Westgard西格玛规则在设定生化个性化质控策略中的应用

The Application of Westgard Sigma Rule in the Setting Process ofBiochemical Personalized Quality Control Strategy

目的对急诊生化分析项目进行Westgard西格玛性能评价,设定个性化的质控规则,确定合适的质控频率,明确改进方向,规范室内质控的开展。方法收集本院急诊生化检测系统21个分析项目共24个月的质控数据所得到的实际累积不精密度(CV)、与对等组的偏倚(BIAS)以及本院设定的允许总误差(TEa),使用Unity Real Time(简称URT)质控管理平台,得到分析项目的σ值、推荐的质控规则、假失控率和误差检出率等信息;并应用新推出的分析批长度Westgard Sigma规则流程图这一工具,来确定各分析项目合适的分析批长度(质控频率);而对于σ<6的分析项目,通过计算其质量目标指数(QGI),查找方法性能不佳的原因进行改进。结果(1)21个生化分析项目的实际累积CV、BIAS和总误差TE均在质量目标设定范围之内,不同项目的σ值不同,采用的质控规则从单规则到多规则,实现了个性化质控规则的设定;(2)21个生化分析项目的分析批长度不尽相同,结合该院平均每日急诊生化类样本数量选择合适的质控检测频率;(3)对于σ<6的17个分析项目中,QGI<0.8有16个项目,提示优先改进精密度;QGI>1.2有1个项目,提示优先改进正确度。结论Westgard西格玛规则是一种科学,实用的质量控制规则选取、分析批长度评估工具,可有效地应用于定量分析项目的质量管理。

Objective To evaluate the performance of emergency biochemical analysis by Westgard Sigma,to set personalized quality control rules,also to determine the appropriate quality control frequency,clarify the improvement direction,and to standardize the development of indoor quality control.Methods The actual cumulative imprecision(CV),Bias with the peer group and total allowable error(TEa)set by the hospital were collected from the quality control data of 21 analysis items in the emergency biochemical testing system of the hospital for 24 months.Unity Real Time(URT)quality control management platform was used to obtain the information,such asσvalue,recommended quality control rules,false runaway rate and error detection rate of the analysis items.And we used the new analysis batch length Westgard Sigma rule flow chart tool to determine the appropriate analysis batch length(quality control frequency)for each analysis item.For analyzing items withσ<6,the quality goal index(QGI)was calculated to identify reasons for the poor performance of the method.Results(1)The actual cumulative CV,BIAS and total error(TE)of 21 biochemical analysis items in the hospital were all within the range of quality objectives.Theσvalues of different items were different,and the quality control rules were applied from single rule to multiple rules,which achieved the setting of personalized quality control rules.(2)The analytical batch lengths of 21 biochemical analysis items were different,and the appropriate quality control test frequency was selected based on the average number of emergency biochemical samples in the hospital every day.(3)Among 17 analysis items withσ<6,16 items with QGI<0.8 which indicated improving precision was a priority;and 1 item with QGI>1.2,prompting priority to improve accuracy.Conclusion Our results indicate that Westgard Sigma rule can serve as a scientific and practical quality control rule selection,as well as an analysis batch length assessment tool,which can be effectively applied to quantitative analysis of project quality management.