应用6σ理论评价临床实验室各阶段性能及设计质控方案  

Application of six sigma quality management strategy to assess total quality performance and design quality control rules in clinical laboratory

作　　者：李园园[1] 李萍[1] 宋昊岚[1] 黄亨建[1] 周君[1] 

机构地区：[1]四川大学华西医院实验医学科,成都610041

出　　处：《中华检验医学杂志》2007年第12期1408-1412,共5页Chinese Journal of Laboratory Medicine

基　　金：美国中华医学基金会资助项目(CMB-00737)

摘　　要：目的运用σ指标全面评价临床实验室检验前、中、后各阶段性能,以期发现问题,指导质量改进。方法根据检验项目的不准确度、不精密度及总允许误差计算σ值,评价检验中阶段性能,并以此设计质量控制方案。对分析性能低于6σ的项目,计算质量目标指数(quality goal index,QGI)查找导致性能不佳的主要原因,指导质量改进。统计标本合格情况、血清钾紧急值通知情况、患者抱怨情况、标本周转时间(turn around time,TAT)等,计算上述4个指标的σ值,利用标本合格情况σ值评价检验前阶段性能,血清钾紧急值通知情况σ值评价检验后阶段性能,患者抱怨情况和 TATσ值评价检验全程性能。结果在27个检验项目中,8个项目分析性能大于6σ,所有项目的平均σ值(即检验中阶段性能)为4.44。在未达6σ的19个检验项目中,12个项目需优先改进精密度。标本合格情况、紧急值通知情况、患者抱怨情况、急诊及常规 TAT 的σ值分别是4.9、2.9、5.6、2.8、2.9。结论σ指标为临床实验室检验各阶段的性能评价提供客观的衡量标准,体现实验室目前所处的性能水平及今后的改进方向。Objective To apply sigma metrics to assess key indicators designed in the laboratory improvement plan to find problems and promote quality improvement. Methods Sigma metrics were calculated to reflect the performance of analytic phase including imprecision, inaccuracy and Turn around time（TAT）. The quality control strategy was designed accordingly. Quality goal index （QGI）was calculated to find the cause of any error for the items exceeding 6 sigma. Quality of pre-, post-analytic and total analytic phase, such as quality of specimen, TAT, panic value notification and satisfaction of physicians and patients were measured in sigma metrics too. Results The average sigma metric of analytic phase was 4.44, while sigma metric for 8 of 27 test items were above 6σ. The main cause of performance under 6σ was poor precision. The sigma metrics of quality of specimen, panic value notification, satisfaction of customer and emergent/routine TAT were 4. 9, 2. 9, 5.6, 2.8, and 2. 9 respectively. Conclusion Sigma metrics provide the objective marker for the evaluation of performance in each stage of analytic process.

关 键 词：全面质量管理 质量控制 质量保证 卫生保健 临床实验室技术 

分 类 号：R446[医药卫生—诊断学]