2011-2019年河南省实验室生物安全行政处罚情况分析

Analysis of administrative penalties related to biosafety of laboratory in Henan province,2011-2019

目的分析2011-2019年河南省医疗卫生机构病原微生物实验室生物安全行政处罚情况及存在问题,为制定卫生监督政策和卫生立法提供基础资料。方法分析数据来源于国家卫生监督信息数据库,从其中导出河南省2011-2019年间所有传染病专业行政处罚案件数据,共28071件,其中生物安全案件共41起,建立数据库并进行统计分析。结果《病原微生物实验室生物安全管理条例》适用严重不足,大部分案件适用简易程序予以警告行政处罚,被处罚人中公有制机构和一二级医院占主体,实验室未备案是最主要的违法行为。结论《病原微生物实验室生物安全管理条例》存在滞后性,行政制裁手段单一。立法者应当不断完善病原微生物实验室生物安全法律规范,增设行政制裁手段,加大行政惩处力度,完善实验室生物安全备案制度。

Objective To analyze the administrative penalties and existing problems related to the biosafety of pathogenic microbe laboratories in the medical and health institutions of Henan from 2011 to 2019,and provide basic data for the formulation of health supervision policies and health legislation.Methods The data on all administrative penalties related to infectious diseases in Henan Province from 2011 to 2019 were extracted from the National Health Supervision Information Database.There were a total of 28071 cases and 41 of them were related to biosafety.Results The application of the Regulation on the Biosafety Management of Pathogenic Microbe Labs was seriously inadequate.In most cases,simplified procedures were used issuing warning as administrative punishment.Among the punished institutions,public ownership institutions,first-level hospitals and second-level hospitals accounted for most of them,and Being undocumented in some laboratories were the main illegal acts.Conclusion The Regulation on the Bio-safety Management of Pathogenic Microbe Labs is lagging behind,and means of administrative penalty is single.Legislators should continue to improve the laws and regulations on the biosafety of pathogenic microbe laboratories,add means of administrative penalty,increase administrative punishment powerfully,and improve the laboratory biosafety filing system.