Callihan Donald R, Downing Marian, Meyer Esmeralda, Ochoa Luis Alberto, Petuch Brian, Tranchell Paul, White David
Consultant, Cockeysville, Maryland, USA.
Biosafety Consultant, Kemah, Texas, USA.
Appl Biosaf. 2021 Sep 1;26(3):113-122. doi: 10.1089/apb.20.0068. Epub 2021 Sep 13.
Risk assessment is a critical tool for evaluating emerging pathogens such as severe acute respiratory syndrome coronavirus 2 because of the limited available information about pathogens and the diseases they cause. Industries adopt unique frameworks for risk assessment, for example, the ISO 35001:2019 biorisk management for laboratories and other related organizations provide tools to identify, assess, control, and monitor risks associated with hazardous biological materials. Industries such as aerospace are known as high-reliability organizations (HROs) because these must balance high-risk operations with minimal catastrophic outcomes. HROs focus on five core principles: preoccupation with failure, reluctance to simplify, sensitivity to operations, resilience, and deference to expertise to evaluate and manage risk. In the present discussion, practices described in the ISO 35001 standard and the HRO model are applied to the current challenges faced by laboratories worldwide. Laboratories processing known or unknown coronavirus disease 2019 (COVID-19) samples, testing COVID-19 vaccine candidates, propagating severe acute respiratory syndromeassociated coronavirus-2, or validating diagnostic assays benefit from implementing such practices. Principles extrapolated from the HRO also help illustrate the importance of the end-to-end processes to ensure successful outcomes. Workplace safety is enhanced by the involvement of all stakeholders, from top leadership to front-line workers. High-quality outcomes as measured by a lack of incidents, accidents, injuries, or near misses are the positive consequences of strictly following standard operating procedures and timely communication of risks and pitfalls. Adopting a systematic framework to identify and manage risks posed by emerging pathogens results in increased workplace safety and higher quality processes and products.
风险评估是评估新型病原体（如严重急性呼吸综合征冠状病毒2）的关键工具，因为关于病原体及其所致疾病的可用信息有限。各行业采用独特的风险评估框架，例如，ISO 35001:2019《实验室及其他相关组织的生物风险管理》为识别、评估、控制和监测与危险生物材料相关的风险提供了工具。航空航天等行业被称为高可靠性组织（HRO），因为这些行业必须在高风险运营与最小灾难性后果之间取得平衡。高可靠性组织注重五个核心原则：对失败的关注、不愿简化、对运营的敏感性、恢复力以及对专业知识的尊重，以评估和管理风险。在当前的讨论中，ISO 35001标准和高可靠性组织模型中描述的做法被应用于全球实验室目前面临的挑战。处理已知或未知的2019冠状病毒病（COVID-19）样本、测试COVID-19候选疫苗、繁殖严重急性呼吸综合征相关冠状病毒2或验证诊断检测方法的实验室，可从实施这些做法中受益。从高可靠性组织推断出的原则也有助于说明端到端流程对于确保成功结果的重要性。从高层领导到一线员工等所有利益相关者的参与提高了工作场所的安全性。通过严格遵守标准操作程序以及及时沟通风险和隐患，以无事故、无意外、无伤害或无未遂事故来衡量的高质量结果是其积极成果。采用系统框架来识别和管理新型病原体带来的风险，可提高工作场所安全性以及流程和产品质量。
