2、analytic81§ Samples notreceived§ Ordering§ CollectionAnalytic10Post-analytic8Total frequency0. 81‰(1189 on 1,454,251 results)Sigma-Metric: 4.7Defects Per Million:8186Szecsi PB, Odum L. Clin Chem Lab Med 20096σ理论认为,大多数企业在3σ~4σ间运转,也就是说每百万次操作失误在6210~66800之间,这些缺陷要求经
3、营者以销售额的15%~30%的资金进行事后的弥补或修正,而如果做到6σ(做100万件事情,其中只有3.4件是有缺陷的),事后弥补的资金将降低到约为销售额的5%。78910• These dramatic errors resulted in 1) an unnecessaysurgery and 2) delayed treatment.• Botherrorswere“pre-analytical”:technicianshadmixed-up patient slides with those of other pa
4、tients.• One of the two patients said: laboratories are a prettyimportant part of the whole medical thing.11实验室不合格标本及Sigma值对比时间送检总数差错总数差错率‰6 Sigma2011.7-2012.62012.7-2013.62013.7-2014.62014.7-2014.123497773739544324622247581650151616227994.7174.0543.7513.
6、d as the systematicapplication of management policies, procedures,and practices to the tasks of analyzing, evaluating,controlling, and monitoring risk (ISO 14971).风险管理:系统地应用管理政策、程序和做法,分析、评价、控制和监控风险。目的: 是将可避免的风险、成本及损失极小化理想:以最少的资源化解最大的危机。1617风险管理工具• ISO14971:200
7、7, Medical devices – Applicationof risk management to medical devices. (EP22-P)• CLSI guideline EP18-A2, “Risk managementtechniques to identify and control errorsources”• CLSI guideline EP23-A, “Laboratory qualitycontrol based on risk management” (C24-A3)• ISO/TS
8、 22367:2008(E), Medical laboratories —Reduction of error through risk managementand continual improvement• ISO 31000:2009, Risk management – Principlesand guid