Circular 35/2024/TT-BYT providing basic quality standards for hospitals

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Circular No. 35/2024/TT-BYT dated November 16, 2024 of the Ministry of Health providing basic quality standards for hospitals
Issuing body: Ministry of HealthEffective date:
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Official number:35/2024/TT-BYTSigner:Tran Van Thuan
Type:CircularExpiry date:Updating
Issuing date:16/11/2024Effect status:
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Fields:Medical - Health
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Effect status: Known

THE MINISTRY OF HEALTH
____

No. 35/2024/TT-BYT

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness

______________________

Hanoi, November 16, 2024

CIRCULAR

Providing basic quality standards for hospitals

____________________

 

Pursuant to the Law on Medical Examination and Treatment dated January 9, 2023;

Pursuant to the Government’s Decree No. 96/2023/ND-CP dated December 30, 2023, detailing a number of articles of the Law on Medical Examination and Treatment;

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

At the request of the Director of the Department of Medical Services Administration;

The Minister of Health hereby promulgates the Circular providing basic quality standards for hospitals.

 

Article 1. Basic quality standards for hospitals

1. Providing basic quality standards for hospitals include:

a) Standards on physical foundations specified in Section I of the Appendix to this Circular;

b) Standards on scale and organizational structure specified in Section II of the Appendix to this Circular;

c) Personnel standards specified in Section III of the Appendix to this Circular;

d) Standards on medical equipment specified in Section IV of the Appendix to this Circular;

dd) Professional standards on physical foundations specified in Section V of the Appendix to this Circular.

2. Scope of application:

These basic quality standards shall only apply to medical examination and treatment establishments licensed to operate in the organization form of hospitals.

3. The evaluation of basic quality standards for hospitals shall be carried out as follows:

a) Evaluation of basic quality standards once a year;

b) The evaluation shall be conducted in the first quarter of the following year;

c) Classification of evaluation.

Satisfying basic quality standards: “Yes” is given in the “Evaluation result” columns of all standards.

Failing to satisfy basic quality standards: One “No” is given in the “Evaluation result” column of any standard.

Article 2. Implementation organization

1. The Department of Medical Services Administration shall:

a) Act as the focal point to direct and organize the implementation of this Circular, and guide the evaluation, and professional contents under the assigned functions and tasks;

b) Monitor and urge medical examination and treatment establishments under the management to evaluate the basic quality standards in accordance with this Circular.

2. The Agency of Traditional Medicine Administration shall direct, provide guidance, carry out inspection and urge the implementation of this Circular within the ambit of the assigned functions and tasks.

3. Departments of Health of provinces and centrally run cities shall:

b) Direct, provide guidance, carry out inspection and urge medical examination and treatment establishments under their management to implement this Circular;

b) Monitor and urge medical examination and treatment establishments under the management to evaluate the basic quality standards in accordance with this Circular.

4. Medical examination and treatment establishments shall:

a) Implement this Circular;

b) Review, supplement and remedy to maintain the medical examination and treatment service quality at the basic level;

c) Conduct evaluation and make reports on evaluation results as prescribed.

Article 3. Effect

This Circular takes effect from January 1, 2025.

Any difficulty arising in the course of implementation shall be reported to the Ministry of Health (via the Department of Medical Services Administration) for consideration and settlement./.

 

 

FOR THE MINISTER

THE DEPUTY MINISTER

 

Tran Van Thuan

 

 

APPENDIX

BASIC QUALITY STANDARDS FOR HOSPITALS

(Attached to the Minister of Health’s Circular No. 35/2024/TT-BYT dated November 16, 2024)

___________________

 

No.

STANDARD

EVALUATION RESULT

Yes

No

I.

Standards on physical foundations

 

 

1.

The hospital must have a fixed location.*

 

 

2.

The hospital must have ambulance access to the emergency area.*

 

 

3.

Departments, divisions, and specialized departments:

 

 

3.1.

Be arranged according to the function of each department *

 

 

3.2.

Ensure infrastructure connectivity between specialized departments for convenient medical examination and treatment, safety for patients, patients' families and medical staff. * *

 

 

4.

Have signs, diagrams and signposts to departments, divisions, specialized and administrative departments.*

 

 

5.

Have emergency vehicles for transportation inside and outside the hospital.*

 

 

6.

Environmental standards:

 

 

6.1.

Have measures for domestic waste treatment.

 

 

6.2.

Have measures for medical waste treatment.

 

 

7.

Radiation safety standards:

 

 

7.1.

Have a license to conduct radiation work.

 

 

7.2.

Have a document assigning persons in charge of radiation safety.

 

 

7.3.

Persons conducting radiation work have a radiation officer certificate.

 

 

7.4.

Dosimeters are available for radiation workers.

 

 

8.

Have electricity and water for operations of medical examination and treatment establishments.

 

 

II.

Standards on scale and organizational structure

 

 

1.

The hospital must be organized with the following departments: Medical examination, clinical, paraclinical, pharmacy and supporting departments.

 

 

2.

Outpatient department must have a reception area, emergency room, short-stay units, examination room, and procedure room (if techniques and procedures are performed).

 

 

3.

Clinical department:

a) For general hospitals: Have at least two of the four departments of internal medicine, surgery, obstetrics and pediatrics.

b) For specialized hospitals, traditional medicine hospitals, and hospitals of odonto-stomatology:  Have at least one clinical department suitable for the scope of professional activities.

 

 

4.

Paraclinical department: Have at least one laboratory and one imaging room.

Particularly, the ophthalmology hospital that does not have a diagnostic imaging division must have a professional support contract with a medical examination and treatment establishment that has been licensed to operate and has a diagnostic imaging division.

 

 

5.

Pharmacy department with the following divisions: pharmacy operations, warehouse and distribution, pharmacy statistics, drug information and clinical pharmacy.

 

 

6.

Department of nutrition; clinical nutrition department; person in charge of nutrition; nutritionist.

 

 

7.

Infection control department; infection control unit; infection control officer.

 

 

8.

Other specialized divisions in the hospital appropriate for the scope of professional activities.

 

 

9.

Departments and divisions to perform the functions of general planning, human resources management, quality management, nursing, finance and accounting, information technology, medical equipment and other necessary functions.

 

 

III.

Personnel standards

 

 

1.

Practitioners are assigned tasks in accordance with the scope of practice approved by competent authorities.

 

 

2.

Practitioners regularly study and continuously update medical knowledge.

 

 

 

IV.

Standards on medical equipment

 

 

1.

Medical equipment for performing technical activities within the scope of professional activities has been approved by competent authorities and management records for such equipment are available.

 

 

2.

Regulations on management, use, inspection, maintenance, repair, replacement of materials and components, and preservation of medical equipment at medical examination and treatment establishments.

 

 

3.

Procedures for use, operation, repair and maintenance to ensure the quality of medical equipment.

 

 

4.

Medical equipment on the list of equipment subject to inspection and calibration must be inspected and calibrated according to regulations.

 

 

5.

Divisions and staff members responsible for managing the use, inspection, maintenance, repair, inspection and calibration of medical equipment.

 

 

V.

Professional standards

 

 

1.

Provision of inpatient treatment and organization of professional shifts to provide 24/7 coverage.

 

 

2.

Outpatient medical examination and treatment process.

 

 

3.

Dissemination, application and development of professional procedures for medical examination and treatment:

 

 

3.1.

Disseminate technical procedures for medical examination and treatment issued by the Ministry of Health or hospital.

 

 

3.2.

Disseminate diagnostic and treatment guidelines issued by the Ministry of Health or hospital.

 

 

3.3.

Apply technical procedures for medical examination and treatment issued by the Ministry of Health or hospital.

 

 

3.4.

Apply diagnostic and treatment guidelines issued by the Ministry of Health or hospital.

 

 

3.5.

Provide training or education or guidance on compliance with prescription regulations.

 

 

4.

Quality management:

 

 

4.1.

Establish a quality management system.

 

 

4.2.

Regulations on the operation of the hospital quality management council.

 

 

4.3.

Overall hospital quality improvement plan/project for the current year or for the next one to three years.

 

 

4.4.

Hospital quality indicators and measurement results.

 

 

4.5.

Laboratory quality management includes: laboratory quality management plan, development of guidance procedures, training for relevant staff, and evaluation of the implementation of the laboratory quality management plan.

 

 

4.6.

Report medical incidents.

 

 

5.

Infection control includes: organization, assignment of tasks; process development.

 

 

     
 

Note: For standards marked with *, only provide supporting documents when there is a change between 02 evaluations.

 

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