诊断试剂应急检验工作机制建设探讨

目的:通过新型冠状病毒诊断试剂应急检验工作,进一步改进和完善突发公共卫生事件应急检验管理体系建设,为检验检测机构积极开展应急检验工作提供借鉴。方法:结合新型冠状病毒肺炎疫情中开展应急检验工作实践,梳理开展应急检验工作流程,探讨突发公共卫生事件的应急检验管理策略及措施。结果与结论:实现应急检验制度化、规范化、程序化,通过合理的应急检验预案制定、应急检验组织架构的建立、应急物资的储备及保障、应急检验人员的培训等方面,构建应急检验管理体系,提高突发公共卫生事件应急检验的能力。建立完善的应急检验管理体系,可以提高应急检验工作效率,协调指导相关工作有序地进行,进一步提高应急检验管理水平。

Discussion on Establishment of Working Mechanism of Emergency Inspection for IVD Reagents

Objective: Further improve and prefect the construction of the emergency inspection management system for public health emergencies, and provide a reference for inspection and testing agencies to actively carrying out emergency inspection work, according to the emergency inspection work of diagnostic reagents for 2019-nCoV. Methods: Combined with the practice of emergency inspection during the outbreak of 2019-nCoV pneumonia, the workflow of emergency inspection was analyzed, and the emergency inspection management strategies and measures for public health emergencies were discussed. Results and Conclusion: In order to achieve the institutionalization, standardization and proceduralization of emergency inspection, the establishment of an emergency inspection management system based on the building of reasonable emergency inspection plans and emergency inspection organization structure, emergency materials storage and guarantee, emergency inspection personnel training, etc., shall improve the emergency inspection ability in public health emergencies. Establishing a sound emergency inspection management system shall improve the efficiency of emergency inspection work, coordinate and guide related work in an orderly manner, and further improve the level of emergency inspection management.