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病原微生物实验室生物安全监管评价指标体系构建

Construction of an evaluation index system for biosafety supervision in pathogenic microbial laboratories

  • 摘要:
    目的  构建病原微生物实验室生物安全监管评价指标体系,评估市(区)级卫生行政主管部门实验室生物安全监管工作开展情况和效果,为创新监管评价方式,发现行政部门管理的薄弱之处、优化实验室生物安全监管提供参考依据。
    方法  于2024年11月—2025年1月选取20名从事实验室生物安全工作并具有权威性的专家学者,运用德尔菲法构建并筛选指标体系,通过层次分析法确定指标权重。2轮问卷回收率均为100%,专家权威系数(Cr)分别为0.940和0.913。第1轮函询专家意见协调系数(0.431)表明专家评价结论一致性强,评价结果可信。
    结果  最终形成了包含3个一级指标:监管系统(0.547 3)、监管过程(0.297 8)和监管结果(0.155 0),9个二级指标:其中组织队伍(0.249 7)、制度建设(0.186 3)和经费情况(0.111 2))权重最高,30个三级指标:其中生物安全专家组(0.101 2)权重最高、其次是人员职能覆盖度(0.089 9)与安全管理总制度(0.089 9)的评价体系。
    结论 本研究基于系统论SPO模型构建了市(区)级卫生行政部门生物安全监管评价指标体系,填补了评价行政部门生物安全监管工作的工具空缺。本指标体系凭借系统、可操作的指标条目,能较为全面、准确地评价实验室生物安全监管工作效果,并应用于规划、实施、检查、反馈四个关键阶段,推动监管从被动响应转向主动防控,进一步保障实验室生物安全。

     

    Abstract:
    Objective To establish a biosafety supervision evaluation index system for pathogenic microorganism laboratories, assess the implementation and effectiveness of laboratory biosafety supervision by municipal/district-level health administrative departments, and provide references for innovating regulatory evaluation methods, identifying weaknesses in administrative management, and optimizing laboratory biosafety supervision.
    Methods After constructing the primary evaluation index system, Delphi qualitative interview were conducted among 20 authoritative experts and scholars engaged in laboratory biosafety to screen the indicators from November 2024 to January 2025. The weights of the selected indicators were calculated using hierarchical analysis.For the two rounds of expert consultation, the response rates were 100% with authority coefficients of 0.940 and 0.913, respectively. The Kendall harmony coefficient for the first round was 0.431, with statistical testing confirming consistency among expert scores (P<0.01), indicating reliable selected indicators within the system.
    Results The final index system comprised 3 first-level indicators (regulatory system, regulatory process, and regulatory outcome, with weights of 0.547 3, 0.297 8, and 0.155 0, respectively), 9 second-level indicators (with organizational team, institutional development, and funding situation having the highest weights at 0.249 7, 0.186 3, and 0.111 2, respectively), and 30 third-level indicators (with the biosafety expert group having the highest weight at 0.101 2, followed by personnel function coverage and overall safety management system, both weighted at 0.089 9).
    Conclusion This study established an evaluation index system for biosafety supervision in pathogenic microorganism laboratories based on the SPO model, addressing a critical gap in administrative department assessment tools. The developed index system enables comprehensive and accurate evaluation of laboratory biosafety supervision through systematic and operational indicators. When applied across the four key stages of planning, implementation, inspection, and feedback, this system promotes a shift from reactive responses to proactive prevention and control measures, ultimately enhancing laboratory biosafety.

     

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