北京医院体外诊断试剂基于绩效管理的全流程闭环管理设计和效果评估  

Design and Effect Evaluation of in Vitro Diagnostic Reagents for Beijing Hospital Based on Performance Management of the Whole Process Closed-loop Management

作　　者：宋景晨[1] 郭芷萱[2] 窦婧婧[1] 刘蕾[3] 吴锁薇[1] 李传保[2] SONG Jingchen;GUO Zhixuan;DOU Jingjing;LIU Lei;WU Suowei;LI Chuanbao(Department of Medical,Beijing Hospital/National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Clinical Laboratory,Beijing Hospital/National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Pharmacy,Beijing Hospital/National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]北京医院、国家老年医学中心,中国医学科学院老年医学研究院医务处,北京100730 [2]北京医院、国家老年医学中心,中国医学科学院老年医学研究院检验科,北京100730 [3]北京医院、国家老年医学中心,中国医学科学院老年医学研究院药学部,北京100730

出　　处：《现代检验医学杂志》2024年第4期197-202,共6页Journal of Modern Laboratory Medicine

基　　金：2022-2023年度北京医院院级科研课题(BJ-2021-226)。

摘　　要：目的构建体外诊断试剂(in vitro diagnostic reagents,IVD reagent)全流程闭环管理方案并实施,优化IVD管理工作。方法基于北京医院IVD管理现状,设计IVD全流程闭环管理方案,包括IVD申请、IVD遴选、IVD申购、IVD采购、IVD领取、IVD入出库和IVD使用等环节。选择关键指标建立评估框架,运用访谈法、查阅相关信息系统的方法收集和统计方案实施前(2020年)和实施后(2023年)的管理数据、采购数据和检测数据,对流程管理、质量管理和成本管理进行评估。结果优化了管理流程,IVD申购时间平均缩短了约60%,IVD采购无需人工处理,实时拆分订单并发送至对应的供应商,IVD领取时间平均缩短了约75%;IVD和检测质量管理满意,供货商资质完善度达到100%,室间质评得到满分,无IVD相关不良事件;成本管理有效,IVD采购成本降低了约15%,分别建立了人免疫缺陷病毒抗体测定、丙型肝炎抗体测定、梅毒螺旋体抗体测定和乙型肝炎表面抗原定量测定四个项目的IVD成本精细化管理模型,IVD损耗的平均值为0.07%~1.21%,标准差为0.07%~0.66%。结论IVD全流程闭环管理方案切实可行,提高了IVD管理工作效率,保证了IVD质量和检测质量,降低了IVD成本,细化了成本管理工作。Objective To establish in vitro diagnostic(IVD)reagents closed-loop management scheme for the whole process and implement,and optimize the IVD management.Methods Based on the status quo of IVD management in Beijing Hospital,the closed-loop management scheme of the whole IVD process was designed,such as IVD application,IVD selection,IVD subscription,IVD purchase,IVD receipt,IVD inbound and outbound,and IVD use.Key indicators were selected to establish an evaluation framework.Management data,procurement data and testing data before(2020)and after(2023)implementation of the program were collected and counted by means of interviews and consulting relevant information systems,and then process management,quality management and cost management were evaluated.Results The management process was optimized,the IVD purchase time was shortened by about 60%on average,the IVD purchase did not need manual processing,the order was split in real time and sent to the corresponding supplier,and the IVD collection time was shortened by about 75%on average.IVD and test quality management were satisfactory,supplier qualification perfection reached 100%,full marks were obtained in the inter-room quality assessment,and no IVD-related adverse events were observed.The cost management was effective,and the IVD procurement cost was reduced by about 15%.IVD cost fine management models were established for four items,namely,human immunodeficiency virus antibody assay,hepatitis C antibody assay,treponemal antibody assay and hepatitis B surface antigen quantitative assay.The average value of IVD loss was 0.07%~1.21%,and the standard deviation was 0.07%~0.66%.Conclusion The IVD whole process closed-loop management scheme is feasible,which can improve the efficiency of IVD management,ensure the quality of IVD and detection,reduce the cost of IVD,and refine the cost management work.

关 键 词：体外诊断试剂 闭环管理 绩效管理 效果评估 

分 类 号：R446[医药卫生—诊断学]