Thông tư 32/2023/TT-BYT hướng dẫn Luật Khám bệnh, chữa bệnh do Bộ trưởng Bộ Y tế ban hành

MINISTRY OF HEALTH -------	THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------
No. 32/2023/TT-BYT	Hanoi, December 31, 2023

 

CIRCULAR

ON ELABORATION OF THE LAW ON MEDICAL EXAMINATION AND TREATMENT

Pursuant to the Law on Medical Examination and Treatment No. 15/2023/QH15 dated January 9, 2023;

Pursuant to Government's Decree No. 95/2022/ND-CP dated November 15, 2022 on functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director of the Department of Medical Examination and Treatment Management and the Director of the Department of Science, Technology and Training, and the Director of the Department of Human Resources;

The Minister of Health promulgates a Circular on elaboration of the Law on Medical Examination and Treatment.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular provides for:

1. Medical Continuing Professional Development for medical examination and treatment (hereinafter referred to as medical CPD) as prescribed in Clause 14, Article 2 and Clause 4, Article 22 of the Law on Medical Examination and Treatment.

2. Scope of medical examination and treatment practice (hereinafter referred to as scope of practice) for professional ranks or titles specified in Clause 3, Article 26 of the Law on Medical Examination and Treatment.

3. Form of license to practice medical examination and treatment (hereinafter referred to as medical license) specified in Clause 5, Article 27 of the Law on Medical Examination and Treatment.

4. Recognition of quality standards of medical examination and treatment facilities (hereinafter referred to as healthcare facilities) promulgated by domestic and foreign organizations as prescribed in Point d, Clause 1 and Clause 4, Article 57 of the Law on Medical Examination and Treatment.

5. Medical records and medical record summaries specified in Clause 1, Article 69 of the Law on Medical Examination and Treatment.

6. Shift work practice in healthcare specified in Clause 3, Article 70 of the Law on Medical Examination and Treatment.

7. Standards and health check-ups specified in Clause 2, Article 83 of the Law on Medical Examination and Treatment.

8. Good Clinical Practice (GCP) as prescribed in Point d, Clause 4, Article 99 of the Law on Medical Examination and Treatment.

9. Regulations on the organization and operation of the expert panel and dispute resolution procedures when a medical accident occurs are specified in Clause 6, Article 101 of the Law on Medical Examination and Treatment.

10. Mobilization and dispatch of persons participating in medical examination and treatment activities in response to natural disasters, calamities, group-A infectious diseases or a state of emergency specified in Clause 4, Article 115 of the Law on Medical Examination and Treatment.

Article 2. Interpretation of terms

1. “medical CPD provider” means a healthcare facility or educational institution that provides training in medical examination and treatment for medical personnel and social-professional organizations that meets the medical CPD requirements laid down in this Circular.

2. “credit hour in medical CPD” means the unit of time for a practitioner to participate in one of the forms of medical CPD with the conversion formula as prescribed in Appendix No. I issued together with this Circular.

3. “Clinical trial” means a research study that investigates the safety and efficacy of new techniques, new methods, and medical devices in human volunteers; identify and detect harmful reactions due to their effects; the ease of use of medical devices for doctors and healthcare workers; assess or validate methods and evaluate the clinical performance of in vitro diagnostic medical devices.

4. “Good Clinical Practice (GCP)” means a set of principles and standards for designing, implementing, supervising, monitoring, checking, recording, analyzing, and reporting clinical trials of new techniques, new methods, and medical devices to ensure the creditability and accuracy of research data and reports, and also protect the rights, safety, and information security of research subjects.

5. “Investigator's Brochure (IB)” means a document with general information about clinical data on investigational new techniques, new methods, and medical devices; pre-clinical document and previous clinical trial documents (if any).

6. “Case Report Form (CRF)” means a paper or electronic paper which is used in a clinical trial on new techniques, new methods, and medical devices to collect data from each participant.

7. “ICD” means international classification of diseases.

Chapter II

MEDICAL CONTINUING PROFESSIONAL DEVELOPMENT FOR MEDICAL PRACTITIONERS

Article 3. CPD hour requirements

1. Medical practitioners are obliged to undertake at least 120 credit hours of medical CPD for 5 consecutive years (1 credit hour for a short-term training and refresher course is equivalent to 1 class period).

2. Medical practitioners who undertake any of the medical CPD activities outlined in Articles 4, 5, 6, and 7 of this Circular can earn credit hours. These credit hours will be totaled to calculate the practitioner's overall medical CPD hours.

Article 4. Medical CPD by undertaking short-term training and refresher courses, conferences, and seminars related to medicine appropriate to the scope of practice

1. Medical CPD by undertaking short-term training and refresher courses:

a) Short-term training and refresher courses in medical examination and treatment are those with training programs and documents developed, evaluated and issued in accordance with this Circular;

b) Short-term training and refresher courses are held in the form of in-person training or combination of in-person and online training, tailored to the professional content of each course;

c) Medical CPD provider is a healthcare facility or educational institution that provides training in medical examination and treatment for medical personnel and social-professional organizations;

d) Medical CPD providers must develop a plan to hold short-term training and refresher courses and make them public on their website before they can be held;

dd) The content of the medical CPD program must align with either the scope of professional activities authorized for the medical CPD provider or the training level of the designated educational institution' disciplines and majors in medical examination and treatment. The medical CPD program must be developed following the guidelines in Appendix III of this Circular and is regularly reviewed and updated to maintain scientific rigor and address practical needs;

e) Medical CPD documents are developed on the basis of the promulgated program and according to the guidelines in Appendix III of this Circular. These documents must be regularly reviewed and updated to maintain scientific rigor and address practical needs;

g) Medical CPD providers can use programs and documents issued by another provider, but only with the written approval of that provider;

h) The head of the medical CPD provider shall select and arrange enough lecturers to meet the requirements of the training program;

i) Certificate of participation in short-term training and refresher courses: Practitioners who successfully complete short-term training and refresher courses will be awarded a certificate according to Appendix II of this Circular.

2. Medical CPD by joining conferences and seminars:

a) Medical conference or seminar is an event organized by medical CPD providers with content related to medical examination and treatment;

b) Organizing body: has a scope of professional activities approved by the competent authority consistent with the content of the conference and seminar;

c) Topic and content: suitable for the scope of medical examination and treatment of the organizing body;

d) Speakers: has a scope of practice appropriate to the content of the report and topic of the conference or seminar;

dd) Form of organization: In person or online;

e) Certificate of participation in conference or seminar: Practitioners who join a conference or seminar will be granted a certificate of completion by the organizing body according to Appendix II of this Circular.

Article 5. Medical CPD by development of medical textbooks and teaching materials, and medical documents

1. Development of medical textbooks, teaching materials, and medical documents involves participation of specialized boards or groups to draft medical textbooks and teaching materials, medical documents, and clinical pathways, and these materials are promulgated by the head of the developing body.

2. Medical practitioners lead or join specialized boards or groups to draft medical textbooks and teaching materials, medical documents appropriate to their scope of practice, and these materials are promulgated by the head of the developing body.

3. Certificate of participation in developing medical textbooks and teaching materials, and medical documents: Medical practitioners who lead or join development of medical textbooks and teaching materials, medical documents, and clinical pathways will earn credit hours and be granted a certificate by the head of the developing body according to Appendix II of this Circular.

Article 6. Medical CPD by conducting scientific research and teaching medicine within the scope of practice

1. Medical CPD by conducting scientific research within the scope of practice:

a) Practitioners lead or join science and technology tasks at grassroots, ministerial, provincial and state levels or technical innovation initiatives, writing scientific articles on medical examination and treatment, both domestically and internationally, in accordance with their scope of practice. These scientific and technological tasks have been accepted, technical innovation initiatives have been recognized, scientific articles have been published in scientific journals, newsletters, and special issues at home and abroad;

b) Certificate of completion of scientific research: Practitioners who complete science and technology tasks at all levels, create technical innovation initiatives, and write scientific articles will earn credit hours and be granted a certificate by the head of the leading body according to Appendix II of this Circular.

2. Medical CPD by teaching medicine within the scope of practice:

a) Teaching medicine is the process of transferring knowledge, skills, and attitudes in medical examination and treatment within the practitioner's scope of practice;

b) Practitioners are assigned or invited to teach training courses that award health-related diplomas or certificates in areas related to their expertise;

c) Certificate of participation in medical teaching: Practitioners engaged in medical teaching within their scope of practice will receive credit hours for their work. The head of the teaching body will calculate these credit hours based on evidence of the practitioner's teaching and grant them a certificate according to Appendix II of this Circular.

Article 7. Medical CPD by self-directed medical CPD and other forms

1. Self-directed medical CPD is the process of independently studying, reflecting on, and researching medical knowledge and skills relevant to their scope of practice.

2. Self-directed medical CPD and other forms include:

a) Practitioners serve as thesis or dissertation advisors appropriate to their scope of practice and these theses and dissertations have been approved by the School-level Thesis and Dissertation Evaluation Council;

b) Practitioners participate in thesis and dissertation evaluation councils; councils for acceptance of science and technology tasks at all levels; the expert panels that evaluate medical training programs and documents appropriate to the scope of practice, the assessment councils, and the medical error review councils;

c) Practitioners engage in professional activities in the field of medical examination and treatment appropriate to their scope of practice, including: direct or indirect case consultation, case analysis;

d) Participate in diploma training courses at home and abroad (excluding study extensions) appropriate to their scope of practice;

dd) Participate in training courses in the following specialties to be granted relevant certificates: specialties, subspecialties, specialized techniques, and technical transfer appropriate to their scope of practice;

3. Certificate of self-directed medical CPD and other forms: Practitioners who complete self-directed medical CPD and other forms may be granted a relevant certificate specified in Appendix II of this Circular by the head of the leading body or the practitioner’s superior body.

Article 8. Conversion to credit hours and certificate of participation in medical CPD

1. Conversion to credit hours of given medical CPD forms is carried out according to Appendix I of this Circular.

2. For medical CPD provided by foreign CPD providers: The head of the practitioner’s superior body shall convert the CPD participation hours to credit hours and issue a relevant certificate to the practitioner according to Appendix II of this Circular.

Article 9. Responsibilities of the medical CPD provider

1. Enable practitioners to undertake medical CPD; monitor and manage; confirm and calculate credit hours for practitioners who undertake medical CPD they provide.

2. Assign staff to be in charge and manage the provider's CPD activities.

3. Organize medical CPD activities in accordance with this Circular and be responsible for the quality of their CPD activities.

4. Manage and keep records, programs, and documents of short-term training courses, conferences and seminars of the medical CPD provider; manage the certification for practitioners who have completed medical CPD in accordance with this Circular.

5. For medical CPD providers that provide short-term training and refresher courses: Before providing a training or refresher course, the medical CPD provider under the management of the Ministry of Health shall send a relevant notice specified in Appendix No. IV of this Circular to the Administration of Science Technology and Training affiliated to the Ministry of Health and the medical CPD provider under the management of the Department of Health shall send relevant notices to both Ministry of Health and Department of Health.

Chapter III

SCOPE OF PRACTICE OF PRACTITIONERS AND FORM OF PRACTICING LICENSES

Article 10. Principles for determining scope of practice of practitioners

1. A practitioner's scope of practice should align with the medical qualifications (diplomas and certificates) they are granted or recognized in Vietnam and be commensurate with their demonstrated abilities in medical examination and treatment. This includes professional methods and techniques specific to their registered specialty.

2. The practitioner's scope of practice includes medical examination and treatment, prescribing subclinical methods, applying medical examination and treatment methods, providing healthcare expertise, prescribing medications, setting care and nutritional regimes, evaluating examination and treatment outcomes, offering consultations and health education to patients according to professional titles and regulations of the Minister of Health specified in Article 11 This Circular corresponding to each professional title or rank.

3. Ensuring the quality of medical examination and treatment services and patient safety.

4. Suitable for practical conditions, especially in units with specific characteristics and diverse levels of healthcare expertise, in disadvantaged and severely disadvantaged socio-economic areas.

5. There is no distinction between practitioners of different levels of healthcare expertise or their practice duration in medical examination and treatment.

Article 11. Scope of practice of practitioners

1. Medical doctors: Their scope of practice is specified in Appendix V of this Circular.

2. Traditional medicine doctors: Their scope of practice is specified in Appendix VI of this Circular.

3. Preventive medicine doctors: Their scope of practice is specified in Appendix VII of this Circular.

4. Odonto-Stomatology doctors: Their scope of practice is specified in Appendix VIII of this Circular.

5. Specialists:

a) Intensive care specialists: Their scope of practice is specified in Appendix V and Appendix IX of the Internal Medicine and Intensive Care sections of this Circular;

b) Nutrition specialists: Their scope of practice is specified in Appendix V and Appendix XV of this Circular;

c) Other specialists: Their scope of practice is specified in Appendix V and Appendix IX of this Circular.

6. Scope of practice of practitioners with the professional title of physical assistant:

a) General physician assistants: Their scope of practice is specified in Appendix No. stipulated in Joint Circular No. 10/2015/TTLT-BYT-BNV dated May 27, 2015 of the Ministry of Health and the Ministry of Home Affairs on codes and standards for professional titles of doctors, preventive medicine doctors, physician assistants);

b) Traditional medicine physician assistants: Their scope of practice is specified in Appendix No. XI of this Circular.

7. The scope of practice of practitioners with the professional title of nurse is specified in Appendix XII of this Circular.

8. The scope of practice of practitioners with the professional title of midwife is specified in Appendix XIII of this Circular.

9. The scope of practice of practitioners with the professional title of medical technician is specified in Appendix XIV of this Circular.

10. The scope of practice of practitioners with the professional title of clinical nutritionist is specified in Appendix No. XV of this Circular.

11. The scope of practice of practitioners with the professional title of clinical psychologist is specified in Appendix XVI of this Circular and provision of continuous and comprehensive care services on cognition, behavior, emotions, and psychosocial aspects for individuals, groups, and families, including assessment of mental disorders, prescribing, developing and implementing psychological interventions at healthcare facilities.

12. The scope of practice of practitioners with the professional title of (out-of-hospital) paramedic is specified in Appendix No. XVII of this Circular.

13. The scope of practice of practitioners with the professional title of herbalist who is allowed to examine and treat diseases using specialized methods and techniques of traditional medicine and the list of techniques specified in Appendix No. XVIII of this Circular.

14. The scope of practice of holder of a folk remedy:

a) Holder of a folk remedy is allowed to examine and use the folk remedy certified by a competent authority to treat a disease or illness;

b) A folk remedy used for treatment must have the proper ingredients, dosage form, uses (indications), dosage, and method of administration;

c) The holder may use many folk remedies certified by competent authorities to treat different diseases or illnesses on the same patient;

d) Holder of a folk remedy and therapy may use them at the same time for the patient;

dd) The holder may not prescribe and use chemical drugs, herbal drugs, and use professional methods and techniques of modern medicine for their medical examination and treatment.

15. The scope of practice of holder of a folk therapy :

a) Holder of a folk therapy is allowed to examine and use the folk therapy certified by a competent authority to treat a disease or illness;

b) A folk therapy used to treat diseases must comply with the proper process, diseases or illnesses approved by the competent authority;

c) The holder may use many folk therapies, combined with folk remedies to treat different diseases and conditions on the same patient;

d) The holder may not use professional methods and techniques of modern medicine to examine or treat diseases outside their scope of practicing folk therapy.

Article 12. Form of medical license

The Ministry of Health, the Department of Health of provinces and cities, the Ministry of National Defense, and the Ministry of Public Security issue medical licenses using Form specified in Appendix No. XIX of this Circular.

Chapter IV

RECOGNITION OF QUALITY MANAGEMENT STANDARDS FOR HEALTHCARE FACILITIES

Article 13. Recognition of international standards and quality management standards for healthcare facilities

1. Recognition of international standards and quality management standards for healthcare facilities by International Society for Quality in Healthcare – ISQua.

2. The Department of Medical Examination and Treatment Administration reviews, publishes, and updates these standards on the Ministry of Health's website, the Department of Medical Examination and Treatment Administration and the management information system of medical examination and treatment.

Article 14. Criteria for recognizing quality management standards for healthcare facilities other than those specified in Article 13 of this Circular

1. General criteria:

a) Standards stipulate application deadlines and methods of evaluating standards;

b) Standards stipulate that quality certification is a voluntary activity of healthcare facilities;

c) Standards ensure scientific rigor and efficiency to manage the quality of each field of medical examination and treatment services;

d) Standards ensure the overall evaluation of quality characteristics: safety, efficiency, timeliness, fairness, and patient-and healthcare worker-centered care;

dd) The standard includes criteria and indicators that ensure full assessment of 3 quality elements: input, process, and performance results.

2. Specific criteria are provided in Form No. 1, Appendix No. XX of this Circular.

Article 15. Application for recognition of quality management standards for healthcare facilities

1. Application form for recognition of quality management standards for healthcare facilities using Form No. 02, Appendix XX of this Circular.

2. The full version of the quality management standard proposed for recognition.

3. Certified copy of the Certificate of assessment and certification of quality of healthcare facilities of the Quality Certification Organization held by the Quality Certification Organization as prescribed in Article 76 and Article 77 of Decree No. 96/2023 /ND-CP dated December 30, 2023 of the Government on elaboration of the Law on Medical Examination and Treatment (hereinafter referred to as Decree No. 96/2023/ND-CP).

4. Certified copy of the Establishment Decision, Business Registration Certificate, or Investment Certificate of the Quality Certification Organization.

5. Documents proving that the standard has been applied on a trial basis at healthcare facilities in Vietnam, including: report on trial application of the standard; opinions of administrative officers of healthcare facilities and experts in the field of quality management.

6. The responses meet the specific criteria for recognition of the quality management standards for the healthcare facility, using Form No. 1, Appendix No. XX of this Circular.

Article 16. Procedures for recognition of quality management standards for healthcare facilities

1. The Quality Certification Organization submits one set of application as prescribed in Article 15 of this Circular to the Ministry of Health (Department of Medical Examination and Treatment Management).

2. Establishment of an Appraisal Council:

a) The Appraisal Council established by the Minister of Health is composed of:

- The leader of the Ministry of Health is the President of the Council;

- The leader of the Department of Medical Examination and Treatment Management is the Standing Deputy President, the Leader of the Legal Department is the Deputy President of the Council;

- Leaders of certain Departments and Institutes of the Ministry of Health, certain quality management experts, representatives of relevant Ministries, agencies, organizations, and associations are invited to become members of the Council corresponding to their expertise in the standard proposed for recognition.

b) The Council is supported by a Secretariat, led by the Head of the Quality Management Department affiliated to Department of Medical Examination and Treatment Management, along with relevant members.

3. Standard appraisal process:

a) The Secretariat reviews and checks the completeness and validity of the application. If the application is complete and valid, the Secretariat shall compare the quality management standards with the recognition criteria specified in Article 14 of this Circular and prepare an appraisal report to submit to the Council;

b) The Council meets to appraise, reach consensus on conclusions, and approve the minutes of the meeting.

c) Within 20 days of receiving a complete and valid application stated in the Acknowledgement Form using Form No. 03, Appendix XX of this Circular, based on the Council's conclusions:

- If the Council agrees to recognize the standards, the Department of Medical Examination and Treatment Administration shall propose the Minister of Health to issue a decision on recognition of the standards of the Quality Certification Organization using Form No. 04 in Appendix XX of this Circular;

- If the Council disagrees to recognize the standards, within 5 working days from the date of the Council's conclusion, the Department of Medical Examination and Treatment Administration shall provide the Quality Certification Organization with explanation in writing.

d) The decision on recognition of the standards of the Quality Certification Organization is published on the website of the Department of Medical Examination and Treatment Administration within 5 working days from the date of issuance of that decision.

Chapter V

GOOD CLINICAL PRACTICE (GCP)

Section 1. Regulations on GCP

Article 17. GCP rules and standards

Promulgate GCP rules and standards in Appendix XXI of this Circular based on reference to guidance from ICH and WHO.

Article 18. GCP evaluations and compliance assessment

1. Initial evaluation: Conducted when the clinical testing body conducts clinical trials of new techniques, new methods or medical equipment (hereinafter referred to as the testing body).

2. Scheduled evaluation: Conducted to maintain compliance with GCP, scheduled assessment is carried out every 3 years from the date of issuance of GCP compliance certificate (excluding unscheduled assessments and inspections).

3. Unscheduled evaluation of GCP compliance is carried out in accordance with Article 27 of this Circular.

4. Assessment of GCP compliance: The Ministry of Health and Department of Health, based on state management requirements, shall assess GCP compliance or integrate GCP compliance assessment into the annual inspection schedule for other professional activities or during unscheduled assessments of the testing body’s compliance with GCP.

Article 19. GCP compliance levels

1. Level 1: The testing body is in full compliance with GCP, with no findings requiring corrective action.

2. Level 2: The testing body may have issues that need to be remedied to meet GCP, provided that such issues do not affect the accuracy and integrity of research data, and the safety and health of clinical trial participants.

3. Level 3: The testing body does not meet GCP in the following cases:

a) There is a matter that does not comply with GCP standards and may compromise the accuracy and integrity of research data and/or the health and safety of clinical trial participants;

b) Commit fraud, falsification, alteration of figures, data and documents.

Section 2. INITIAL EVALUATION OF GCP COMPLIANCE

Article 20. Application for initial evaluation of GCP compliance

1. Application form for initial evaluation of GCP compliance is provided in Form No. 01 in Appendix XXII of this Circular.

2. Declaration of general information about the testing body; facilities, list of medical devices; list of personnel who are eligible for GCP compliance assessment; standard operating procedures (SOPs), the quality control system for clinical trials and documents to prove and confirm those declarations. Documentation details follow the instructions in Appendix No. XXII of this Circular.

3. Copy of the operating license if the testing body is a healthcare facility; copy of the establishment decision or a copy of the business registration certificate accompanied by a copy of the certificate of scientific and technological activities if the testing body is a scientific and technological organization.

Article 21. Procedures for receiving applications for and evaluation of GCP compliance

1. The testing body submits one set of application as prescribed in Article 20 of this Circular to the Ministry of Health (Department of Science, Technology and Training).

2. Within 10 working days of receiving the application, the Department of Science, Technology and Training checks the completeness and validity of the application. In case the application is complete and valid, the Department of Science, Technology and Training organizes an evaluation team according to Article 28 of this Circular to undertake an on-site evaluation at the testing body within 15 working days.

In case the application is not complete and valid, the Department of Science, Technology and Training shall notify the testing body in writing.

3. The evaluation team undertakes an on-site evaluation of the testing body’s compliance with the GCP standards specified in Appendix No. XXI of this Circular.

4. Based on the on-site evaluation results at the testing body, the evaluation team discusses with the testing body about the evaluation matters to meet GCP and prepares an evaluation report Form No. 02, Appendix No. XXIII of this Circular, which determines the level of GCP compliance of the testing body according to Article 19 of this Circular.

Article 22. Process for evaluating GCP compliance

1. The evaluation team announces the Decision to establish the evaluation team; purposes, evaluation matters and plan at the testing body.

2. The testing body presents a summary of the organization, personnel, activities, application of GCP or other issues according to the evaluation matters.

3. The evaluation team undertakes an on-site evaluation of the implementation of GCP application at the testing body according to each specific evaluation matter.

4. The evaluation team meets with the testing body to notify the testing body's level of compliance with GCP according to Article 19 of this Circular, non-compliant issues that need to be remedied, found during the evaluation process (if any); discuss with the clinical testing body if they have a different opinion on any non-compliant matter with the team's evaluation.

5. Prepare and sign an evaluation report: The evaluation report is signed by the leader of the clinical testing body and the head of the evaluation team; the report must show the composition of the evaluation team, location, time, scope of evaluation, and list and specifically analyze non-compliant issues that the testing body needs to remedy (if any) compared with the corresponding provisions of this Circular, evaluate the level of compliance with GCP of the testing body according to Article 19 of this Circular, differences of opinion between the evaluation team and the testing body on GCP compliance issues (if any). The report is made into 2 copies: 1 copy is kept at the testing body, 1 copy is kept at the application receiving agency.

Article 23. Handling of GCP evaluation results

1. In case the GCP compliance evaluation report concludes that the testing body meets GCP as prescribed in Clause 1, Article 19 of this Circular, then within 10 working days of signing the evaluation report, the Minister of Health assigns the Department of Science, Technology and Training to issue a Certificate of GCP compliance according to Form No. 03 specified in Appendix No. XXIII of this Circular.

2. In case the GCP compliance evaluation report concludes that the testing body needs to address their non-compliance as prescribed in Clause 2, Article 19 of this Circular:

a) Within 5 working days of completing the on-site evaluation at the testing body and signing the evaluation report, the Department of Science Technology and Training sends a GCP compliance evaluation report with a written notification of non-compliant issues that need to be remedied to the testing body;

b) After resolving the mentioned non-compliant issues, the testing body must have a written report with evidence (documents, photos, videos, certificates) proving that they have been completed that;

c) Within 20 days of receiving the remediation report from the testing body, the Department of Science, Technology and Training shall review that report and conclude on the GCP compliance status of the testing body:

- In case the remediation is satisfactory: the Department of Science, Technology and Training shall comply with Clause 1 of this Article.

- In case the remediation is unsatisfactory: the Department of Science, Technology and Training shall issue a written request for further remediation.

d) Within 6 months from the date the Department of Science, Technology and Training issues a written request for further remediation, if the testing body fails to submit such a report as requested, their submitted application will be considered invalid and the evaluation of GCP compliance must be done again from the beginning.

3. In case the GCP compliance evaluation report concludes that the testing body does not meet GCP as prescribed in Clause 3, Article 19 of this Circular: Within 5 working days of completing the on-site evaluation at the testing body and signing the evaluation report, the Department of Science Technology and Training sends a notice of GCP non-compliance together with a GCP compliance evaluation report to the testing body and refuses to issue a certificate of GCP compliance.

4. Within 5 working days of issuing the certificate of GCP compliance, the Department of Science, Technology and Training shall publish on the Ministry of Health's website and the Department of Science, Technology and Training’s website the following information:

a) Name and address of the testing body that meets GCP;

b) Full name of the person in charge, practice certificate number (if the testing body is a healthcare facility);

c) Number of certificate of GCP compliance (if any);

d) Expiry date of GCP compliance evaluation and next periodic evaluation date;

dd) Scope of operation of the testing body.

Section 3. EVALUATION OF GCP COMPLIANCE MAINTENANCE

Article 24. Scheduled evaluation of GCP compliance maintenance

1. Every December, the Department of Science, Technology and Training publishes on their website a list of testing bodies subject to evaluation of GCP compliance maintenance in the following year.

2. Based on the list published by the Department of Science, Technology and Training, each testing body must submit an application for evaluation of GCP compliance maintenance as prescribed in Clause 6 of this Article to the Department of Science, Technology and Training withing 60 days, before the expiration date of the issued certificate of GCP compliance.

3. In case the testing body fails to submit such an application for scheduled evaluation within the time limit specified in Clause 2 of this Article, within 15 working days from the deadline, the Department of Science, Technology and Training shall issue a document requesting the testing body to submit the application according to regulations.

4. Within 45 days from the date the Department of Science, Technology and Training issues a written request, the testing body must submit a report on their GCP compliance maintenance together with an explanation for late submission. If the testing body fails to submit a report after this deadline, the Department of Science, Technology and Training shall undertake an unscheduled evaluation to check if the testing body maintains their GCP compliance according to Article 27 of this Circular.

5. After submitting the application for scheduled evaluation of GCP compliance maintenance within the prescribed time, the testing body may continue to conduct their clinical trials of new techniques, new methods or medical devices according to the scope specified in the issued certificate of GCP compliance until there are results from the mentioned scheduled evaluation and must ensure maintenance of meeting GCP principles and standards.

6. Application for scheduled evaluation of GCP compliance maintenance includes:

a) Application form for scheduled evaluation of GCP compliance maintenance laid down in Form No. 04 specified in Appendix XXIII of this Circular;

b) Summary report on clinical trials of new techniques, new methods or medical devices of the testing body during the last 3 years from the previous evaluation (excluding unscheduled evaluations, inspections and examinations by the Ministry of Health, Department of Health) to the date of application for the scheduled evaluation;

c) Updated documentation on the testing body's facilities, technical capabilities, and personnel (if changed).

7. The process and handling of results from evaluation of GCP compliance maintenance shall comply with Article 22 and Article 23 of this Circular.

Article 25. Handling of results from scheduled evaluation of GCP compliance maintenance

1. In case the GCP compliance evaluation report concludes that the testing body meets GCP as prescribed in Clause 1, Article 19 of this Circular:

Within 10 working days of completing the on-site evaluation at the testing body and signing the evaluation report, the Department of Science, Technology and Training shall issue a certificate of GCP compliance according to Form No. 03 in Appendix XXIII of this Circular.

2. In case the GCP compliance evaluation report concludes that the testing body needs to remedy the non-compliance as prescribed in Clause 2, Article 19 of this Circular:

a) Within 5 working days of completing the on-site evaluation at the testing body and signing the evaluation report, the Department of Science, Technology and Training shall send a written request to the testing body to remedy the non-compliance, send a remediation report to the Department of Science, Technology and Training;

b) Within 45 days from the date the Department of Science, Technology and Training issues a written request, the testing body must complete the remediation and submit a written report with evidence (documents, images, videos, certificates) to prove they have completed the remediation of existing issues stated in the evaluation report;

c) Within 20 days of receiving the remediation report accompanied by evidence (documents, photos, videos, certificates), the Department of Science, Technology and Training to evaluate the results from remediation by the testing body and conclude on the testing body’s GCP compliance status as follows:

- If the remediation is satisfactory: The Department of Science, Technology and Training shall issue a certificate of GCP compliance according to Form No. 03 in Appendix XXIII of this Circular.

- If the remediation is unsatisfactory: the Department of Science, Technology and Training shall issue a written request for further remediation of remaining non-compliant issues. The extension period for remediation and report is 45 days from the date of the written request.

d) Within 90 days of completing the on-site evaluation, if the testing body fails to submit a remediation report or the remediation done as prescribed in Point c of this Clause is still unsatisfactory, the Department of Science, Technology and Training shall issue a notice of GCP non-compliance, and the Department of Science, Technology and Training shall then, depending on the nature and extent of the violation, take one or more measures according to Points a and b, Clause 3 of this Article.

3. In case the GCP compliance evaluation report concludes that the testing body does not meet GCP as prescribed in Clause 3, Article 19 of this Circular: Within 5 working days of completing the on-site evaluation at the testing body and signing an evaluation report, based on the evaluation of the detected existing risks to the quality of research, health and safety of participants of new techniques, new methods, and medical devices , the Department of Science, Technology and Training shall issue a notice of GCP non-compliance, and the Department of Science, Technology and Training shall then, depending on the nature and extent of the violation, take one or more of the following measures:

a) Propose competent authorities to impose administrative penalties on the testing body in accordance with law on penalties for administrative violations;

b) Revoke the certificate of GCP compliance issued to the testing body.

4. Within 5 working days from the date of conclusion that a testing body is evaluated as GCP compliant or from the date of issuance of the decision on revocation of the certificate of GCP compliance, the Department of Science, Technology and Training shall update corresponding information on their website as prescribed in Clause 4, Article 23 of this Circular.

Article 26. Change control

1. At intervals between scheduled evaluations, the testing body must apply for evaluation of GCP compliance or report changes using Form No. 05 specified in Appendix No. XXIII issued herewith if they falls under one of the following cases:

a) Change the scope of the certificate of GCP compliance;

b) Change the location of clinical trials of new techniques, new methods or medical devices; change the location of one of the technical rooms serving clinical trials of new techniques, new methods or medical devices (examination rooms, treatment rooms, emergency rooms, laboratories) at a new location;

c) Change or add one of the technical rooms to serve clinical trials of new techniques, new methods or medical devices (examination rooms, treatment rooms, emergency rooms, laboratories) at the same location of clinical trials;

d) Change information about the name and address of the testing body, update information related to the testing body, change the names of departments and divisions of the testing body related to the clinical trials of new techniques, new methods or medical devices.

2. If a testing body makes any changes as prescribed in Points a and b, Clause 1 of this Article, they must send an application for evaluation of GCP compliance as prescribed in Article 20 of this Circular. The procedures of evaluating GCP compliance, classifying results and handling results from evaluating GCP compliance are carried out according to Articles 22 and 23 of this Circular.

3. In case the testing body makes any changes specified in Points c and d, Clause 1 of this Article, the testing body shall send a written report on such change along with documentation corresponding to the change to the Department of Science, Technology and Training.

Article 27. Unscheduled evaluation of GCP compliance

1. Unscheduled evaluation of GCP compliance at the testing body is undertaken in one of the following cases:

a) The testing body fails to submit a report on evaluation of GCP compliance maintenance as prescribed in Article 24 of this Circular;

b) The testing body has made changes or additions as prescribed in Point c, Clause 1, Article 26 of this Circular, and those changes and additions pose a risk of affecting the accuracy and integrity of research data on clinical trials or affect the safety and rights of clinical trial participants;

c) The testing body has been found in serious violation of GCP principles and standards, based on inspection findings of competent authorities;

d) The testing body has been reported to seriously violate GCP principles and standards.

2. Documentation of and procedures for unscheduled evaluation at the testing body are set out in Clauses 6 and 7, Article 24 of this Circular.

Section 4. EVALUATION TEAM OF GCP COMPLIANCE

Article 28. Composition and qualifications of evaluation team members

1. The Minister of Health establishes an evaluation team of GCP compliance composed of:

a) Representative of the Leadership of the Department of Science, Technology and Training as the team leader;

b) Representative of the Leadership of the Legal Department as the deputy team leader;

c) Representative of the Leadership of the Department of Infrastructure and Medical Devices as the deputy team leader (evaluation of GCP compliance by a testing body of medical device);

d) Representatives from units affiliated to the Ministry of Health as members, including: Department of Science, Technology and Training; Department of Medical Examination and Treatment Management; Legal Department; Department of Infrastructure and Medical Devices; Department of Traditional Medicine and Pharmacy Administration;

dd) Representative of the Department of Health of province where the testing body is headquartered as member;

e) Experts in the field of expertise related to the scope of evaluation as members. Members of relevant agencies and units where necessary;

g) Expert from the Department of Science, Technology and Training as the team secretary.

2. Standing evaluation team of GCP compliance specified in Clause 1 of this Article is located at the Department of Science, Technology and Training affiliated to Ministry of Health. The evaluation team leader invites appropriate members for each specific evaluation case.

3. Evaluation team members who are experts in specialized fields related to the scope of evaluation must have the following qualifications:

a) Obtain at least a bachelor’s degree;

b) Have been trained on GCP and GCP evaluation;

c) Be honest, objective ,and strictly comply with regulations and legal regulations during the evaluation process, have no conflicts of interest with the testing body being evaluated according to Clause 4 of this Article.

4. Principles for assessing conflicts of interest: Members of the evaluation team are considered to have conflicts of interest with the testing body being evaluated if they fall into one of the following cases:

a) Have worked within the last 5 years for the evaluated testing body;

b) Have engaged in consulting services within the last 5 years for the evaluated testing body;

c) Have a financial interest in the evaluated testing body;

d) Have a spouse, child, parent, sibling, parent's sibling, or spouse, or child working for the evaluated testing body.

Article 29. Responsibilities and powers of the evaluation team and responsibilities of the testing body

1. Responsibilities of the evaluation team:

a) Evaluate all activities of the testing body according to the corresponding GCP principles and standards specified in Article 17 of this Circular and relevant technical regulations; specifically record the evaluation matters, non-compliant issues, disagreement between the evaluation team and the testing body (if any); prepare evaluation reports;

b) Keep all relevant information about the evaluation and testing body confidential; except in cases with the consent of the testing body or at the request of a competent authority to serve inspection and investigation.

2. Powers of the evaluation team:

a) Inspect the entire area related to clinical trials of new techniques, new methods or medical devices of the testing body;

b) Request to provide documents related to clinical trials of new techniques, new methods or medical devices of the testing body;

c) Collect documents and evidence (copy documents, take photos, record videos) to prove the non-compliant issues found during the evaluation process;

d) Make a report and request the testing body to suspend clinical trials of new techniques, new methods or medical devices if during the evaluation process the team has found that the testing body has violated the regulations that seriously affect the accuracy and integrity of research data and/or the safety and health of participants in clinical trials, and then report it to competent persons as per regulations.

3. Responsibilities of the testing body:

a) Implement this Circular in line with the circumstances of the testing body;

b) Maintain compliance with GCP principles and standards throughout the testing body’s operation;

c) Carry out clinical trials of new techniques, new methods or medical devices in accordance with the licensed scope on the basis of compliance with legal regulations;

d) Comply with regulations on deadlines, applications, and procedures for evaluating GCP compliance in accordance with this Circular;

dd) Submit to unscheduled inspection and evaluation of GCP compliance maintenance conducted by competent authorities as per the law.

Chapter VI

STANDARDS AND HEALTH CHECK-UPS

Section 1. GENERAL PROVISIONS ON STANDARDS AND HEALTH CHECK-UPS

Article 30. People who need to have a health check-up

1. People who need to have a health check-up:

a) Health check-ups for Vietnamese citizens and foreigners living and working in Vietnam: periodic health check-ups; health assessment of fitness for school or work; health check-ups for students;

b) Health check-ups upon request;

c) Health check-ups for Vietnamese guest workers.

2. The health check-ups in this Chapter does not apply to the following cases:

a) Outpatient and inpatient medical examination in healthcare facilities;

b) Medical examination, forensic examination, forensic mental examination;

c) Examination to issue injury certificate;

d) Occupational disease examination;

dd) Health check-ups for people under the management of the Ministry of National Defense and the Ministry of Public Security;

e) Health check-ups for specific industries and professions.

Article 31. Principles of performing health check-ups

1. Health check-ups are performed at healthcare facilities that have been licensed to operate medical examination and treatment according to the Law on Medical Examination and Treatment.

2. Mobile health check-ups at agencies, organizations and units are carried out in accordance with Article 79 of the Law on Medical Examination and Treatment and Articles 82 and 83 of Decree No. 96/2023/ND-CP.

3. For people with a health check-up certificate issued by a competent healthcare facility of a foreign country, that health check-up certificate is used in cases where Vietnam and that country have an agreement or mutual recognition agreement and the validity period of that health check-up certificate is not more than 6 months from the date of issue. The health check-up certificate must be translated into Vietnamese and have a certified translation.

Article 32. Use of health standards to classify health

1. The health classification of people undergoing health check-ups (hereinafter referred to as examinees) is carried out in accordance with the regulations of the Ministry of Health on health classification standards for recruitment and periodic examination of workers.

2. For cases of health check-ups according to health standards of a field issued or recognized by competent authorities of Vietnam, health classification is based on the health standards in that field.

3. For cases of health check-ups upon request, if the healthcare facility does not fully examine all specialties as prescribed in the health check-ups form issued in this Circular, the health check-up facility will only examine and make conclusions for with each specialty as required and without health classification.

Article 33. Health check-up costs

1. Corporate and individual applicants for a health check-up must pay the health check-ups costs to the health check-up facility, according to the prices approved by a competent authority or based on an agreement made between the applicant and the facility, except for cases of exemption or reduction as prescribed by law.

2. In case the examinee requests two or more health check-up certificates, that examinee must pay an additional fee for issuing extra certificates according to the regulations of that healthcare facility.

3. Collection, payment, management and use of fees from health check-ups are carried out in accordance with law.

Section 2. APPLICATIONS AND PROCEDURES FOR HEALTH CHECK-UPS, HEALTH CHECK ITEMS AND HEALTH CLASSIFICATION

Article 34. Health check-up applications

1. Health check-up application of people aged 18 (eighteen) years or older is a health check-up application form No. 01, Appendix No. XXIV of this Circular, with a portrait photo 4cm x 6cm, taken on a white background within no more than 6 (six) months prior to the date of application submission.

2. Health check-up application of people under 18 (eighteen) years old is a health check-up application form No. 02, Appendix No. XXIV of this Circular, with a portrait photo 4cm x 6cm, taken on a white background within no more than 6 (six) months prior to the date of application submission.

3. An application for health check-up for a legally incapacitated person or person with limited active legal capacity but not subject to a periodic medical examination shall include:

a) An application form for health check-up as prescribed in Clause 1 or Clause 2 of this Article;

b) Written consent of the patient's relative specified in Clause 11, Article 2 of the Law on Medical Examination and Treatment.

4. As for periodic examinees, their application shall include:

a) Periodic health check-up book according to Form No. 03, Appendix No. XXIV of this Circular;

b) Referral letter from their employer in case of a single periodic health check-up or being on the list of periodic health checkups issued by their employer to perform periodic health check-ups under a contract.

Article 35. Health check-up process

1. An examinee will submit an application according to the prescribed form of the health check-up facility.

2. After receiving the health check-up application, the health check-up facility shall carry out the following:

a) Verify the identity of the examinee by comparing them with the photo on the application;

b) Affix the fan stamp on the photo after verification according to Point a of this Clause for the cases specified in Clauses 1, 2 and 3, Article 37 of this Circular;

c) Check and compare valid identification documents of the patient for the cases specified in Clause 3, Article 37 of this Circular;

d) Instruct on the health check-up process for the examinee or their guardian (if any);

dd) The health check-up facility shall develop, promulgate, and implement their health check-up procedures;

e) Return results and keep medical examination records.

Article 36. Health check items

1. For health check-ups for people aged 18 (eighteen) years or older but not subject to periodic health check-ups: Examine health check items in the application form for health check-up No. 01, Appendix No. XXIV of this Circular.

2. For health check-ups for people under 18 (eighteen) years old but not subject to periodic health check-ups: Examine health check items in the application form for health check-up No. 02, Appendix No. XXIV of this Circular.

3. For periodic health check-ups: Examine health check items in the periodic health check-up book Form No. 03, Appendix No. XXIV of this Circular.

4. For female employees, their periodic health check-up will include the obstetrics check items mentioned in the list specified in Appendix No. XXV of this Circular.

5. Every health check items of each specialty must be examined. In difficult cases, it is necessary to consult or order a subclinical test to determine the diagnosis and the degree of illness and disease as a basis for health classification.

6. In the case of health check-up upon request, only examination and conclusions are made for each specialty upon request and health classification is not required.

Article 37. Health classification

1. Health classification standards of people undergoing health check-ups comply with regulations of the Minister of Health.

2. The examiner shall document relevant diseases and disabilities from the specialized examination and classify the patient's health based on their specialty. 

3. Based on all specialty examination results, the practitioner that is designated to determine the final health classification and sign both the health check-up certificate and periodic health check-up book (hereinafter referred to as health classification determiner) shall determine the final health category as follows:

a) The health classification of examinee is carried out in accordance with the regulations of the Minister of Health on health classification standards for recruitment and periodic examination of workers;

b) In case the examinee has a disease or disability, the health classification determiner will recommend treatment and rehabilitation options or refer them for further examination and treatment.

4. After classifying the health, the health classification determiner must sign, clearly state their full name, and stamp the health check-up facility’s seal on the health check-up certificate or periodic health check-up book. The use of seals in official transactions by health check-up facilities is regulated by laws on seal management and use.

5. For cases of health check-ups according to health standards of a field issued or recognized by competent authorities of Vietnam, health classification is based on the health standards in that field.

6. For cases of health check-ups upon request, if the healthcare facility does not fully examine all specialties as prescribed in the health check-ups form issued in this Circular, the health check-up facility will only examine and make conclusions for with each specialty as requested by the person being examined and without health classification.

Article 38. Issuance and archive of health check-up certificate

1. The health check-up certificate is issued 1 (one) copy to the examinee and 1 copy is kept at the health check-up facility. The archive duration of health check-up documentation is as prescribed in section 20, group 01 Documentation on medical examination, treatment, and rehabilitation issued with Circular No. 53/2017/TT-BYT dated December 29, 2017 of the Minister of Health on archive duration of specialized records and documentation in the health sector. Periodic health check-up applications are preserved and archived by examinees’ superior bodies.

2. In case the examinee requests multiple health check-up certificates, the health check-up facility shall issue multiple copies of the health check-up certificate. Issuance of multiple copies is carried out in accordance with Decree No. 30/2020/ND-CP dated March 5, 2020 of the Government on clerical work (hereinafter referred to as Decree No. 30/2020/ND-CP).

3. Time limit for returning health check-up certificates and periodic health check-up books:

a) For individual health check-ups: the health check-up facility returns the health check-up certificate and periodic health check-up book to the examinee within 24 (twenty-four) hours from the end of the examination, except in cases where additional examination or testing is required at the request of the health examiner;

b) For group health check-ups under contract: the health check-up facility returns health check-up certificates and periodic health check-up books to the examinees according to the arrangement stated in the contract.

4. Validity period of health check-up certificate and periodic health check-up results:

a) The health check-up certificate is valid for 12 (twelve) months from the date of signing;

b) Results of periodic health check-up are valid according to law.

Chapter VII

MOBILIZATION AND DISPATCH OF PERSONS PARTICIPATING IN MEDICAL EXAMINATION AND TREATMENT ACTIVITIES IN RESPONSE TO NATURAL DISASTERS, CALAMITIES, GROUP-A INFECTIOUS DISEASES OR A STATE OF EMERGENCY

Article 39. Mobilization and dispatch of persons participating in medical examination and treatment activities in response to natural disasters, calamities, group-A infectious diseases or a state of emergency

1. In case the unit or locality's human resources do not meet the requirements for medical examination and treatment in the event of a natural disaster, calamity, group A infectious disease, or state emergency, in addition to the mobilization and dispatch of professionals in line with the circumstance as per the law, competent authorities and persons may mobilize and dispatch the following persons to participate in medical examination and treatment, including testing, sample collection, vaccination, first aid, and emergency care:

a) Medical practitioners in Vietnam (including foreigners) are allowed to perform testing, vaccination, medical examination, and treatment, first aid, and emergency care outside the permitted scope of practices in their medical licenses;

b) Foreigners and overseas Vietnamese who have been licensed by foreign competent authorities to practice medical examination and treatment are allowed to perform testing, vaccination, first aid, emergency care and other activities at healthcare facilities established to perform or assign the performance of receiving patients, providing first aid, providing health care, and treating people infected with group A infectious diseases or patients in accidents, patients who need first aid, emergency care, and treatment in natural disasters, calamities, or state of emergency without a medical license issued by a competent agency of Vietnam;

c) Students and trainees of schools in the health sector; people who are eligible for medical licenses but have not yet been granted medical licenses may participate in testing, vaccination, medical examination and treatment of group A infectious diseases, first aid, first aid, emergency care, and medical examination and treatment for people suffering from natural disasters, calamities, or state of emergency.

Article 40. Grounds and authority for mobilization and dispatch of persons participating in medical examination and treatment activities in response to natural disasters, calamities, group-A infectious diseases or a state of emergency

1. Grounds for mobilization and dispatch of persons participating in medical examination and treatment activities in response to natural disasters, calamities, group-A infectious diseases or a state of emergency:

a) At the request of Presidents of the People's Committees of provinces and centrally affiliated cities, Directors of Departments of Health, Presidents of the People's Committees of urban districts, suburban districts, provincial cities, centrally affiliated cities who seek human resources to participate in testing, vaccination, medical examination and treatment in the event of a natural disaster, calamity, group A infectious disease epidemic or state of emergency, using Form specified in Appendix No. XXVII of this Circular;

b) At the request of heads of healthcare facilities, facilities that admit and treat patients with group A infectious disease, and preventive health facilities that seek human resources to participate in preventing and controlling group A infectious diseases, or emergency care and treatment of patients in natural disasters, calamities, or state of emergency;

c) According to the Minister of Health’s mobilization of additional human resources to support local governments, healthcare facilities, and preventive health facilities to further prevent and control group A infectious diseases, emergency care and treatment of patients in natural disasters, calamities, or state of emergency.

2. Authority for mobilization and dispatch of persons participating in testing, vaccination, medical examination and treatment in response to natural disasters, calamities, group-A infectious diseases or a state of emergency:

a) The Minister of Health may mobilize and dispatch forces to participate in the prevention and control of group A infectious diseases, first aid, and treatment of patients in natural disasters, calamities, or state of emergency nationwide, except for forces managed by the Ministry of National Defense and the Ministry of Public Security;

b) Presidents of People's Committees of provinces or agencies authorized by People's Committees of provinces may mobilize and dispatch forces to participate in prevention and control of group A infectious diseases, first aid and treatment of patients in natural disasters, calamities, or state of emergency in the provinces;

c) Heads of healthcare facilities, facilities that admit and treat patients with group A infectious diseases, preventive facilities, and health-sector training institutions may mobilize and dispatch forces to participate in prevention and control of group A infectious diseases, first aid and treatment of patients in natural disasters, calamities, or state of emergency within their scope of management.

Article 41. Receipt and assignment of people to participate in testing, vaccination, medical examination, and treatment of group A infectious diseases, first aid and treatment of patients in natural disasters, calamities, or state of emergency

1. Directors of Departments of Health shall receive and assign forces mobilized by competent agencies to each facility to perform vaccination, testing, medical examination and treatment, care of patients with group A infectious diseases, perform first aid and treatment of patients in natural disasters, calamities, or state of emergency.

2. Heads of healthcare facilities, facilities that admit and treat patients, preventive medicine facilities, and health-sector training institutions shall receive and assign detailed tasks to each position and person suitable to the professional requirements to participate in prevention and control of group A infectious diseases or perform emergency care and treatment of patients in natural disasters, calamities, or state of emergency.

Chapter VIII

ON-CALL PRACTICE IN HEALTHCARE

Article 42. Healthcare entities that provide on-call practice

On-call practice, for the purpose of this Chapter, applies to health facilities with inpatient beds; healthcare facilities with beds for monitoring and treatment of patients ; out-of-hospital emergency care facilities (hereinafter referred to as healthcare facilities).

Article 43. Rules for on-call practice

1. On-call practice outside of office hours and on holidays, and days off must be organized by healthcare facilities to ensure continuous medical examination and treatment 24 hours a day.

2. On-call shifts must be strictly organized, with adequate human resources, means of transportation, medical devices, and drugs for emergency care.

3. On-call positions must be easily accessible and have sufficient contact information.

4. On-call staff must be present before the on-call time to receive the handover from the previous on-call shift, and then hand over to the next on-duty shift when the time ends, must not leave the duty position and must comply with the on-duty orders of the superior.

5. On-call schedule is made monthly and announced at least one week before the on-call time, approved by the hospital leader, and specified on the board for each on-call position. Officers, public employees, and employees who have been assigned in an on-call schedule can only change their own on-call schedule with those who are at their same level, together with the approval from the leader.

Article 44. Duties of on-call positions in the hospital

1. On-call leaders:

a) On-call leaders: Director, deputy director, dean of department, head of department who are designated by the director to participate in leadership on-call and this type of on-call practice must be authorized in writing.

b) Duties of on-call leaders:

- Check and supervise on-call shifts in the hospital.

- Direct the resolution of difficult problems and situations that are beyond the professional capabilities of on-call subordinate staff.

- Direct the handling of unusual security and order incidents occurring in the hospital.

- Report to the superior body of the hospital on special and unexpected cases that occur beyond their authority.

2. On-call clinical staff:

a) Organization of on-call clinical practice:

- The head of on-call shift is a practitioner holding the position of dean, deputy dean, or doctor with a postgraduate degree.

- On-call clinical doctor is a qualified practitioner who independently solves tasks and is responsible for their task solution.

- Nurses, midwives, and medical technicians who are practitioners assigned to on-call clinical practice by the hospital director.

b) Duties of the head of on-call clinical shift:

- Manage human resources during the on-call shift.

- Examine and order treatment for emergency cases, newly arrived patients and seriously ill patients undergoing treatment with unusual developments when the on-call clinical doctor of the department cannot resolve the issue.

- Report and seek advice from direct leadership in cases beyond their professional capacity to handle and special cases such as suicide, epidemics, catastrophes, and mass emergencies.

- Notify the on-call security guard and report to the on-call leaders in case of loss of security and order in the hospital.

- Check and urge on-call positions to fulfil their duties.

c) Duties of on-call doctors:

- Receive patients coming to the emergency room.

- Monitor and handle transferred patients.

- Guide and urge on-call staff to fully implement instructions.

- Assign responsibilities to each on-call member to closely monitor and promptly respond to any adverse changes in level-1 seriously-ill patients.

- Examine patients and document medical records after each visit.

d) Duties of on-call nurses, midwives, and medical technicians:

- On-call nurses are nurses of each department who can organize inter-department nursing duties as decided by the hospital director.

- Carry out doctor's orders and provide patient care and follow-up care.

- Urge patients to follow hospital regulations.

- Preserve records, medicine cabinets, and assets of the department.

- Detect a patient with unusual developments, at risk of death, report to the on-call doctor, and record all developments in the monitoring sheet.

3. On-call subclinical staff:

a) Organize separate on-call practice for each department, depending on the workload in each department to arrange the appropriate number of on-call staff;

b) Duties of on-call subclinical staff: perform tasks for diagnosis and treatment according to clinical instructions.

4. On-call logistics and administration staff:

a) On-call pharmacy and medical device staff shall ensure adequate supply of medicine and operation of medical devices to serve the on-call team;

b) The on-call finance and accounting staff shall ensure the collection of hospital fees from outpatients and inpatients outside of business hours;

c) The on-call IT staff shall ensure that the hospital management network system operates normally;

d) On-call electricity and water staff shall ensure operation of generators when there is an unexpected power outage; repair abnormal electricity and water damage;

dd) On-call administration staff must ensure communication by phones and other forms of information (according to regulations of the healthcare facility);

e) On-call security guards shall ensure security and order in the hospital;

g) On-call drivers shall ensure that ambulances are ready to perform duty when ordered.

5. Out-of-hospital on-call permanent staff:

a) In addition to the people assigned to be on call as mentioned above at the 4 permanent levels, depending on the actual circumstances of each hospital, hospital leaders can arrange on-call permanent staff outside the hospital to be ready to provide professional and administrative support when needed;

c) On-call permanent staff must keep in constant contact during their on-call time and be present at the hospital when mobilized.

Article 45. Required items in an on-call shift report

1. After an on-call shift, the on-call sub-teams shall document developments of all required report items in the on-call book; faculties and departments must hold briefings to hear the on-call shift reports from the following on-call sub-teams: clinical, subclinical, logistics, and administration sub-teams.

2. An on-call clinical report must document all developments of the following during the on-call shift:

a) Death: Clearly state the patient's progress, treatment, cause, time of death, and specific actions after the patient's death;

b) Emergency: Clearly state the name, age, address, diagnosis, and solution for each patient coming to the emergency room;

c) Serious developments of inpatients: Clearly state the developments of illness and treatment for each patient;

d) Medicines: release statistics and reports on the number of medicines used during the on-call shift.

3. On-call subclinical staff: Report emergency tests and paraclinical techniques performed during the on-call shift.

4. On-call logistics and administration staff: Report the items as prescribed in Clause 4, Article 44 of this Circular.

5. On-call leaders: Give general comments on the progress of on-call shift at the hospital-wide briefing.

Article 46. On-call practice at a healthcare facility that is not a hospital but has inpatient beds or beds for monitoring and treatment of patients

1. A healthcare facility that is not a hospital but has inpatient beds or beds for monitoring and treatment of patients (except for the case specified in Clause 2 of this Article) must arrange human resources for an on-call shift as follows: There is at least 1 practitioner with the title of doctor or physician assistant and 1 practitioner with one of the following titles: nurse, midwife, or medical technician.

2. A commune-level health station must arrange human resources for an on-call shift as follows: There is at least 1 practitioner with one of the following titles: doctor, physician assistant, nurse, midwife, medical technician.

Article 47. Out-of-hospital on-call emergency

1. Out-of-hospital emergency facilities (including patient transport facilities established under the Law on Medical Examination and Treatment No. 40/2009/QH12) shall organize 24-hour emergency operations (including holidays and days off) according to Decision No. 01/2008/QD-BYT dated January 21, 2008 of the Minister of Health on emergency and intensive care and anti-toxic care.

2. Healthcare faculties with out-of-hospital emergency operations must arrange:

a) 24-hour human resources on call;

b) the minimum number of people for one on-call shift as follows:

- 1 practitioner with the title of doctor or physician.

- 1 practitioner with one of the following titles: nurse, midwife, or medical technician.

- 1 ambulance driver.

c) Staff in the on-call emergency shift specified in Point b of this Clause must be distinct from personnel assigned to other concurrent on-call shifts and can be arranged in the form of permanent duty.

Chapter IX

ORGANIZATION AND OPERATION OF THE EXPERT PANEL AND DISPUTE RESOLUTION PROCEDURES UPON OCCURRENCE OF MEDICAL ACCIDENTS

Article 48. Organization of the Expert Panel

1. The organizational structure and number of members of the Expert Panel include:

a) President: 1 person;

b) Deputy President: 1-2 people;

c) Members: At least 3 people;

d) Secretary: At least 1 person.

2. Principles for establishing the Expert Panel:

a) Ensure independence, objectivity, and no conflicts of interest;

b) Panel members must have a scope of practice or professional qualifications related to medical accidents;

c) The number of members of the Panel (including the President) must be an odd number.

Article 49. Operation of the Expert Panel

1. Conditions for holding an Expert Panel meeting: at least 2/3 of the Panel members must be present.

2. Meeting sessions:

a) The Panel may meet in one or more sessions;

b) Each member of the Panel uses relevant medical records to make an evaluation of the medical accident;

c) The Panel has a collective discussion and concludes by majority vote based on the opinions of its members and take legal responsibility for its conclusions;

d) The content discussed at the Panel session must be recorded in minutes, with all signatures of the Panel members attending the session.

3. The conclusion of the Expert Panel must determine the cause of the medical accident:

a) In case a medical accident occurs due to the causes specified in Clause 2, Article 100 of the Law on Medical Examination and Treatment, it is concluded that the practitioner did not make any healthcare professional errors.

b) In case a medical accident occurs due to healthcare professional errors during medical examination and treatment, the following must be specifically concluded:

- Whether the practitioner commits a violation in one of the cases specified in Clause 1, Article 100 of the Law on Medical Examination and Treatment.

- Levels of healthcare professional errors and actions to be taken against the practitioner(s) (if any).

4. The written conclusion signed by the President of the Panel must have content consistent with the conclusion in the Panel meeting minutes and be made into 2 copies, 1 copy is kept at the agency that established the Panel, 1 copy is sent to the agency that requests to establish the Panel unless the establishing agency is a healthcare facility where the medical accident occurs. The signature of the President of the Panel must be authenticated by the agency that established the Panel.

5. During the Panel meeting, if necessary, the President of the Panel may request their establishing agency to invite more experts to participate in the meeting without having to supplement the decision on establishment of the Panel.

Article 50. Dispute resolution procedures upon occurrence of medical accidents

1. Dispute resolution procedures for hospitals under the management of the Department of Health (including hospitals of ministries and agencies, except hospitals under the Ministry of National Defense and the Ministry of Public Security):

a) When a medical accident occurs and there is a dispute that needs to be resolved, at the request of the patient, the patient's representative, the practitioner(s), the investigation body, or the court, the hospital must establish an Expert Panel as prescribed in Clause 1, Article 101 of the Law on Medical Examination and Treatment (hereinafter referred to as the grassroots Expert Panel);

b) In case the parties to dispute do not agree with the conclusion of the Expert Panel specified in Point a of this Clause, they may send a written request to the Department of Health to establish another Expert Panel to resolve it together with documentation related to the dispute;

c) In case the parties to dispute do not agree with the conclusion of the Expert Panel specified in Point b of this Clause, they may send a written request to the Ministry of Health to establish another Expert Panel to resolve it together with documentation related to the dispute. The conclusion of the Expert Panel of the Ministry of Health is final and conclusive;

d) In case the parties to dispute do not agree with the conclusion of the Expert Panel established by the Ministry of Health, the parties shall file a lawsuit to court.

2. Dispute resolution procedures for healthcare facilities under the management of the Department of Health other than hospitals (including healthcare facilities other than hospitals of ministries and agencies, except facilities under the Ministry of National Defense and the Ministry of Public Security):

a) When a medical accident occurs and there is a dispute that needs to be resolved, at the request of the patient, the patient's representative, the practitioner(s), the investigation body, or the court, the healthcare facility shall send a request to the Department of Health in writing to establish an Expert Panel together with documents related to the dispute;

b) In case the parties to dispute do not agree with the conclusion of the Expert Panel specified in Point a of this Clause, they may send a written request to the Ministry of Health to establish another Expert Panel to resolve it together with documentation related to the dispute. The conclusion of the Expert Panel of the Ministry of Health is final and conclusive;

c) In case the parties to dispute do not agree with the conclusion of the Expert Panel established by the Ministry of Health, the parties shall file a lawsuit to court.

3. Dispute resolution procedures for hospitals and infirmaries under the management of the Ministry of National Defense and the Ministry of Public Security:

a) When a medical accident occurs and there is a dispute that needs to be resolved, at the request of the patient, the patient's representative, the practitioner(s), the investigation body, or the court, the hospital/infirmary must establish an Expert Panel as prescribed in Clause 1, Article 101 of the Law on Medical Examination and Treatment (hereinafter referred to as the grassroots Expert Panel);

b) In case the parties to dispute do not agree with the conclusion of the Expert Panel specified in Point a of this Clause, they may send a written request to the Department of Military Medicine affiliated to Ministry of National Defense, Department of Health affiliated to Ministry of Public Security to establish another Expert Panel to resolve it together with documentation related to the dispute;

c) In case the parties have a dispute and do not agree with the conclusion of the Expert Panel specified in Point b of this Clause, they may send a written request to the Ministry of Health to establish another Expert Panel to resolve it together with documentation related to the dispute. The conclusion of the Expert Panel of the Ministry of Health is final and conclusive;

d) In case the parties to dispute do not agree with the conclusion of the Expert Panel established by the Ministry of Health, the parties shall file a lawsuit to court.

4. Dispute resolution procedures for healthcare facilities under the management of the Ministry of National Defense and the Ministry of Public Security other than hospitals or infirmaries, or being infirmaries but not eligible for establishing an Expert Panel:

a) When a medical accident occurs and there is a dispute that needs to be resolved, at the request of the patient, the patient's representative, the practitioner(s), the investigation body, or the court, the healthcare facility shall send a request to the Department of Military Medicine affiliated to Ministry of National Defense, Department of Health affiliated to Ministry of Public Security in writing to establish a Expert Panel together with documents related to the dispute;

b) In case the parties to dispute do not agree with the conclusion of the Expert Panel specified in Point a of this Clause, they may send a written request to the Ministry of Health to establish another Expert Panel to resolve it together with documentation related to the dispute; The conclusion of the Expert Panel of the Ministry of Health is final and conclusive;

c) In case the parties to dispute do not agree with the conclusion of the Expert Panel established by the Ministry of Health, the parties shall file a lawsuit to court.

5. Dispute resolution procedures for hospitals under the management of the Ministry of Health:

a) When a medical accident occurs and there is a dispute that needs to be resolved, at the request of the patient, the patient's representative, the practitioner(s), the investigation body, or the court, the hospital must establish an Expert Panel as prescribed in Clause 1, Article 101 of the Law on Medical Examination and Treatment (hereinafter referred to as the grassroots Expert Panel);

b) In case the parties to dispute do not agree with the conclusion of the Expert Panel specified in Point a of this Clause, they may send a written request to the Ministry of Health to establish another Expert Panel to resolve it together with documentation related to the dispute; The conclusion of the Expert Panel of the Ministry of Health is final and conclusive;

c) In case the parties to dispute do not agree with the conclusion of the Expert Panel established by the Ministry of Health, the parties shall file a lawsuit to court.

6. Dispute resolution procedures for healthcare facilities under the management of the Ministry of Health but other than hospitals:

a) When a medical accident occurs and there is a dispute that needs to be resolved, at the request of the patient, the patient's representative, the practitioner(s), the investigation body, or the court, the healthcare facility shall send a request to the Department of Health in writing to establish an Expert Panel together with documents related to the dispute. The conclusion of the Expert Panel of the Ministry of Health is final and conclusive;

b) In case the parties to dispute do not agree with the conclusion of the Expert Panel established by the Ministry of Health, the parties shall file a lawsuit to court.

Chapter X

MEDICAL RECORDS

Article 51. Medical records, medical forms used in medical records

1. 82 medical records and medical forms issued together with this Circular include:

a) Medical records in Appendix XXVIII of this Circular;

b) Medical forms in Appendix XXIX of this Circular;

Article 52. Regulations on use of medical records and documentation of medical records

1. Regulations on use of medical records:

a) Healthcare facilities use medical records in paper and electronic forms.

b) Healthcare facilities that use electronic medical records must ensure that all information fields of the medical records are complete.

2. Regulations on documentation of medical records:

a) Accurately, truthfully, and completely document all information in medical records, medical examination results, subclinical tests, functional tests, diagnosis, treatment, care, and other information related to the patient's treatment process at a healthcare facility;

b) The documentation must comply with the contents and professional instructions that have been issued;

c) Use clear and scientific words, present easily to understand and read. Do not use abbreviations in documents provided for patients, including: summaries of medical records, documents handed over to other healthcare facilities, referral letters for medical examination and treatment, health insurance-covered medical documents, follow-up appointment letters. For abbreviations, they must follow the list of symbols and abbreviations used in medical records that have been developed and issued for uniform use at the healthcare facility;

d) Information in the medical records should clearly show the time and person who documented it.

Chapter XI

IMPLEMENTATION

Article 53. Entry into force

1. This Circular comes into force as of January 1, 2024.

2. The following documents cease to be effective from the effective date of this Circular:

a) Circular No. 35/2019/TT-BYT dated December 30, 2019 of the Minister of Health;

b) Circular No. 55/2015/TT-BYT dated December 29, 2015 of the Minister of Health;

c) Circular No. 14/2013/TT-BYT dated May 6, 202013 of the Minister of Health;

d) Circular No. 09/2023/TT-BYT dated May 5, 2023 of the Minister of Health;

dd) Standing regulations in Clause 1, Part IV of Decision No. 1895/1997/QD-BYT dated September 19, 1997;

e) Decision No. 4069/2001/QD-BYT dated September 28, 2001 of the Minister of Health;

g) Medical record summary form (CV-01) replaces "Medical record summary form" in Appendix 4 issued with Circular No. 18/2022/TT-BYT dated December 31, 2020. 2022 of the Minister of Health;

h) Decision No. 1941/QD-BYT dated May 22, 2019 of the Minister of Health;

i) Decision No. 3730/QD-BYT dated August 5, 2021 of the Minister of Health;

k) Circular No. 41/2011/TT-BYT dated November 14, 2011 of the Minister of Health;

l) Circular No. 41/2015/TT-BYT dated November 16, 2015 of the Minister of Health;

m) Regulations on medical CPD in Circular No. 22/2013/TT-BYT dated August 9, 2013 of the Minister of Health.

Article 54. Terms of reference

In case the documents referenced in this Circular are superseded or amended , the new documents shall prevail.

Article 55. Transitional provisions

1. In case a practitioner has been granted a medical certificate (hereinafter referred to as a medical license) according to the Law on Medical Examination and Treatment No. 40/2009/QH12, their scope of practice is applied according to regulations of this Circular.

2. For testing bodies that have been granted a Certificate of GCP compliance with the scope of clinical drug trials (pharmaceutical drugs, herbal drugs, traditional drugs, biological products, therapeutic biological products), the testing bodies shall review and prepare conditions to meet GCP principles and standards as prescribed in this Circular and send documents as prescribed in Article 20 of this Circular to the Department of Science, Technology and Training.

3. The Department of Science, Technology and Training shall check and evaluate if they comply with GCP based on the documentation of the testing bodies. In case the application of a testing body is complete and meets the requirements specified in this Circular, the Ministry of Health shall assign the Department of Science, Technology and Training to issue a certificate of GCP compliance with the trial scope of corresponding new techniques, new methods and/or medical devices within 20 working days of receiving the complete and valid application.

4. The Department of Science, Technology and Training shall undertake an on-site evaluation at the testing body in one of the following cases:

a) The testing body requests a certificate of compliance with good clinical practice for medical device trial;

b) Documents proving the eligibility of the testing body do not meet the requirements in this Circular;

c) Documents show signs of erasures or modifications;

d) The testing body has been sanctioned by a competent authority for administrative violations related to clinical trials.

5. In case of on-site evaluation at the testing body, the handling of evaluation results is carried out in Article 23 of this Circular.

Article 56. Implementation

1. Chief of the Ministry Office, Director of the Department of Medical Examination and Treatment Management, Director of the Department of Science, Technology and Training, Director of the Department of Traditional Medicine and Pharmacy, Directors of Departments, Directors of Departments under the Ministry Health, heads of agencies and units under the Ministry, Directors of Health Departments of provinces, heads of health agencies of Ministries, branches and relevant organizations shall implement this Circular.

Difficulties that arise during the implementation of this Circular should be reported to Department of Medical Examination and Treatment Management or Department of Science, Technology and Training affiliated to the Ministry of Health for consideration./.

 

PP. MINISTER DEPUTY MINISTER Tran Van Thuan