Biorisk Management in High-Containment Laboratories: Assessment of Certification Systems and Need for Global Standardization
Abstract
Laboratory-acquired infections (LAIs) and accidental pathogen escape from laboratory settings (APELS) are still a significant concern, even with biosafety guidelines and manuals in place. The actual number of these events is probably underestimated because there are no mandatory reporting systems or standard surveillance frameworks. In this review, a clear overview is given about the evolution of biosafety, the worldwide distribution and governance of high-containment laboratories (BSL-3 and BSL-4), and the key factors that lead to laboratory incidents. The focus is specifically on human error, inadequate training, and differences in standard operating procedures as primary causes of biosafety failures. Furthermore, current regulatory frameworks are described, pointing out the lack of consistency in laboratory practices, infrastructure needs, and national policies, especially the variances in biosafety level recommendations for high-risk pathogens. Certification systems as potential tools to improve standardization and consistency in operations are discussed. Among these, ISO 35001 is a detailed standard for managing biorisks, including risk assessment, staff training, incident reporting, and processes for ongoing improvement. However, its use is still limited, and certification is not mandatory for laboratory licensing everywhere. Additionally, existing standards do not fully cover structural aspects and national differences in how pathogens are handled. This review also…
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