الفهرس 
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Abstract
Summary
The process of radiotherapy is very complex and requires understanding of the principles of medical physics, radiobiology, radiation safety, quality management, radiotherapy planning and interaction of radiotherapy with other modalities. It requires collaboration between radiation oncologists, radiation therapists, medical physicists and radiation engineers. Increased complexity of radiotherapy process caused many types of errors. Accidental errors in radiotherapy may result from human error, operating error or equipment failures. The risk of failures has increased due to the interaction of many health care personnel working together on highly advanced technologies.
FMEA is a proactive risk assessment strategy used to identify and anticipate potential errors and to take action before a radiation incident occurs. The FMEA technique offers several advantages as a safety analysis tool. It allows one to consider the severity and detectability of a failure mode in addition to its occurrence frequency.
The aim of this Study is to perform a prospective risk assessment by FMEA of the 3D radiotherapy process in clinical oncology Department at Ain-Shams University Hospital to quantify the most significant sources of risk and to recommend risk mitigation strategies.
The FMEA was conducted over 12 -months period from April 2020 to April 2021 at Clinical Oncology and Nuclear Medicine Department at Ain-Shams University Hospital. First, a process map was created consisting of a detailed flow chart of the main steps of 3D radiotherapy process. This process map formed the foundation of the FMEA and Delphi round questionnaires. A purposive sample of 20 radiation personnel including: Head of department, Oncology staff, assistant lecturers, residents, physicists, technicians and engineers were invited to participate.
The Delphi method was used in this study to gain consensus among staff members about the level of risk associated with failure modes they have identified in the first round. Semi structured interviews were done with each radiotherapy personnel. These interviews were conducted after creating six different forms of questionnaire for every category of radiotherapy involved personnel
Round 1, Radiotherapy personnel identified 152 failure modes in the 10 stages of the radiotherapy process. Each personnel was asked to give a score for severity, occurrence and lack of detectability. Failure modes were ranked according to RPN and Severity scoring.
Round 2, Confirmation of the results of round (1) was done. After the end of round (2), the average (S), (O), (D) and RPN scoring for each failure mode were calculated. The failure modes were re-ranked according to the average RPN & (S) scoring. Fifty-eight failure causes for the highest ranked 32 failure modes were identified. All suggested failure causes fall into nine main categories including Human factors, documentation error and communication error, inadequate procedure /policy, medical devices failure, lack of financial resources, work load and lack of standard institutional guidelines.
Round 3, Twenty six top ranked failure modes with RPN value equal to or more than 24 were discussed with radiotherapy personnel to suggest at least one preventive measure for each failure mode. Six more failure modes with severity score equal to or more than 3 were also considered Sixty-three preventive measures and checkpoints were suggested by participants. These included accurate documentation (accurate, complete & timely), appropriate communication (including interdisciplinary, intra-disciplinary, horizontal &vertical communication), adequate task allocation(adequate job description for each member involved in radiation therapy),financial support (for new accessories, facilities & techniques), regular training &workshops for radiotherapy personnel( at least twice /year), adequate number of qualified radiotherapy personnel, adequate procedure /policy, regular preventive maintenance (not only on demand)and standard institutional guidelines (updated yearly). Risk analysis was done after anticipating application of these risk reduction strategies according to participants view.
Application of FMEA in 3-D radiotherapy was proved to be an effective proactive approach for risk assessment. This was elaborated by identification of potential failure modes, focusing on the top ranked ones and also suggesting risk reduction measures