Abstract:
Objective To strengthen the biosafety management of pathogen microbiology laboratories, understand the current management status of biosafety laboratories in various institutions, analyze existing issues, and explore solutions.
Methods Using the registration system, we obtained the registration data of pathogen microbiology laboratories in Hangzhou as of the end of May 2023. From June to September 2023, we randomly selected 221 entities responsible for establishing pathogen microbiology laboratories in Hangzhou and their 636 successfully registered subordinate laboratories. On-site evaluation of pathogen microbiology laboratories in Hangzhou was conducted in accordance with the Specification for the Evaluation of Biosafety Laboratory Management and the on-site evaluation results regarding laboratory infection risks were analyzed.
Results The overall compliance rate with biosafety requirements among the inspected institutions in Hangzhou was 95.22%. There were differences in overall compliance rate among various types of institutions (χ2 = 431.816, P < 0.001). The laboratories from different institutions showed differences in compliance rates (P < 0.05) in organizational management, laboratory facilities/equipment, personnel management, management of strains/samples, management of laboratory waste, housekeeping management, and fire safety management. No difference was observed in the compliance rates for routine management evaluation indicators (P > 0.05).
Conclusions The laboratories in medical institutions of the county level and above and independent testing institutions in Hangzhou demonstrate good biosafety management status, whereas the management status of laboratories in private medical institutions, biotechnology enterprises, and township health centers needs improvement.