高级别兽医生物安全实验室的初步定量风险评估研究
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F203;S851.6

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国家质检总局科技计划项目(2016IK082);国家认监委行业标准制定计划项目(2017RBO36)


Study on Preliminary Quantitative Risk Assessment for High Level Veterinary Biosafety Laboratories
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    摘要:

    [目的] 探讨高级别兽医生物安全实验室的定量风险评估方法。[方法] 对2005年以来通过认可的高级别兽医生物安全实验室,就设施、设备、管理体系和运行管理四大类风险要素开具的不符合项进行梳理、分析,通过模型构建,利用@Risk风险分析管理软件,对实验室运行中可能出现的事故概率进行初步量化评估。[结果]比较分析了有代表性的高级别兽医生物安全实验室现场评审发现的不符合项,按照比例权重依次为管理体系(30.3%)、设施(25.7%)、运行管理(18.2%)、其他(15.2%)和设备(10.6%)。构建了设施-事故、设备-事故、管理体系-事故和运行管理-事故的发生概率模型,通过50%百分位数统计量和平均值统计量分析各要素对事故概率的影响,由高到低依次为运行时间、运行管理、设施(平均值统计量分析时,在体系之后)、体系和设备;通过模型运算估计,就目前部分兽医实验室运行状况看,实验室年度内发生生物安全事故的概率最小为0.38%,平均发生事故的概率为2.5%,90%的可能发生事故的概率事件集中在0.8%~6.7%。严重疏于运行管理情况下,发生事故概率将有2.3%~2.5%升高至13.1%。[结论 ]高等级兽医生物安全实验室有多重要素影响其安全,应在注重设施建设、设备配置、体系编制基础上,加强日常运行的管理。

    Abstract:

    [Objective] To discuss the quantitative risk assessment method for high level veterinary biosafety laboratories. [Methods] Non-conformance items of facilities,equipment,management system and operation management obtained from the review process of high level veterinary biosafety laboratories which have acquired laboratory accreditation since 2005 were analyzed. Through modeling,the preliminary risk assessment of accident probability while laboratory running was simulated with @RISK software. [Results] Non-conformity items of different terms from representative high level veterinary laboratories while reviewed were compared and analyzed. According to proportion weight,the order of the four categories of non-conformity is as follow:the management system(30.3%),facilities(25.7%),run management(18.2%),other factors(15.2%)and equipment(10.6%). The model of facilities-accident,equipment-accident,management system-accident and run management-accident was established respectively. By analyzing the impact to accident probability by 50% percentiles and average values respectively,the order from high to low was running time,operation management,facilities(following the item of management system while analyzed by average value),management systems and equipment. By model operation,the biosafety accident probability occurred at the observed laboratory was estimated at least 0.38%,and average accident probability was 2.5%. Meanwhile,90% of accident probability might be at the range from 0.8% to 6.7% under recent laboratory status. Furthermore,the accident probability will rise from 2.3%~2.5% to 13.1% if the laboratory was under very poor running management condition. [Conclusion] There are multi-factors that can impact the biosafety of high level veterinary biosafety laboratories. We should enforce their daily running management on basis of paying much more attention to facilities construction,equipment layout and establishment of management systems.

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王君玮,王荣,白倞怿,赵格,周永运,翟培军,洪军.高级别兽医生物安全实验室的初步定量风险评估研究[J].《中国动物检疫》编辑部,2017,34(8):59-63.

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  • 在线发布日期: 2017-08-02
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