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Failure modes and effects analysis for surface-guided DIBH breast radiotherapy.

Megan Bright1, Ryan D Foster1, Carnell J Hampton2

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|February 3, 2022
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Summary

Surface-guided deep inspiration breath-hold radiation therapy for breast cancer has risks. Failure Modes and Effects Analysis identified key error points, mainly from manual inputs, guiding process improvements.

Keywords:
DIBHFMEASGRT

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Area of Science:

  • Radiation Oncology
  • Medical Physics
  • Patient Safety

Background:

  • Deep inspiration breath-hold (DIBH) is widely used in breast radiation therapy (RT) to minimize cardiac and lung dose.
  • Surface-guided (SG) techniques enhance DIBH accuracy but introduce new potential error risks due to their technical complexity.
  • Limited data exist on the specific error risks associated with SG-DIBH in breast RT.

Purpose of the Study:

  • To identify and analyze potential failure modes within the SG-DIBH breast RT process using Failure Modes and Effects Analysis (FMEA).
  • To assess the reproducibility of FMEA scoring between different staff cohorts and training levels.
  • To evaluate the feasibility of expedited FMEA training for efficient risk management in SG-DIBH implementation.

Main Methods:

  • A subset of radiation therapy (RT) staff and a patient safety representative conducted an FMEA on the SG-DIBH RT process.
  • A second cohort of RT staff, with abbreviated FMEA training, reviewed the process maps and provided scoring to validate findings.
  • Risk Priority Numbers (RPN) were calculated, and high-risk failure modes were addressed through policy changes, checklists, and standardization.

Main Results:

  • The FMEA identified 57 distinct failure modes across 16 process steps, with many high-risk errors linked to manual operator inputs and verification.
  • Reproducibility analysis showed only a 5% statistically significant difference in average RPN between the two cohorts.
  • Significant differences in RPN scores were observed between physicists (12%) and therapists, highlighting interdisciplinary variations.

Conclusions:

  • Abbreviated FMEA training can yield comparable risk scoring to traditional methods within a single department, enabling time savings.
  • Involving staff across different professional roles (e.g., physicists, therapists) is crucial for a comprehensive understanding of SG-DIBH risks.
  • Standardization and addressing operator-dependent errors are key to improving the safety and reliability of SG-DIBH breast radiation therapy.