6σ标准在临床生化质量管理中的应用.pdfVIP

• 269. l临床输血与检验 2014 年7 月第 16 卷第3 期 6σ 标准在临床生化质量管理中的应用 王伦善贾建安金玉亮黄其峰 E摘要】 目的 应用标准分析l临床生化检验质控数据，评价常规检验项目的方法性能，改进检验质量。方法 收集 2012 年度临床生化检验项目室内质量控制及室间质量评价数据z 按照美国临床实验室改进修正法案中允许总误差(TEa) 标准，采用公式σ= (TEa-Bias)/CV%.计算各检验项目的总分析性能。值，联合方法性能决定图，评价分析性能，设计最佳 室内质量控制方案，提出并实施改进措施。结果 全部22 个常规生化检测项目平均西格玛值2.83.其中12 个质量水平大于 旬，其余 10 个项目均小于311 ， 存在较严重的质量缺陷，采取质量改进措施后σ 值明显提高。结论 6σ 质量标准的应用，有助 于了解和提高临床生化检验质量水平，是一项有效的实验室质量管理工具。 E关键词E 全面质量管理 六西格玛标准 允许总误差 方法性能决定图 E中团分类号1 R446.1 (文献标识码1 A (文章编号1 1671-2587(2014)03-0269-04 Application or Six Sigma Metrics in Quality Management or Clinical Chemistry Laboratory WANG Lun-shan ,JIA Jian- an ,JIN Yu-líang ,et at. 105th Hos户ital of PLA.H e!ei 230031 (Abstractl Objective To assess and improve the performance of clinical chemistry laboratory by using the six sigma quality management criterion. Methods Data were col1ected from routine internal quality control and external quality as- sessment in clinical chemistry laboratory in 2012. A l10wable analytical error was defined according to the Clinical Laborato- ry Improvement Amendments. The sigma value was calculated according the equation 11= (Tea IBias 1)/CV % • and Method of evaluation decision chart was made. The quality control strategy based on 6σwas also designed and used for evaluatíon of the clinical chemical tests. Results Sigma metrics respectively with the average was 2. 83 in 22 routine tests ,12 analytes of which reached more than 3 Sigma Quality Level , the other 10 analytes were less than 3 Sigma metrics. There were seri- ous quality defects in some tests and Sigma value was remarkably increased after implementation of quality improvement strategy in internal quality control program. Conclusion Application of 6 Sig