体外诊断试剂院内管理的风险分析与控制

Risk analysis and control of in-hospital management of in vitro diagnostic reagents

目的:探讨体外诊断试剂院内管理的风险分析与控制,确保医院体外诊断试剂供应质量。方法:选取2018-2019年医院试剂管理全流程中的数据,采用鱼骨图分析法对体外诊断试剂在医院使用全生命周期的风险点进行分析,形成风险清单,采用Kaiser模型对风险清单数据进行评估,健立院内体外诊断试剂管理流程,针对不同的风险等级给出风险应对和控制措施。结果:针对体外诊断试剂全生命周期共列出13个风险点,4个重点管理流程,风险点中5个为优先改进的高风险因素。2019年的风险评估和监控,院内对试剂工作的临床满意度同比达到99%,试剂不良事件发生率同比下降37%,检测项目耗占比整体同比下降2%。结论:风险分析与控制能够有效指导院内试剂管理流程和制度的修订,提高试剂使用效率,提升医院试剂管理水平。

Objective:To explore risk analysis and control of in-hospital management of in vitro diagnostic(IVD)reagents to ensure the supply quality of in vitro diagnostic reagents in hospitals.Methods:Data from the whole process of hospital reagent management from 2018 to 2019 were selected and the fishbone diagram analysis method was used to analyze the risk points of the whole life cycle of IVD reagents in the hospital,the risk list was formed.Kaiser model was adopted to evaluate the risk list data,the management process of in-hospital IVD reagents was established and risk response and control measures were provided for different risk levels.Results:A total of 13 risk points and 4 key management processes were listed for the entire life cycle of IVD reagents,and 5 of the risk points were high risk factors for priority improvement.In 2019 risk assessment and monitoring,the hospital's clinical satisfaction with reagent work reached 99%year-on-year,the incidence of reagent adverse events decreased by 37%,and the overall cost of testing items decreased by 2%year-on-year.Conclusion:Risk analysis and control can effectively guide the revision of the reagent management procedures and systems in the hospital,improve the efficiency of reagent use and improve the reagent management level of the hospital.