患者数据指数加权移动均值法、室内质量控制室间化和自动审核在基层医疗机构临床实验室质量管理中的应用  

Application of EWMA,HIQC and autoverification in primary medical institutions

作　　者：孟茜 卫桢 白建华 郝晓柯 曾宪飞 MENG Xi;WEI Zhen;BAI Jianhua;HAO Xiaoke;ZENG Xianfei(Xi'an Area Medical Laboratory Center,Xi'an 710116,Shaanxi,China;School of Medicine,Northwest University,Xi'an 710069,Shaanxi,China)

机构地区：[1]西安区域医学检验中心,陕西西安710116 [2]西北大学医学院,陕西西安710069

出　　处：《检验医学》2023年第9期884-889,共6页Laboratory Medicine

基　　金：工信部5G+医疗健康试点项目;西安市科技计划项目(22YYCJ-QCY3-0004)。

摘　　要：目的探讨患者数据指数加权移动均值(EWMA)法、室内质量控制(IQC)室间化和自动审核3种质量管理方法在基层医疗机构临床实验室的适用性。方法收集2021年6—11月西安区域医学检验中心所辖3家基层社区卫生服务中心葡萄糖、总胆固醇、三酰甘油、总蛋白、白蛋白、尿素6个检测项目的IQC数据,采用EWMA法进行分析,评估EWMA法的应用效果。基于标准差系数(SDI)、变异系数比值(CVR)等质量评价指标,进行实验室间结果一致性比对。建立24项生化检验项目自动审核规则体系,比较人工审核与自动审核的符合率和自动审核通过率,以及使用自动审核规则前后实验室样本周转时间(TAT)等关键指标的差异。结果传统IQC趋势与EWMA质控趋势一致,EWMA可早于传统IQC识别检验系统偏移,但年龄分布不均会造成EWMA假失控报警。3家基层社区卫生服务中心中,有1家尿素项目SDI超出允许范围,存在严重负偏移,与同期室间质量评价(EQA)回报结果的偏移趋势一致。验证期自动审核与人工审核符合率为100%,正式使用期间自动审核总通过率为95.33%。实验室内TAT中位数和第90百分位数分别较使用前缩短24和136 min。结论患者数据EWMA、IQC室间化和自动审核系统在基层医疗机构临床实验室质量管理中应用效果良好,能灵敏识别实验室检测体系性能变化,辅助处理失控,保证实验室检测结果准确,并可有效缩短实验室内TAT。Objective To investigate the applicability of 3 quality management methods,exponentially weighted moving average(EWMA)of patient data,interlocalization of internal quality control(IQC)and automatic audit,in clinical laboratories of primary medical institutions.Methods The IQC data of 6 items including glucose,total cholesterol,triglyceride,total protein,albumin and urea were collected from 3 primary community health service centers under the supervision of Xi'an Area Medical Laboratory Center from June to November 2021.EWMA was used to analyze,and the application effect of EWMA was evaluated.Based on the standard deviation coefficient(SDI),coefficient of variation ratio(CVR)and other quality evaluation indexes,the consistency of results between clinical laboratories was compared.Automatic audit rules for 24 biochemical determination items were established,the coincidence rate and pass rate of manual audit and automatic audit were compared,and the differences in key indexes such as clinical laboratory sample turn-around time(TAT)before and after using automatic audit rules were compared as well.Results The trend of traditional IQC was consistent with the trend of EWMA quality control,EWMA can be offset earlier than traditional IQC identification and inspection system,but the uneven age distribution caused the false out-of-control alarm of EWMA.Among the 3 primary community health service centers,1 item(urea)SDI exceeded the allowable range and had serious negative deviation,which was consistent with the deviation trend of the results of external quality assessment(EQA)in the same period.The coincidence rate of automatic audit and manual audit during verification period was 100%,and the total pass rate of automatic audit during formal use was 95.33%.The median and 90th percentile of TAT were shortened by 24 and 136 min,respectively.Conclusions EWMA of patient data,interlocalization of IQC and automatic audit perform well in the quality management of primary medical institutions.They can sensitively identify the cha

关 键 词：基层医疗机构 临床实验室 患者数据 指数加权移动均值 实时质量控制 室内质量控制室间化 自动审核 

分 类 号：R446.1[医药卫生—诊断学]