Risk Assessment and Mitigation in Blood Transfusion Practices Using Failure Mode and Effects Analysis: a Quality Improvement Study in North Malabar
Year: 2026
Type: article
Abstract: Background: Blood transfusion is a complex, step-by-step clinical procedure susceptible to multiple failure points that compromise patient safety. The purpose of this research was to assess transfusion-related risk at a resource-limited teaching hospital in North Malabar employing Failure Mode and Effects Analysis (FMEA) and instituting correction measures. Methods: A interdisciplinary Failure Mode and Effects Analysis was performed over three months (Feb–May 2025). The transfusion pathway—from ordering to administration—was charted and examined over 15 organized sessions. Failure modes were ranked by Hazard Scoring Matrix to create Risk Priority Numbers (RPNs) to determine high-risk steps. Interventions were created for failure modes with RPN > 75, with a PDCA (Plan–Do–Check–Act) approach. Results: Significant high-risk failure modes were mislabeling (RPN 100), sampling errors (RPN 72–95), incomplete requisition forms (RPN 43), and patient misidentification (RPN 73–90). Barcode wristbands, automated labeling, phlebotomy staff dedicated to the task, and staff training were associated with significant RPN reductions: misidentification (RPN 25), mis-sampling (RPN 30), and labeling errors (RPN 50). Discussion: Structured Failure Mode and Effects Analysis methodology, facilitated by automation and training staff, substantially reduced most important risks in transfusion processes. Multidisciplinary intervention design and local adjustment improved both process safety and clinical outcomes. Nevertheless, subjectivity of RPN scoring and single-center focus may impact generalizability. Conclusion: Failure Mode and Effects Analysis successfully detected and prevented major transfusion-related hazards at a North Malabar hospital. The study confirms that technology-based, protocol-driven interventions have the potential to enhance safety in transfusion practice. Ongoing follow-up and multicenter validation are suggested for long-term benefits.
Source: Acta Innovations
Institution: Northern State Medical University
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7223306046