ISO 15189医学实验室认可标准下血细胞分析仪故障修复后的检验质量验证  

Verification of Inspection Quality after Repair of Blood Cell Analyzer Failure by ISO 15189 Medical Laboratory Accreditation Standards

作　　者：张金彪[1] 代荣琴[2] ZHANG Jin-biao;DAI Rong-qin(Department of Laboratory Diagnosis,Cangzhou Integrated Traditional Chinese and Western Medicine Hospital,Hebei Cangzhou 061001,China;Department of Medical Technology of Cangzhou Medical College,Hebei Cangzhou 061001,China)

机构地区：[1]河北省沧州中西医结合医院实验诊断科,河北沧州061001 [2]沧州医学高等专科学校医学技术系,河北沧州061001

出　　处：《现代检验医学杂志》2020年第5期168-172,共5页Journal of Modern Laboratory Medicine

摘　　要：在ISO 15189实验室认可管理模式下,医疗设备发生故障时,如何进行修复后验证,实验室应该根据CNASCL02系列文件的相关规定进行一系列验证操作:更新标识、修复后验证、故障前追溯。对标准文件的理解程度和行为规范是影响检验质量的重要原因,也是不符合项的主要来源,对CNAS-CL02和CNAS-CL02-A001中相关设备维修条款是否理解透彻,是正确实施验证的前提。如何根据故障原因科学、适宜的选用验证方法是验证成功的关键。以此方可保证故障修复后的检验质量。How to perform post-repair verification when the medical equipment failed,by the laboratory accreditation management mode of the ISO 15189,the laboratory should perform a series of verification operations according to the criterions of the CNAS-CL02 refered the series of documents:update identification,post-repair verification and traceability before failure.The understanding of standard documents and codes of conduct were the most important reasons that affected the quality of inspections,and were also the main source of non-compliance.A thorough understanding of the relevant equipment maintenance terms in CNAS-CL02 and CNAS-CL02-A001 was a prerequisite for correct implementation of verification.How to choose the appropriate verification method according to the cause of the failure was the key to successful verification.In this way,the quality of inspection after fault repair could be guaranteed.

关 键 词：医学实验室认可 血细胞分析仪 故障修复 质量验证 

分 类 号：R446[医药卫生—诊断学]