Application of Failure Mode and Effects Analysis (FMEA) for Risk Management in Hospital Laboratories

Hospital laboratories play a fundamental role in ensuring timely and accurate diagnostic information that supports clinical decision-making and patient care. However, laboratory processes—such as specimen collection, handling, analysis, and reporting—are inherently complex and susceptible to various errors that may compromise patient safety and treatment outcomes. Failure Mode and Effects Analysis (FMEA) is a structured, proactive risk assessment tool that allows healthcare institutions to systematically identify, evaluate, and mitigate potential failures within critical workflows. This paper examines the application of FMEA in the context of hospital laboratory risk management. Through process mapping and collaboration among multidisciplinary teams—including laboratory staff, clinicians, and quality managers—potential failure modes were identified across different laboratory phases. Each failure mode was analyzed using a standardized scoring system for severity (S), occurrence (O), and detectability (D), leading to the calculation of a Risk Priority Number (RPN). High-priority risks such as sample mislabeling, equipment malfunction, and reagent expiration were addressed with targeted interventions, including barcode implementation, enhanced equipment maintenance protocols, and improved inventory systems. The findings indicate that FMEA significantly improves error detection and prevention in laboratory operations, promotes a culture of safety, and enhances compliance with international quality standards such as ISO ۱۵۱۸۹. Moreover, the participatory nature of FMEA fosters organizational learning and continuous quality improvement. Despite requiring time and training investment, FMEA offers a cost-effective approach to reducing diagnostic errors and improving patient outcomes. The study recommends routine application of FMEA and its integration with digital health technologies for real-time risk monitoring in clinical laboratories.

کلیدواژه ها:

FMEA ، Risk Management ، Hospital Laboratory ، patient safety ، Diagnostic errors ، quality improvement