International Journal of Radiation Oncology * Biology * Physics
Volume 74, Issue 3 , Pages 852-858, 1 July 2009

Evaluation of Safety in a Radiation Oncology Setting Using Failure Mode and Effects Analysis

  • Eric C. Ford, Ph.D.

      Affiliations

    • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD
    • Corresponding Author InformationReprint requests to: Eric C. Ford, Ph.D., Johns Hopkins University, Department of Radiation Oncology and Molecular Radiation Sciences, 401 N. Broadway, Baltimore, MD 21231. Tel: (410) 502-1477; Fax: 401-502-1419
  • ,
  • Ray Gaudette, M.S.

      Affiliations

    • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD
  • ,
  • Lee Myers, Ph.D.

      Affiliations

    • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD
  • ,
  • Bruce Vanderver, M.D.

      Affiliations

    • Center for Innovation in Quality Patient Care, Johns Hopkins University, Baltimore, MD
  • ,
  • Lilly Engineer, Dr.P.H., M.D., M.H.A.

      Affiliations

    • Center for Innovation in Quality Patient Care, Johns Hopkins University, Baltimore, MD
  • ,
  • Richard Zellars, M.D.

      Affiliations

    • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD
  • ,
  • Danny Y. Song, M.D.

      Affiliations

    • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD
  • ,
  • John Wong, Ph.D.

      Affiliations

    • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD
  • ,
  • Theodore L. DeWeese, M.D.

      Affiliations

    • Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD

Received 10 June 2008; received in revised form 8 October 2008; accepted 19 October 2008. published online 30 April 2009.

Purpose

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 and Materials

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.

Patient Safety, Quality Improvement, Quality Assurance

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 Conflict of interest: none

PII: S0360-3016(08)03684-5

doi:10.1016/j.ijrobp.2008.10.038

International Journal of Radiation Oncology * Biology * Physics
Volume 74, Issue 3 , Pages 852-858, 1 July 2009