FAILURE MODE AND EFFECT ANALYSIS FOR THREE DIMENSIONAL RADIOTHERAPY AT AIN SHAMS UNIVERSITY HOSPITAL

Introduction: Three-dimensional radiotherapy (3-D) is an important modality in the management of cancer. This complex process is liable to many types of errors. Risk management approaches are mandatory to decrease the risk of these errors. Failure mode & effect analysis (FMEA) is a proactive risk assessment strategy used to identify and anticipate potential errors and to take action before a radiation incident occurs.

Aim: The aim of this study is to apply a proactive risk analysis of the 3-D radiotherapy process, to quantify the most significant sources of failures using FMEA & to recommend risk reduction measures. Methods: A FMEA was conducted over a 12-months period at Clinical Oncology and Nuclear Medicine Department at Ain-Shams University Hospital. A detailed process map for the 3-D radiotherapy technique was created starting from the decision taken for radiotherapy till the end of radiotherapy sessions. The Delphi method was used in this study to achieve consensus among participants about the level of risk associated with failure modes. Semi-structured interviews were conducted with twenty radiation personnel to identify potential failure modes in each step of the 3-D radiotherapy process. Scoring of the failure modes was identified in round 1, according to Severity, Occurrence, and lack of detectability scores. Round 2 confirmed the results of round 1. In Round 3:Risk mitigation strategies were suggested.

Results: The 3-D radiotherapy process map consisted of 69 process steps of the 10 stages of the 3-D radiotherapy process. One hundred fifty-two failure modes were identified. Thirty-two top-ranked failure modes were prioritized according to the risk priority number (RPN) and severity scoring. An affinity diagram for these preventive measures was

constructed. Conclusion: FMEA is an effective proactive risk assessment approach in 3-D radiotherapy as elaborated by identification of potential failure modes, focusing on the top-ranked ones and also suggesting risk reduction measures.