6σ质量标准在临床生化检验室内质量控制中的应用研究

Application of Six Sigma Quality Management method in Quality Control of Clinical Chemistry Laboratory

目的应用6σ质量标准分析临床生化检验质量控制数据,评价检验项目质量水平,改进检验质量。方法收集2007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;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σ值,绘制6σ性能决定图,评价分析性能,并设计质量控制方案。结果 28个临床生化常规检验项目中,检验项目总分析性能σ≥6、5、4和3者,分别占25%、35.7%、57.1%和71.4%,所有检验项目的平均σ=4.77;当σ≥5时,采用1_(3S)(n=2)质量控制规则能满足质量要求。结论 6σ质量标准的应用,有助于提高临床生化检验质量水平,6σ管理是一项有效的质量管理工具。

Objective To assess and improve the performance of clinical chemistry laboralory by applying the six sigma（60） quality management criterion. Methods Data were collected from routine internal quality control and external quality assessment in clinical chemistry laboratory during 2007. Allowable analytical error was defined according to the Clinical Laboratory Improvement Amendments. The sigma value was calculated according the equation σ-（TEa-bias）/Coefficient of variation （CV）,and 6σ decision chart was made. The quality control strategy based on 6σ was also designed and used for evaluation of the clinical chemical tests. Resuits 25 %,35.71% ,57. 1% and 71.4% of all 28 tests were over 6,5,4 and 3 sigma metrics respectively with the averaged 4.77. The results met the requirement with the rule of vs（n=2） when the σ metric values have been over 5.0. Conclusion Six Sigma methodology is an effective tool for quality management in clinical chemistry laboratory.