Objective To calculate the δ level of the immune quantitative items to verify the performance and analyze the distribution of the reasons of losing control,as the basis for improvement. Method From January 2018 to December 2018,the quality control of all quantitative items which was out of control in the immunization room,36 items totally,including thyroid hormone,reproductive hormone,insulin,troponin, hepatitis B quantitative items and tumor markers,involving seven sets of Siemens Centaur XP,Roche E601 and Abbott I2000 chemiluminescent devices. Results There were 184 times of losing control,and the causes of out-of-control were: random error 25.6%,instrument maintenance 20.7%,instrument component failure 8.7%,calibration 15.8%,calibration expiration 5.4%,reagent factor 1.1%,operation factor 13.6%,reagent batch difference 3.3%,average setting 3.8%,matrix effect 1.6%,quality control product improper preservation 0.5%. Conclusion Reasonable analysis of the causes of out-of-control,correction of human factors in time,be sensitive to 1 ~ 3 s random errors,and continuous observation to improve the reliability of the test results.%目的 计算免疫定量项目的δ水平进行性能验证;分析失控原因分布,作为改进工作的基础.方法 统计免疫室2018年1月至12月所有定量项目的室内质控失控情况,包括甲状腺激素、生殖激素、胰岛素、肌钙蛋白、乙肝定量五项及肿瘤标志物等共计36项,涉及西门子Centaur XP、罗氏E601、雅培I2000化学发光仪共七台.结果 统计失控次数184次,失控原因分布:随机误差25.6%、仪器维护保养后20.7 %、仪器部件故障8.7%、定标后15.8%、定标过期5.4%、试剂因素1.1%、操作因素13.6 %、试剂批间差3.3%、均值设置3.8%、质控品基质效应1.6%、质控品保存不当0.5%.结论 合理地分析失控原因,及时纠正人为因素,对1~3s随机误差保持敏感性,并持续观察以提高检验结果的可靠性.
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