Quyết định 08/2008/QĐ-BYT về điều kiện đối với cơ sở y tế lấy, ghép mô, bộ phận cơ thể người

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.

4. Have a technical section, comprising;

- A post-transplantation treatment unit.

- A post-transplantation examination and supervision unit.

5. Have an experimental transplantation unit.

6. Have laboratories for blood test, blood transfusion, biochemistry, microbiology, pathological surgery, diagnostic radiography and functional exploration. Be capable of or enter into association with other parties for testing immunology and quantifying anti-rejection drugs to meet requirements on diagnosis and supervision of donors and recipients before, during and after human organ transplantation.

7. Have a blood ventilation and dialysis unit for kidney transplantation.

8. Have adequate medical equipment and instruments, meaning to fully have equipment and instruments (of their own or through association with other parties) for transplantation of each human organ.

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

III. MEDICAL ESTABLISHMENTS REMOVING AND TRANSPLANTING ORGANS OF DEAD HUMANS (BRAIN DEATH)

1. Medical establishments which do not transplant human organs must:

a/ Have a recovery ward and specialists for recovering brain-dead persons pending removal of organs.

b/ Have sufficient conditions and equipment for determining brain death as prescribed by law.

c/ Have a team of experts for determining brain death as prescribed by law.

d/ Have a system of communication and means of transport meeting prescribed requirements.

2. Medical establishments which transplant human organs must:

a/ Satisfy the conditions specified in Section II and Clause 1 of this Section.

b/ Have a team of experts for removing human organs and equipment for preserving and transporting human organs to sites of transplantation.

B. ORDER OF AND PROCEDURES FOR LICENSING MEDICAL ESTABLISHMENTS FOR REMOVAL AND TRANSPLANTATION OF HUMAN TISSUES AND ORGANS

1. Dossiers of registration for removal and transplantation of human tissues and organs:

- A written request to the Ministry of Health for registration of removal and transplantation of human tissues and organs; medical establishments under provincial/municipal Health Services, the Ministry of Defenses Army Medical Department and the Ministry of Public Securitys Health Department must obtain a written approval of their respective state management agencies (provincial/ municipal Health Services, the Ministry of Defenses Army Medical Department and the Ministry of Public Securitys Health Department).

- A scheme on removal and transplantation of human tissues and organs, covering contents on personnel organization, material foundations and medical equipment and funds for operation.

2. Order of and procedures for licensing medical establishments for removal and transplantation of human tissues and organs:

a/ Step 1: A medical establishment satisfying the conditions specified in Sections I, II and III shall submit to the Ministry of Health a dossier of registration for removal and transplantation of human tissues and organs.

b/ Step 2: The Minister of Health shall issue a decision to establish an appraisal council which shall appraise the medical establishments conditions for removal and transplantation of human tissues and organs.

An appraisal council is composed of specialists in surgery, recovery, hematology-immunology, microbiology and other specialties related to the removal and transplantation of human organs.

c/ Step 3: After being appraised, the medical establishment shall complete contents of its schemes in conformity with conclusions of the appraisal council (if any) in its report oil appraisal results to the Ministry of Health for consideration.

d. Step 4: Within 10 working days from the date of receiving a valid dossier the Minister of Health shall issue a decision to establish an appraisal council: within 15 days, the appraisal council shall conduct on-site appraisal and report appraisal results to the Ministry of Health. Based on the councils appraisal results, the Minister of Health shall issue a decision recognizing the medical establishments satisfaction of conditions for removal and transplantation of human tissues and organs; when a medical establishment fails to meet these requirements, within 5 days, the Ministry of Health shall issue a written reply clearly stating the reason.

A medical establishment may remove and transplant human tissues and organs only after the Health Ministers decision recognizing its satisfaction of conditions for removal and transplantation of human tissues and organs is issued.