Circular No. 30/2014/TT-BYT on humanitarian medical examination and treatment

CIRCULAR

Regulations on charitable medical examination and treatment

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Pursuant to the Law on Diagnosis and Treatment No. 40/2009/QH12 dated November 23, 2009;

Pursuant to the Law on Red Cross Activities No. 11/2008/QH12 dated June 12, 2008;

Pursuant to the Government Decree No. 03/2011/NĐ-CP dated January 7, 2011 detailing and guiding the implementation of the Law on Red Cross Activities;

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 on charitable medical examination and treatment.

1. This Circular stipulates the application of conditions regarding qualifications, certificates, and certificates of practice related to traditional medicine issued before the effective date of the Medicine Law No. 105/2016/QH13 (before January 1, 2017), in accordance with economic and social development needs and the demand for medical examination and treatment at each locality during different periods, the content and basis of specialized practice for obtaining a traditional medicine practitioner license.

Article 1. This Circular stipulates the conditions, authority, files, and procedures for permitting domestic and foreign organizations and individuals to conduct charitable medical examination and treatment in Vietnam.

2. This Circular does not apply to:

a) Charitable medical examination and treatment activities organized by the Ministry of National Defense;

b) Red Cross medical examination and treatment facilities participating in providing medical examination and treatment services to insured persons and conducting medical examination and treatment with payment for medical services.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Charitable medical examination and treatment is the activity of providing free medical examination, treatment, and drug distribution to patients.

2. Charitable medical examination and treatment team is a group of domestic and foreign healthcare personnel organized by domestic and foreign individuals or organizations to provide charitable medical examination and treatment to the public.

3. Mobile Red Cross medical examination and treatment team is a team established by the Vietnam Red Cross Society to provide charitable medical examination and treatment to people in areas with particularly difficult economic and social conditions, disaster-stricken areas, epidemic zones, and other areas when needed.

Article 3. Forms of organizing charitable medical examination and treatment activities

1. Charitable medical examination and treatment facilities may be organized in one of the following forms:

a) Hospitals including general hospitals, specialized hospitals, traditional medicine hospitals;

b) Outpatient clinics including general outpatient clinics, specialized outpatient clinics, traditional medicine outpatient clinics;

c) Maternity homes;

d) Diagnostic imaging clinics, laboratories;

e) Healthcare service facilities including injection (inoculation), bandage change, pulse counting, temperature measurement, blood pressure measurement, home health care services, emergency services, patient transportation support services.

2. Domestic charitable medical examination and treatment teams.

3. Foreign charitable medical examination and treatment teams.

4. Mobile Red Cross medical examination and treatment teams.

5. Domestic or foreign individuals providing charitable medical examination and treatment.

Article 4. Conditions for issuing permits for charitable medical examination and treatment facilities

1. Charitable medical examination and treatment facilities specified in Clause 1, Article 3 of this Circular must meet the requirements regarding scale, physical infrastructure, human resources organization, and medical equipment corresponding to the organizational form prescribed in Section 1, Chapter III of Circular No. 41/2011/TT-BYT dated November 14, 2011 of the Minister of Health guiding the issuance of practice certificates for practitioners and operation permits for medical examination and treatment facilities (hereinafter referred to as Circular No. 41/2011/TT-BYT) issued by the Ministry of Health or the People's Committee Health Departments of centrally-administered cities and provinces (hereinafter referred to as Health Departments).

2. The signboard of the medical examination and treatment facility must clearly indicate that it is a charitable medical examination and treatment facility.

3. There must be documentation proving a stable financial source to ensure the operation of charitable medical examination and treatment activities.

Article 5. Conditions for permitting activities for domestic medical examination and treatment humanitarian teams (hereinafter referred to as domestic medical humanitarian teams) (hereinafter referred to as the domestic humanitarian medical examination and treatment team)

1. Physical conditions:

a) In cases where domestic medical humanitarian teams conduct medical examinations and treatments at medical examination and treatment facilities, such facilities must have an operating permit in accordance with the Law on Medical Examination and Treatment;

b) In cases where domestic medical humanitarian teams conduct medical examinations and treatments at other locations, these locations must meet the following conditions:

- Having reception areas, specialized outpatient rooms, minor surgery rooms (if minor surgeries are performed), emergency rooms - observation wards;

- Meeting the conditions for infection control, radiation safety, medical waste management, fire prevention and fighting as prescribed by law;

- Ensuring sufficient electricity, water, and other conditions necessary for humanitarian medical examinations and treatments.

2. Personnel conditions:

a) The person responsible for technical and professional matters of the domestic medical humanitarian team must meet one of the following conditions:

- Being a doctor with a practice certificate for medical examination and treatment issued by the Ministry of Health or the People's Committee of a province/city according to the Law on Medical Examination and Treatment (hereinafter referred to as the practice certificate) with the scope of professional activities stated in the practice certificate matching the registered technical specialties of the team and having at least 36 months of experience practicing medical examinations and treatments;

- Being a traditional medicine practitioner or a person with a family prescription or a family treatment method who has a practice certificate issued by the Ministry of Health or the People's Committee of a province/city according to the law if conducting medical examinations and treatments using traditional medicine.

b) Other members of the team directly involved in medical examinations and treatments must have a practice certificate. In cases where direct participants in medical examinations and treatments are not required to have a practice certificate under the Law on Medical Examination and Treatment, they must hold appropriate academic degrees or certificates corresponding to their assigned professional scope;

c) If there is dispensing of medication, the dispenser must have a minimum qualification of pharmacy assistant or a doctor with a practice certificate.

3. Conditions regarding medical equipment and drugs:

a) Having adequate medical equipment, anti-shock kits, emergency medications, and disease-treatment drugs suitable for the registered scope of humanitarian medical examinations and treatments;

b) Medical equipment must have clear origins and drugs used for humanitarian medical examinations and treatments must be within the list permitted for circulation in Vietnam and still within their expiration dates.

4. Scope of Technical Activities:

a) Strictly adhering to regulations on professional techniques and the scope of professional activities allowed by the Ministry of Health or the People's Committee of a province/city or relevant ministries and sectors;

b) If performing surgeries at mobile medical examination and treatment facilities such as aircraft, ships, trains, automobiles, or other specialized mobile means, a professional support agreement must be made with local medical examination and treatment facilities to ensure patient health and safety.

5. If domestic medical humanitarian teams conduct medical examinations and treatments at medical examination and treatment facilities, they must obtain written consent from those facilities.

6. If domestic medical humanitarian teams conduct medical examinations and treatments at locations outside medical examination and treatment facilities, they must obtain written consent from the People's Committee of the commune, ward, or town where the humanitarian medical examinations and treatments are conducted.

Article 6. Conditions for Permitting the Operation of Foreign Medical Aid Missions

Foreign medical aid missions, when conducting medical aid activities, must meet the conditions stipulated in Clause 1, Point c Clause 2 and Clauses 3, 4, 5, and 6 of Article 5 of this Circular, in addition to the following conditions:

1. The person responsible for technical and professional matters must satisfy one of the following conditions:

a) Being a physician with a practice certificate issued by the Ministry of Health or the Department of Health in accordance with the laws on medical examination and treatment, or having a practice certificate for medical examination and treatment recognized by the Government of Vietnam under Article 22 of the Law on Medical Examination and Treatment; being proficient in Vietnamese or registering the language to be used during medical examinations and treatments and complying with the provisions of Article 23 of the Law on Medical Examination and Treatment;

b) Being a traditional doctor or a person with a family herbal prescription or a person with a family healing method who has a practice certificate issued by the Ministry of Health or the Department of Health in accordance with the laws on medical examination and treatment, or having a practice certificate for medical examination and treatment recognized by the Government of Vietnam under Article 22 of the Law on Medical Examination and Treatment if conducting medical aid using traditional medicine; being proficient in Vietnamese or registering the language to be used during medical examinations and treatments and complying with the provisions of Article 23 of the Law on Medical Examination and Treatment.

2. Other members of the mission directly involved in medical examinations and treatments must have a practice certificate. If members of the mission are foreigners or overseas Vietnamese residents, they must have a practice certificate for medical examination and treatment issued by the Ministry of Health or a practice certificate for medical examination and treatment recognized by the Government of Vietnam under Article 22 of the Law on Medical Examination and Treatment; being proficient in Vietnamese or registering the language to be used during medical examinations and treatments and complying with the provisions of Article 23 of the Law on Medical Examination and Treatment.

Article 7. Conditions for Permitting Domestic and Foreign Individuals to Conduct Medical Aid Activities

1. Physical conditions:

a) Complying with the provisions of Point a Clause 1 of Article 5 of this Circular;

b) In cases where domestic and foreign individuals conduct medical aid activities at locations other than healthcare facilities, the location where such activities take place must meet the following conditions:

- Having a reception area for patients, specialized consultation rooms, or injection and dressing rooms for injection and dressing services;

- Meeting the conditions for infection control, radiation safety, medical waste management, fire prevention and fighting as prescribed by law;

- Ensuring adequate electricity, water, and other conditions necessary for conducting medical aid activities.

2. Personnel conditions:

Domestic and foreign individuals conducting medical aid activities must have a practice certificate for medical examination and treatment issued by the Ministry of Health or the Department of Health or a practice certificate for medical examination and treatment recognized by the Government of Vietnam under Article 22 of the Law on Medical Examination and Treatment; being proficient in Vietnamese or registering the language to be used during medical examinations and treatments and complying with the provisions of Article 23 of the Law on Medical Examination and Treatment.

3. Conditions regarding medical equipment and drugs:

a) Having sufficient medical equipment, anti-shock kits, emergency medications, and appropriate medications for the scope of professional activities registered for medical aid by domestic and foreign individuals;

b) Medical equipment must have clear origins and drugs used for humanitarian medical examinations and treatments must be within the list permitted for circulation in Vietnam and still within their expiration dates.

4. Scope of Technical Activities:

Conducting medical examinations and treatments within the scope of professional activities specified in the issued practice certificate and consistent with the list of professional technical skills approved by competent state authorities for medical aid.

5. If domestic and foreign individuals conduct medical aid activities at healthcare facilities, they must obtain written consent from those healthcare facilities.

6. If domestic and foreign individuals conduct medical aid activities at locations other than healthcare facilities, they must obtain written consent from the People's Committee of the commune, ward, or town where the medical aid activities are conducted.

Article 8. Competence to Issue Licenses or Approve Medical Examination and Treatment Activities for Humanitarian Purposes

1. The competence to issue licenses for medical examination and treatment activities for humanitarian purposes as stipulated in Clause 1, Article 3 of this Circular shall be implemented in accordance with Article 38 of Circular No. 41/2011/TT-BYT.

2. Competence to approve medical examination and treatment activities for humanitarian purposes:

a) The Minister of Health shall approve individuals and teams from within and outside the country organizing medical examinations and treatments at medical examination and treatment facilities under the Ministry of Health.

b) Leaders of Ministries and sectors shall approve individuals and teams from within and outside the country organizing medical examinations and treatments at medical examination and treatment facilities under their management.

c) The Director of the Department of Health shall approve individuals and teams from within and outside the country, and mobile Red Cross medical examination and treatment teams organizing medical examinations and treatments at medical examination and treatment facilities under the Department of Health and other locations within their administrative area, except for cases specified in Point a, Clause 2 of this Article.

Article 9. Documents and Procedures for Application for Issuance, Reissuance, and Amendment of Licenses for Medical Examination and Treatment Activities for Humanitarian Purposes

1. Documents for issuance, reissuance, and amendment of licenses for medical examination and treatment activities for humanitarian purposes as stipulated in Clause 1, Article 3 of this Circular include:

a) Documents as prescribed in Article 39 of Circular No. 41/2011/TT-BYT;

b) A document proving stable financial sources to ensure the operation of medical examination and treatment activities for humanitarian purposes.

2. Procedures for issuance, reissuance, and amendment of licenses for medical examination and treatment activities for humanitarian purposes shall be carried out in accordance with Article 40 of Circular No. 41/2011/TT-BYT.

Article 10. Documents and Procedures for Approval of Individuals and Teams from Within and Outside the Country to Conduct Medical Examination and Treatment Activities for Humanitarian Purposes

1. Documents for application for approval of domestic and foreign teams to conduct medical examination and treatment activities for humanitarian purposes are as follows:

a) An application form for permission to conduct medical examination and treatment activities for humanitarian purposes according to the model prescribed in Appendix 01 issued together with this Circular;

b) A document assigning and appointing persons responsible for technical and professional matters for domestic and foreign teams conducting medical examination and treatment activities for humanitarian purposes, and mobile Red Cross medical examination and treatment teams;

c) A list of members participating in medical examinations and treatments according to the model prescribed in Appendix 02 issued together with this Circular;

d) Certified copies of practice certificates of medical practitioners;

đ) Certified copies of academic and professional certificates of persons directly involved in medical examinations and treatments but not required to have a practice certificate under the law on medical examinations and treatments;

e) A plan for organizing medical examination and treatment activities for humanitarian purposes according to the model prescribed in Appendix 3 issued together with this Circular;

g) A document granting permission from the medical examination and treatment facility or the head of the location where the team plans to organize medical examination and treatment activities for humanitarian purposes;

h) A document proving stable financial sources to ensure the operation of medical examination and treatment activities for humanitarian purposes;

i) For mobile Red Cross medical examination and treatment teams, they must also supplement the decision establishing the mobile Red Cross medical examination and treatment team of the Vietnam Red Cross Society.

2. Documents for application for approval of domestic and foreign individuals to conduct medical examination and treatment activities for humanitarian purposes are as follows:

a) An application form for permission to conduct medical examination and treatment activities for humanitarian purposes according to the model prescribed in Appendix 01 issued together with this Circular;

b) Certified copies of practice certificates of medical practitioners;

c) A plan for organizing medical examination and treatment activities for humanitarian purposes according to the model prescribed in Appendix 3 issued together with this Circular;

d) A document granting permission from the medical examination and treatment facility or the head of the location where the individual plans to organize medical examination and treatment activities for humanitarian purposes;

đ) A document proving stable financial sources to ensure the operation of medical examination and treatment activities for humanitarian purposes.

3. Submission of documents for application for approval to conduct medical examination and treatment activities for humanitarian purposes:

a) Domestic and foreign teams conducting medical examination and treatment activities for humanitarian purposes under the competence stipulated in Point a, Clause 2, Article 8 of this Circular shall submit one set of documents to the Department of Medical Examination and Treatment - Ministry of Health or to the Department of Traditional Medicine Management in cases involving traditional medicine;

b) Domestic and foreign teams conducting medical examination and treatment activities for humanitarian purposes under the competence stipulated in Point b, Clause 2, Article 8 of this Circular shall submit one set of documents to relevant Ministries and Sectors;

c) Domestic and foreign teams conducting medical examination and treatment activities for humanitarian purposes under the competence stipulated in Point c, Clause 2, Article 8 of this Circular shall submit one set of documents to the Department of Health.

4. Procedure for Review and Approval of Permission to Conduct Medical Examination and Treatment Activities for Humanitarian Purposes:

a) After receiving the application documents for permission to conduct medical examination and treatment activities for humanitarian purposes, the competent authority as stipulated in Article 8 of this Circular shall send the organization or individual applying for medical examination and treatment activities for humanitarian purposes a receipt for document submission according to the model prescribed in Appendix 4 issued together with this Circular;

b) In case the application documents for permission to conduct medical examination and treatment activities for humanitarian purposes are incomplete, within ten working days from the date recorded on the receipt for document submission (the time of supplementary document submission is calculated based on the stamp of the document receiving office), the document receiving office must issue a notification to the organization or individual applying for permission to complete the documents, specifying in detail which documents or contents need to be modified or supplemented;

c) Within ten days from the date of receiving complete and valid documents, the competent state agency must issue a document approving the conduct of medical examination and treatment activities for humanitarian purposes, if not approved, then a document explaining the reasons must be issued.

Article 11. Effective Date

This Circular takes effect from October 15, 2014. Circular No. 01/2002/TT-BYT dated February 6, 2002, of the Minister of Health guiding the organization and operation of medical examination and treatment facilities for humanitarian purposes, ceases to be effective from the date this Circular takes effect.

Article 12. Cross-referencing Provisions

In cases where the referenced documents in this Circular are replaced or amended, they shall be applied according to the replacement or amended documents.

Article 13. Implementation Organization

1. The Department of Medical Examination and Treatment under the Ministry of Health shall be responsible for directing, guiding, inspecting, and auditing the implementation of this Circular throughout the country.

2. The Vietnam Red Cross shall be responsible for:

a) Directing, guiding levels of the Association to improve organizational structure, personnel, upgrade infrastructure and medical equipment of existing Red Cross medical examination and treatment facilities in accordance with the provisions of this Circular;

b) Inspecting and supervising the implementation of this Circular at Red Cross medical examination and treatment facilities.

3. The Department of Health shall be responsible for directing, guiding, inspecting, and auditing the implementation of this Circular within its jurisdictional area.

4. Organizations and individuals conducting humanitarian medical examinations and treatments shall be responsible for:

a) Being permitted to conduct humanitarian medical examinations and treatments only after receiving a written approval from the competent state authority;

b) Submitting a report on the results of their activities within ten working days following the conclusion of the humanitarian medical examination and treatment period to the Ministry of Health or the Department of Health or the ministry or agency that granted permission for the humanitarian medical examination and treatment.

During the implementation process, if there are any difficulties, organizations and individuals are requested to promptly reflect them to the Ministry of Health (Department of Medical Examination and Treatment) for research and resolution./.