis suspended.

2. Duration of the suspension of part of or the entirepracticeof a medical facility:

a) The duration ofpracticesuspension is written in the decision to suspend the medical facility frompractice, depends on the nature and seriousness of the violations, the capacity for rectification of the medical facility, and shall not exceed 12 months.

b) If the medical facility is suspended frompracticefor fewer than 12 months:

If the medical facility fails to rectify the medical errors after this period, the competent authority shall consider extending the suspension of part of or the entirepracticeof the medical facility, but the total duration shall not exceed 12 months, or consider revoking the operating license in accordance with Article 5 of this Circular.

c) If the medical facility is suspended frompracticefor 12 months:

If the medical facility fails to rectify the medical errors after 12 months, it shall has its operating license revoked in accordance with Article 5 of this Circular if its entirepracticeis suspended, or must apply for re-issuance of the operating license to change the scope ofpracticeif part of itspracticeis suspended.

Article 11. Procedure for permitting a practitioner to return topracticeafter suspension

1. An application for permission for the practitioner to return topracticeconsists of:

a) A written request for permission to return topracticeunder the form in Appendix 5 to this Circular;

b) A certified true copy of the practicing certificate;

c) A report on rectification of medical errors made by the practitioner;

d) The certificate of update of continuous update of medical knowledge related to the medical errors during the suspension;

dd) An authenticated copy of the work permit issued to the foreign practitioner or the Vietnamese practitioner residing abroad by a Vietnam’s labor authority.

2. Procedure for permitting a practitioner to return topractice:

a) The practitioner shall send 01 application prescribed in Clause 1 of this Article to the agency that issued the decision on suspension frompractice;

b) After receiving the application, the agency shall send the practitioner a notice of application receipt according to Appendix 6 to this Circular;

c) The agency shall verify the application within 10 days from the date written on the notice of application receipt. If the application is not valid, the agency shall request the practitioner in writing to supplement it, specifying the necessary changes and additional documents. After the additional documents are received, the agency shall send the practitioner a notice of receipt of additional documents according to Appendix 6 to this Circular. The agency shall request the practitioner to supplement the application until it is complete;

d) Within 20 days from the date of receipt of the valid application written on the notice of application receipt, the agency shall issue a decision to permit the practitioner to return topractice. If the practitioner is not permitted to return topractice, a written explanation must be made.

dd) The agency that issues the decision to permits the practitioner to return topracticeshall post information about such permission on its website and send a written notification to the agency that issued the practicing certificate if the agency that issues the decision to permits the practitioner to return topracticeis not the issuer of the practicing certificate.

Article 12. Procedure for permitting a medical facility to return topracticeafter suspension

1. An application for permission for the medical facility to return topracticeconsists of:

a) A written request for permission to return topracticeunder the form in Appendix 7 to this Circular;

b) A report on the rectification of medical errors, measures taken for ensuring the fulfillment of conditions in Article 43 of the Law on Medical examination and treatment, and relevant documents;

c) A certified true copy of the operating license of the medical facility.

2. Procedure for permitting a medical facility to return topractice:

a) The medical facility shall send 01 application prescribed in Clause 1 of this Article to the agency that issued the decision on suspension frompractice;

b) After receiving the application, the agency shall send the medical facility a notice of application receipt according to Appendix 8 to this Circular;

c) The agency shall verify the application within 10 days from the date written on the notice of application receipt. If the application is not valid, the agency shall request the medical facility in writing to supplement it, specifying the necessary changes and additional documents. After the additional documents are received, the agency shall send the medical facility a notice of receipt of additional documents according to Appendix 8 to this Circular. The agency shall request the medical facility to supplement the application until it is complete;

d) Within 20 days from the date of receipt of the valid application written on the notice of application receipt, the agency shall issue a decision to permit the medical facility to return topractice. If the medical facility is not permitted to return topractice, a written explanation must be made.

The agency may establish a commission to assess the rectification of medical errors or the measures taken to ensure the sufficient conditions of the medical facility where necessary.

dd) The agency that issues the decision to permits the medical facility to return topracticeshall post information about such permission on its website and send a written notification to the agency that issued the operating license to the medical facility if the agency that issues the decision to permits the medical facility to return topracticeis not the issuer of the operating license.

Chapter V

RESPONSIBILITIES OF MEDICAL FACILITIES AND MEDICAL PRACTITIONERS

Article 13. Responsibilities of a medical facility

1. When the decision to revoke the operating license takes effect, the medical facility shall:

a) Stop the provision of medical examination and treatment in any shape or form;

b) Send a report to the superior agency of the quantity of patients, their condition, plans for moving patients to another capable medical facility for further examination and treatment;

c) Implement the plans for maintaining the health of the patients and moving the patients being examined and treated at the facility to another capable medical facility for further examination and treatment.

d) Within 05 working days from the day on which the decision to on revocation is received, the head or legal representative of the medical facility shall return the original operating license to the agency that issues the decision on revocation.

2. When the decision to suspend thepracticetakes effect, the medical facility shall:

a) Stop the provision of medical examination and treatment under the decision of the competent agency;

b) Send a report to the superior agency of the quantity of patients, their condition, plans for maintaining their health and moving patients to another capable medical facility for further medical examination and treatment;

c) Implement the plans for maintaining the health of the patients and moving the patients being examined and treated at the facility to another capable medical facility for further examination and treatment.

Article 14. Responsibilities of a practitioner

1. When the decision to revoke the practicing certificate takes effect, the practitioner shall:

a) Stop the provision of medical examination and treatment in any shape or form;

b) The patients being treated by the practitioner when the decision on revocation of the practicing certificate is received must be transferred to a capable medical facility to ensure their safety and health.

b) Within 05 working days from the day on which the decision to revoke the practicing certificate is received, the practitioner shall return the original practicing certificate to the agency that issues the decision on revocation.

2. When the decision to suspend thepracticetakes effect, the practitioner shall:

a) Stop the provision of suspended medical examination and treatment under the decision of the competent agency;

b) The patients being treated by the practitioner when the decision to suspend the practitioner frompracticeis received must be transferred to a capable medical facility to ensure their safety and health.

Chapter VI

IMPLEMENTATION

Article 15. Effect

This Circular takes effect on December 15, 2013.

Article 16. Terms of reference

Where the documents cited in this Circular are superseded or amended, the new or amended documents shall prevail.

Article 17. Responsibility for implementation

the Chief of the Ministry Office, the Chief Inspector of the Ministry, the Director of the Department of Medical Services, the Department of Traditional Medicines, Directors of Departments affiliated to the Ministry of Health, heads of units affiliated to the Ministry of Health, Directors of Services of Health, heads of medical agencies affiliated to other Ministries, relevant organizations and individuals are responsible for the implementation of this Circular.

Units and local governments shall report the difficulties during the implementation of this Circular to the Ministry of Health for consideration and settlement./.

The Minister

Nguyen Thi Kim Tien