Chương IV Thông tư 32/2023/TT-BYT: Thừa nhận tiêu chuẩn quản lý chất lượng cơ sở khám bệnh, chữa bệnh

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.