西格玛管理在职业健康体检血细胞分析检测质量控制中的应用

目的 应用西格玛性能验证图评价某职业健康体检机构血细胞分析检测项目中主要指标的检测性能,指导质量改进。方法 收集该机构2016年10月实验室血细胞分析检测的室内质量控制数据和2016年第二次全国室间质量评价结果。将该实验室的血细胞分析检测项目的室内控制累积变异系数作为不精密度(%)的估计值,将室间质评结果中的百分差值作为该实验室的偏倚(%)估计,采用卫生行业标准WS/T406-2012的允许总误差作为质量控制规范,用专业软件绘制该实验室的血细胞分析检测中主要八个项目的西格玛性能验证图。结果 白细胞计数的西格玛值达到了“δ≥6”水平,检验性能一流; 血红蛋白的西格玛值位于“4≤δ<5”,检验性能良好; Hct,HCV和MCHC的西格玛值均在“3≤δ<4”,处于临界水平; 而红细胞、血小板和MCH的西格玛值位于“2≤δ<3”水平,检验性能欠佳。结论 西格玛性能验证图可直观地反映该实验室对血细胞计数不同检测项目的检测性能水平,促进质量改进。

Application of Sigma Management in Quality Control of Blood Cell for Occupational Health Examination

Abstract:Objective To evaluate the performance of the main indicators in the blood analysis of an occupational health examination agencyby Sigma verification of performance chart and guide quality improvement.Methods Collected blood testing laboratory internal quality control(IQC)data in October 2016 and 2016 second national external quality assessment(EQA)results of the blood analysis laboratory in the agency.Regarded theaccumulated coefficient of variability as the estimation value of imprecision.Used the percentage difference in EQA results as the estimation value of bias(%)of the laboratory.The total allowable error in health industry standard WS/T406-2012 was adopted as the quality specification(%).Sigma verification of performance chart of the main eight projects in the blood analysis were drawn withprofessional software.Results The sigma value of WBC reached σ≥6 level,as the first-class performance,and the sigma values of HGBin the 4≤σ<5 level,test performance was good.The sigma value of Hct,HCV and MCHC all were in the 3≤σ<4 level,as the critical level,and the sigma values of RBC,platelet and MCH in the 2≤σ<3 level,as poor performance.Conclusion Sigma verification of performance chart could reflectthe level of the laboratory testing performance on different test items of blood count,promote the quality improvement.