Study Objectives: Sepsis is an increasing problem in the practice of emergency medicine with significant mortality. Early aggressive resuscitation of sepsis patients in the emergency department (ED) has been shown to decrease mortality. The Institute for Healthcare Improvement (IHI) advocates that all patients with severe sepsis receive the evidence-based Sepsis Resuscitation Bundle (the Bundle) within the first 6 hours of presentation. But, sepsis is a complex disease state and resuscitation can be resource and time intensive, involving care coordination between multiple departments. Additionally, there remains wide variation in the delivery of severe sepsis resuscitation, compliance with the Bundle, and sepsis outcomes within and across institutions. We hypothesize that using Failure Mode Effects and Criticality Analysis (FMECA) methodology, an innovative proactive risk assessment, we can identify critical areas for improvement in (1) Bundle compliance, and (2) overall ED sepsis resuscitation care delivery. Methods: FMECA is a moderated focus group, conducted through meetings with clinicians involved in a specific process of care. We assembled a convenience sample of 13 ED physicians, nurses, managers, and pharmacists from an urban teaching hospital. For the purposes of this study, we limited the discussion to the actions of the Bundle conducted in the ED. Two 2-hour sessions were held to (1) describe the process of sepsis resuscitation; and (2) systematically review each process step and identify potential failures, their causes, the frequency and consequence of each, and institutional safeguards already in place. The research team then “risk-binned” each process step as high, medium, or low according to the identified frequency and consequence scores. Risks were further divided into those that impact Bundle compliance and those that impact sepsis care delivery. Results: Out of 33 total process steps, 15 high-risk failures were identified: all pertained to care delivery and 11 pertained directly to meeting a Bundle component. The components of the Bundle with the most high-risk failure modes were (1) antibiotic delivery within 3 hours of ED admission, and (2) vasopressors administered for persistent hypotension. Additional high-risk steps in the process that do not pertain directly to Bundle completion included: initial physician evaluation, the decision to pursue care for septic shock, and the decision to place the central venous catheter in order to pursue the treatment of septic shock. Conclusion: FMCEA is effective in identifying critical areas for improvement in a process. Using this technique, we have identified clear areas of potential process improvement and clinician education both to achieve 100% compliance with the Bundle: antibiotic and vasopressor delivery, and direct patient care, including physician cognition and decisionmaking abilities. In order to improve patient safety, efficiency of care delivery, and patient mortality outcomes, focus should be placed on processes of care that involve departments outside the ED, such as the pharmacy; and overcoming cognitive challenges through clinician education and training. Future multi-center work using FMECA should be conducted to improve generalizability of the results.
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