Evaluation of safety in a radiation oncology setting using failure mode and effects analysis.
OBJECTIVE
Failure mode and effects analysis (FMEA) is a widely used tool for prospectively evaluating safety and reliability. We report our experiences in applying FMEA in the setting of radiation oncology.


METHODS
We performed an FMEA analysis for our external beam radiation therapy service, which consisted of the following tasks: (1) create a visual map of the process, (2) identify possible failure modes; assign risk probability numbers (RPN) to each failure mode based on tabulated scores for the severity, frequency of occurrence, and detectability, each on a scale of 1 to 10; and (3) identify improvements that are both feasible and effective. The RPN scores can span a range of 1 to 1000, with higher scores indicating the relative importance of a given failure mode.


RESULTS
Our process map consisted of 269 different nodes. We identified 127 possible failure modes with RPN scores ranging from 2 to 160. Fifteen of the top-ranked failure modes were considered for process improvements, representing RPN scores of 75 and more. These specific improvement suggestions were incorporated into our practice with a review and implementation by each department team responsible for the process.


CONCLUSIONS
The FMEA technique provides a systematic method for finding vulnerabilities in a process before they result in an error. The FMEA framework can naturally incorporate further quantification and monitoring. A general-use system for incident and near miss reporting would be useful in this regard.
Ford
Eric C
EC
Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21231, USA. eric.ford@jhmi.edu
Gaudette
Ray
R
Myers
Lee
L
Vanderver
Bruce
B
Engineer
Lilly
L
Zellars
Richard
R
Song
Danny Y
DY
Wong
John
J
Deweese
Theodore L
TL
D000465:Algorithms; D006801:Humans; D019300:Medical Errors / Q000517:prevention & control*; D011336:Probability; D011786:Quality Control; D018787:Radiation Oncology / Q000592:standards*; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D017751:Safety Management / Q000379:methods*