6σ质量标准评价凝血实验性能及质控方案的探讨

Application of Six Sigma in Quality Control of Quality Management Coagulation Tests

目的探讨6σ质量标准在凝血实验性能评价及质控方案设计中的应用。方法统计与检验前、后及全程质量指标相关的“标本合格情况”临床危急值通知情况”报告时间”“临床／患者抱怨、投诉情况“标本漏检、误检情况”，计算各指标的每百万缺陷率（DPM），并转化成σ值。用“标本合格情况”σ值评价检验前阶段的质量性能，用“临床危急值通知情况”和“报告时间”σ值评价检验后阶段的质量性能，用“临床／患者抱怨、投诉情况”和“标本漏检、误检情况”σ值评价检验全程的质量性能。根据检验项目的不准确度（bias）、不精密度（CV）以及临床允许总误差（TEa），利用公式σ值=｜TEa—bias｜／CV，计算A值，评价检验过程中性能；根据Westgard等对σ值的说明，制定适合于各项目的质控方案，对于σ值〈6的项目，根据公式QGI—bias／1．5CV计算质量目标指数（QGI），找出性能不佳的原因，并确立性能改进的方向。结果“标本合格情况”“临床危急值通知情况”“报告时间”“临床／患者抱怨、投诉情况”“标本漏检、误检情况”的σ值分别为3．6，5．0，3．8，4．2，5．5；PT，APTT和Fib中APTT检测性能达到6σ，PT和Fib的σ值都在4左右，QGI低于0．8，方法精密度超出允许范围，需要优先改进精密度。结论6σ质量标准能对实验室检测全过程各个环节的性能作出全面评价，并对质控规则的选择和性能改进方向的确立具有指导意义。

Objective To discuss the performance of coagulation tests and the selection of quality control procedures using six sigma. Methods Using six sigma metrics to measure the quality of pre-,post-analytic and total analytic phase,such as the quality of the specimen,panic value notification,time of reports release（TRR）,satisfaction of physicians and patients, specimens omitted or mistested. Sigma metrics were calculated to reflect the performance of analytic phase including imprecision and inaccuracy. The quality control strategy was designed accordingly. Quality goal index （QGI） was calculated to find the cause of any error for the items below 6σ. Results The sigma metrics of quality of the specimen,panic value notification, time of reports release （TRR）,satisfaction of physicians and patients,specimens omitted or mistested were 3.6, 5.0,3.8,4.2 and 5.5 respectively. The sigma metrics of APTT was above 6σ. The main cause of performance below 6σ was poor precision. Conclusion Six sigma quality management is very useful for laboratory total quality management（TQM）.