创建中国特色的器官获取组织质量管理体系

Establishment of quality management system of Organ Procurement Organization with Chinese characteristics

质量保证是器官获取组织(OPO)的责任,创建OPO质量管理体系是高质量开展人体器官捐献工作面临的新任务。当前我国OPO质量管理中存在着缺乏完善的管理机构、规范的管理流程、科学的评价指标、高素质的专业人才和浓厚的安全文化氛围等问题,有必要从思想观念转变、质量管理体系建设和过程实施管理等3个方面,紧密结合OPO的实际状况,参照国际通用质量管理体系标准进行顶层设计,更需要OPO管理者充分发挥领导作用,确保OPO在质量管理体系的持续改进中高效运行。

Quality assurance is the responsibility of Organ Procurement Organization(OPO).The establishment of OPO quality management system is a novel task for implementing high-quality human organ donation.At present,the quality management of OPO still has certain problems,such as lack of comprehensive management organization,standardized management process,scientific evaluation index,qualified professionals and strong safety culture atmosphere,etc.It is necessary to deliver top-level design from three perspectives of ideological concept change,quality management system construction and process implementation management in combination with the actual situation of OPO and reference to the criteria of international general quality management system.More importantly,the managers of OPO should play a leading role in ensuring the efficient operation of OPO in the persistent improvement of quality management system.