实验室生物安全备案及管理系统模型的建立与应用研究

Establishment and implementation of laboratory biosafety record keeping and management

目前对BSL-1和BSL-2级病原微生物实验室,国家规定需向市级政府卫生主管部门或者兽医主管部门备案,对其实验操作内容、仪器设备情况、人员培训考核等均有相应的考核监督机制,但强调不够。病原微生物实验室生物安全管理工作是关系到经济发展、社会稳定、人民群众身体健康和生命安全的大事,任何疏忽都可能造成难以弥补的损失。本研究借鉴、整合目前国际上较有效的病原微生物实验室生物安全管理方法、制度等,根据国内病原微生物实验室的实际情况,利用先进的计算机技术,针对BSL-1和BSL-2级病原微生物实验室建立一套能够对实验室生物安全进行规范化管理的系统模型,根据本单位内部考核相关指标验证体系,使得病原微生物实验室的生物安全问题得到统一规范管理。

The Chinese government has been paying close attention to biosafety practice in pathogen research laboratories since the occurrence of severe acute respiratory syndrom（SARS） outbreaks. There are measures in place for the management of the biosafety level-1 （ BSL-1 ） , BSL-2 pathogenic microbiology laboratories, including experimental details of operation, conditions of study equipment, and personnel training assessments. The management of laboratory biosafety is related to economic development of the region, social stability, and public health. Any negligence to safety events may cause irreparable loss. With advanced computer technology, this study aimed to set up a management system model for BSL-1 and BSL-2 laboratories, in accordance with conditions of domestic pathogenic microbiology laboratories, to meet the growing demand of standardized laboratory biosafety via the integration of presently effective international practice on laboratory biosafety of pathogenic microorganisms. Internal assessments were verified by the Shanghai Public Health Clinical Center Affiliated to Fudan University.