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[目的]研究病原微生物实验室的风险管理方法。[方法]采用风险损失清单法和现场调查法,对1家从事药物研发的企业实验室开展风险调查和评估。[结果]该实验室存在生物安全警示标志不规范、没有危害评估报告、未建立不良事件报告制度、检验报告在污染区打印、洗手池的水龙头为手触式、实验人员未佩戴防护镜或面罩、新进人员不熟悉操作过程、有工勤人员进入实验室、压力蒸汽消毒设施未定期检测、实验室产生废弃物存放场所不安全、不是由专业单位处置实验室产生废弃物等11个隐患,分别制定了风险控制措施。[结论]开展实验室生物安全风险控制技术研究,建立以风险评估为基础的安全监测与预警系统,解决当前生物实验室监管模式与实验室实际情况不适应的突出问题。损失清单表法和现场调查法虽被列为风险识别的两种基本方法,但可以同时使用,互相借鉴,均可作为评估依据。
[Objective] To study risk management methods in pathogenic microorganisms laboratory. [Methods] The Risk LIST and field survey were used to carry out the risk investigation and assessment on one enterprise laboratory engaged in drug research and development. [Results] The laboratory had non-standard bio-safety warning signs, no hazard assessment report and no adverse event reporting system. The test report was printed in the contaminated area. The faucet in the wash basin was touched by hand. The test workers did not wear goggles or mask , New staff are not familiar with the operation process, there are workers into the laboratory, pressure steam disinfection facilities are not regularly detected, laboratory waste storage place unsafe, not by the professional unit to dispose of laboratories and other 11 hidden dangers of waste, Separately formulated risk control measures. [Conclusion] To carry out research on laboratory biosafety risk control technology and establish safety monitoring and early warning system based on risk assessment so as to solve the prominent problems that current biotechnology laboratory supervision mode is not suitable for laboratory actual situation. Although the list of loss lists and on-site investigation are listed as two basic methods of risk identification, they can be used at the same time and learned from each other.