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Application of Systems and Control Theory-Based Hazard Analysis to Radiotherapy

T Pawlicki

T Pawlicki1*, A Samost2 , N Leveson2 , (1) UC San Diego, La Jolla, CA, (2) Massachusetts Institute of Technology, Cambridge, MA


WE-G-BRA-6 (Wednesday, July 15, 2015) 4:30 PM - 6:00 PM Room: Ballroom A

Purpose: The process of delivering radiation occurs in a complex socio-technical system heavily reliant on human operators. Furthermore, both humans and software are notoriously challenging to account for in traditional hazard analysis models. High reliability industries such as aviation have approached this problem through using hazard analysis techniques grounded in systems and control theory. The purpose of this work is to apply the Systems Theoretic Accident Model Processes (STAMP) hazard model to radiotherapy. In particular, the System-Theoretic Process Analysis (STPA) approach is used to perform a hazard analysis of a proposed on-line adaptive cranial radiosurgery procedure that omits the CT Simulation step and uses only CBCT for planning, localization, and treatment.

Methods: The STPA procedure first requires the definition of high-level accidents and hazards leading to those accidents. From there, hierarchical control structures were created followed by the identification and description of control actions for each control structure. Utilizing these control structures, unsafe states of each control action were created. Scenarios contributing to unsafe control action states were then identified and translated into system requirements to constrain process behavior within safe boundaries.

Results: Ten control structures were created for this new CBCT-only process which covered the areas of hospital and department management, treatment design and delivery, and vendor service. Twenty three control actions were identified that contributed to over 80 unsafe states of those control actions resulting in over 220 failure scenarios.

Conclusion: The interaction of people, hardware, and software are highlighted through the STPA approach. STPA provides a hierarchical model for understanding the role of management decisions in impacting system safety so that a process design requirement can be traced back to the hazard and accident that it is intended to mitigate.

Funding Support, Disclosures, and Conflict of Interest: Varian Medical Systems, Inc.

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