6σ 质量管理方法在临床化学检测性能评价中的应用

目的:应用六西格玛(6σ)质量管理方法分析临床生化检验项目质量控制数据,评价其分析性能,设计生化检验项目的质量控制方法并指导其质量改进。方法:收集2010年度临床生化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,设计质量控制方案,计算检验项目的质量目标指(QGI),查找导致性能不佳的主要原因,提出优先改进方法。结果:临床生化检验项目中,常规生化和干式生化的检验项目达到6西格玛水平分别占66.6%和58.4%,达到5～6西格玛水平分别占4.8%和8.3%,达到4～5西格玛水平分别占4.8%和8.3%,4.达到3～4西格玛水平分别占4.8%和16.7%,在3西格玛水平以下分别占19%和8.3%,全部检验项目的平均σ值分别为9.33和6.95。在12个6σ值<6的检验项目中有50%要优先改进精密度,25%需要优先改进准确度,其余则两者都要改进。结论:6σ质量管理方法可以有效地应用于临床化学检测性能评价,设计个性化的质量控制方案可更有效地控制质量,有助于不断提高临床实验室生化检验项目质量水平。

The Analysis and Evaluation of the Quality Control in Clinical Laboratory by the Six Sigma(6σ) Quality Management Method

Objective: To analyze the data of quality control and evaluate its performance in clinical laboratory by applying the six sigma(6σ) quality management method,design chemical test project quality control method and improve the method.Methods: The data were collected from internal quality control and external quality assessment in clinical laboratory during 2010.The total allow able analytical error(TEa) was defined according to the Clinical Laboratory Improvement Amendments.The value was calculated according to the equation σ =(TEa%-bias%) /coefficient of variation(CV%).The normalized 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: 66.6% and 58.4%,4.8% and 8.3%,4.8% and 8.3%,4.8% and16.7%,19% and 8.3%.All the analysis results were over 6,5～6,4～5,3～4and <3σ metric respectively with the average of 9.33.Of all the analysis less than 6σ metric,50% needed to be improved for the imprecision.25% needed to be improved for the Accuracy,the rest of The rests are both improved.Conclusions: Effective application of 6σ quality management method in Performance Evaluation of Clinical Chemical Test Items,Design personalized quality control schemes can be more effective control of quality,6σ quality management method is helpful in finding out the influence factors and it is an effective tool for quality management in clinical laboratory.