我国疾病预防控制机构生物安全三级实验室建设与管理现状调查

Current status of BSL-3 laboratory construction and management in China’s CDC system

  • 摘要:
    目的 掌握我国疾控系统生物安全三级(BSL-3)实验室建设与管理现况,为进一步做好我国高等级实验室生物安全建设管理工作提供建议。
    方法 通过电话和问卷调研收集各BSL-3实验室建设现状,并确定现场调研对象;对开展实验活动的实验室开展现场调研了解运行情况,并对调研信息进行整理和分析。
    结果 20家已建成并投入使用的BSL-3实验室中,65.54%的实验室人员为实验操作人员;获批可开展实验活动的病原微生物共18种;55.00%的实验室每年运行天数大于100 d;30.00%实验室开展过共享合作;实验室需要重点关注的情况有风险评估报告针对性不强、实验活动操作不规范、实验活动与菌(毒)种保存记录不全面清晰等。实验室主要存在维护经费不足、人员生物安全风险意识不足等问题。
    结论 截至2024年,疾控系统BSL-3实验室建设已覆盖全国。然而,实验室在建设与运行过程中仍面临一些问题和挑战,需通过国家和地方的协同推进,加强建设与管理,不断完善实验室体系,促进BSL-3实验室向规范化和高质量运行方向发展,充分发挥其在国家生物安全战略资源平台的作用。

     

    Abstract:
    Objectives To understand the current status of biosafety level-3 (BSL-3) laboratory construction and managementin in centers for disease control and prevention (CDC) system in China, and provide recommendations for to strengthen biosafety governance.
    Methods Data on BSL-3 laboratory construction were collected through telephone interviews and questionnaire survey. Laboratories conducting experimental activities were selected for on-site assessments to evaluate operational conditions and discuss existing issues and challenges. All the collected data were systematically summarized and analyzed.
    Results In the 20 operational BSL-3 laboratories, 65.54% of staff were experimental operators. Eighteen pathogenic microorganisms were approved for use. Over half of the laboratories (55.00%) had a annual operation for more than 100 days, and 30.00% had resource-sharing or collaborative activities. Major problems included insufficiently targeted risk assessment reports, non-standardized experimental procedures, and incomplete or unclear records of experimental activities and strain/toxin storage. In addition, inadequate maintenance funding and insufficient staff biosafety risk awareness existed.
    Conclusions By 2024, BSL-3 laboratories in the CDC system had achieved nationwide coverage in China. However, deficiencies in construction and operation remain. Strengthened coordination between national and local authorities is needed to improve laboratory management and promote standardized and high-quality operation of BSL-3 laboratories, thereby enabling them as a strategic resource platform for national biosafety.

     

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