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目的:通过对生化分析仪质量控制(QC)数据的σ值研究,探讨6σ质量管理方式在生化室内质量控制及检测分析方法中的应用与评价。方法:从我院2008年7月-12月参加浙江省生化室内质控的数据中抽取15个项目,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,对分析性能低于6σ的项目,计算质量目标指数(qualitygoalindex,QGI)查找导致性能不佳的主要原因,指导质量改进。结果:在15个检验项目中,5个项目分析性能大于6σ,所有项目的平均σ值为5.54。在未达6σ的10个检验项目中,5个项目需优先改进精密度。结论:σ指标为临床实验室检验中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 study the value of σ of biochemical analyzer quality control (QC) data and to explore the application and evaluation of 6σ quality management method in biochemical laboratory quality control and detection and analysis methods. Methods: From July 2008 to July 2008 in our hospital to participate in the quality control of biochemical laboratory data in Zhejiang Province to extract 15 projects, according to the test items of inaccuracy, imprecision and total allowable error σ value, the evaluation of the test phase Performance. For projects that analyze performance below 6σ, calculate the qualitygoalindex (QGI) to find the main cause of poor performance and guide quality improvement. Results: Among the 15 test items, the performance of 5 items was greater than 6σ, and the average σ of all items was 5.54. In less than 6σ of the 10 test items, five projects need to give priority to improving the precision. Conclusion: The σ-index provides an objective measure for the performance evaluation of clinical laboratory tests, and reflects the laboratory’s current performance level and future improvement direction.