MO‐G‐BRE‐07: Risk Assessment of Surface Image Guided Stereotactic Radiosurgery

Abstract

Purpose:To develop a process map detailing the steps in the clinical workflow for surface imaging guided stereotactic radiosurgery (SRS), conduct a failure mode and effects analysis (FMEA) based on the process map, and perform fault tree analysis (FTA) on the steps with the highest risk priority number (RPN).Methods:A multi‐disciplinary team was assembled to develop a comprehensive process map listing the steps from initial consult to final treatment of a patient receiving surface image guided SRS. This process map represents the ideal workflow that would lead to successful treatment. An FMEA was conducted to determine the failure modes for each of the surface imaging related steps in the workflow and their relative risks. The risk priority numbers were calculated as the product of the occurrence, severity, and lack of detectability. The failure modes were ranked by RPN to determine the relative risk of the various steps in the process, and FTA was used to identify the potential causal relationshipsResults:The SRS process map contained over 90 steps, resulting in an FMEA with over 150 failure modes – about 25% associated with surface imaging. Based on the FMEA, the steps with the highest RPN were related to image registration, target delineation, and image handling. Surface imaging processes had considerably lower RPNs on average due to the high detectability of failure.Conclusion:The process map and FMEA presented in this work has reinforced the importance of image registration and target delineation in SRS. Clinicians considering proactive quality management of their SRS and/or surface imaging programs should be able to use the process map and FMEA as a template for their analyses. Although the occurrence rate and detection efficiency are dependent on the policies and procedures of an institution, the steps with the greatest RPN should not vary greatly.