CAJ | 학술논문

目的在实验室信息管理系统上建立监测检验质量关键指标的体系,实现对实验室检验质量关键指标的管理.方法收集2014年1月1日至12月31日北京协和医院检验科完成的临床标本.在LIS上设计交互式的输入程序完成信息采集,实现不合格标本率、标本标识错误率、标本丢失事件等指标的统计;记录每份样本的标本采集时间、标本到达实验室时间、标本检测时间、标本审核时间、危急值回报时间等,在LIS系统留下轨迹信息,完成对检验结果回报时间(TAT)合格率、危急值报告通知率等指标的计算;采集每项检测项目的质控信息,形成室内质量控制的数据库,实现质控的失控率、检验项目总误差等关键质量指标的监测.结果样本管理监测显示2014年度不合格标本率均小于质量目标(1％),但识别出1～2月份的不合格标本率较高,4个病区标本不合格率＞2％;标本标示错误率为0.47例/10 000例,实现质量目标(＜2例/10 000例);本年度未发生标本丢失事件,实现质量目标.检验报告管理监测显示TAT合格率总体均在可接受范围内(＞95％),但识别11月份血常规项目TAT合格率(94.75％)延时,并通过流程改进解决了该问题;危急值回报率实现质量目标(≥98％),但危急值回报及时率需要加强.质量控制管理的监测显示活化部分凝血活酶时间(APTT)项目在8月份的总误差(CV)明显上升(5.02％),超过了系统设定的允许CV(5.0％),并通过更换试剂解决了该问题;凝血酶时间(TT)1至12月份项目CV均远低于允许CV(12.5％),下一年度TT的允许CV下调至10％.结论依托LIS的强大数据库管理模式和信息处理能力,建立适合的实验室关键指标监控方案可以达到客观高效的管理实验室检验质量关键指标.
목적 재실험실신식관리계통상건립감측검험질량관건지표적체계,실현대실험실검험질량관건지표적관리.방법 수집2014년1월1일지12월31일북경협화의원검험과완성적림상표본.재LIS상설계교호식적수입정서완성신식채집,실현불합격표본솔、표본표식착오솔、표본주실사건등지표적통계;기록매빈양본적표본채집시간、표본도체실험실시간、표본검측시간、표본심핵시간、위급치회보시간등,재LIS계통류하궤적신식,완성대검험결과회보시간(TAT)합격솔、위급치보고통지솔등지표적계산;채집매항검측항목적질공신식,형성실내질량공제적수거고,실현질공적실공솔、검험항목총오차등관건질량지표적감측.결과 양본관리감측현시2014년도불합격표본솔균소우질량목표(1％),단식별출1～2월빈적불합격표본솔교고,4개병구표본불합격솔＞2％;표본표시착오솔위0.47례/10 000례,실현질량목표(＜2례/10 000례);본년도미발생표본주실사건,실현질량목표.검험보고관리감측현시TAT합격솔총체균재가접수범위내(＞95％),단식별11월빈혈상규항목TAT합격솔(94.75％)연시,병통과류정개진해결료해문제;위급치회보솔실현질량목표(≥98％),단위급치회보급시솔수요가강.질량공제관리적감측현시활화부분응혈활매시간(APTT)항목재8월빈적총오차(CV)명현상승(5.02％),초과료계통설정적윤허CV(5.0％),병통과경환시제해결료해문제;응혈매시간(TT)1지12월빈항목CV균원저우윤허CV(12.5％),하일년도TT적윤허CV하조지10％.결론 의탁LIS적강대수거고관리모식화신식처리능력,건립괄합적실험실관건지표감공방안가이체도객관고효적관리실험실검험질량관건지표.
Objective To establish a system of monitoring the key indicator of quality for inspection (KIQI) on a laboratory information system (LIS),and to have a better management of KIQI.Methods Clinical sample made in PUMCH were collected during the whole of 2014.Next,interactive input program were designed to accomplish data collecting of the disqualification rate of samples,the mistake rate of samples and the occasions of losing samples,etc.Then,a series moment of sample collection,laboratory sample arrived,sample test,sample check,response to critical value,namely,trajectory information left on LIS were recorded and the qualification rate of TAT,the notification rate of endangering result were calculated.Finally,the information about quality control were collected to build an internal quality control database and the KIQI,such as the out-of-control rate of quality control and the total error of test items were monitored.Results The inspection of the sample management shows the disqualification rates in 2014 were all below the target,but the rates in January and February were a little high and the rates of four wards were above 2％.The mistake rates of samples was 0.47 cases/10 000 cases,attaining the target (＜ 2 cases/ 10 000 cases).Also,there was no occasion of losing samples in 2014,attaining the target too.The inspection of laboratory reports shows the qualification rates of TAT was within the acceptable range (＞95％),however the rates of blood routine in November (94.75％) was out of range.We have solved the problem by optimizing the processes.The notification rate of endangering result attained the target(≥98％),while the rate of timely notification is needed to improve.Quality inspection shows the CV of APTT in August (5.02％) was rising significantly,beyond the accepted CV(5.0％).We have solved the problem by changing the reagent.The CV of TT in 2014 were all below the allowable CV,thus the allowable CV of the next year lower to 10％.Conclusion It is an objective and effective method to manage KIQI with the powerful management mode of database and information process capability on LIS.