Abstract

Failure mode effect analysis (FMEA) is a proactive multistep tool used to analyze risks, identify failures before they occur, and prioritize preventive measures. A multidisciplinary team trained on FMEA methodology analyzed the process of treatment of septic patients and recorded processes under 3 major phases (recognition of severe sepsis, referral, and resuscitation). The team identified potential failure modes in each process; assigned severity, occurrence, and detection scores for each; and calculated the risk priority numbers (RPNs). Finally, higher-priority failure modes (RPN of ≥300) were analyzed to redesign the care process. We identified 27 processes and 48 failure modes with a mean RPN of 270. Twenty-two high-risk failures were identified by RPN of 300 or higher. All identified critical processes were related to phase 1 (recognition of sepsis) and phase 3 (resuscitation). The most critical process seemed to be related to the initial workup and treatment of septic patients, with 4 potential failure modes and a total RPN of 1485. Patient safety and care reliability issues are a major concern in health care. This study suggests that tools such as FMEA can enable a detailed analysis of the care process of septic patients by outlining potential failure modes and guiding improvement efforts.

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