Recognition of Quality Management Standards for Medical Examination and Treatment Establishments

The Recognition of Quality Management Standards for Medical Examination and Treatment Establishments aims to acknowledge the application of advanced quality management systems according to international standards in the medical field. Correctly performing this procedure enhances service quality and creates a legal basis for medical establishments to strengthen their reputation. This article provides an overview of the conditions, dossier, and procedural sequence.

Criteria for recognizing quality management standards for medical examination and treatment facilities.

Based on Article 14 of Circular 32/2023/TT-BYT, for standards not automatically recognized under international standards (Article 13), criteria include:

1. General Criteria:
   • Regulations on the application period and assessment methods.
   • Quality certification is a voluntary activity of medical establishments.
   • Ensuring scientific nature and effectiveness.
   • Assessing overall quality characteristics: safety, effectiveness, timeliness, equity, patient-centeredness, and staff-centeredness.
   • Covering 3 quality components: Input, Process, and Result.
2. Specific Criteria: Prescribed in Form No. 1, Appendix XX, Circular 32/2023/TT-BYT.

The competent authority recognizes the quality management standards for medical examination and treatment facilities.

According to Article 16 of Circular 32/2023/TT-BYT, the Ministry of Health (specifically the Department of Medical Service Administration) is responsible for receiving dossiers.

• Appraisal Council: Established by the Minister of Health, chaired by Ministry Leadership, with members from Departments/Institutes and experts.
• Decision: The Minister of Health issues the Decision on Recognition based on the Council’s conclusion.

Required Dossier for accreditation of quality management standards for medical examination and treatment facilities.

Article 15 of Circular 32/2023/TT-BYT details mandatory documents:

1. Request Form: Request for recognition (Form No. 02, Appendix XX).
2. Standard Document: Full text of the quality management standard proposed for recognition.
3. Operation Registration: Certified copy of the Certificate of registration for assessment and certification activities (per Decree 96/2023/ND-CP).
4. Legal Entity Proof: Certified copy of Establishment Decision, Enterprise Registration Certificate, or Investment Certificate.
5. Pilot Application Proof: Reports on pilot application at medical establishments in Vietnam; summary of opinions from managers and experts.
6. Criteria Response: Document responding to specific criteria (Form No. 1, Appendix XX).

Procedure for requesting recognition of quality management standards for medical examination and treatment facilities.

The process is strictly regulated in Article 16 of Circular 32/2023/TT-BYT:

Step 1: Submission The Quality Certification Organization submits 01 complete dossier set to the Department of Medical Service Administration (Ministry of Health).

Step 2: Council Establishment The Minister of Health approves the Decision to establish the Appraisal Council.

Step 3: Appraisal

• The Secretariat checks validity and compares standards against criteria.
• The Council meets to appraise and agree on conclusions.

Step 4: Decision Issuance Within 20 days from receiving a valid dossier:

• If agreed: The Department submits to the Minister to issue the Decision on Recognition (Form No. 03, Appendix XX).
• If disagreed: The Department notifies the refusal reason in writing within 05 working days.

Step 5: Publication The Decision is published on the Department’s website within 05 working days from issuance.

Consulting services for procedures to request accreditation of quality management standards for medical examination and treatment facilities in Long Phan.

Long Phan Consulting Company provides comprehensive solutions:

• Consulting & Evaluation: Assessing the Client’s standards against legal regulations; analyzing scientific and practical aspects to enhance approval chances.
• Dossier Preparation: Drafting the Request Form and Criteria Response; reviewing legal validity of pilot application documents.
• Representation: Submitting the dossier and working with the Department of Medical Service Administration; monitoring the appraisal process by the Secretariat and Council.

Frequently Asked Questions about the Accreditation Procedure for Quality Management Standards of Medical Examination and Treatment Facilities

Below are some frequently asked questions regarding the procedure for requesting accreditation of quality management standards for medical examination and treatment facilities. Please refer to them:

Do ISQua-recognized standards need Council appraisal?

No. Standards recognized by the International Society for Quality in Health Care (ISQua) are recognized by the Ministry of Health based on ISQua results without Council appraisal. (Legal Basis: Clauses 1 and 2, Article 13, Circular 32/2023/TT-BYT).

Is pilot application in Vietnam required?

Yes. The dossier must include documents proving the standard has been piloted, such as pilot reports and expert opinions. (Legal Basis: Clause 5, Article 15, Circular 32/2023/TT-BYT).

Is the standard mandatory for medical establishments?

No. A prerequisite for recognition is that the standard must specify that quality certification is a voluntary activity. (Legal Basis: Point b, Clause 1, Article 14, Circular 32/2023/TT-BYT).

What is the legal status requirement for the applicant?

The applicant must be a Quality Certification Organization granted a Certificate of registration for assessment activities under Decree 96/2023/ND-CP and have a legal establishment decision/registration. (Legal Basis: Clauses 3 and 4, Article 15, Circular 32/2023/TT-BYT).

Where is the result published?

On the website of the Department of Medical Service Administration within 05 working days from the Decision date. (Legal Basis: Point d, Clause 3, Article 16, Circular 32/2023/TT-BYT).

Conclusion

Completing the Recognition of Quality Management Standards for Medical Examination and Treatment Establishments is a legal milestone affirming the organization’s capacity. Please contact Long Phan Consulting Company via Hotline 1900636389 for optimal legal solutions.