高质量发展背景下公立医院体外诊断试剂的管理与改进  

Management and Improvement of in Vitro Diagnostic Reagents in Public Hospitals Under the Background of High-Quality Development

作　　者：涂伟丽 钱英 TU Weili;QIAN Ying(Office of Purchasing and Supply,The First Affiliated Hospital with Nanjing Medical University,Nanjing Jiangsu 210029,China)

机构地区：[1]南京医科大学第一附属医院采购供应办公室,江苏南京210029

出　　处：《中国医疗设备》2023年第3期119-123,共5页China Medical Devices

基　　金：国家卫生健康委医院管理研究所合作项目(20210127)。

摘　　要：目的探讨体外诊断试剂院内管理的风险,分析体外诊断试剂管理的意义和难点,确保医院体外诊断试剂的供应及管理质量,保障医疗质量与安全。方法选择使用试剂管理系统前(2020年度)、使用试剂管理系统后(2021年度)共两年的采购、运输、使用、售后等配送的试剂数据。通过指标对比分析法,评价考核试剂的采购规模、订单响应率、符合率、冷链运输合格率、试剂质量管理达标率、不良事件上报率、年度供应商评价、供应商资质完善度。结果通过信息化平台系统建设,体外诊断试剂得到精细化管理,规范了采购流程、出入库流程,检验试剂管理取得了明显成效。使用试剂管理系统后,年度订单增长32.45%、试剂品种数增长2.69%、试剂总量增长19.56%、试剂订单响应率增长7.80%、运输符合率增长5.88%、冷链运输合格率增长18.06%,使用中试剂质量管理达标率增长9.77%,不良事件上报率下降87.69%、年度供应商评价均分提高8.31%、供应商资质完善度提高4.71%,各关键指标均有明显改善。结论通过管理的持续改进,有效提高了体外诊断试剂的使用效率,提升了医院的试剂管理水平。Objective To explore the risks of in vitro diagnostic reagents management in hospital,analyze the significance and difficulties of in vitro diagnostic reagents management,to ensure the supply and management quality of in vitro diagnostic reagents in hospital,and ensure the quality and safety of medical treatment.Methods The reagent data of procurement,transportation,use and after-sales other distribution for 2 years before using the reagent management system(2020)and after using the reagent management system(2021)were selected.The procurement scale,order response rate,compliance rate,cold chain transportation qualification rate,reagent quality management compliance rate,adverse event reporting rate,annual supplier evaluation and supplier qualification perfection degree were evaluated by index comparative analysis.Results Through the construction of the information platform system,the in vitro diagnostic reagents have been managed in fine detail,and the procurement process and the warehousing process have been standardized,and the management of testing reagents has achieved obvious results.After the reagent management system was used,the annual order increased by 32.45%,the number of reagent varieties increased by 2.69%,the total amount of reagents increased by 19.56%,the order response rate of reagent increased by 7.80%,the transportation compliance rate increased by 5.88%,the cold chain transportation qualification rate increased by 18.06%,the reagent quality management compliance rate in use increased by 9.77%,the adverse event reporting rate decreased by 87.69%,the annual supplier evaluation average score increased by 8.31%,and the supplier qualification perfection degree increased by 4.71%.All key indicators were significantly improved.Conclusion The continuous improvement of management can effectively improve the use efficiency of in vitro diagnostic reagents and improve the hospital’s reagent management level.

关 键 词：体外诊断试剂 管理系统 规范流程 持续改进 

分 类 号：R197.3[医药卫生—卫生事业管理]