临床生化检验室质量控制中六西格玛质量标准的应用分析

Application Analysis of Six Sigma Quality Standard in Quality Control of Clinical Biochemical Laboratory

目的:分析六西格玛质量标准在临床生化检验室内质量控制中的应用。方法:对本单位综合门诊部2021年2月到6月间临床生化室全自动生化分析仪(日立7600型)检验的10项检验指标应用空间质量和室内质控评估数据进行评价,将临床实验室改进方法规定的允许总误差、偏移以及变易系数对各项目的目标指数和西格玛水平展开评估,并辅助标准化西格玛性能评价图对项目的检测性能进行分析,制定个体化改进措施。结果:对于全自动生化分析仪检验的10项指标进行评估,钙西格玛值在2-3,葡萄糖、丙氨酸氨基转移酶西格玛值在3-4,总胆固醇、总蛋白西格玛值在在4-5,天门冬氨酸氨基转移酶西格玛值在5-6,碱性磷酸酶、尿酸、甘油三酯、肌酸激酶西格玛值>6。葡萄糖的QGI值在0.8-1.2,钙、总蛋白、总胆固醇、天门冬氨酸氨基转移酶、丙氨酸氨基转移酶QGI值<0.8。结论:在临床生化检验项目中应用六西格玛质量标准能有效提高临床生化检验项目性能,有利于帮助临床实验室及时借鉴问题,并合理采取有效措施控制项目检测质量。

Objective:To analyze the application of Six Sigma quality standard in the quality control of clinical biochemical laboratory.Methods:The space quality and internal quality control evaluation data were used to evaluate the 10 inspection indexes of the full-automatic biochemical analyzer(Hitachi 7600) in the clinical biochemistry laboratory of the General Outpatient Department in Yangzhou Center for Disease Control and Prevention from February to June 2021.The allowable total error,deviation and variation coeffi cient specifi ed in the clinical laboratory improvement method were used to evaluate the target index and Sigma level of each item,and assist the standardized Sigma performance evaluation chart to analyze the detection performance of the project and formulate individual improvement measures.Results:For the evaluation of the 10 indicators tested by the automatic biochemical analyzer,the calcium Sigma value was 2-3,the glucose and alanine aminotransferase Sigma value was 3-4,the total cholesterol and total protein Sigma value was 4-5,the aspartate aminotransferase Sigma value was 5-6,and the alkaline phosphatase,uric acid,triglyceride,creatine kinase Sigma value was higher than 6.The QGI value of glucose is 0.8-1.2,and the QGI value of calcium,total protein,total cholesterol,aspartate aminotransferase and alanine aminotransferase is lower than 0.8.Conclusion:The application of Six Sigma quality standard in clinical biochemical test items can effectively improve the performance of clinical biochemical test items,help clinical laboratories learn from problems in time,and take reasonable and effective measures to control the test quality of items.