医疗机构临床实验室自建检测方法流程与管理专家共识

Expert consensus on the workflow and management of laboratory developed tests in medical institutions

随着临床医学和检验医学的不断发展,实验室自建检测方法(包括自制试剂等)流程与管理规范化成为医疗机构的迫切需求。北京医学会检验医学分会、上海市医学会检验医学专科分会组织专家进行了政策学习、文献归纳、专业讨论与总结,并形成该专家共识。该共识基于自建检测的质量、风险、性能三方面核心关键要素,围绕术语、研发与产品准备、检验流程、登记备案、督查、检验前中后环节、转化应用与推广等内容给出了共识性建议,以期为医疗机构开展相应工作提供参考。

With the continuous development of clinical medicine and laboratory medicine,the normalization of workflow and management of laboratory developed tests(LDTs)(including self-made reagents,etc.)has become anxious needs for medical institutions.The Laboratory Medicine Society of Beijing Medical Association and the Laboratory Medicine Society of Shanghai Medical Association organized experts to conduct policy learning,literature review,professional discussion and summary,and formed this expert consensus.Based on the core key elements of quality,risk,and performance of LDTs,this consensus provides consensus on terminology,research and development,product preparation,inspection process,registration and documentation,supervision,pre-,mid-,post-analytical processes,transformative application and promotion,etc.It is expected to give reference for medical institutions carrying out corresponding work.