Circular No. 04/2015/TT-BYT on recognizing quality management standards for medical examination and treatment facilities

CIRCULAR

Regulations on Recognition of Quality Management Standards

healthcare facilities for diagnosis and treatment

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

Pursuant to Decree No. 87/2011/NĐ-CP dated September 27, 2011 of the Government detailing some provisions of the Law on Medical Examination and Treatment;

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

The Minister of Health issues this Circular regulating the recognition of quality management standards for medical examination and treatment facilities.

Article 1. Scope of Regulation

1. This Circular shall regulate:

a) Recognition of certain international and foreign quality management standards for medical examination and treatment facilities for application in Vietnam;

b) Criteria, documentation, and procedures for recognizing other standards, except those already recognized by the Ministry of Health under Point a Clause of this Article regarding quality management for medical examination and treatment facilities.

2. Certification activities of organizations certifying conformity to standards for medical examination and treatment facilities shall be carried out in accordance with laws on medical examination and treatment and national technical regulations and standards, and thus are not within the scope of regulation of this Circular.

Article 2. Recognition of International and Foreign Quality Management Standards for Medical Examination and Treatment Facilities

1. International and foreign quality management standards for medical examination and treatment facilities that have been recognized by the International Society for Quality in Healthcare (ISQua) shall be recognized by the Ministry of Health for application in Vietnam. This list shall be published and updated on the website of the Department of Medical Examination and Treatment Management.

2. Domestic quality management standards for medical examination and treatment facilities that have been recognized by ISQua shall also be recognized by the Ministry of Health in accordance with Clause 1 of this Article.

Article 3. Criteria for Recognizing Quality Management Standards for Medical Examination and Treatment Facilities Other Than Those Recognized Under Article 2 of This Circular

Clause 1. General criteria

a) Standards specifying the duration of applicability and methods for evaluating the standards;

b) Standards stipulating that certification of quality is a voluntary activity of medical examination and treatment facilities;

c) Standards ensuring scientific and effective quality management in each field of medical examination and treatment services;

d) Standards ensuring comprehensive evaluation of quality characteristics: safety, effectiveness, timeliness, fairness, patient-centeredness, and healthcare worker-centeredness;

đ) Standards including criteria and indicators ensuring comprehensive evaluation of three quality components: input, process, and outcome.

2. Specific criteria are detailed in Appendix No. 01 issued together with this Circular.

Article 4. Documentation for Requesting Recognition of Quality Management Standards for Medical Examination and Treatment Facilities

1. Application form for requesting recognition of quality management standards for medical examination and treatment facilities as prescribed in Appendix No. 02 issued together with this Circular.

2. Full text of the quality management standard requested for recognition.

3. Certified copy of the Certificate of Registration for Conformity Certification issued to the Certification Organization in accordance with Clause 4, Article 13 of Decree No. 87/2011/NĐ-CP dated September 27, 2011 of the Government detailing and guiding implementation of certain provisions of the Law on Medical Examination and Treatment.

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

5. Documentation proving that the standard has been tested at medical examination and treatment facilities in Vietnam, including: report on testing the application of the standard; summary of opinions from managers of medical examination and treatment facilities and experts in the field of quality management.

6. Response to specific criteria for recognizing quality management standards for medical examination and treatment facilities according to the model prescribed in Appendix No. 01 issued together with this Circular.

Article 5. Procedures for Recognizing Quality Management Standards of Medical Examination and Treatment Facilities

1. The quality certification organization submits one set of files as prescribed in Article 4 of this Circular to the Department of Medical Examination and Treatment under the Ministry of Health.

2. Establishment of the Appraisal Board:

a) The Appraisal Board, established by the Decision of the Minister of Health approving its establishment, includes:

- The leader of the Ministry of Health serves as the Chairman of the Board;

- The leader of the Department of Medical Examination and Treatment serves as the Permanent Vice-Chairman, and the leader of the Legal Affairs Department serves as the Vice-Chairman of the Board.

- Leaders of some Departments, Bureaus, Institutes under the Ministry of Health, some experts on quality management, representatives of relevant Ministries, sectors, organizations, associations are invited to participate as members according to the specific fields of the proposed standards for recognition.

b) The Secretariat assists the Board, headed by the Director of the Quality Management Division of the Department of Medical Examination and Treatment, with some related members.

3. Appraisal Process:

a) The Secretariat reviews and checks the completeness and validity of the file. If the file is complete and valid, the Secretariat has the responsibility to compare the quality management standard with the criteria for recognition prescribed in Article 3 of this Circular and prepare an appraisal report to submit to the Board;

b) The Board convenes to appraise, reach a conclusion, and approve the minutes;

c) Within twenty days from the date of receiving all valid files recorded on the Receipt Form according to Model 04 attached to this Circular, based on the Board's conclusion:

- In case the Board agrees to recognize the standard, the Department of Medical Examination and Treatment will submit to the Minister of Health for issuance of the Recognition Decision of the quality certification organization according to Model 03 attached to this Circular;

- In case the Board refuses to recognize the standard, within five working days from the date of the Board's conclusion, the Department of Medical Examination and Treatment will notify in writing the quality certification organization that submitted the application file and specify the reasons.

d) The Recognition Decision of the quality certification organization shall be published on the Department of Medical Examination and Treatment's electronic information website within five working days from the date of issuing the Recognition Decision.

Article 6. Responsibilities for Implementation

1. The Department of Medical Examination and Treatment shall be responsible for:

a) It acts as the focal point to assist the Ministry of Health in managing the recognition activities of quality of medical examination and treatment facilities and implementing this Circular.

b) Supervise the quality certification activities in Vietnam of the Organization that has been recognized for quality management standards.

2. Provincial/Municipal Health Services under the central government, Sector Health Services have the responsibility to supervise the quality certification activities of the Organization for medical examination and treatment facilities under their jurisdiction.

3. The quality certification organization is responsible for reporting to the Department of Medical Examination and Treatment under the Ministry of Health about the results of quality certification for medical examination and treatment facilities in Vietnam immediately after issuing the quality certificate and periodically reporting the results of monitoring the quality of medical examination and treatment facilities during the validity period of the quality certificate.

Article 7. Effective Date

This Circular takes effect from May 1, 2015.

During implementation, if there are difficulties or obstacles, it is recommended that agencies, organizations, and individuals reflect these issues to the Ministry of Health (Department of Medical Examination and Treatment) for guidance, clarification, or consideration for resolution./.