北京市生物安全二级临床实验室生物安全管理现状分析  

Analysis of the current status of biosafety management in biosafety level 2 clinical laboratories in Beijing

作　　者：张迪[1] 柳芳超 弭凤玲[1] 李自慧[1] 王清涛[2] 梁玉芳[2] 李晓峰 潘军华 ZHANG Di;LIU Fangchao;MI Fengling;LI Zihui;WANG Qingtao;LIANG Yufang;LI Xiaofeng;PAN Junhua(Department of Science and Technology,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China;Department of Laboratory Medicine,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China;Department of Science and Education,Beijing Municipal Hospital Administration,Beijing 101117,China)

机构地区：[1]首都医科大学附属北京胸科医院科技处,北京101149 [2]首都医科大学附属北京朝阳医院检验科,北京100020 [3]北京市医院管理中心科教处,北京101117

出　　处：《中国医药导报》2025年第4期104-109,共6页China Medical Herald

基　　金：首都卫生发展科研专项项目(首发2022-1G-2162)。

摘　　要：目的了解北京市实验室生物安全管理水平的现状,及时发现潜在的可快速整改完善的生物安全隐患,为生物安全管理者制订生物安全管理制度与政策提供基于现状的科学依据。方法2023年9月至2024年1月选取北京市临床检验中心管理范围下生物安全二级(BSL-2)临床检验实验室为调查对象,共发放了220份问卷,回收202份,回收率为91.8%。围绕可快速整改的生物安全隐患进行横断面问卷调查,分别基于生物安全基础管理、人员管理、流程管理、制度管理和生物安全管理组织机制5个维度44个指标进行评价。结果北京市BSL-2临床检验实验室潜在的生物安全风险,主要体现在权重系数较高的基础管理与人员管理方面,其中设施管理方面整体符合率较低,问题包括未设置菌毒种保存的专用区域或设置不规范(39.70%),未设置标本接收专用通道或窗口(18.59%),换气系统定期检查不及时或记录不完整的问题(23.62%),未建立工作人员心理健康档案(62.90%),未对使用实验室的外来人员进行生物安全培训(38.69%)。针对流程管理、制度管理、生物安全管理组织机制方面,所有指标符合率均>90%。医院性质与实验室所在区域尚不能认为影响实验室生物安全管理水平,二、三级医院的实验室生物安全管理水平比较,差异有统计学意义(P<0.05)。在流程管理方面,独立检验机构流程管理得分低于综合医院及专科医院的临床检验实验室,差异有统计学意义(P<0.05)。结论北京市BSL-2临床检验实验室生物安全总体情况较好,但也应重视设置菌毒种的专用区域,确保实验室分区合理,建立人员心理健康档案。这些措施将提升实验室的生物安全管理水平,减少潜在风险,确保实验室操作的安全性和有效性。Objective To understand the current status of biosafety management in laboratories in Beijing,identify potential biosafety hazards that can be quickly rectified,and provide a scientific basis for biosafety managers to develop management systems and policies based on the current situation.Methods From September 2023 to January 2024,biosafety level 2(BSL-2)clinical testing laboratories under the management scope of Beijing Clinical Testing Centers were selected as the subjects for investigation.A total of 220 questionnaires were distributed and 202 were recovered,with a recovery rate of 91.8%.A cross-sectional questionnaire survey was conducted focusing on the rapid rectification of biosafety hazards,and the evaluation was carried out based on 90 indicators from 5 dimensions of biosafety basic management,personnel management,process management,system management,and biosafety organization system.Results The potential biosafety risks of BSL-2 clinical laboratory in Beijing are mainly reflected in the basic management and personnel management with high weight coefficient,among which the overall conformity rate of facility management is low,including the failure to set a special area for the storage of bacteria and virus strains or the setting is not standardized(39.70%),and the failure to set a special channel or window for specimen receiving(18.59%).The ventilation system was not regularly checked or the records were incomplete(23.62%),the staff’s mental health records were not established(62.90%),and biosafety training was not conducted for external staff using the laboratory(38.69%).In terms of process management,system management,and biosafety organization mechanism,the conformity rate of all indicators was above 90%.The nature of the hospital and the location of the laboratory could not be considered to affect the laboratory biosafety management index.The difference between the laboratory biosafety management index of the second and third level hospitals were statistically significant(P<0.05).In terms of proces

关 键 词：生物安全管理 临床检验实验室 现状分析 

分 类 号：R197[医药卫生—卫生事业管理]