摘要
目的按照国家有关规定对我院临床基因扩增检验实验室进行风险评估,以加强实验室的生物安全,确保规范开展临床基因扩增检验工作。方法风险评估方法采用现场评估,并综合分析所采取措施的防范效果。结果回顾分析显示贵州省细胞工程重点实验室临床基因扩增检验实验室主要存在着危害度等级2级和3级的感染性微生物危害,主要可能存在乙型肝炎病毒、人乳头瘤病毒和结核杆菌等12种常见微生物危害风险,实验室建立的4个工作区布局合理,并采取了有效的控制风险措施,质量、技术管理体系完善,并能严格贯彻执行,有效防范了生物风险。结论健全风险评估机制和建立防范措施是保证基因扩增检验实验室生物安全的关键措施,也是使实验室良好运行的重要举措。
Objective Risk assessment of clinical gene amplification testing laboratory was performed in accordance with the relevant state regulations in our hospital. This is in order to strengthen the laboratory biosafety and ensure to strictly carry out the specifications in clinical gene amplification testing. Methods Biosafety risk assessment was performed by an on-site assessment. And preventive effects of taken measures were analyzed by synthesis. Results Clinical gene amplification testing laboratory has two and three criticality levels of infectious microbes harm in Key Laboratory of Cell Engineering in Guizhou Province. There may be usual twelve infective microorganisms in the clinical gene amplification laboratory, such as hepatitis B virus, human papillomavirus and mycobacterium tuberculosis and so on. They are the hazard level 2 and 3 infection microbiological hazards. The working areas were established by four rational layouts. The effective risk control measures were adopted. And have a set of perfect quality, technology management system, then are strictly implemented thoroughly for effective prevention of biological risks. Conclusion Establishment and improvement of risk assessment mechanism is not only the key measures for laboratory biosafety, but also the important safeguard for fine laboratory running.
出处
《中国医药指南》
2017年第32期297-298,F0003,共3页
Guide of China Medicine
关键词
基因扩增
生物安全
风险评估
质量控制
Gene amplification
Biosafety
Risk assessment
Quality control
