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

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.