Presentation
PS1 - A Prospective Systems Safety Analysis: Systems-Theoretic Process Analysis (STPA) Applied To An Interventional Radiology Procedure
DescriptionThis project explores an initial application of a prospective systems safety analysis known as Systems-Theoretic Process Analysis (STPA) to an Interventional Radiology (IR) procedure. Interventional Radiology is a sub-discipline of Radiology that often performs therapeutic procedures involving high doses of radioactive pharmaceuticals for treatment. In addition to the significant risks high-dose IR procedures present to patients and staff, the system is highly dependent on human reliability to prevent error. Often, safety analyses in healthcare rely on retrospective approaches which can limit opportunities to gain safety insights. In an effort to shift towards a more prospective approach, where interest lies in anticipating and preventing hazards, the Systems-Theoretic Process Analysis (STPA) method was applied. The study applied STPA, a tool under the Systems-Theoretic Accident Model and Processes (STAMP) model, to analyze the system design and prospectively identify areas of weak system constraints, ahead of a potential accident occurring. STPA has often been used to analyze complex systems in high-risk industries as it considers multiple causal factors and utilizes a holistic approach. In addition to Systems Theory, one of the key fundamentals of STPA is to reduce human errors that are influenced by system design.
A multidisciplinary team, including Quality and Safety, Radiation Safety, and Interventional Radiology, was organized to perform the safety analysis ensuring an integrated approach. Several in-person observations and interviews were conducted with multiple roles to understand the work system structure, environment, unique perspectives, and cognitive loads on each role involved. During the STPA analysis, a control structure was created to display the hierarchy of entities who have some level of control over the system as well as gaps in feedback loops. Organizational and external environmental factors were also captured in the control structure. From the control structure, over 300 unsafe control actions were formulated, identifying areas of weak, unsafe, or missing controls. Causal scenarios, scenarios in which multiple causal factors and unsafe control actions would potentially lead to an error, were defined by the team through a series of iterative sessions. Links to leadership, culture, organizational and environmental factors, human factors and reliability, and usability of tools and technology were identified during causal scenario generation. Human Factors theory was utilized in understanding and defining the mental models and contextual factors that play a role in potential causal scenarios. Lastly, system constraints were built off of the analysis to place safety controls on the system to ultimately prevent safety errors from reaching the patient.
The findings from this study were itemized in a Risk Register to prioritize risk and guide implementations of safety constraints. Several findings highlighted the high risks associated with a critical document, known as the Written Directive, which is utilized by the team to document the treatment plan, deviations in treatment, and radioactivity levels. The findings inspired the complete redesign of the Written Directive form while further implementations from the analysis are upcoming. The team has found this initial application of STPA on an Interventional Radiology procedure to be to operationally, socially, and culturally impactful. The shift from linear, retrospective analyses to a holistic, prospective method which respects the complexity of sociotechnical health systems has proven to be valuable and insightful to the group and to patient safety. Future applications of STPA coupled with Human Factors practices are under way in other projects.
A multidisciplinary team, including Quality and Safety, Radiation Safety, and Interventional Radiology, was organized to perform the safety analysis ensuring an integrated approach. Several in-person observations and interviews were conducted with multiple roles to understand the work system structure, environment, unique perspectives, and cognitive loads on each role involved. During the STPA analysis, a control structure was created to display the hierarchy of entities who have some level of control over the system as well as gaps in feedback loops. Organizational and external environmental factors were also captured in the control structure. From the control structure, over 300 unsafe control actions were formulated, identifying areas of weak, unsafe, or missing controls. Causal scenarios, scenarios in which multiple causal factors and unsafe control actions would potentially lead to an error, were defined by the team through a series of iterative sessions. Links to leadership, culture, organizational and environmental factors, human factors and reliability, and usability of tools and technology were identified during causal scenario generation. Human Factors theory was utilized in understanding and defining the mental models and contextual factors that play a role in potential causal scenarios. Lastly, system constraints were built off of the analysis to place safety controls on the system to ultimately prevent safety errors from reaching the patient.
The findings from this study were itemized in a Risk Register to prioritize risk and guide implementations of safety constraints. Several findings highlighted the high risks associated with a critical document, known as the Written Directive, which is utilized by the team to document the treatment plan, deviations in treatment, and radioactivity levels. The findings inspired the complete redesign of the Written Directive form while further implementations from the analysis are upcoming. The team has found this initial application of STPA on an Interventional Radiology procedure to be to operationally, socially, and culturally impactful. The shift from linear, retrospective analyses to a holistic, prospective method which respects the complexity of sociotechnical health systems has proven to be valuable and insightful to the group and to patient safety. Future applications of STPA coupled with Human Factors practices are under way in other projects.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives