• Rahul K Khare, Anna P Nannicelli, Emilie S Powell, Nicholas P Seivert, James G Adams, and Jane L Holl.
• Department of Emergency Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL; Center for Healthcare Studies, Northwestern University, Feinberg School of Medicine, Chicago, IL. Electronic address: rkhare@northwestern.edu.
• Ann Emerg Med. 2013 Oct 1;62(4):388-398.e12.

Study ObjectiveThe Centers for Medicare & Medicaid Services currently endorses a door-to-balloon time of 90 minutes or less for patients presenting to the emergency department (ED) with ST-segment elevation myocardial infarction. Recent evidence shows that a door-to-balloon time of 60 minutes significantly decreases inhospital mortality. We seek to use a proactive risk assessment method of failure mode, effects, and criticality analysis (FMECA) to evaluate door-to-balloon time process, to investigate how each component failure may affect the performance of a system, and to evaluate the frequency and the potential severity of harm of each failure.MethodsWe conducted a 2-part study: FMECA of the door-to-balloon time system and process of care, and evaluation of a single institution's door-to-balloon time operational data using a retrospective observational cohort design. A multidisciplinary group of FMECA participants described the door-to-balloon time process to then create a comprehensive map and table listing all process steps and identified process failures, including their frequency, consequence, and causes. Door-to-balloon time operational data were assessed by "on" versus "off" hours.ResultsFifty-one failure points were identified across 4 door-to-balloon time phases. Of the 12 high-risk failures, 58% occurred between ECG and catheterization laboratory activation. Total door-to-balloon time during on hours had a median time of 55 minutes (95% confidence interval 46 to 60 minutes) compared with 77 minutes (95% confidence interval 68 to 83 minutes) during off hours.ConclusionThe FMECA revealed clear areas of potential delay and vulnerability that can be addressed to decrease door-to-balloon time from 90 to 60 minutes. FMECAs can provide a robust assessment of potential risks and can serve as the platform for significant process improvement and system redesign for door-to-balloon time.Copyright © 2013 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

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