Circular No. 08/2019/TT-BYT guides standards and quotas for the use of specialized machinery and equipment in the healthcare sector.

CIRCULAR

GUIDELINES ON STANDARDS AND QUANTITIES FOR THE USE OF SPECIALIZED EQUIPMENT IN THE HEALTH SECTOR

On the basis of Law on Management and Use of Public Assets No. 15/2017/QH14 dated July 20, 2017 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Health; June 21, 2017;

Decree No. 75/2017/ND-CP Decision No. 50/2017/QĐ-TTg dated December 31, 2017 of the Prime Minister prescribing standards and quantities for the use of machinery and equipment;

Pursuant to Decision No. 50/2017/QĐ-Ttg dated December 31, 2017, of the Prime Minister stipulating standards and quotas for the use of machinery and equipment;

On the proposal of the Director of the Department of Medical Equipment and Infrastructure;

The Minister of Health issues this Circular to guide standards and quantities for the use of specialized equipment in the health sector.

Article 1. Scope of Regulation and Applicability

Article 1. This Circular guides standards and quantities for the use of specialized equipment serving public health activities under the management of the Ministry of Health.

2. This Circular applies to:

a) Health public institutions directly under the Ministry of Health;

b) Health public institutions directly under provincial health departments;

c) Health public institutions directly under other ministries and sectors.

Article 3. Standards and quantities for the use of specialized equipment shall not be used as a basis for calculating specific payment levels between social insurance agencies and healthcare facilities.

Article 2. Classification of specialized equipment in the health sector

Clause 1. Machinery and equipment are considered specialized equipment in the health sector when they meet the following conditions simultaneously:

a) They are medical devices as defined in Clause 2, Article 2 of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on management of medical devices and Clause 1, Article 1 of Decree No. 169/2018/NĐ-CP dated December 31, 2018 of the Government amending and supplementing certain articles of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on management of medical devices;

b) They meet the fixed asset standards prescribed by the regulations on management and depreciation of fixed assets at the unit.

Clause 2. Specialized equipment in the health sector (hereinafter referred to as specialized medical equipment) includes:

a) Specialized medical equipment with specific characteristics;

b) Other specialized medical equipment.

Article 3. Standards and Quantities for the Use of Specialized Medical Equipment with Specific Characteristics

Standards and quantities for the use of specialized medical equipment with specific characteristics are implemented according to the provisions set out in Appendix 1 attached to this Circular.

Article 4. Standards and Quantities for the Use of Other Specialized Medical Equipment

Determination of standards and quantities for the use of other specialized medical equipment outside those specified in Article 3 of this Circular must be based on the following criteria:

Clause 1. Functions, tasks, and powers approved by competent authorities;

Clause 2. Organizational structure and scale of operations approved by competent authorities in the Charter of Organization and Operation and Development Plan (if any) of the health public institution. For health public institutions that are healthcare facilities, it must also be based on the scope of professional activities and the actual number of beds in use at the facility.

Clause 3. Physical infrastructure conditions for installation and human resources for operation and use of machinery and equipment.

Clause 4. Quantity and frequency of use of each type of specialized medical equipment at the time of establishing the standard and projected demand for each type of specialized medical equipment over the next three years. In cases where the health public institution is newly established, only the projected demand for each type of specialized medical equipment over the next three years needs to be considered.

Article 5. Authority to issue and approve standards and norms for the use of specialized medical equipment

1. The authority to issue and approve standards and norms for the use of specialized medical equipment for healthcare units under the management of Ministries, ministerial-level agencies, and provincial People's Committees shall be implemented in accordance with point b, Clause 2, Article 8 of Decision No. 50/2017/QD-TTg dated December 31, 2017.

2. The authority to approve and issue standards and norms for the use of specialized medical equipment for healthcare units under the management of the Ministry of Health:

a) The head of public health service units that self-fund their regular expenses and investment costs shall issue and approve standards and norms for the use of specialized machinery and equipment within their field of healthcare, except in cases stipulated in Clause 3, Article 6 of this Circular;

b) The Minister of Health shall approve or delegate the authority to approve standards and norms for the use of specialized machinery and equipment within the field of healthcare for subordinate healthcare units under the Ministry of Health, excluding cases stipulated in point a of this Clause or those requiring the use of specialized medical equipment exceeding the standards and norms prescribed in Article 3 of this Circular.

Article 6. Establishment, approval, and adjustment of standards and norms for the use of specialized medical equipment

1. Application dossier for approval of norms:

a) A request for approval of standards and norms for the use of specialized medical equipment from the head of the healthcare unit, following the model prescribed in Appendix 2 attached to this Circular;

b) A list of existing specialized medical equipment along with specific quantities of each type;

c) The charter of organization and operation and development plan of the unit (if applicable);

d) A list of staff and facilities of the unit. For medical examination and treatment establishments, an additional document approving the scope of professional activities must be attached;

đ) An explanatory statement on the need for each type of supplementary specialized medical equipment over the next three years;

The documents specified in points b, d, and đ of this Clause must be signed and stamped by the head of the unit.

2. The head of the healthcare unit is responsible for directing the establishment of the application dossier, report, and materials to determine standards and norms for the use of specialized medical equipment in compliance with Articles 3 and 4 of this Circular.

3. In cases where a healthcare unit requires the use of specialized medical equipment exceeding the standards and norms prescribed in Article 3 of this Circular, the head of the healthcare unit shall report to the authorized person as stipulated in Article 5 of this Circular for review and decision after obtaining a written agreement from the Ministry of Health.

4. Adjustment of norms: In cases where a healthcare unit newly supplements or adjusts its scope of professional activities, it may adjust the standards and norms for the use of specialized medical equipment in accordance with Articles 3 and 4 of this Circular.

5. Approval procedure for norms: Within thirty days from the date of receipt of the complete dossier as stipulated in Clause 1 of this Article, the authorized person as stipulated in Article 5 of this Circular shall be responsible for approving the standards and norms for use. If not approved, a written response with clear reasons must be provided.

Article 7. Effective Date

This Circular takes effect from August 1, 2019.

Article 8. Transitional Provisions

1. Decisions on standards and norms for the use of specialized medical equipment approved before the effective date of this Circular shall continue to be applied if they comply with the provisions of this Circular without having to re-execute the procedures for establishing and approving standards and norms for the use of specialized medical equipment.

2. In cases where specialized medical equipment already equipped before the effective date of this Circular exceeds the standards and norms for use prescribed in this Circular, the healthcare unit responsible for managing and using the specialized medical equipment shall report to the competent agency or person as stipulated in Clause 1, Article 5 of this Circular for consideration and decision on handling methods in accordance with Section 3, Chapter III of Decree No. 151/2017/NĐ-CP dated December 26, 2017 of the Government detailing certain provisions of the Law on Management and Use of State Property.

Article 9. Responsibility for implementation

1. The Heads of the Department of Medical Equipment and Construction, the Department of Planning and Finance, the Director of the Department of Medical Examination and Treatment, the Director of the Office of the Ministry, the Director of the Inspectorate of the Ministry, the Heads of Departments, Directors of Agencies, and General Directors of Departments, Agencies, and General Departments under the Ministry of Health, the Directors of Provincial Health Services, the Heads of Health Sectors, and the Heads of relevant agencies, organizations, and units are responsible for implementing this Circular.

2. Healthcare units are responsible for:

a) Establishing standards and norms for the use of specialized medical equipment of the unit and submitting them to the competent authority for approval in accordance with this Circular;

b) Being responsible for the information in the application dossier for approval of standards and norms for the use of specialized medical equipment.

During the implementation process, if there are difficulties or obstacles, relevant agencies, organizations, and individuals are requested to promptly reflect these issues to the Ministry of Health (Department of Medical Equipment and Construction) for consideration and resolution.

                                                                             Signed. THE MINISTER

                                                                            DEPUTY CHAIRMAN

                                                                              NGUYEN VIET TIEN