CCP's "Management Regulations for Clinical Application of Human Organ Transplantation Technology (2020 Edition)"

Press Release (Translation) : Medical Administration and Hospital Authority, National Health Commission, CCP

Ref : http://www.nhc.gov.cn/yzygj/s3586/202008/8039802045c44503a83957214c1a77ed.shtml 

　　 1. Background

　　 In June 2006, the former Ministry of Health issued the "Regulations for the Technical Management of Liver, Kidney, Heart, and Lung Transplantation" (Weiyifa [2006] No. 243), which played an important role in regulating the clinical application of human organ transplantation in my country. With the continuous deepening of the cause of organ donation and transplantation in my country, the "Technical Management Regulations for Liver, Kidney, Heart, and Lung Transplantation" issued in 2006 can no longer meet the current needs for the high-quality development of human organ donation and transplantation. Pancreas and small intestine transplantation operations also mature gradually. Therefore, our committee initiated the revision of the "Technical Management Specifications for Liver, Kidney, Heart, and Lung Transplantation" in 2019, and added the technical management specifications for pancreas and small bowel transplantation.

　　 2. Main content

The "Management Regulations for the Clinical Application of Human Organ Transplantation Technology (2020 Edition)" (hereinafter referred to as the "Management Regulations") issued this time is the basis for my country to carry out six human organ transplant technologies including human liver, kidney, heart, lung, pancreas, and small intestine. Requirements mainly include medical institutions, personnel, technical management, training management, etc.

　　 (1) Basic requirements of medical institutions. In accordance with the reform spirit of the State Council’s “delegation, regulation, and service”, the "Management Regulations" abolished the hierarchical restrictions on medical institutions that carry out human organ transplantation technology. At the same time, the requirements for the management of the clinical application of human organ transplantation in medical institutions have been strengthened. First, it is clear that medical institutions need to have a clinical application and ethics committee for human organ transplantation that meets the requirements; the second is the establishment and standardization of the management of human organ transplantation technology in medical institutions to carry out the requirements; the third is to refine the site, equipment and facility requirements for the development of human organ transplantation technology, and further clarify the conditions for carrying out the liver, kidney, heart, lung, pancreas, small intestine and other human organ transplantation technologies. .

　　 (2) Basic requirements for personnel. The "Management Regulations" canceled the requirements for the number of surgical cases related to human organ transplant doctors; it is clear that the clinical application of human organ transplantation technology should be carried out by human organ transplant doctors recognized by the provincial health administrative department or the military health department, and the medical institution. The number of human organ transplant doctors in related transplant projects has put forward specific requirements; related requirements have been added for brain death determination technicians and transplant data network direct reporting personnel.

　　 (3) Basic requirements for technical management. The "Management Regulations" canceled the non-technical management requirements such as cold ischemia time during the preservation of human donated organs that should be stipulated in the relevant professional diagnosis and treatment specifications, and the number of human organ transplant operations carried out by medical institutions. Adjust the preoperative inspection items for some human organ transplants; further strengthen the main responsibility of medical institutions, and put forward specific requirements for the admission of human organ transplant physicians, the implementation of transplant operations, ethical review procedures, and transplant quality management in medical institutions. Clearly regulate the use of China Human Organ Distribution and Sharing Computer System (COTRS), and complete relevant data reporting within 72 hours after surgery.

　　 (4) Training management requirements. The "Management Regulations" have strengthened the requirements for training management. For specific requirements, please refer to the supporting documents "Management Measures for the Training and Accreditation of Human Organ Transplant Doctors (Trial)" and "Basic Requirements for Human Organ Transplant Doctors Training Base (Trial)".