Purpose: To identify high priority risks in a new radiation treatment workflow for alleviating severe COVID-19 pneumonia using a multi-phase failure modes and effects analysis (FMEA).
Methods: A comprehensive FMEA survey of 133 possible causes of failure was developed for a clinical trial workflow treating mechanically ventilated COVID-19+ patients with low-dose whole lung radiation therapy (Phase I). The occurrence, severity, and detection risk of each possible cause of failure was scored by 3 physicists using an adapted scoring guide based on TG-100 recommendations. High-risk potential failure modes were identified using the average risk priority number (RPN) and severity scores. The responses were used to create a second targeted survey containing high-priority risks throughout the treatment workflow (Phase II). The second survey was completed by 13 participants in Radiation Oncology including therapists, physicians, and physicists. Scores from the Phase II survey were evaluated to identify steps requiring possible intervention and examine risk perception patterns.
Results: Based on the results of the initial survey, 30 high-priority failure modes were selected for the Phase II survey. Strong internal consistency was shown in both surveys using Cronbach’s alpha (α > 0.82). The 10 failures with the largest RPN values concerned COVID-19 transmission (N = 6), wrong treatment (N = 3), and patient injury (N = 1). The average RPN was larger for COVID-related failures (RPN = 108) than other failure types (RPN = 67) due to the perceived difficulty of failure detection.
Conclusion: The high ranking of failures concerning nosocomial transmission of COVID-19 suggest that these steps may require the most quality management intervention for the treatment of critically ill COVID-19+ patients. The results also suggest that a multi-phase FMEA survey may provide useful information for assessing risks in radiation therapy procedures, supporting efforts to adapt FMEAs to clinical procedures in the literature.