临床实验室检测系统分析性能采用σ验证的必要性

Role of sigma validation for the analysis performance of determination systems among clinical laboratories

为了实现符合临床需求的质量目标,临床实验室专家设计了质量控制方法,并以此为基础,建立了以质量目标为目的的质量控制方法。Westgard的西格玛(σ)多规则质量控制方法就是以临床需求为质量控制目标而设计并建立的。要建立一个质量控制方法,除了有明确的临床质量目标外,还必须强化检测系统概念,对检测系统的分析性能予以验证或确认。Westgard还提出,为确保实现临床质量目标,正在使用中的检测系统是否符合质量要求也需验证。由于临床实验室对每个需要检测的项目均只做1次检测就发出检验报告,因此可以完整叙述并形成质量控制理论,且用于实践的只能是误差理论和以总误差为质量目标的质量控制方法,不确定度不适用于临床实验室单次检测的做法。

Experts design and establish quality control methods,like sigma（σ） multi-rule quality control method by Westgard,in order to meet the requirements of clinical laboratories. In this process,besides clear clinical quality objectives,the concept of determination system should be available and must be strengthened,the analysis performance of determination system should be veri？ed or con？rmed,and whether determination systems meet the requirements or not also should be veri？ed. Determination report is issued after each item determined just for 1 time. Therefore,quality control methods with complete description and theory,such as using error and total error,not using uncertainty,are suitable for single-time determination.