基于风险管理的Westgard西格玛分析批长度规则在尿液有形成分定量检测方法质量控制中的应用

目的通过研究应用Westgard西格玛分析批长度计算规则,对尿液有形化学成分检测选择合适的质量控制（QC）策略,以降低漏检、错检的风险。 方法收集本实验室尿液有形成分分析仪在2020年1-8月期间的内部质量控制（IQC）的室内质控数据,以及在线室间质评系统（SNCS）中室内质控值与组间均值的偏倚数据,依据《上海市医疗机构临床实验室质量管理规范》中规定的尿液有形成分允许总误差（TEa）作为本研究的质量控制目标。 结果分析批长度为1 000个患者样本作为白细胞和红细胞检测的质量控制策略,性能均显示为“世界一流”,σ=8.19和σ=8.00,选择1_3s（N=2）;分析批长度为200个患者样本作为细菌检测的质量控制策略,其性能为“良好”,σ=4.71,选择1_3s/2_2s/R_4s/4_1s（N=4）;分析批长度为45个患者样本作为上皮细胞检测的质量控制策略,其性能为“临界”,σ=3.29,选择1_3s/2_2s/R_4s/4_1s/6_x（N=6）;而管型检测的质量控制策略,CAST σ＜3,其系统性能有待改进。另外,在σ＜6的检测项目中,上皮细胞和细菌两个项目的质量目标指数（QGI）≤0.8,需优先改进精密度。 结论运用Westgard西格玛分析批长度规则,有助于我们对尿液有形成分检测流程的优化、改善,另外,依据QGI可以查找性能不佳的具体原因,制订有效且优先的改进策略。

Application of Westgard Sigma analysis batch length rules based on risk management in the quality control of urine forming composition

ObjectiveTo select the appropriate quality control (QC) strategy for the detection of urine forming components through the application of Westgard Sigma analysis batch length rules to reduce the risk of missed and false detection. MethodsThe internal quality control (IQC) data of urine forming components analyzer and the data of bias of IQC relative to the group mean values in SNCS (Sysmex Network Communication System) were collected from January to August 2020 in our laboratory. The total allowable error (TEa) of urine visible components stipulated in "Quality Management Standard for Clinical Laboratories of Medical Institutions in Shanghai" was adopted as the quality objective in this study. ResultsThe quality control strategy for white blood cell and red blood cell analysis appears "World class", σ=8.19 for WBC and σ=8.00 for RBC, Selected 1_3s (N=2). The analysis batch length of 200 patients were used as the quality control strategy for bacterial detection, and its performance was good (BACT, σ=4.71), Selected1_3s/2_2s/R_4s/4_1s(N=4). The analysis batch length of 45 patients were used as the quality control strategy for epithelial cells tesing, whose results was "critical", σ=3.29, selected 1_3S/2_2S/R_4S/4_1S/6_x(N=6). However, the quality control strategy of CAST, σ＜3, needs to be improved. By the way, the QGI of EC and BACT is less than 0.8 in the detection items with σ＜6, and the precision should be improved as priority. ConclusionsThe Westgard Sigma analysis batch length rule help us to optimize and improve the urine forming components analysis easily. In addition, QGI can be used to identify specific reasons for poor performance and formulate effective and prioritized improvement strategies.