应用六西格玛质量标准评价电化学发光系统性能和设计质量控制方案  

Application of six sigma quality management in quality control of electrochemiluminescence

作　　者：罗浩元[1] 刘集鸿[1] 雷艳梅[1] 梁金霞[1] 曾涛[1] 

机构地区：[1]广东省惠州市第一人民医院,516001

出　　处：《实用医技杂志》2014年第12期1266-1268,共3页Journal of Practical Medical Techniques

摘　　要：目的应用六西格玛（6σ）质量管理方法对Roche Cobas E601电化学发光免疫分析系统检测项目的性能进行量化,并设计各项目的质量控制方案,指导质量持续改进。方法根据σ=[允许总误差（TEa）-偏倚（Bias）]/变异系数（CV）,计算14个检测项目的σ水平,评价各项目的分析性能。其中TEa以卫生部临床检验中心（NCCL）室间质量评价的评价标准,Bias以本室参加NCCL室间质量评价的平均偏倚计算所得,本室室内质量控制日间不精密度（CV%）反映不精密度。根据Westgard等对σ值的说明,制定个体化的室内质量控制方案;同时计算各项目的质量目标指数（QGI）,对于性能未达到6σ的项目,查找导致性能不佳的主要原因,并确立性能改进的方案。结果 14个检测项目的总性能σ水平为3.80~9.19,平均σ=6.20,σ≥6、5、4、3的分别占42.9%、21.4%、28.6%、7.1%;分析性能未达到6σ的项目中,75%需要优先改进精密度。结论 6σ质量标准能对电化学发光免疫分析系统的性能作出全面的评价,对设计个体化的质量控制方案和指导质量持续改进具有重要意义。Objective Application of 6 sigma（6σ） quality standard to quality of Roche Cobas E601 electroche-miluminescence （ECL） test item analysis performance, and design the appropriate quality control strategy to improve quality control. Methods The sigma value of 14 items were calculated according the equation σ=（TEa-Bias）/coefficient of variation （CV） to reflect the performance of analytic phase. Define the analytical quality requirement for the test in the form of a total allowable error （TEa） by reference NCCL proficiency testing criteria and determine the imprecision and inaccuracy of each item. The quality control strategy was designed accordingly. Quality goal index（QGI） was calculated to find the cause of any error for the items which was below 6σ and improved the strategy. Results The value of σ was between 3.80-9.19 and average was 6.20, 42.9%, 21.4%, 28.6% and 7.1% of all 14 items were over 6, 5, 4 and 3 sigma metrics respectively with the averaged. The accuracy of 75% items required improved which value was below 6σ. Conclusion Six σ quality standard could comprehensively evaluated ECL test item analysis performance , it is of great significance to design individualized quality control plan and quality improvement.

关 键 词：电化学发光 性能评价 质量控制 质量改进 

分 类 号：R197.3[医药卫生—卫生事业管理]