6σ质量管理方法在临床实验室质量控制中的应用研究  

Application research on 6σ quality management method in the quality control of clinical laboratory

作　　者：刘忠民[1] 高月亭[1] 肖洪广[1] 刘利东[1] 车玉传[1] 

机构地区：[1]广州医学院医学检验系,广东广州510182

出　　处：《检验医学》2010年第3期224-227,共4页Laboratory Medicine

摘　　要：目的应用六西格玛(6σ)质量管理方法分析临床检验项目质量控制数据,评价其分析性能,设计质量控制方法,指导质量改进。方法收集2007年度临床检验项目室内质量控制及室间质量评价的数据,按照美国临床实验室改进修正法案允许总误差(TEa)标准,采用公式σ值=[TEa-偏倚(bias)]/变异系数(CV),计算检验项目的σ值,绘制标准化6σ性能决定图,评价检验项目分析性能,绘制标准化操作过程规范图,设计质量控制方案,计算检验项目的质量目标指数,查找导致性能不佳的主要原因,提出优先改进方法。结果22个临床常规检验项目中,检验项目分析性能σ值≥6、5、4和3者,分别占27%、41%、59%和68%,全部检验项目的平均σ值为4.72;当σ值≥5时,采用13S(n=2)质量控制方法能满足质量控制要求,在16个σ值<6的检验项目中,需要优先改进精密度的项目占63%。结论6σ质量管理是临床实验室开展质量控制的一项有效的管理工具,有助于不断提高临床实验室质量水平。Objective To analyze the data of quality control and evaluate its performance in clinical laboratory by applying the six sigma（6σ）quality management method,and design and improve the method.Methods The data were collected from internal quality control and external quality assessment in clinical laboratory during 2007.The total allowable analytical error（TEa） was defined according to the Clinical Laboratory Improvement Amendments.The σ value was calculated according to the equation σ=（TEa-bias）/coefficient of variation（CV）.The normalized 6σ decision chart and normalized operational process specification chart were made for evaluating the analysis performance.The quality control strategy based on 6σ was also designed and used for the evaluation of the clinical detections.The quality goal index was also calculated for finding out the problems.Results 27%,41%,59% and 68% of all analytes were over 6,5,4 and 3 σ metric respectively with the average of 4.72.The results met the requirement according to the 13S（n=2） when the σ metric values had been over 5.Of all analytes less than 6 σ metric,63% needed to be improved for the imprecision.Conclusions 6σ quality management method is helpful in finding out the influence factors and it is an effective tool for quality management in clinical laboratory.

关 键 词：六西格玛 质量控制 临床实验室 操作过程规范图 

分 类 号：R195.1[医药卫生—卫生统计学]