Decision No. 4701/2003/QĐ-BYT on Issuing the Regulations on Hospitals Meeting the Conditions to Perform Kidney Transplantation Techniques

Pursuant to …;

Regarding the issuance of Regulations on Hospitals Meeting Conditions to Perform Kidney Transplantation Techniques

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 THE MINISTER OF HEALTH

Pursuant to the Law on Protecting People's Health;

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Based on the proposal of the Director of the Treatment Department and the Director of the Science and Training Department;

DECISION:

Article 1. Now hereby promulgates with this Decision the Regulations on hospitals meeting conditions to perform kidney transplantation techniques.

Article 2. The Regulations on hospitals meeting conditions to perform kidney transplantation techniques shall apply to state-owned, semi-state-owned, and private health care facilities.

Article 3. This Decision shall take effect fifteen days from the date of publication in the Official Gazette.

Article 4. The Heads of the Office, Directors of the Treatment Department, Heads of the Inspectorate, Heads of Departments, and Directors of Bureaus under the Ministry of Health, Heads of subordinate units under the Ministry, Directors of Provincial and Municipal Health Services; and Heads of Health Services in sectors are responsible for implementing this Decision.

REGULATIONS

Hospitals Meeting Conditions to Perform Kidney Transplantation Techniques
(Issued together with Decision No. 4701/2003/QĐ-BYT dated September 3, 2003 of the Minister of Health)

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This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

Article 1. The kidney transplant facility must have medical staff with the appropriate technical qualifications for kidney transplantation and sufficient material and technical conditions, departmental organization, equipment, and technical facilities, which have been reviewed and recognized by the Ministry of Health as meeting the conditions to perform kidney transplantation techniques.

Article 2. Kidney transplantation must be carried out strictly according to the kidney transplantation technique procedures issued by the Ministry of Health.

II. SPECIFIC PROVISIONS

Clause 1. Medical Staff

- Must have a team of medical staff capable of performing kidney transplants, these staff members must be trained and provided with knowledge about kidney transplantation, and must be certified by the training institution designated by the Ministry of Health.

- The head of the kidney transplant team must be someone who has directly performed kidney transplants on patients at a hospital recognized by the Ministry of Health as meeting the conditions to perform kidney transplantation techniques.

Clause 2. Material and Technical Conditions - Departmental Organization

Sub-Clause 2.1. Clinical

- Must have surgical and internal medicine departments that have developed specialized fields such as vascular surgery, nephrology, and urology.

- Must have a dialysis department and blood purification units in the postoperative ward.

- Must have a surgery-anesthesia-recovery department ensuring the removal, washing, transplantation, and post-transplant care of kidneys.

Sub-Clause 2.2. Paraclinical

- Must have hematology, blood transfusion, biochemistry, microbiology, diagnostic imaging, functional testing, and pathology departments to ensure diagnosis and monitoring of both kidney donors and recipients before, during, and after transplantation.

- Must have an experimental kidney transplant unit;

- Must ensure the availability of immunological, viral, and cyclosporine A concentration tests.

Article 3. Medical Equipment and Medications

- Must have adequate medical equipment and instruments to ensure kidney removal, washing, preservation, and transplantation.

- Must have a sufficient supply of medications necessary to meet treatment requirements.

Article 4. Funding for Kidney Transplantation from Various Sources

- Contributions from patients;

- Hospital funding;

- Other legitimate sources of funding (if any).

Management and utilization of the aforementioned funding must comply with current regulations.

Article 5. Operational Mechanism

The hospital director organizes and manages the kidney transplantation process and is responsible to the Minister of Health and the law regarding kidney transplantation at the hospital.

III. IMPLEMENTATION

Clause 1. After meeting the above conditions, the hospital reports to the Ministry of Health to register for kidney transplantation.

Clause 2. The Ministry of Health's Council for Reviewing Hospitals Meeting Conditions for Kidney Transplantation will conduct an assessment at the hospital and report the results to the Minister of Health.

Clause 3. The Minister of Health will base their decision to recognize or not recognize the hospital as meeting the conditions for kidney transplantation on the Council's assessment report.

The hospital may only proceed with kidney transplantation after receiving a recognition decision from the Minister of Health./.