Qizhi Diao,1 Yongpei Long,2 Fangyu Yang,3 Cuihui Nong,1 Huamiao Tang,1 Xiangmin Zhou,1 Guoqiang Zhu,4 Qiang Ding5 

1Hainan Branch, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, Sanya, People’s Republic of China; 2Department of Laboratory Medicine, The People’s Hospital of Jianyang City, Sichuan, People’s Republic of China; 3Department of Clinical Laboratory Medicine, University-Town Hospital of Chongqing Medical University, Chongqing, People’s Republic of China; 4Chong Qing King Med Center for Clinical Laboratory Co., Ltd, Chongqing, People’s Republic of China; 5The Sixth People’s Hospital of Chongqing, Chongqing, People’s Republic of China

Correspondence: Guoqiang Zhu; Qiang Ding, Email Guoqiangzhu01@163.com; yung10167086@126.com

Background and Objective: Inadequate risk assessment and a lack of risk monitoring are common deficiencies in clinical laboratory, and are also the main causes of biosafety incidents. Therefore, we summarized the experience of implementing adequate risk assessment and maintaining risk monitoring, and established a procedure for continuously improving biosafety management.
Methods: Learning from our laboratory’s experience in implementing risk assessment, risk response, and risk monitoring before and during the COVID-19 epidemic, we summarized the procedures for fully identifying risks, accurately evaluating risks, maintaining risk monitoring, establishing and regular reviewing safety indicators. On this basis, we established a system for continuously improving biosafety management through risk monitoring and reviewing safety indicator.
Results: We identified a total of 30 unacceptable risks prior to the COVID-19 pandemic, and developed and implemented appropriate risk control measures. After risk control, residual risks were acceptable, and no biosafety incidents have occurred. During the COVID-19 pandemic, after multiple risk monitoring, we identified ten new risks, three ineffective risk control measures, and multiple control measures for excessive protection. Then, we timely adjusted risk control measures to avoid laboratory personnel infection and excessive protection. Meanwhile, We established eight safety indicators and identified two improvement opportunities through regular reviews.
Conclusion: Adequate risk identification and accurate risk assessment are particularly important for effectively controlling biosafety risks. Biosafety management should be continuously improved to deal with ineffective and excessive protection caused by various changes in experimental activities. Continuous improvement of biosafety management can be achieved through risk monitoring, regular review of safety indicators, and management reviews. This study will help laboratory managers to fully and accurately assess risks, as well as update risks and their control measures through risk monitoring, and the continuous improvement procedure established in the study has certain reference value for laboratories to effectively respond to emerging infectious diseases and avoid excessive protection.

Keywords: risk assessment, risk monitoring, management review, continuous improvement, biosafety management