基于患者数据的实时质量控制在提升室内质量管理效能中的应用价值评价

Evaluation of the value of patient data-based real-time quality control in improving the effectiveness of indoor quality management

目的探讨基于患者数据的实时质量控制(PBRTQC)在提升室内质量管理效能中的应用价值。方法从与实验室信息系统(LIS)对接的PBRTQC实时质控智能监控平台上,收集2023年8月1日到2024年4月1日西安区域医学检验中心普检部患者红细胞计数(RBC)、白细胞计数(WBC)、硫酸脱氢表雄酮(DHEA-S)检测结果共35631条,基于该平台进行患者数据分布特征检验、EWMA实时质控图程序建立、性能验证、效果评估、最佳程序选择及实时运行。统计最佳PBRTQC程序建立的性能评价指标、EWMA实时质控图的截断限范围、加权系数、累积均值、标准差SD、变异系数CV及其同一时间段的室内质控数据累积均值、SD及CV,同时与质量目标(1/3TEa)进行比较。根据质控过程记录、报警信息,变异系数分析比较在出现警告或报警提示时PBRTQC和传统室内质量控制的质控状态。结果RBC、WBC及DHEA-S最佳程序的评价指标分别为误差检出概率(Ped)在93%~97%之间,大于90%,假阳性率(FPR)0.0~0.5%,假阴性率(FNR)3.0%~7.0%,误差出现后平均检测出误差所需的患者样本量(ANPed)ANPed 5-11,符合最佳PBRTQC程序的质控效能质量要求。最佳程序EWMA质控图的患者结果截断浓度范围为RBC(3.92~5.16)×10^(12)/L、WBC(4.28~7.50)×10^(9)/L、DHEA-S(830~2160)μg/L;(2160~4210)μg/L。加权系数分别为0.05,0.03,0.03。真实世界应用中EWMA实时质控图显示检测系统分析性能稳定优秀,如失控报警:RBC,1次真报警,Ped 95.85%,FPR 0%。质控品室内质控:WBC,1次假报警;DHEA-S,21次假报警。EWMA累计CV均小于质量目标;质控品室内质控DHEA-S高低水平累计CV分别为:7.66%,9.47%,低水平累计CV大于质量目标(8.33%),除失控后高低水平累计CV为:4.12%,6.25%。结论PBRTQC EWMA法可实时、连续监测检测系统的患者数据,动态识别和较早提示分析过程中分析性能的微小变化,可作为质控品室内质控的补充,提高实验室质量管理效能。

ObjectiveTo explore the application value of patient data-based real-time quality control(PBRTQC)in enhancing the effectiveness of internal quality control(IQC)management.MethodsFrom the PBRTQC real-time quality control intelligent monitoring platform integrated with the laboratory information system(LIS),a total of 35,631 test results of red blood cell(RBC)count,white blood cell(WBC)count,and dehydroepiandrosterone sulfate(DHEA-S)were collected from patients of the Department of General Xi'an Area Medical Laboratory Center from August 1,2023,to April 1,2024.The platform was used in patient data distribution characteristics test,EWMA real-time quality control chart procedure establishment,performance validation,effect evaluation,best procedure selection,and real-time operation.The performance evaluation indexes of the best PBRTQC procedure establishment,the cut-off limit range,weighting coefficient,cumulative mean,standard deviation(SD),coefficient of variation(CV)of the EWMA real-time quality control chart,and the cumulative mean,SD,and CV of its internal quality control data in the same period were counted,and at the same time compared with the quality target(1/3TEa).Coefficient of variation analyses were performed to compare the quality control status of PBRTQC and conventional internal quality control in the presence of warning or alarm prompts based on quality control process records,and alarm messages.ResultsThe evaluation indexes of the optimal procedures for RBC count,WBC count,and DHEA-S were the probability of error detection(Ped)between 93%-97%and greater than 90%,the false positive rate(FPR)between 0.0%-0.5%,the false negative rate(FNR)between 3.0%-7.0%,and the average number of the patient sample until error detection(ANPed)between 5-11,which is in line with the optimal quality control efficacy quality requirements for the PBRTQC procedure.The patient outcome cut-off concentrations for the optimal procedure EWMA quality control charts ranged from RBC count(3.92-5.16)×10^(12)/L,WBC count(4.28-7.50)×10^(9)/L,and DHEA-S(830-2160)μg/L;(2160-4210)μg/L.The weighting coefficients were 0.05,0.03,and 0.03,respectively.The real-world application of the EWMA real-time quality control charts showed stable and excellent analytical performance of the measurement system,such as out-of-control alarm:RBC count,1 true alarm,Ped of 95.85%,and FPR of 0%.The cumulative CV of EWMA was less than the quality target;the cumulative CV of DHEA-S was 7.66%and 9.47%,respectively,and the cumulative CV of low level was greater than the quality target(8.33%),and the cumulative CV of high and low levels were 4.12%and 6.25%.ConclusionThe PBRTQC EWMA method can monitor the patient data-in real-time and continuous way.It can also dynamically identify and provide early indication of small changes in analytical performance during the analysis process,and can be used as a supplement to quality control products to improve the efficacy of laboratory quality management.