应用六西格玛理论评价临床实验室检验性能及设计质控方案

Apply Six Sigma Quality Management to Assess the Quality Performance of Clinical Laboratory and Design Quality Control

目的:运用西格玛指标评价临床实验室检验阶段性能,以发现问题,指导质量改进。方法:收集本实验室2006年下半年室内质量控制数据及CAP能力比对实验的数据,计算CV%及BIAS%。根据检验项目的CV%、BIAS%及总允许误差计算西格玛值,同时绘制标准化西格玛性能评价图,评价临床实验室检验阶段性能,并设计质量控制方案。计算未达6西格玛的项目的QGI值,查找导致性能不佳的主要原因,指导质量改进。结果:60%的检验项目性能大于4西格玛,所有检验项目的平均西格玛值为4.44,在未达6西格玛的检验项目中,63%的项目需要优先改进精密度。结论:检验阶段的质量控制仍不能减少,设计个体化的质量控制方案可更有效地控制质量。

Objective： Apply sigma metrics to assess the performance of clinical laboratory, then find problems and promote quality improvement. Method： we collected data of imprecision and inaccuracy from routine internal quality control and proficiency test of College of American pathologists （CAP） respectively. Then we calculated sigma metrics which reflect the performance of examinatorial process with equation, and designed quality control strategy. In addition, we calculated quality goal index for analysis with sigma metrics below 6 to find problem. Result： Sigma metrics of 60% analysis are above four, the average sigma metric of all analysis is 4.44. The main problem of analysis which are below 6sigma is their bad imprecision. Conclusion： The examinatorial process still needs more intensive and individualized quality control than the CLIA minimum requirement of two levels per day.