Process-based quality management for clinical implementation of adaptive radiotherapy

Area of Science:

• Radiation Oncology
• Medical Physics
• Quality Assurance

Background:

• Intensity-modulated adaptive radiotherapy (ART) offers potential therapeutic benefits but faces significant quality assurance (QA) hurdles.
• Current QA standards, like pretreatment patient-specific IMRT QA, may limit online ART feasibility.
• A robust framework for ART clinical implementation is lacking.

Purpose of the Study:

• To apply Failure Mode and Effects Analysis (FMEA) to intensity-modulated ART.
• To identify high-priority errors and develop risk-mitigation strategies for ART implementation.
• To address obstacles hindering the clinical adoption of online ART.

Main Methods:

• A team of medical physicists, a clinical engineer, and a radiation oncologist conducted an FMEA.
• Utilized a set of 216 potential radiotherapy failures from AAPM TG-100, focusing on 127 relevant to ART.
• Recalculated Risk Priority Numbers (RPN) by assessing occurrence, severity, and detectability for ART, identifying failures with RPN ≥ 200 as critical.

Main Results:

• ART increased RPN for 38% of potential failures, with 75% of these linked to segmentation and treatment planning.
• Forty-three of 127 failures (34%) were identified as potentially critical.
• Recommended mitigation strategies include advanced software, specialized QA tools, and increased trained personnel.

Conclusions:

• FMEA demonstrates that intensity-modulated ART presents distinct risks compared to standard IMRT.
• Safe clinical implementation of ART is achievable with appropriate risk-mitigation strategies.
• The study provides a framework for managing ART-related risks.