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Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy.

Sangkyu Lee1, Dale Michael Lovelock1, Alex Kowalski1

  • 1Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

Journal of Applied Clinical Medical Physics
|October 28, 2021
PubMed
Summary

This study used failure modes and effects analysis to improve paraspinal stereotactic body radiotherapy (SBRT) safety. Treatment planning posed the most risks, highlighting the need for accurate external treatment record evaluation.

Keywords:
failure modes and effects analysisquality assuranceroot cause analysisspinal metastasisstereotactic body radiotherapy

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Area of Science:

  • Radiation Oncology
  • Medical Physics
  • Quality Improvement

Background:

  • Paraspinal stereotactic body radiotherapy (SBRT) carries inherent risks of severe complications.
  • A systematic evaluation of safety protocols is crucial for high-risk radiotherapy procedures.

Purpose of the Study:

  • To assess the safety of a paraspinal SBRT program using failure modes and effects analysis (FMEA).
  • To identify and mitigate risks within the SBRT workflow to enhance patient safety and treatment quality.

Main Methods:

  • A multidisciplinary team conducted an FMEA of the paraspinal SBRT workflow, segmenting it into simulation, treatment planning, delivery, and machine quality assurance (QA).
  • Potential failure modes (PFMs) were identified, scored by frequency, severity, and detectability, and assigned a risk priority number (RPN).
  • Fault tree analysis was used to determine root causes of high-RPN failures, leading to the implementation of corrective actions.

Main Results:

  • The analysis identified numerous PFMs across all SBRT workflow phases, with treatment planning yielding the highest median RPN (68.3).
  • Key high-risk failures included inadequate evaluation of prior radiotherapy, incorrect image registration leading to contouring errors, and undetected patient movement.
  • Remedial actions such as enhanced staff education, standardized imaging protocols, improved image fusion, and additional QA were implemented.

Conclusions:

  • A systematic FMEA effectively identified critical safety risks in paraspinal SBRT.
  • Treatment planning emerged as a significant area for PFMs impacting treatment safety and quality.
  • Accurate assessment of external treatment records remains a critical challenge in SBRT safety.