Decision No. 08/2008/QD-BYT the Ministry of Health promulgating the Regulation on conditions for medical establishments removing and transplanting human tissues and organs and order of and procedures for licensing their operation

DECISION

PROMULGATING THE REGULATION ON CONDITIONS FOR MEDICAL ESTABLISHMENTS REMOVING AND TRANSPLANTING HUMAN TISSUES AND ORGANS AND ORDER OF AND PROCEDURES FOR LICENSING THEIR OPERATION

THE MINISTER OF HEALTH

Pursuant to the Governments Decree No. 188/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the November 29, 2006 Law on Donation, Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers;

At the proposal of the director of the Medical Examination and Treatment Management Department of the Ministry of Health,

DECIDES

Article 1. To promulgate together with this Decision the Regulation on conditions for medical establishments removing and transplanting human tissues and organs and order of and procedures for licensing their operation.

Article 2. This Decision takes effect 15 days after its publication in CONG BAO.

Article 3. The director of the Office, the Chief Inspector, directors of Departments, directors of Bureaus, of the Ministry of Health, directors of provincial/municipal Health Services, directors of the Health Ministry-attached hospitals, and heads of health agencies under the management of other branches shall implement this Decision,

REGULATION

ON CONDITIONS FOR MEDICAL ESTABLISHMENTS REMOVING AND TRANSPLANTING HUMAN TISSUES AND ORGANS AND ORDER OF AND PROCEDURES FOR LICENSING THEIR OPERATION
(Promulgated together with the Health Ministers Decision No. 08/2008/QD-BYT of February 14, 2008)

A. MEDICAL ESTABLISHMENTS REMOVING AND TRANSPLANTING HUMAN TISSUES AND ORGANS MUST SATISFY THE FOLLOWING CONDITIONS:

I. MEDICAL ESTABLISHMENTS REMOVING AND TRANSPLANTING HUMAN TISSUES MUST:

1. Have sufficient medical personnel who are professionally capable and qualified, and have been trained at tissue transplantation establishments and granted a specialty certificate or diploma by these establishments,

2. Have a chief of the tissue transplantation team who is capable of transplanting tissues on humans: and specialists who have been trained in removal of tissues from the deceased,

3. Have an operating room fully equipped for transplantation of tissues on humans,

4. Have a section for post-transplantation treatment and supervision,

5. Have laboratories (of their own or through association with other establishments) to meet requirements on diagnosis and supervision of donors and recipients before, during and after transplantation such as blood lest, blood transfusion, biochemistry, microbiology, pathological surgery, diagnostic radiography, functional exploration, immunologic test and quantification of anti-rejection drugs (cyclosporin A, tacrolim).

6. Have adequate medical equipment and instruments, meaning to fully have special-use equipment and instruments (of their own or through association with other parties) for each kind of tissue transplantation.

7. Have sufficient types and volumes of medicines and drugs for post-transplantation treatment.

8. Have a sterilized place for removal of tissues of the deceased.

9. Have an experimental transplantation unit (in cooperation with research or training institutions).

II. MEDICAL ESTABLISHMENTS REMOVING AND TRANSPLANTING ORGANS OF LIVING HUMANS MUST:

1. Have sufficient medical personnel who are professionally capable and qualified, and have been trained at human organ transplantation establishments and granted a specialty certificate or diploma by these establishments.

2. Have a chief of the human organ transplantation team who has directly conducted or participated in transplant operations.

3. Have at least three closed and interrelated sterilized rooms of positive pressure arranged in a one-way direction, including one for removal, treatment and preservation of human organs; one for transplantation; and one for post-transplantation recovery.

Three closed and interrelated rooms mean three rooms which are interconnected in a closed space separated from the outside environment.