Cong Ying, Li Jinkai, Lou Dingshuo, Zhu Jianliang, Zhang Deyong, Cheng Dongqing, Chen Xiuying
Lishui Center for Disease Control and Prevention, Lishui, China.
School of Medical Technology and Information Engineering, Zhejiang Chinese Medical University, Hangzhou, China.
Front Bioeng Biotechnol. 2025 Aug 8;13:1637056. doi: 10.3389/fbioe.2025.1637056. eCollection 2025.
The management of biosafety laboratories for pathogenic microorganisms is directly related to public health and the effectiveness of biological experiments. However, persistent non-compliance issues in biosafety level 2 (BSL-2) laboratory management remain a challenge. This study aimed to assess the quality control of BSL-2 laboratories for pathogenic microorganisms in Lishui.
By combining the Biosafety Online Supervision Systems and on-site inspections, this study assessed the quality control of 73 medical institutions and the 128 biosafety laboratories under their management in Lishui.
The results discovered that the 73 medical institutions had low compliance rates in several fields: Responsibilities of the biosafety management (80.82%), development of system documentation (65.75%), risk assessment (84.56%), training of laboratory personnel (82.19%), and biosafety labeling (52.05%). Additionally, 128 laboratories had low pass rates for the access control management system (85.94%), hand/eye wash and shower stations (85.94%), and biosafety cabinet operations (89.06%).
This study demonstrates that future efforts should focus on strengthening laboratory personnel training and implementing biosafety management responsibilities to ensure safe and regulation-compliant operations in laboratories handling pathogenic microorganisms.
病原微生物生物安全实验室的管理直接关系到公众健康和生物实验的有效性。然而，生物安全二级（BSL-2）实验室管理中持续存在的不符合规定问题仍然是一项挑战。本研究旨在评估丽水市病原微生物BSL-2实验室的质量控制情况。
本研究通过结合生物安全在线监督系统和现场检查，对丽水市73家医疗机构及其管理的128个生物安全实验室的质量控制情况进行了评估。
结果发现，73家医疗机构在几个方面的合规率较低：生物安全管理职责（80.82%）、体系文件制定（65.75%）、风险评估（84.56%）、实验室人员培训（82.19%）和生物安全标识（52.05%）。此外，128个实验室的门禁管理系统（85.94%）、洗眼/洗手和淋浴设施（85.94%）以及生物安全柜操作（89.06%）的合格率较低。
本研究表明，未来应着重加强实验室人员培训并落实生物安全管理责任，以确保处理病原微生物的实验室安全且合规运行。
