具有批长度的Westgard西格玛规则在血脂质量控制方面的应用

Application of Westgard sigma rule with batch length in quality control of serum lipid analytes

目的探讨具有批长度的Westgard西格玛规则在血脂项目质量控制上的应用价值。方法收集本实验室血脂项目2019年1—6月的室内质控(IQC)数据及2019年国家卫健委第一次室间质量评价(EQA)数据,并以国家卫健委临检中心EQA评价标准作为质量目标来计算各项目的西格玛(σ)水平。同时应用具有批长度的Westgard西格玛规则指导实验室制定个性化室内质控方案,并依据血脂项目(σ<6)的质量目标指数(QGI)制定质量改进措施。结果本实验室高密度脂蛋白胆固醇(HDL-C)和低密度脂蛋白胆固醇(LDL-C)的σ水平>6,其分析性能达到“世界一流”水平,故选择13s规则(质控品的数量,N=2),分析批长度为1000个患者样品作为室内质控方案;甘油三酯(TG)、载脂蛋白A(Apo-A)、载脂蛋白B(Apo-B)以及脂蛋白a[Lp(a)]是σ水平介于5~6之间,其分析性能达到“优秀”等级,故选择13s/22s/R4s(N=2)规则,分析批长度为450个患者样品作为室内质控方案;而总胆固醇(TC)的σ水平介于4~5之间,其分析性能处于“良好”等级,故选择13s/22s/R4s/41s(N=4)规则,分析批长度为200个患者样品作为该项目的室内质控方案。依据血脂项目QGI的判断结果,TC和TG需要优先改进精密度,Apo-A、Apo-B和Lp(a)则需要优先提高正确度。结论具有批长度的Westgard西格玛规则能够指导实验室合理制定个性化的室内质控方案,并促进实验室检测质量的不断提高。

Objective To investigate the application value of Westgard sigma rule with batch length in quality control of serum lipid analytes.Methods The laboratory's internal quality control(IQC)data of serum lipid analytes from January to June 2019 and the first external quality assessment(EQA)data of National Center for Clinical Laboratories(NCCL)in 2019 were collected,and the EQA evaluation standard of NCCL was used as quality goal to calculate the sigma level of each analyte.At the same time,the Westgard sigma rule with batch length was used to guide the laboratory to develop a personalized internal quality control schemes,and to develop quality improvement measures based on the quality goal index(QGI)of serum lipid analytes(sigma<6).Results The sigma levels of HDL-C and LDL-C in the laboratory were>6,and their analytical performance had reached the"world-class"level.Therefore,13s rule(the number of quality control products was N=2)was selected,and 1000 patient samples with analysis batch length were taken as the internal quality control scheme.The sigma levels of TG,Apo-A,Apo-B,and Lp(a)ranged from 5 to 6,and their analytical performance had reached the"excellent"grade,so 13s/22s/R4s(N=2)rules and with analysis batch length of 450 patient samples were selected.While the sigma level of TC was 4-5,and its analytical performance was in the"good"grade,so 13s/22s/R4s/41s(N=4)rules and with analysis batch length of 200 patient samples were selected.According to the evaluation criteria of QGI,TC and TG needed to improve the precision firstly,while Apo-A,Apo-B,and Lp(a)needed to improve the accuracy firstly.Conclusion The Westgard sigma rule with batch length can help laboratories to reasonably formulate personalized internal quality control schemes,and promote the continuous improvement of laboratory testing quality.