Risk assessment of the acute stroke diagnostic process using failure modes, effects, and criticality analysis

Acad Emerg Med. 2023 Mar;30(3):187-195. doi: 10.1111/acem.14648. Epub 2023 Jan 27.


Introduction: To date, many emergency department (ED)-based quality improvement studies and interventions for acute stroke patients have focused on expediting time-sensitive treatments, particularly reducing door-to-needle time. However, prior to treatment, a diagnosis of stroke must be reached. The ED-based stroke diagnostic process has been understudied despite its importance in assuring high-quality and safe care.

Methods: We used a learning collaborative to conduct a failure modes, effects, and criticality analysis (FMECA) of the acute stroke diagnostic process at three health systems in Chicago, IL. Our FMECA was designed to prospectively identify, characterize, and rank order failures in the systems and processes of care that offer opportunities for redesign to improve stroke diagnostic accuracy. Multidisciplinary teams involved in stroke care at five different sites participated in moderated sessions to create an acute stroke diagnostic process map as well as identify failures and existing safeguards. For each failure, a risk priority number and criticality score were calculated. Failures were then ranked, with the highest scores representing the most critical failures to be targeted for redesign.

Results: A total of 28 steps were identified in the acute stroke diagnostic process. Iterative steps in the process include information gathering, clinical examination, interpretation of diagnostic test results, and reassessment. We found that failure to use existing screening scales to identify patients with large-vessel occlusions early on in their ED course ranked highest. Failure to obtain an accurate history of the index event, failure to suspect acute stroke in triage, and failure to use established stroke screening tools at ED arrival to identify potential stroke patients were also highly ranked.

Conclusions: Our study results highlight the critical importance of upstream steps in the acute stroke diagnostic process, particularly the use of existing tools to identify stroke patients who may be eligible for time-sensitive treatments.

Keywords: diagnostic error; emergency medicine; patient safety; quality improvement; stroke.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Emergency Service, Hospital
  • Humans
  • Quality Improvement
  • Risk Assessment
  • Stroke* / diagnosis
  • Stroke* / therapy
  • Triage