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目的对高致病性病原微生物菌毒种或样本运输生物安全的现行评价指标进行筛选和重构,选择关键性指标从而实现快速评价放行的要求。方法在本市现行使用的高致病性病原微生物菌毒种或样本运输生物安全监督检查评价表的基础上,采取德尔菲研究法组织7名专家对所有21项评价指标进行咨询,经过2轮咨询,对21项指标评分和统计分析,采用界值法并充分结合专家意见筛选评价指标。结果通过2轮咨询,建立了7项关键性指标作为高致病性病原微生物菌毒种或样本的运输安全快速评价指标,包括申办有效的准运证书、运输人员、运输车辆、运输包装以及运输后报告等5个方面。结论建立了一套针对高致病性病原微生物菌毒种和样本运输生物安全的现场快速评估指标,对卫生监督部门来说,缩短了评价放行的时间,提高了运输安全监管效率;对运输部门提供了一套自我评估快速放行的评价指标,对确保运输过程中的生物安全具有重要意义。
OBJECTIVE To screen and reconstruct the current evaluation indexes of biosafety of pathogenic microorganisms or samples for pathogenicity of pathogenic microorganisms and to select the key indexes so as to realize the requirement of rapid assessment of release. Methods Based on the evaluation table of biosafety and surveillance of pathogenic microorganism strains or samples transported by the city, 7 experts from Delphi Research Organization were consulted for all 21 evaluation indexes. After 2 rounds of evaluation, Consulting, scoring and statistical analysis of 21 indicators, using the cut-off method and fully integrating the opinions of experts screened evaluation indicators. Results Through two rounds of consultation, seven key indicators were set as rapid transportation safety evaluation indicators for high pathogenic microorganism strains or samples, including bidding for effective transportation permit, transportation personnel, transport vehicles, transport packaging and transportation After the report and other five aspects. Conclusion A set of on-site rapid assessment index for the pathogenicity and pathogenicity of pathogenic microorganism strains was established. For the health supervision department, the time for evaluation release was shortened and the efficiency of transportation safety supervision was improved. Provides a set of evaluation indicators for rapid assessment of self-evaluation, and is of great significance for ensuring the biosafety in transportation.