When an Incident Is Not a Crisis: Management of Incidents and Nonconformities in Biobanking

Incident reporting systems are vital tools for enhancing safety, quality, and continuous improvement in biomedical and health care environments, yet they remain underdeveloped within biobanking, a sector characterized by complexity, high reliability, and multidisciplinary operations. This article addresses the implementation of incident management (IM) and corrective action/preventive action (CAPA) frameworks in biobanks, with a focus on minor- to mid-level incidents and nonconformities.

We conducted a structured literature review using PubMed, Google Scholar, and ResearchGate resources and distinctive keywords or keyword combinations. Relevant articles were screened across biomedical, laboratory safety, and high-reliability domains. In addition, case studies from the literature and operational experiences in biobanks were analyzed, focusing on frequent but underreported incidents.

Findings indicate that robust IM and CAPA adoption align with the level of quality management system (QMS) implementation. Case studies highlighted the role of psychosocial factors-such as psychological safety, trust, and nonpunitive reporting-in addition to technical processes like root cause analysis. Effective IM is demonstrated to require more than formal structures; it depends on fostering psychological safety and a trust-based "Restorative Just" culture.

We provide the first synthesis of challenges, best practices, and cultural adaptations for IM in biobanking. For the first time, our article provides a thorough synthesis of current challenges, best practices, and cultural adaptations needed to handle incidents, and also a practical toolkit consisting of clear definitions, incident categories, and an implementation guideline to develop efficient nonconformity management in biobanking.