Systems‐theoretic process analysis of a CT‐guided online adaptive radiation therapy system in a multi‐vendor environment

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I whakaputaina i:Journal of Applied Clinical Medical Physics vol. 26, no. 12 (Dec 1, 2025)
Kaituhi matua: Foote, Colleen
Ētahi atu kaituhi: McClatchy, David M, Yan, Susu, Olberg, Sven, Remillard, Kyla, Miles, Nathaniel, Pursley, Jennifer
I whakaputaina:
John Wiley & Sons, Inc.
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Urunga tuihono:Citation/Abstract
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022 |a 1526-9914 
024 7 |a 10.1002/acm2.70330  |2 doi 
035 |a 3283066901 
045 0 |b d20251201 
100 1 |a Foote, Colleen  |u Division of Radiation Biophysics, Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA 
245 1 |a Systems‐theoretic process analysis of a CT‐guided online adaptive radiation therapy system in a multi‐vendor environment 
260 |b John Wiley & Sons, Inc.  |c Dec 1, 2025 
513 |a Journal Article 
520 3 |a Background Online adaptive radiation therapy (ART) is a relatively new process, and it is recommended that institutions starting an online ART program conduct a risk analysis to identify potential hazards. While Failure Modes and Effects Analysis (FMEA) is common, Systems‐Theoretic Process Analysis (STPA) has also been used to evaluate online ART workflows. Purpose An STPA hazard analysis was performed for a CT‐guided online ART system in a multi‐vendor environment. The goal was to identify potential risks and mitigations to guide the development of adaptive workflows and the quality management (QM) program. Methods The STPA hazard analysis was performed in four steps. First, process maps for online ART were generated to describe the interactions between users and systems. In the second step, the process maps were refined to a single control structure diagram model. In the third step, potential unsafe control actions (UCAs) were enumerated by the physicists involved in the analysis. Finally, mitigation strategies to address the UCAs were identified. Results A total of 496 UCAs were identified for 119 control actions, of which 239 (48.2%) were prioritized for mitigation due to having low or medium levels of detectability. The most frequent causal scenarios were accidental omission (20.1%), rushing (17.2%), and lack of training (15.9%). The most common consequences were delays (26.8%) and having to repeat work (13.5%). The two mitigation strategies considered to address the most causal scenarios were requiring trained adaptive staff (28.9%) and having physics oversight (19.9%). Conclusions The STPA led to valuable insights into the potential causes of unsafe control actions and various mitigation strategies that were used to develop the QM program. Notably, most UCAs were attributable to interactions between users and the system, rather than system failures. It is recommended that every institution starting an online ART program perform a risk assessment for their environment. 
610 4 |a Varian Medical Systems Inc 
651 4 |a United States--US 
651 4 |a Palo Alto California 
653 |a Software 
653 |a Simulation 
653 |a Physics 
653 |a Failure 
653 |a Therapists 
653 |a Physicists 
653 |a Information systems 
653 |a Oncology 
653 |a Feedback 
653 |a Radiation therapy 
653 |a Health physics 
653 |a Risk assessment 
700 1 |a McClatchy, David M  |u Division of Radiation Biophysics, Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA 
700 1 |a Yan, Susu  |u Division of Radiation Biophysics, Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA 
700 1 |a Olberg, Sven  |u Division of Radiation Biophysics, Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA 
700 1 |a Remillard, Kyla  |u Division of Radiation Biophysics, Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA 
700 1 |a Miles, Nathaniel  |u Division of Radiation Biophysics, Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA 
700 1 |a Pursley, Jennifer  |u Division of Radiation Biophysics, Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA 
773 0 |t Journal of Applied Clinical Medical Physics  |g vol. 26, no. 12 (Dec 1, 2025) 
786 0 |d ProQuest  |t Science Database 
856 4 1 |3 Citation/Abstract  |u https://www.proquest.com/docview/3283066901/abstract/embedded/6A8EOT78XXH2IG52?source=fedsrch 
856 4 0 |3 Full Text  |u https://www.proquest.com/docview/3283066901/fulltext/embedded/6A8EOT78XXH2IG52?source=fedsrch 
856 4 0 |3 Full Text - PDF  |u https://www.proquest.com/docview/3283066901/fulltextPDF/embedded/6A8EOT78XXH2IG52?source=fedsrch