六西格玛理论与标准化操作过程规范工具的实验室应用

目的 应用6σ理论与标准化操作过程规范工具两种质量管理方法评价临床化学实验室检测方法分析性能并设计质量控制方案.方法 选择2013年第一次卫生部临床检验中心常规化学室间质评回报结果平均值作为不正确度偏倚,同时选取2013年1月～4月两水平室内质控的累积CV％平均值作为不精密度变异.通过σ水平值、Westgard标准化方法决定图与操作过程规范图评价钾（K）、钠（Na）、氯（Cl）等25种检测方法分析性能并设计最佳质量控制方案,同时结合质量目标指数进行质量改进.结果 达到5σ或“优秀”性能的检测方法比例分别为72％（18/25）和84％（21/25）,质量控制措施只需选择“N=2,13.5s或13.0s”;小于5σ或未达到“优秀”性能的检测方法的比例分别为28％（7/25）和16％（4/25）,质量控制措施采取“N=4,12.5s,多规则”或最大化质量控制,质量目标指数提示方法误差主要来源于不精密度变异.对方法性能欠佳的镁（Mg）、直接胆红素（DBil）、Na与Cl采取最大化质量控制后,Mg与DBil性能改善显著,σ水平分别上升至4.2与5.3,控制规则也降为“N=4,12.5s”与“N=2,13.0s”,但Na与Cl仍然未达到分析质量要求.结论 结合两种质量管理方法对实验室检测方法质量控制设计、误差分析、性能评价与持续质量改进具有十分重要意义.

Laboratory Application of Six Sigma Theory and Normalized OPSpecs Quality-Planning Tool

Objective To evaluate the performance of detection methods of clinical chemistry laboratory and design plans of quality control with 6σ theory and normalized OPSpecs quality-planning tool.Methods Selected the first routine chemical EQA average results of 2013 as bias error and chose the cumulative average CVof two level internal quality control of 2013 january to april as imprecision error.Evaluated the performance of potassium,sodium,chlorine and other detection methods and designed the plans of quality control with σ level.Method Decision Chart and OPSpecs Charts and meanwhile combined with the quality goal index for quality improvement.Results The ratios of methods achieving 5σ or excellent performance were 72 ％ and 84％ respectively and the plans of quality control only needed ＂N 2,13.5s or 13.0s＂.The ratios of methods less than 5σ or non excellent performance were 28 ％ and 16 ％ and the plans of quality control needed ＂N 4,12.3 s,multi-rule＂ or the maximize quality control and the quality goal index pointed out method error came mainly from the imprecision error.After taking the maximize quality control,the performance of Mg and DBil improved noticeablyand control rules became ＂N 4,12.s＂ and ＂N 2,13.0s＂,But Na and Cl still not reached the quality requirements.Conclusion Combining the two methods of quality management have very important significance in the design of quality control,error analysis,performance evaluation and continuous quality improvement.