医学实验室认可在临床微生物学检验领域的实践  

Application of medical laboratory accreditation in the field of clinical microbiology

作　　者：贾红兵[1,2] 李爽[2] 鄢盛恺[2] 

机构地区：[1]中国医学科学院北京协和医学院研究生院,北京100005 [2]中日友好医院检验科,北京100029

出　　处：《实验与检验医学》2011年第4期339-342,共4页Experimental and Laboratory Medicine

摘　　要：临床微生物学检验作为医学实验室的认可领域之一,其认可在我国目前主要根据CNAS-CL02:2008《医学实验室质量和能力认可准则》和CNAS-GL23:2008《医学实验室质量和能力认可准则在临床微生物学检验领域的指南》来进行的。本文根据临床微生物检验领域医学实验室认可不同阶段,针对学习认可文件、编写标准化作业指导书、现场评审、分析前质量控制、建立危急结果回报制度、持续改进质量和管理体系以及存在的问题等进行论述与讨论,以促进我国临床微生物检验领域医学实验室认可的发展与进步。Clinical microbiology is one field of the clinical laboratory for medical laboratory accreditation,which is accredited according to CNAS-CL02： 2008 ＂Accreditation Criteria for the Quality and Competence of Medical Laboratories Identical to ISO 15189：2007＂ and CNAS-GL23： 2008 ＂Guidance on the Medical Labroratory Quality and Competence Accreditation Criteria in the Field of Clinical Microbiology＂ in China.In the review,we summarize the experiences on different stages of medical laboratory accreditation in the field of clinical microbiology.Some key issues were discussed including learning accreditation documents,compiling standard operation procedure（SOP）,on-site inspection,quality control of pre-examination procedures,establishing the system of reporting critical results,continuous improvement of quality and management system,and existing problems on the medical accreditation.We hope the review contributes to the development of medical laboratory accreditation in the field of clinical microbiology in China.

关 键 词：医学实验室认可 临床微生物学 质量管理体系 

分 类 号：R446[医药卫生—诊断学]