| Notice of the National Health Commission on Issuing the Administrative Provisions on the Procurement and Distribution of Donated Organs | | 国家卫生健康委关于印发人体捐献器官获取与分配管理规定的通知 |
| (No. 2 [2019] of the National Health Commission) | | （国卫医发〔2019〕2号） |
| Health commissions of all provinces, autonomous regions and municipalities directly under the Central Government, and the Health and Family Planning Commission of Xinjiang Production and Construction Corps: | | 各省、自治区、直辖市卫生健康委，新疆生产建设兵团卫生计生委： |
| For the purposes of promoting human organ donation and transplantation, further regulating the procurement of human organs, improving the system for the procurement and distribution of human organs and spurring the sound and sustainable development of human organ donation and transplantation undertaking, we have produced the Administrative Provisions on the Procurement and Distribution of Donated Organs ("the Provisions") after revising the Administrative Provisions on the Procurement and Distribution of Donated Organs (for Trial Implementation) (No. 11 [2013] of the National Health Commission), the Provisions are hereby issued to you for your compliance. | | 为积极推进人体器官捐献与移植工作，进一步规范人体器官获取，完善人体器官获取与分配体系，推动人体器官捐献与移植事业健康、可持续发展，我委对《人体捐献器官获取与分配管理规定（试行）》（国卫医发〔2013〕11号）进行修订，形成了《人体捐献器官获取与分配管理规定》。现印发给你们，请遵照执行。 |
| National Health Commission | | 国家卫生健康委 |
| January 17, 2019 | | 2019年1月17日 |
| Administrative Provisions on the Procurement and Distribution of Donated Organs | | 人体捐献器官获取与分配管理规定 |
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| Chapter I General Provisions | | 第一章 总则 |
| Article 1 For the purposes of promoting human organ donation and transplantation, further regulating the procurement of human organs, improving the system for the procurement and distribution of human organs and spurring the sound and sustainable development of human organ donation and transplantation undertaking, the Provisions are hereby formulated based on the work reality according to such regulations and policies as the Regulations on Human Organ Transplantation. | | 第一条 为积极推进人体器官捐献与移植工作，进一步规范人体器官获取，完善人体器官获取与分配体系，推动人体器官捐献与移植事业健康、可持续发展，依据《人体器官移植条例》等法规政策，结合工作实际，制定本规定。 |
| Article 2 The Provisions shall apply to the procurement and distribution of organs donated from deceased donors (the "Donated Organs", including portions of an organ). | | 第二条 本规定适用于公民逝世后捐献器官（以下简称捐献器官，包括器官段）的获取与分配。 |
| Article 3 For the purpose of the Provisions, the Organ Procurement Organization (OPO) is a special medical organization or institution that is affiliated to an eligible medical institution, comprises surgeons, neurosurgeons, physicians and nurses of the Department of Critical Care Medicine and human organ donation coordinators, and procures, restores, maintains, keeps and transfers human organs taken from deceased donors. | | 第三条 本规定中人体器官获取组织（以下简称OPO）是指依托符合条件的医疗机构，由外科医师、神经内外科医师、重症医学科医师及护士、人体器官捐献协调员等组成的从事公民逝世后人体器官获取、修复、维护、保存和转运的医学专门组织或机构。 |
| Article 4 The National Health Commission supervises and manages the procurement and distribution of donated organs nationwide. | | 第四条 国家卫生健康委负责全国人体捐献器官获取与分配的监督管理工作。 |
| Administrative departments of health above the county level supervise and manage the procurement and distribution of donated organs within their respective jurisdictions. | | 县级以上卫生健康行政部门负责辖区内人体捐献器官获取与分配的监督管理工作。 |
| Article 5 A medical institution shall strengthen the daily management of the OPO set up by it to guarantee the operation of the OPO in a standardized manner. | | 第五条 医疗机构应当加强对所设OPO的日常管理，保障其规范运行。 |
| Chapter II Procurement of Donated Organs | | 第二章 捐献器官的获取 |
| Article 6 The OPO shall procure a donated organ after the donor dies according to the standard procedures and technical specifications for the procurement of human organs. The types and quantity of donated organs shall be consistent with those stated in the informed consent on the donation of human organs. | | 第六条 OPO获取捐献器官，应当在捐献者死亡后按照人体器官获取标准流程和技术规范实施。获取捐献器官种类和数量，应当与人体器官捐献知情同意书一致。 |
| Article 7 The OPO shall perform the following duties: | | 第七条 OPO应当履行以下职责： |
| 1. Medically assessing potential donors within the scope of its services. | | （一）对其服务范围内的潜在捐献者进行相关医学评估。 |
| 2. Checking the informed consent for the donation of human organs and other legal documents before procuring the organs. | | （二）获取器官前核查人体器官捐献知情同意书等合法性文件。 |
| 3. Maintaining the functions of donated organs. It shall procure the corresponding donated organ according to the donor's last will or the common written will of the donor's spouse, grown-up children and parents after the donor dies. | | （三）维护捐献器官功能。捐献者死亡后，依据捐献者生前意愿或其配偶、成年子女、父母共同书面意愿获取相应捐献器官。 |
| 4. Uploading clinical data and legal documents on potential donors, donors and donated organs to the Chinese Computer System for Human Organ Distribution and Sharing ("the Organ Distribution System", website: www.cot.org.cn). | | （四）将潜在捐献者、捐献者及其捐献器官的临床数据和合法性文件上传至中国人体器官分配与共享计算机系统（以下简称器官分配系统，网址：www.cot.org.cn）。 |
| 5. Using the Organ Distribution System to initiate the automatic distribution of donated organs. | | （五）使用器官分配系统启动捐献器官的自动分配。 |
| 6. Procuring, keeping and transporting donated organs, and delivering such donated organs to the hospitals where human organ transplantation recipients on the recipient waiting list are located and who are qualified for human organ transplantation ("the Transplanting Hospitals") for confirmation based on the distribution results of the Organ Distribution System. | | （六）获取、保存、运送捐献器官，并按照器官分配系统的分配结果与获得该器官的人体器官移植等待者（以下简称等待者）所在的具备人体器官移植资质的医院（以下简称移植医院）进行捐献器官的交接确认。 |
| 7. Carrying out medical treatment to the body of the donor according to the ethical principles, cherishing the memory of the deceased and comforting the deceased's family members. | | （七）对捐献者遗体进行符合伦理原则的医学处理，并参与缅怀和慰问工作。 |
| 8. Protecting the personal privacy of the donor, the recipient and those on the recipient waiting list, and safeguarding their legitimate rights and interests. | | （八）保护捐献者、接受者和等待者的个人隐私，并保障其合法权益。 |
| 9. Organizing special trainings for related medical workers of the medical institution within the scope of its services with respect to the identification of potential donors, first aid and organ function maintenance, and conducting academic exchanges and scientific research. | | （九）组织开展其服务范围内医疗机构相关医务人员的专业培训，培训内容涉及潜在捐献者的甄别、抢救、器官功能维护等。开展学术交流和科学研究。 |
| 10. Cooperating with the Red Cross societies and other human organ donation management institutions at all levels in publicizing, mobilizing, coordinating and witnessing human organ donations, and in mourning and commemoration. | | （十）配合本省份各级红十字会人体器官捐献管理机构做好人体器官捐献的宣传动员、协调见证、缅怀纪念等工作。 |
| Article 8 The OPO shall set up a donated organ procurement team with the required expertise and specialized capabilities, formulate medical standards for the identification and selection of potential donors, establish standard technical specifications for donated organ procurement, and provide professionals and special equipment so as to guarantee the quality of the organs procured. | | 第八条 OPO应当组建具备专门技术和能力要求的人体捐献器官获取团队，制定潜在捐献者识别与筛选医学标准，建立标准的人体捐献器官获取技术规范，配备专业人员和设备，以确保获取器官的质量。 |
| Article 9 A medical institution that intends to set up an OPO shall conform to the planning of the provincial administrative department of health as well as the basic conditions and management requirements for the OPO. | | 第九条 医疗机构成立OPO，应当符合省级卫生健康行政部门规划，并符合OPO基本条件和管理要求。 |
| Article 10 The OPO shall be independent of the Human Organ Transplantation Department. | | 第十条 OPO应当独立于人体器官移植科室。 |
| Article 11 The provincial administrative department of health shall plan the setting up of OPOs within its jurisdiction in accordance with the principles of satisfying the demand, being the only organ procurement organization and of proximity so that OPOs can be set up as widely as possible across the province and meet the needs of the recipients, rationally dividing areas of services of the OPOs without overlapping. | | 第十一条 省级卫生健康行政部门应当根据覆盖全省、满足需要、唯一、就近的原则做好辖区内OPO设置规划，合理划分OPO服务区域，不得重叠。 |
| Article 12 The provincial administrative department of health shall, based on the planning for the setting up of OPOs, reduce the number of OPOs to be set up when needs are satisfied, and gradually establish a uniform OPO across the province. | | 第十二条 省级卫生健康行政部门应当根据OPO设置规划，在满足需要的前提下减少OPO设置数量，逐渐成立全省统一的OPO。 |
| Article 13 The provincial administrative department of health shall timely submit a list of OPOs and their service areas to the National Health Commission for record. Where the provincial administrative department of health changes its list of OPOs or its service areas, it shall present the changed list or service areas to the National Health Commission for record within five working days of change. | | 第十三条 省级卫生健康行政部门应当将OPO名单及其服务区域及时报国家卫生健康委备案。变更OPO名单或服务区域，应当在变更后5个工作日内报国家卫生健康委备案。 |
Article 14 The OPO shall procure donated organs within the area of service designated by the provincial administrative department of health and shall not transfer potential donors or procure organs beyond the area.
．．．．．． | | 第十四条 OPO应当在省级卫生健康行政部门划定的服务区域内实施捐献器官的获取，严禁跨范围转运潜在捐献者、获取器官。
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