CAJ | 학술논문

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。
목적：분석2009년1월지2013년12월내몽고임업총의원검험과림상생화항목실내질공실공원인，총결규정조시급예방조시，축보강저실공솔。방법삼조 Westgard 질공규칙，회고성분석5년간사용 OLYMPUS AU5421／AU640전자동생화분석의급배투적시제、질공품、교준품진행일상실내질량공제적실공결과，근거교준품、시제、인위인소、질공품、의기급기타인소등6대원인통계분석실공정황。결과림상생화항목실내질공5년간공실공242례차，실공발생차수정축년하강추세，실공원인중섭급교준품69례차、시제54례차、질공품50례차、인위인소31례차、의기23례차、기타원인15례차。교준품원인、시제원인、질공품원인점질량공제실공소유원인적70％이상，여인위인소、의기인소급기타원인비교차이유통계학의의（P ＜0．05）。결론교준품、시제、질공품문제이급인위인소、의기문제시발생질량공제실공적주요원인，림상실험실응침대기채취유효조시，제정규범적 SOP 문건，엄격공제생화검측항목적질량，지속개진림상검험질량。
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.