目的：分析2009年1月至2013年12月内蒙古林业总医院检验科临床生化项目室内质控失控原因，总结纠正措施及预防措施，逐步降低失控率。方法参照 Westgard 质控规则，回顾性分析5年间使用 OLYMPUS AU5421／AU640全自动生化分析仪及配套的试剂、质控品、校准品进行日常室内质量控制的失控结果，根据校准品、试剂、人为因素、质控品、仪器及其它因素等6大原因统计分析失控情况。结果临床生化项目室内质控5年间共失控242例次，失控发生次数呈逐年下降趋势，失控原因中涉及校准品69例次、试剂54例次、质控品50例次、人为因素31例次、仪器23例次、其它原因15例次。校准品原因、试剂原因、质控品原因占质量控制失控所有原因的70％以上，与人为因素、仪器因素及其它原因比较差异有统计学意义（P ＜0．05）。结论校准品、试剂、质控品问题以及人为因素、仪器问题是发生质量控制失控的主要原因，临床实验室应针对其采取有效措施，制定规范的 SOP 文件，严格控制生化检测项目的质量，持续改进临床检验质量。%Objective To analyze out-of-control reasons of clinical biochemical internal quality control from January 2009 to December 2013 in Department of Clinical Laboratory, Inner Mongolia Forestry General Hospital, to summarize the corrective and preventive measures, and to reduce out-of-control rate gradually.Methods According to the reference of Westgard quality control rules, the out-of-control results of daily internal quality control by OLYMPUS AU5421/AU640 automatic biochemical analyzer and original reagents, control materials and calibrators were analyzed retrospectively for 5 years.In terms of calibrators, reagents, human factors, control materials, instruments and other factors, the statistical analysis about out-of-control reasons was performed.Results For 5 years, there were 242 out-of-control cases, including 69 calibration problems, 54 reagent problems, 50 control material problems, 31 human factor problems, 23 instrument problem and 15 other problems.Calibration, reagent, control material reasons accounted for more than 70% of all reasons, and compared with human factor, instrument and other reasons, there was statistical significance (P <0.05). Conclusions Calibrators, reagents, human factors, control materials and instruments are the main reasons causing out-of-control situations.Clinical laboratories should take effective measures, regulate the standard operating procedure, strictly control the quality of biochemical determination and persist in improving the quality of clinical inspection.
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