Socio-Technical Risk Analysis for the Digitalized Transfusion Process: The e-TRAST Tool

Objective: This study aims to develop an integrated risk assessment methodology that considers Human and Organizational Factors (HOFs) to enhance the safety and efficiency of digital health solutions in the transfusion sector. Methodology: The research study has been articulated in three research phases. First, through a literature review we identified critical HOFs influencing eHealth safety and adoption. Second, we developed the e-TRAST framework (digitalized Transfusion Risk Analysis from a Socio-Technical perspective), integrating Failure Modes, Effects, and Criticality Analysis (FMECA) with the Cognitive Reliability and Error Analysis Method (CREAM) to assess risks in digitalized transfusion processes. Finally, we validated the framework through expert judgement elicitation and we pilot-tested it into a digitalized process of an Italian hospital using a Software as Medical Device (SaMD) for transfusion management system. Results: The study identified key HOFs impacting transfusion safety, leading to the development and preliminary validation of a risk assessment tool tailored for healthcare facilities. Pilot testing revealed that incorporating HOFs adjusted risk occurrence levels for 25% of failure modes, emphasizing the role of human and organizational elements in patient safety. The framework provides a structured approach to contribute to patient safety, optimizing workflows, and supporting regulatory compliance for SaMD in the transfusion context.