Abstract：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.
涂伟丽，钱英. 高质量发展背景下公立医院体外
诊断试剂的管理与改进[J]. 中国医疗设备, 2023, 38(3): 119-123.
TU Weili, QIAN Ying. Management and Improvement of in Vitro Diagnostic Reagents in Public Hospitals
Under the Background of High-Quality Development. China Medical Devices, 2023, 38(3): 119-123.
