A Risk-Informed Approach to Understanding Human Error in Radiation Therapy (NUREG-2170)

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Publication Information

Manuscript Completed: September 2016
Date Published: June 2017

Prepared by:
J. Wreathall1, W.S. Brown2, L. Militello3, S.E. Cooper4 C. Lopez3, C. Franklin4

1The WreathWood Group
2Brookhaven National Laboratory
3Applied Decision Science, LLC
4U.S. Nuclear Regulatory Commissionn

S.E. Cooper, NRC Project Manager

Office of Nuclear Regulatory Research
U.S. Nuclear Regulatory Commission
Washington, DC 20555-000

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A critical part of the U.S. Nuclear Regulatory Commission (NRC) mission is licensing and regulating the use of byproduct materials, including in radiation therapy. More than half of the reported misadministration events in the medical use of byproduct materials in radiation therapy are attributed to human error.

In support of the NRC recommendation to continue to apply and extend a risk-management framework (as discussed in NUREG-2150 [1], A Proposed Risk Management Regulatory Framework), this report discusses an approach to improve patient safety that is based on human reliability analysis (HRA), traditionally part of probabilistic risk assessments (PRAs). Using HRA and related disciplines, four key elements for improving patient safety are highlighted: 1) improved understanding of human error in radiation therapy; 2) improved ability to anticipate errors; 3) effective strategies for supporting humans in managing complexity; and 4) methods to evaluate and monitor the effectiveness of corrective actions. This report also includes reviews of studies conducted by the NRC using human reliability analysis methods and recommends the continued application of these methods. Successful safety improvements from commercial aviation and nuclear power industries are examined and offered as an example of the feasibility of this approach. It is important to emphasize that target audiences for this document include, but are not limited to, decision makers, regulators, designers, and external vendors engaging with the risk-informed framework.

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