凝血检验结果自动审核规则建立与验证的多中心研究  

A multicenter study on the establishment and validation of autoverification rules for coagulation tests

作　　者：曲林琳[1] 吴俊[2] 吴卫[3] 王蓓丽 刘向祎[5] 江虹[6] 黄珣钡[6] 杨大干[7] 李永哲[3] 杜彦丹 郭玮 孙德华[9] 王玉明[10] 马伟 朱明清[12] 王贤[13] 隋洪 寿玮龄[3] 李强[9] 迟林[5] 李爽[5] 刘晓璐[7] 王卓[10] 曹君[12] 包春喜 夏永泉[13] 曹辉[2] 安倍莹[1] 郭芙瑜 冯厚梅[9] 闫岩 黄光日 续薇[1] Qu Linlin;Wu Jun;Wu Wei;Wang Beili;Liu Xiangyi;Jiang Hong;Huang Xunbei;Yang Dagan;Li Yongzhe;Du Yandan;Guo Wei;Sun Dehua;Wang Yuming;Ma Wei;Zhu Mingqing;Wang Xian;Sui Hong;Shou Weiling;Li Qiang;Chi Lin;Li Shuang;Liu Xiaolu;Wang Zhuo;Cao Jun;Bao Chunxi;Xia Yongquan;Cao Hui;An Beiying;Guo Fuyu;Feng Houmei;Yan Yan;Huang Guangri;Xu Wei(the First Hospital of Jilin University,Changchun 130021,China;Beijing Jishuitan Hospital,Beijing 100035,China;Peking Union Medical College Hospital,Beijing100730,China;Zhongshan Hospital of Fudan University,Shanghai 200032,China;Beijing Tongren Hospital,Beijing 100730,China;West China Hospital,Sichuan University,Chengdu 610041,China;the First Affiliated Hospital,College of Medicine,Zhejiang University,Hangzhou 310009,China;Inner Mongolia Forestry General Hospital,Yakeshi 022150,China;Nanfang Hospital of Nanfang University,Guangzhou 510515,China;lothe Second Hospital of Kunming Medical University,Kunming 650101,China;Suzhoa Municipal Hospital,Suzhou 215000,China;the First Affiliated Hospital of Suzhou University,Suzhou 215006,China;Nanjing Drum Tower Hospital,Affiliated Hospital of Nanjing University,Nanjing 210008,China;Dongguan Kanghua Hospital,Dongguan 523080,China)

机构地区：[1]吉林大学第一医院检验科,长春130021 [2]北京积水潭医院检验科,北京100035 [3]北京协和医院检验科,北京100730 [4]复旦大学附属中山医院检验科,上海200032 [5]北京同仁医院检验科,北京100730 [6]四川大学华西医院检验科,成都610041 [7]浙江大学附属第一医院检验科,杭州310009 [8]内蒙古林业总医院检验科,牙克石022150 [9]南方医科大学南方医院检验科,广州510515 [10]昆明医科大学第二附属医院检验科,昆明650101 [11]苏州市立医院检验科,苏州215000 [12]苏州大学附属第一医院检验科,苏州215006 [13]南京鼓楼医院检验科,南京210008 [14]东莞康华医院检验科,东莞523080

出　　处：《中华检验医学杂志》2020年第8期802-811,共10页Chinese Journal of Laboratory Medicine

摘　　要：目的建立多中心凝血检验结果的自动审核规则,在保证检验质量的同时减轻人工审核及复检工作负荷,缩短周转时间(TAT)时间。方法收集来自14家医院检验科2019年12月至2020年3月期间凝血标本共14394份:规则建立组11230份(含Delta check 1182份),规则验证组3164份(含Delta check 487份);临床试应用77269份。应用Sysmex CS系列全自动凝血分析仪检测凝血酶时间(TT)、凝血酶原时间(PT)、国际标准化比值(INR)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FBG)、D-二聚体(DD)、血浆纤维蛋白(原)降解产物(FDP)同时将临床信息、仪器参数、检测结果、临床诊断、抗凝药物使用和HCT、TG、TBIL、DBIL等相关信息汇总;根据历史数据从小到大排序后累积第2.5和97.5百分位数,根据临床建议、危急值、特殊用药史和相关指南确定自动审核拦截条件及限值;进行一期和二期验证,分别计算阳性符合率、阴性符合率、假阴性、假阳性、自动审核通过率、通过正确率(与人工审核一致率)和TAT时间。结果(1)自动审核规则33条,涉及TT、PT/INR、APTT、FBG、DD、FDP、Delta check、反应曲线及性状异常;(2)规则建立组自动审核通过率为68.42%(7684/11230),假阴性为0(0/11230),与人工审核一致率为98.51%(11063/11230),其中阳性符合率为30.09%(3379/11230),阴性符合率为68.42%(7684/11230);规则验证组自动审核通过率为60.37%(1910/3164),假阴性为0(0/11230),与人工审核一致率为97.79%(3094/3164),其中阳性符合率为37.42%(1184/3164),阴性符合率为60.37%(1910/3164);(3)自动审核规则试应用,77269份凝血检测标本,检验结果报告平均TAT缩短分别为8.5~83.1 min。结论本研究建立了凝血检验结果自动审核规则33条,验证显示能够在保证检验准确性的同时缩短TAT,提高凝血检验效率。Objective To establish autoverification rules for coagulation tests in multicenter cooperative units,in order to reduce workload for manual review of suspected results and shorten turnaround time(TAT)of test reports,while ensure the accuracy of results.Methods A total of 14394 blood samples were collected from fourteen hospitals during December 2019 to March 2020.These samples included:Rules Establishment Group 11230 cases,including 1182 cases for Delta check rules;Rules Validation Group 3164 cases,including 487cases for Delta check;Clinical Application Trial Group 77269 cases.Samples were analyzed for coagulation tests using Sysmex CS series automatic coagulation analyzers,and the clinical information,instrument parameters,test results,clinical diagnosis,medication history of anticoagulant and other relative results such as HCT,TG,TBIL,DBIL were summarized;on the basis of historical data,the 2.5 and 97.5 percentile of all data arranged from low to high were initially accumulated;on the basis of clinical suggestions,critical values and specific drug use as well as relative guidelines,autoverification rules and limits were established.The rules were then input into middleware,in which Stage I/Stage II validation was done.Positive coincidence,negative coincidence,false negative,false positive,autoverification pass rate,passing accuracy(coincidence of autoverification and manual verification)were calculated.Autoverification rules underwent trial application in coagulation results reports.Results(1)The autoverification algorisms involve 33 rules regarding PT/INR,APTT,FBG,D-dimer,FDP,Delta check,reaction curve and sample abnormalities;(2)Autoverification Establishment Group showed autoverification pass rate was 68.42%(7684/11230),the false negative rate was 0%(0/11230),coincidence of autoverification and manual verification was 98.51%(11063/11230),in which positive coincidence and negative coincidence were respectively 30.09%(3379/11230)and 68.42%(7684/11230);Autoverification Validation Group showed autoverification p

关 键 词：血液凝固试验 临床实验室技术 临床实验室信息系统 多中心研究 

分 类 号：R446.1[医药卫生—诊断学]