Application of systems and control theory-based hazard analysis to radiation oncology.

PURPOSE Both humans and software are notoriously challenging to account for in traditional hazard analysis models. The purpose of this work is to investigate and demonstrate the application of a new, extended accident causality model, called systems theoretic accident model and processes (STAMP), to radiation oncology. Specifically, a hazard analysis technique based on STAMP, system-theoretic process analysis (STPA), is used to perform a hazard analysis. METHODS The STPA procedure starts with the definition of high-level accidents for radiation oncology at the medical center and the hazards leading to those accidents. From there, the hierarchical safety control structure of the radiation oncology clinic is modeled, i.e., the controls that are used to prevent accidents and provide effective treatment. Using STPA, unsafe control actions (behaviors) are identified that can lead to the hazards as well as causal scenarios that can lead to the identified unsafe control. This information can be used to eliminate or mitigate potential hazards. The STPA procedure is demonstrated on a new online adaptive cranial radiosurgery procedure that omits the CT simulation step and uses CBCT for localization, planning, and surface imaging system during treatment. RESULTS The STPA procedure generated a comprehensive set of causal scenarios that are traced back to system hazards and accidents. Ten control loops were created for the new SRS procedure, which covered the areas of hospital and department management, treatment design and delivery, and vendor service. Eighty three unsafe control actions were identified as well as 472 causal scenarios that could lead to those unsafe control actions. CONCLUSIONS STPA provides a method for understanding the role of management decisions and hospital operations on system safety and generating process design requirements to prevent hazards and accidents. The interaction of people, hardware, and software is highlighted. The method of STPA produces results that can be used to improve safety and prevent accidents and warrants further investigation.

[1]  Eric C Ford,et al.  A streamlined failure mode and effects analysis. , 2014, Medical physics.

[2]  L. Potters,et al.  Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine , 2013, Front. Oncol..

[3]  Ward Edwards,et al.  Dynamic Decision Theory and Probabilistic Information Processings1 , 1962 .

[4]  Nancy G. Leveson,et al.  Engineering a Safer World: Systems Thinking Applied to Safety , 2012 .

[5]  B. Franklin,et al.  Is Failure Mode and Effect Analysis Reliable? , 2009, Journal of patient safety.

[6]  Stanley H Benedict,et al.  Intracranial stereotactic positioning systems: Report of the American Association of Physicists in Medicine Radiation Therapy Committee Task Group No. 68. , 2005, Medical physics.

[7]  Blandine Antoine Systems Theoretic Hazard Analysis (STPA) applied to the risk review of complex systems : an example from the medical device industry , 2013 .

[8]  Peter Checkland,et al.  Systems Thinking, Systems Practice , 1981 .

[9]  W. Ashby,et al.  An Introduction to Cybernetics , 1957 .

[10]  Julian R Perks,et al.  Failure mode and effect analysis for delivery of lung stereotactic body radiation therapy. , 2012, International journal of radiation oncology, biology, physics.

[11]  D. Gupta,et al.  The Use of Failure Mode and Effect Analysis in a Radiation Oncology Setting: The Cancer Treatment Centers of America Experience , 2014, Journal for healthcare quality : official publication of the National Association for Healthcare Quality.

[12]  Barrett Caldwell,et al.  Analysis of treatment delivery errors in brachytherapy using formal risk analysis techniques. , 2003, International journal of radiation oncology, biology, physics.

[13]  Eric C Ford,et al.  Evaluation of safety in a radiation oncology setting using failure mode and effects analysis. , 2009, International journal of radiation oncology, biology, physics.

[14]  N Cao,et al.  Validating FMEA output against incident learning data: A study in stereotactic body radiation therapy. , 2015, Medical physics.

[15]  Lawrence B Marks,et al.  The impact of advanced technologies on treatment deviations in radiation treatment delivery. , 2007, International journal of radiation oncology, biology, physics.

[16]  Aubrey Samost,et al.  A systems approach to patient safety : preventing and predicting medical accidents using systems theory , 2015 .

[17]  David D. Wilson,et al.  Safety and feasibility of STAT RAD: Improvement of a novel rapid tomotherapy-based radiation therapy workflow by failure mode and effects analysis. , 2015, Practical radiation oncology.

[18]  Bryony Dean Franklin,et al.  Failure mode and effects analysis outputs: are they valid? , 2012, BMC Health Services Research.

[19]  Ryan P Manger,et al.  Failure mode and effects analysis and fault tree analysis of surface image guided cranial radiosurgery. , 2015, Medical physics.

[20]  Juan López-Tarjuelo,et al.  Failure mode and effect analysis oriented to risk-reduction interventions in intraoperative electron radiation therapy: the specific impact of patient transportation, automation, and treatment planning availability. , 2014, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[21]  Marco Krengli,et al.  Application of failure mode and effects analysis to intracranial stereotactic radiation surgery by linear accelerator. , 2014, Practical radiation oncology.

[22]  Simon H. Lavington,et al.  The MU5 Multicomputer Communication System , 1977, IEEE Transactions on Computers.

[23]  Nancy G. Leveson,et al.  An investigation of the Therac-25 accidents , 1993, Computer.

[24]  T Pawlicki,et al.  Consensus recommendations for incident learning database structures in radiation oncology. , 2012, Medical physics.

[25]  R. Orecchia,et al.  Application of failure mode and effects analysis to intraoperative radiation therapy using mobile electron linear accelerators. , 2012, International journal of radiation oncology, biology, physics.

[26]  Nancy G. Leveson,et al.  A new accident model for engineering safer systems , 2004 .