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2023年杭州市生物安全实验室现场评价与分析

Field evaluation and analysis of biosafety laboratories in Hangzhou, 2023

  • 摘要:
    目的 为加强病原微生物实验室生物安全管理,了解各类机构生物安全实验室的管理现状,分析存在的问题并探索解决对策。
    方法 通过备案系统获取2023年5月底杭州市病原微生物实验室备案的相关数据,于2023年6—9月随机抽取杭州市221家病原微生物实验室设立单位及其下设的636个已成功备案的实验室,依据《生物安全实验室管理评价规范》对杭州市病原微生物实验室开展现场评价,并对实验室感染风险的现场评价结果进行分析。
    结果 杭州市被抽检机构生物安全总体指标符合率为95.22%。各类机构实验室总体指标符合率差异有统计学意义(χ2=431.816,P<0.001)。不同机构实验室的组织管理、实验室设施设备、人员管理、菌(毒)种和样本管理、实验废物管理、内务管理、消防管理评价指标符合率比较,差异均有统计学意义(P<0.05);日常管理评价指标符合率比较,差异无统计学意义(P>0.05)。
    结论 杭州市区县级及以上医疗机构和独立检验检测机构的实验室生物安全管理状况较好,民营医疗机构、生物技术企业和乡镇卫生院的实验室管理状况有待加强。

     

    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.

     

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