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目的分析实验室检测项目的六西格玛(6σ)水平,探讨应用6σ评价方法评价和管理室内质控并改进生化检验质量。方法收集2013年-2015年本室9次常规化学室间质评数据,及各项目室内质控数据的累积变异系数(CV);以卫生行业标准WS/T 403—2012《临床生物化学常规检验项目分析质量指标》规定的允许总误差(TEa),计算本室已开展的室间质评项目的σ水平。结果共23个检测项目,2013年有10个项目的σ水平>6σ,14个项目的σ水平>3σ,<2σ的项目有3个。2014年室内质评结果 5个项目σ水平>6σ,17个项目的σ水平>3σ,其中σ水平<2σ的项目2个。2015年室内质评结果 9个项目σ水平>6σ,20个项目的σ水平>3σ,其中σ水平<2σ的项目1个。结论应用6σ标准分析室内质控、室间质评数据,能更全面有效地评价临床生化检验项目的性能指标,有助于实验室发现问题,采取措施,持续改进检验质量。
Objective To analyze the six sigma level of laboratory test items and to evaluate and manage indoor quality control and improve the quality of biochemical tests using 6σ evaluation method. Methods The data of nine routine chemical laboratory tests and the coefficient of variation (CV) of each laboratory’s quality control data collected during 2013 to 2015 were collected. Based on the health industry standard WS / T 403-2012, “Clinical Laboratory Biochemistry Test Project analysis of quality indicators, ”the total allowable error (TEa), to calculate the room has been carried out indoor assessment project σ level. A total of 23 test results were obtained. In 2013, there were 10 projects with σ level> 6σ, 14 projects with σ level> 3σ, and <2σ with 3 projects. The results of indoor assessment in 2014 showed that σ = 6σ for 5 projects, σ> 3σ for 17 projects, and 2 for σ <2σ. The results of indoor assessment in 2015 showed that there were 9 projects with σ level> 6σ, 20 projects with σ level> 3σ and 1 with σ level <2σ. Conclusion The application of 6σ standard analysis of indoor quality control and inter-laboratory qualitative evaluation data can evaluate the performance indexes of clinical biochemical test items more comprehensively and effectively, which can help the laboratory to discover problems and take measures to continuously improve the quality of testing.