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Safety 2: Hands On Session: FMEA in Safety

E Yorke

E Yorke*, A Houston , A Kelly , H Piszko , N Stein , J Topf , Memorial Sloan-Kettering Cancer Center, New York, NY

SU-B-Salon AB-2 Sunday 10:00:00 AM - 12:00:00 PM Room: Salon AB

Failure Modes and Effects Analysis (FMEA) is a quality management tool adopted from industry and introduced to radiation oncology a few years ago. Together with other QM measures – incident reporting and fault-tree analysis- FMEA helps to identify risky points in clinical processes and to devise error (or ‘failure mode’ ) mitigation measures. FMEA has been thoroughly described in several publications, including the Proceedings of the 2013 AAPM Summer School.

Typically, a group of involved clinicians choose a process, list its steps (process tree) and then brainstorm as to what failure modes at each step can lead to risky situations. They then rank each failure mode (1-10 with 10 being the worst) as to its occurence likelihood (O), potential severity(S) and likelihood of detection before reaching the patient (D). Its potential impact is summarized by the Risk Probability Number (RPN), the product of O, S and D. FMEA is iterative, as mitigation strategies need to be re-evaluated after implementation and increased experience may bring new failure modes to light. FMEA is well suited to both large and small-scale clinical processes. Small-scale processes, with a limited number of steps a small number of participants, can be performed quite quickly.

This lecture presents two examples of this sort. The first is an FMEA of monitor-unit calculations for simple, after-hours (‘on-call’) treatments. The FMEA was performed by one physicist and, through informal presentations to other physicists and periodic therapist and new resident inservices, has helped modify department policy over a several-year period. The second is a newly initiated FMEA of deep-inspiration-breath-hold for treatment of the left breast, performed by the physicists and simulation therapists involved in the treatment. We expect this FMEA to help identify risky areas and guide development of mitigating measures for this process.

Learning Objectives:
1.To know the basic steps of an FMEA2.
2. To know the definitions and relative scales for the FMEA parameters O, S and D
3. To understand the FMEA approach in relation to small-scale clinical processes


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