Circular No. 35/2013/TT-BYT on the recovery of practice certificates and operating licenses and the suspension of professional activities for medical practitioners and healthcare facilities

CIRCULAR

Regulations on Revoking Practice Certificates, Licenses for Operation, and Suspension of Professional Activities

of Practitioners and Medical Examination and Treatment Facilities

___________________________

 

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

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Department of Medical Examination and Treatment Management,

The Minister of Health issues this Circular to regulate the revocation of practice certificates, licenses for operation, and suspension of professional activities of practitioners and medical examination and treatment facilities.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates:

1. Procedures for revoking practice certificates and licenses for operation of medical examination and treatment (hereinafter referred to as license for operation).

2. Cases where a practitioner of medical examination and treatment (hereinafter referred to as practitioner) and medical examination and treatment facility may be suspended partially or entirely from professional activities.

3. Procedures and timeframes for suspending partially or entirely the professional activities of practitioners and medical examination and treatment facilities.

Article 2. Scope of Application

1. This Circular applies to:

a) Practitioners and medical examination and treatment facilities under the management authority of the Ministry of Health, Provincial Department of Health (hereinafter referred to as Provincial Department of Health).

c) Medical examination and treatment facilities nationwide (excluding those specified in Point c Clause 2 Article 2 hereof).

a) Violations by practitioners and medical examination and treatment facilities that result in the confiscation of their practice certificates or licenses for operation or suspension of their activities according to laws on administrative violations;

2. This Circular does not apply to:

b) Practitioners with practice certificates issued by the Ministry of National Defense practicing at medical examination and treatment facilities under the management authority of the Ministry of National Defense;

c) Medical examination and treatment facilities under the management authority of the Ministry of National Defense.

1. Partial suspension of professional activities of a practitioner means that the practitioner is not allowed to perform one or several technical procedures within the scope of professional activities recorded in their practice certificate.

Article 3. Explanation of Terms

2. Full suspension of professional activities of a practitioner means that the practitioner is not allowed to perform any technical procedure within the scope of professional activities recorded in their practice certificate.

3. Partial suspension of professional activities of a medical examination and treatment facility means that the facility is not allowed to perform one or several technical procedures within the scope of professional activities recorded in its license for operation or temporarily ceasing all professional activities of one or several departments of the facility.

4. Full suspension of professional activities of a medical examination and treatment facility means that the facility is not allowed to perform any medical examination and treatment activities within the scope of professional activities recorded in its license for operation.

PROCEDURES FOR REVOKING PRACTICE CERTIFICATES AND LICENSES FOR OPERATION OF MEDICAL EXAMINATION AND TREATMENT

Chapter II

Article 4. Procedures for revoking practice certificates

1. When one of the violations stipulated in Clause 1 Article 29 of the Law on Medical Examination and Treatment is discovered, the revocation procedures shall be carried out as follows:

a) The competent authority prescribed in Clause 1, Clause 2 Article 26 of the Law on Medical Examination and Treatment issues a decision to revoke the practice certificate according to the model prescribed in Appendix No. 1 of this Circular;

b) Within five working days from the date of receipt of the decision to revoke the practice certificate marked with the post office's acceptance stamp, the practitioner must submit the original practice certificate to the competent state agency that issued the decision to revoke.

If the decision-making agency is not the agency that issued the practice certificate to the practitioner, it must notify the competent state agency that issued the practice certificate to the practitioner.

c) The decision-making agency publishes information about the revocation of the practice certificate for medical examination and treatment on its official website or portal.

2. In cases of violation stipulated in point d Clause 1 Article 29 of the Law on Medical Examination and Treatment, before implementing the procedures prescribed in Clause 1 of this Article, there must be a conclusion by the specialized council prescribed in Articles 74 and 75 of the Law on Medical Examination and Treatment determining that the practitioner has made serious technical errors causing severe consequences to the health or life of patients.

3. The Minister of Health authorizes the Director of the Provincial Department of Health to revoke the practice certificate of practitioners holding a practice certificate issued by the Minister of Health or another Provincial Department of Health but practicing at a medical examination and treatment facility within the management area and notify the competent authority that issued the practice certificate to the practitioner.

3. The Minister of Health authorizes the Director of the Department of Health to revoke the practice certificate for cases where a practitioner holds a practice certificate issued by the Minister of Health or another provincial-level Department of Health, but engages in medical examination and treatment activities at medical examination and treatment facilities within the management area, and to notify the competent authority that issued the practice certificate to such practitioner.

Article 5. Procedures for Revoking the Operating License of Medical Examination and Treatment Facilities

1. When discovering any violation stipulated in Clause 1, Article 48 of the Law on Medical Examination and Treatment, the revocation procedures shall be carried out as follows:

a) The competent authority specified in Clause 1 and Clause 2, Article 45 of the Law on Medical Examination and Treatment issues a decision to revoke the operating license according to the model prescribed in Appendix 2 of this Circular;

b) Within five working days from the date of receiving the operating license revocation decision marked with the post office receipt, the medical examination and treatment facility must submit the original operating license to the competent state agency that issued the revocation decision;

c) The agency issuing the revocation decision shall publish information about the revocation of the medical examination and treatment operating license on its portal or website.

2. In cases of violation stipulated in Point b, Clause 1, Article 48 of the Law on Medical Examination and Treatment, before implementing the procedures stipulated in Clause 1 of this Article, there must be a conclusion by the Inspection Team of the competent authority determining that the medical examination and treatment facility does not meet the conditions as prescribed in Article 43 of the Law on Medical Examination and Treatment.

Chapter III

CASES OF PARTIAL OR COMPLETE SUSPENSION OF THE PROFESSIONAL ACTIVITIES OF PRACTITIONERS AND MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 6. Cases of partial or complete suspension of the professional activities of practitioners due to technical errors

1. A practitioner who violates any provision stipulated in Clause 1, Article 73 of the Law on Medical Examination and Treatment but has not caused serious consequences to the health or life of patients to the extent that their practice certificate must be revoked according to Point d, Clause 1, Article 29 of the Law on Medical Examination and Treatment shall be partially or completely suspended from professional activities.

2. The degree of technical error of the practitioner shall be determined by the Professional Council stipulated in Articles 74 and 75 of the Law on Medical Examination and Treatment and serves as the basis for the competent authority to decide on the partial or complete suspension of the professional activities of the practitioner.

Article 7. Cases of partial or complete suspension of the professional activities of medical examination and treatment facilities

1. A medical examination and treatment facility that has technical errors or fails to meet any of the conditions stipulated in Article 43 of the Law on Medical Examination and Treatment must have its professional activities partially or completely suspended.

2. The degree of technical error of the medical examination and treatment facility shall be determined by the Professional Council stipulated in Articles 74 and 75 of the Law on Medical Examination and Treatment and serves as the basis for the competent authority to decide on the partial or complete suspension of the professional activities of the medical examination and treatment facility.

3. A medical examination and treatment facility shall have its professional activities partially or completely suspended in the following cases:

a) Complete suspension of professional activities when it fails to meet all of the conditions regarding scale, infrastructure, or medical equipment or organizational and personnel structure as prescribed in Circular No. 41/2011/TT-BYT dated November 14, 2011, guiding the issuance of practice certificates for practitioners and operating licenses for medical examination and treatment facilities by the Minister of Health;

b) Partial suspension of professional activities when it fails to meet any of the conditions stipulated in Article 43 of the Law on Medical Examination and Treatment but does not fall under the cases specified in Point a of this Clause.

Chapter IV

PROCEDURES AND TIME LIMITS FOR PARTIAL OR COMPLETE SUSPENSION OF THE PROFESSIONAL ACTIVITIES OF PRACTITIONERS AND MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 8. Procedures for suspending part or all of the professional activities of practitioners

1. When discovering violations as stipulated in Article 6 of this Circular, the procedures for suspending part or all of the professional activities of practitioners shall be carried out as follows:

a) The Minister of Health authorizes the Director of the Department of Medical Examination and Treatment to issue a decision to suspend part of the professional activities of practitioners who are practicing at medical examination and treatment facilities under the Ministry of Health and other ministries and sectors, according to the model specified in Appendix 3 of this Circular;

b) The Minister of Health authorizes the Director of the Provincial Health Department to issue a decision to suspend part of the professional activities of practitioners who have been issued practice certificates by the Minister of Health or the Minister of National Defense or by the provincial health department but are conducting medical examination and treatment activities at medical examination and treatment facilities within their jurisdiction, except in cases provided for in Clause 3 of this Article, and notify in writing the competent authority that issued the practice certificate to such practitioners according to the model specified in Appendix 3 of this Circular;

c) In cases where the authority issuing the suspension decision is not the authority that issued the practice certificate to the practitioner, there must be a written notification to the competent state authority that issued the practice certificate to such practitioner;

d) The authority issuing the decision to suspend part or all of the professional activities of practitioners shall publish information about the suspension of the professional activities of such practitioners on its website or electronic portal.

2. Prior to implementing the procedures stipulated in Clause 1 of this Article, there must be a conclusion on the professional technical errors of the practitioner by the specialized council as prescribed in Articles 74 and 75 of the Law on Medical Examination and Treatment.

Article 9. Procedures for suspending part or all of the professional activities of medical examination and treatment facilities

1. When discovering violations as stipulated in Article 7 of this Circular, the procedures for suspending part or all of the professional activities of medical examination and treatment facilities shall be carried out as follows:

a) The Minister of Health authorizes the Director of the Department of Medical Examination and Treatment to issue a decision to suspend part of the professional activities of medical examination and treatment facilities under the Ministry of Health or other ministries and sectors, according to the model specified in Appendix 4 of this Circular;

b) The Provincial Health Department issues a decision to suspend the professional activities of medical examination and treatment facilities according to the model specified in Appendix 4 of this Circular;

c) In cases where the authority issuing the suspension decision is not the authority that issued the operating permit to the medical examination and treatment facility, there must be a written notification to the competent state authority that issued the operating permit to such medical examination and treatment facility;

d) The authority issuing the suspension decision shall publish information about the suspension of the professional activities of the medical examination and treatment facility on its website or electronic portal.

2. Prior to implementing the procedures stipulated in Clause 1 of this Article, there must be a conclusion by the specialized council as prescribed in Articles 74 and 75 of the Law on Medical Examination and Treatment or a report from the inspection team of the competent authority determining that the medical examination and treatment facility does not meet the conditions as prescribed in Article 43 of the Law on Medical Examination and Treatment.

Article 10. Duration of suspension of part or all of the professional activities of practitioners and medical facilities

1. Duration of suspension of part or all of the professional activities of practitioners:

a) The duration of suspension of professional activities shall be recorded in the decision to suspend the professional activities of the practitioner based on the nature, severity of the violation, and the practitioner's ability to rectify the situation, but not exceeding 24 months at maximum.

b) In cases where the practitioner is suspended for less than 24 months: if the practitioner has not corrected the professional errors within the suspension period, the competent state authority may consider extending the suspension period for part or all of the professional activities of the practitioner, with the total suspension period and extension period not exceeding 24 months, or may consider revoking the professional certificate according to the procedures stipulated in Article 4 of this Circular.

c) In cases where the practitioner is suspended for 24 months: if the practitioner fails to correct the professional technical errors within the 24-month suspension period, the professional certificate must be revoked according to the procedures stipulated in Article 4 of this Circular for practitioners who have been suspended from all professional activities; for practitioners suspended from part of their professional activities, they must apply for reissue of the professional certificate to change the scope of professional activities.

2. Duration of suspension of part or all of the professional activities of medical facilities:

a) The duration of suspension of professional activities shall be recorded in the decision to suspend the professional activities of the medical facility based on the nature, severity of the violation, and the medical facility's ability to rectify the situation, but not exceeding 12 months at maximum.

b) In cases where the medical facility is suspended for less than 12 months:

If the medical facility has not corrected the professional errors within the suspension period, the competent state authority may consider extending the suspension period for part or all of the professional activities of the medical facility, with the total suspension period and extension period not exceeding 12 months, or may consider revoking the operating license according to the procedures stipulated in Article 5 of this Circular.

c) In cases where the medical facility is suspended for 12 months:

If the medical facility fails to correct the professional technical errors within the 12-month suspension period, the operating license must be revoked according to the procedures stipulated in Article 5 of this Circular for medical facilities suspended from all professional activities; for medical facilities suspended from part of their professional activities, they must apply for reissue of the operating license to change the scope of professional activities.

Article 11. Procedures for allowing practitioners to continue practicing medical activities after being suspended from professional activities

1. The application dossier for allowing practitioners to continue professional activities includes:

a) A request form for continuing to practice medical activities according to the model prescribed in Appendix 5 attached to this Circular;

b) A certified copy of the professional certificate;

c) A report on the rectification of professional technical errors by the practitioner;

d) A certificate of continuous medical knowledge update related to the professional technical errors of the practitioner during the suspension period;

đ) A certified copy of the work permit issued by the competent state authority on labor affairs in Vietnam for foreign practitioners or Vietnamese residing abroad;

2. Procedures for allowing practitioners to continue practicing medical activities:

a) The practitioner submits one set of the dossier prescribed in Clause 1 of this Article to the competent state authority that issued the decision to suspend the professional activities;

b) Upon receipt of the dossier, the competent state authority sends the practitioner a Receipt Form for Dossier according to the model prescribed in Appendix 6 attached to this Circular;

c) Within 10 days from the date recorded on the Receipt Form for Dossier, the competent state authority must review the dossier. If the dossier is incomplete, the dossier receiving authority must notify the practitioner in writing to complete the dossier, specifying the required additional documents and necessary corrections. After receiving the completed dossier, the competent state authority sends the practitioner a Receipt Form for Supplementary Dossier according to the model prescribed in Appendix 6 attached to this Circular; if the dossier remains incomplete, the competent state authority continues to require the practitioner to supplement until the dossier is complete;

d) Within 20 days from the date recorded on the Receipt Form for Dossier of a valid dossier, the competent state authority must issue a decision allowing the practitioner to continue professional activities; if the practitioner is not allowed to continue professional activities, the authority must provide a written response stating the reasons;

đ) The authority issuing the decision to allow the practitioner to continue professional activities must publish information about the decision on its electronic portal or website and notify in writing the competent state authority that issued the professional certificate to the practitioner if the authority issuing the decision to allow the practitioner to continue professional activities is not the same authority that issued the professional certificate to the practitioner.

Article 12. Procedures for permitting healthcare facilities to continue medical examination and treatment activities after being suspended from specialized technical operations

1. The application dossier for permitting healthcare facilities to continue specialized operations includes:

a) A request form for continuing medical examination and treatment activities according to the model prescribed in Appendix 7 issued together with this Circular;

b) A report on the correction of errors in specialized technical operations or measures taken to ensure conditions stipulated in Article 43 of the Medical Examination and Treatment Law and related documents;

c) A certified copy of the operating license of the healthcare facility.

2. Procedures for permitting healthcare facilities to continue specialized operations:

a) The healthcare facility shall submit one set of the dossier prescribed in Clause 1 of this Article to the competent state agency that issued the decision to suspend specialized operations;

b) Upon receipt of the dossier, the competent state agency shall issue to the healthcare facility a receipt for the dossier in accordance with Appendix 8 issued together with this Circular;

c) Within ten days from the date recorded on the receipt for the dossier, the competent state agency must review the dossier. In case the dossier is not valid, the agency receiving the dossier must notify the healthcare facility in writing to complete the dossier, specifying the required supplementary documents and necessary amendments. After receiving the supplementary dossier, the competent state agency shall issue to the healthcare facility a receipt for the supplementary dossier in accordance with Appendix 8 issued together with this Circular; if the dossier remains invalid, the competent state agency will continue to require the healthcare facility to supplement until the dossier is completed;

d) Within twenty days from the date recorded on the receipt for the valid dossier, the competent state agency must issue a decision permitting the healthcare facility to continue specialized operations; if it does not permit continuation of specialized operations, it must provide a written response stating the reasons;

If necessary, the agency receiving the dossier may establish a team to verify the correction of errors in specialized technical operations or measures taken to ensure the operational conditions of the healthcare facility.

e) The agency issuing the decision permitting the healthcare facility to continue specialized operations shall publish information about the permission on its website or electronic portal and notify in writing the competent state agency that issued the operating license to the healthcare facility, if the agency issuing the decision is not the same agency that issued the operating license.

Chapter V

RESPONSIBILITIES OF HEALTHCARE FACILITIES AND MEDICAL PRACTITIONERS

Article 13. Responsibilities of medical examination and treatment facilities

1. Immediately upon the effective date of the decision revoking the operating license, the healthcare facility must implement the following contents:

a) Not to carry out any form of medical examination and treatment activities;

b) Report to the direct management agency the number of patients, their condition, and plans and schemes for transferring patients to other healthcare facilities with sufficient conditions to continue their examination and treatment;

c) Be responsible for organizing and implementing schemes to ensure patient safety and transferring patients currently undergoing examination and treatment at their facility to other healthcare facilities with sufficient conditions to continue their examination and treatment;

d) Within five working days from the date of receipt of the decision revoking the license, the head or legal representative of the healthcare facility has the responsibility to return the original operating license to the competent authority that issued the decision revoking the license.

2. Immediately upon the effective date of the decision suspending specialized operations, the healthcare facility must implement the following contents:

a) Not to carry out medical examination and treatment activities as decided by the competent authority;

b) Report to the direct management agency the number of patients, their condition, schemes to ensure patient safety, and plans for transferring patients to other healthcare facilities with sufficient conditions to continue their examination and treatment;

c) Be responsible for organizing and implementing schemes to ensure patient safety or transferring patients currently undergoing examination and treatment at their facility to other healthcare facilities with sufficient conditions to continue their examination and treatment.

Article 14. Responsibilities of Practitioners

1. Upon the effective date of the decision to revoke the practice certificate, the practitioner must perform the following tasks:

a) Shall not engage in any form of medical examination and treatment activities;

b) In cases where, at the time of receiving the decision to revoke the practice certificate, the practitioner is caring for or treating patients, they shall have the responsibility to refer or transfer the patients to another healthcare facility that has the necessary conditions to continue their examination and treatment to ensure the safety of health and life of the patients;

c) Within five working days from the date of receipt of the decision to revoke the certificate, the practitioner shall be responsible for returning the original copy of the practice certificate to the competent authority that issued the revocation decision.

2. Upon the effective date of the decision to suspend professional activities, the practitioner must perform the following tasks:

a) Shall not engage in medical examination and treatment activities related to the scope of suspended professional activities according to the decision of the competent authority;

b) In cases where, at the time of receiving the decision to suspend professional activities, the practitioner is caring for or treating patients, they shall have the responsibility to refer or transfer the patients to another healthcare facility that has the necessary conditions to continue their examination and treatment to ensure the safety of health and life of the patients.

Chapter VI

IMPLEMENTING PROVISIONS

Article 15. Effective Date

This Circular takes effect from December 15, 2013.

Article 16. Reference Provisions

In cases where the referenced documents in this Circular are replaced or amended, implementation shall be carried out in accordance with the replaced or amended documents.

Article 17. Responsibility for Implementation

The Director of the Ministry's Office, the Inspector General of the Ministry, the Director of the Department of Medical Examination and Treatment Management, the Director of the Department of Traditional Medicine Management, the Heads of Departments, Directors of Bureaus, and General Directors of Bureaus and General Departments under the Ministry of Health, the Heads of subordinate agencies and units of the Ministry, the Provincial Health Department Directors of centrally governed cities and provinces, and the Heads of health agencies of other Ministries, sectors, and relevant organizations and individuals are responsible for implementing this Circular. During the implementation process, if there are difficulties or obstacles, the units and localities shall report to the Ministry of Health for study and resolution.

During the implementation process, if there are difficulties or obstacles, the units and localities shall report to the Ministry of Health for study and resolution./.