Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy

Radiation Oncology

Viviana Vitolo⁴  Ivan Veronese²  Marco Schwarz³  Roberto Orecchia⁵  Silvia Molinelli⁴  Marco Krengli⁶  Stefano Lorentini¹  Piero Fossati⁵  Francesco Dionisi¹  Mario Ciocca⁴  Marie Claire Cantone² 

[1] Agenzia Provinciale per la Protonterapia, Trento, Italy;Dipartimento di Fisica, Università degli Studi di Milano, Via Celoria 16, 20133, Milano, Italy;Azienda Provinciale per i Servizi Sanitari, Trento, Italy;Centro Nazionale di Adroterapia Oncologica (CNAO Foundation), via Campeggi 53, 27100, Pavia, Italy;European Institute of Oncology, Università degli Studi di Milano, Milano, Italy;Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy

关键词: Treatment planning;    Protons;    FMEA;    Accidental exposures;    Patient safety;    Risk assessment;   

Others  :  1153877
DOI  :  10.1186/1748-717X-8-127

 received in 2012-11-28, accepted in 2013-05-19,  发布年份 2013

【 摘 要 】

Background

A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to the actively scanned proton beam radiotherapy process implemented at CNAO (Centro Nazionale di Adroterapia Oncologica), aiming at preventing accidental exposures to the patient.

Methods

FMEA was applied to the treatment planning stage and consisted of three steps: i) identification of the involved sub-processes; ii) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system, iii) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125.

Results

Thirty-four sub-processes were identified, twenty-two of them were judged to be potentially prone to one or more failure modes. A total of forty-four failure modes were recognized, 52% of them characterized by an RPN score equal to 80 or higher. The threshold of 125 for RPN was exceeded in five cases only. The most critical sub-process appeared related to the delineation and correction of artefacts in planning CT data. Failures associated to that sub-process were inaccurate delineation of the artefacts and incorrect proton stopping power assignment to body regions. Other significant failure modes consisted of an outdated representation of the patient anatomy, an improper selection of beam direction and of the physical beam model or dose calculation grid. The main effects of these failures were represented by wrong dose distribution (i.e. deviating from the planned one) delivered to the patient. Additional strategies for risk mitigation, easily and immediately applicable, consisted of a systematic information collection about any known implanted prosthesis directly from each patient and enforcing a short interval time between CT scan and treatment start. Moreover, (i) the investigation of dedicated CT image reconstruction algorithms, (ii) further evaluation of treatment plan robustness and (iii) implementation of independent methods for dose calculation (such as Monte Carlo simulations) may represent novel solutions to increase patient safety.

Conclusions

FMEA is a useful tool for prospective evaluation of patient safety in proton beam radiotherapy. The application of this method to the treatment planning stage lead to identify strategies for risk mitigation in addition to the safety measures already adopted in clinical practice.

【 授权许可】

   
2013 Cantone et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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