西格玛方法在临床生化检验质量管理中的应用  

The application of sigma metrics quality models in quality management of clinical biochemistry laboratory

作　　者：李润青 宫丽君 王腾蛟 朱东 杨松[1] 赵海滨 胡小蕊 张志远[1] 赵秀英[1] 

机构地区：[1]清华长庚医院检验医学科清华大学I临床学院,北京102200

出　　处：《中华检验医学杂志》2017年第9期727-732,共6页Chinese Journal of Laboratory Medicine

基　　金：2011年北京市卫生系统高层次卫生技术人才学科骨干资助项目（2011）

摘　　要：目的分析检验前、中、后阶段及全过程的质量指标，改进临床生化检验质量。方法检验中阶段：TEa%标准来源于我国卫生行业标准WS/T403－2012，∣Bias%∣来自2016年度卫生部临检中心正确度验证系列分析结果，CV%来源于六个月的室内质控数据，按公式Sigma＝（TEa%－∣Bias%∣）/CV%，计算检验中阶段检验项目的Sigma值，绘制标准化Sigma方法性能决定图，评估检测性能，并以此设计个性化质量控制方案。计算低于6 Sigma的检验项目的质量目标指数（QGI），指导改进方向。检验前、后阶段及全过程7个指标的Sigma评估：其中利用标本不合格评价检验前阶段性能；危急值未通知、危急值未及时通知评价检验后阶段性能，hs－cTnT TAT不合格、急诊生化项目TAT不合格、检验报告更改、室间质评不合格四个指标评价检验全过程性能。对比改进前后变化，确认改进效果。结果17个生化项目平均Sigma值为5.29，其中8个项目（UA、K、ALP、CK、AMY、AST、TG、Na）性能达到卓越到世界级表现（≥5 Sigma）；6个项目（LDH、Cre、TC、ALT、Mg、Glu）性能达到临界到好的表现（5〉Sigma≥3）；BUN性能表现差（3〉Sigma≥2）；Ca、TP性能为不可接受（Sigma〈2）存在严重的质量缺陷。标本不合格、危急值未通知、危急值未及时通知、hs－cTnT TAT不合格、急诊生化项目TAT不合格、检验报告更改、室间质评不合格的Sigma值改进前平均分别是4.17、3.60、2.75、1.72、3.27、4.52、3.33；改进后平均达到4.30、4.30、2.90、2.45、3.75、4.80、3.60。结论西格玛方法是较理想的临床生化检验质量管理方法，便于发现问题、提出改进措施并对改进效果进行确认，以达到持续质量改进的目的。ObjectiveTo improve the quality of clinical biochemistry laboratory by quality indicators of pre-analytical, analytical, post-analytical phase and the whole process.MethodsAnalytical Phase： The Sigma values of items were calculated, applying the equation Sigma=（TEa%-Bias%）/CV%. Total allowable error （TEa） is from analyticalal specification defined in WS/T403-2012 of China, Bias% is from the evaluation results of National Center for Clinical Laboratory （NCCL） trueness verification PT series and CV% is from internal quality control data during the last 6 months in our lab. Normalized Sigma metrics plot was made to evaluate the analysis performance and the quality control strategies were designed accordingly. The quality goal indexes （QGI） were also calculated to propose improvement measures for items below 6 Sigma. Quality indicators of pre-, post-analytical and whole analytical phase, such as quality of specimen, critical value notification, critical value notification in time, TAT of hs-cTnT, TAT of emergency biochemical items, rewrite of laboratory reports and unacceptable performance in EQA-PT were measured in Sigma metrics too. The Sigma metrics changes before and after taking improvement measures were compared to conform the effectiveness.ResultsThe average Sigma value of 17 biochemical tests was 5.29, of which 8 items （UA, K, ALP, CK, AMY, AST, TG, Na） achieved excellent to world class level （≥5 Sigma）, 6 items （LDH, Cre, TC, ALT, Mg, Glu） achieved marginal to good level （5〉Sigma≥3）, BUN performed poorly （3〉Sigma≥2）, Ca, TP performed unacceptably （Sigma〈2） with serious quality defects. The Sigma values of unacceptable specimen, critical value notification, critical value notification in time, unacceptable turn around time （TAT） of hs-cTnT, unacceptable turn around time （TAT） of emergency biochemical items, rewrite of laboratory reports, unacceptable performance in EQA-PT were 4.17, 3.60, 2.75, 1.72, 3.27, 4.52, 3.33 respectively, rising to 4.30, 4

关 键 词：临床化学试验 质量控制 实验室 医院 质量指标 卫生保健 质量改进 

分 类 号：R446[医药卫生—诊断学]