Evaluation of biosafety and biosecurity at the National Bio and Agro- Defense Facility using High Reliability Organization system requirements as a standard

Authors: Lyons, Amy; Warhurst, Rachael; Poole, Heather; Jones, Brandy; Fink, Sean; Vu, Hao; Delarosa, Mary; Weekly, Susan

Submitted to: Symposium Proceedings
Publication Type: Abstract Only
Publication Acceptance Date: 1/8/2021
Publication Date: N/A
Citation: N/A

Interpretive Summary: This poster looks at similarities and differences between high reliability organization (HRO) program requirements and other requirements of a Select Agent program to see similarities (areas of synergy) and differences (areas of potential conflict) that may indicate whether an HRO program is suitable for application at the National Bio and Agro-Defense Facility (NBAF) and also whether HRO criteria may be used as a foundation for the evaluation of the NBAF biosafety program.

Technical Abstract: The National Bio and Agro-Defense Facility (NBAF) is attempting the first-ever stand-up of a High Reliability Program in a high-containment laboratory. A high reliability organization (HRO) is an organization that has succeeded in avoiding catastrophes in an environment where incidents can be expected due to risk factors and complexity. This framework has been effective in eliminating errors in the nuclear industry, aircraft carriers, firefighting, and other high-risk operations. In 2014, a series of biosafety incidents in federal laboratories brought biological research risks into public focus. To strengthen biosafety and biosecurity, the Federal Experts Security Advisory Panel (FESAP) reviewed these incidents and provided top-level recommendations (FESAP 1.1 and FESAP 1.2) that suggested the creation of a culture of biosafety, laboratory biosecurity, and responsible conduct in the life sciences, as well as, appropriate organizational and governance structures for compliance with regulations and guidelines. Although there have been ad-hoc attempts to define conditions for these FESAP recommendations, including publications on training, information resources, and implementation strategies, there is still no unified strategy for the stand-up, review and assessment of a validated methodology that can be used across laboratories and institutes to implement FESAP recommendations. In addition to the FESAP 1.1 and 1.2 recommendations, FESAP 1.7 includes the establishment of a voluntary, anonymous, non-punitive incident reporting system for research laboratories — a hallmark of an HRO program that has proven difficult to implement in a research laboratory due to requirements by the Federal Select Agent Program (FSAP) and the Agricultural Select Agent Program (AgSAS). In this analysis, we align the requirements of an HRO program with the FESAP recommendations to provide a semi-quantifiable way to assess the efficacy of biosafety and biosecurity programs at NBAF using, or adapting, assessment methods already used in other organizations. We further assess the challenges of implementing HROs under FSAP reporting requirements and suggest a path forward for resolution. This assessment will be applied to the actual implementation of an HRO program at a high-containment laboratory, providing a long-term study of the impact and compatibility of an HRO program on biosafety and biosecurity.