【摘要】 目的对血细胞分析项目进行六西格玛性能评价,选择个性化质控规则,提出改进方向,为提高检测质量奠定基础。方法根据血细胞分析项目的不精密度[变异系数(CV)]、不正确度[偏移(Bias)]和允许总误差(TEa),应用Unity Real Time质控软件(简称URT)Westgard Advisor功能,得到分析项目西格玛(σ)值、σ度量图和个性化规则等信息。对σ值未能达到6的项目,通过质量目标指数(QGI)查找导致方法性能不佳的主要原因,并根据分析批长度Westgard西格玛规则流程图,确定分析项目分析批长度。结果不同血细胞分析项目性能特征和建议质控规则并不相同,各项目从单独1个规则到多规则均选择了个性化质控规则。对σ值未达到6的分析项目,根据QGI提示,除血红蛋白项目需优先改进正确度外,其他项目均需优先改进精密度;实验室在用检测系统经综合评估后,确定分析批长度为200份,与实际系统每日检测样本量一致。结论应用URT对血细胞分析等定量分析项目进行六西格玛性能评价,可根据性能特征选择个性化质控规则,并根据QGI进行持续改进;根据分析批长度Westgard西格玛规则流程图确定合适的分析批长度,可确保检测质量。更多还原

【Abstract】 Objective To evaluate blood cell analysis projects through using 6 sigma （σ） performance evaluation,to select the individual quality control rules in order to improve the determination quality. Methods By using the function of Unity Real Time software platform’s Westgard Advisor,the information of σ value,σmeasurement figure and suggested rules was obtained according to imprecision [coefficient of variation(CV)],inaccuracy [bias(Bias)] and allowable total error(TEa). The projects whose σ values did not reach 6 were analyzed,and the main causes of poor method analysis performance were evaluated through quality goal index(QGI). The project analysis length was identified according to the analysis length of Westgard σ flow chart of Westgard σ rules. Results The performance characteristics and recommended rules of each item of blood cell analysis are not the same. The selection of individual quality control rules for each item was realized by a single rule or multiple rules. To analyze the projects whose σ values did not reach 6,QGI indicated that,except hemoglobin,accuracy improvement was the priority,while the other items indicated precision improvement was the priority. The length of the analysis batch determined by the comprehensive evaluation of system was 200,which was consistent with the daily sample size of system of about 200. Conclusions The Unity Real Time software platform can be applied to perform 6σ performance evaluation for quantitative analysis projects such as blood cell analysis,select individual quality control rules according to performance characteristics,and make continuous improvement according to QGI.According to the flow chart of Westgard σ rules,the appropriate batch length is determined to ensure the quality of patient test results.更多还原