245 Background: Traditional approaches to improve safety in clinical operations focus on reacting to adverse events and intervening at the process level to prevent recurrence. A need exists to proactively explore safety at the system level and evaluate human factors that lead to errors. We developed and piloted a system safety assessment methodology to identify vulnerabilities in the Research Pharmacy at Dana-Farber Cancer Institute. Methods: We developed an interview tool based on the human factors analysis and classification system (HFACS) to obtain staff member perspectives on safety vulnerabilities. Detailed process maps were created for safety critical processes. Policies, procedures, and job aids were evaluated for effectiveness at preventing errors. Interfaces between the Research Pharmacy and other areas were studied to identify potential expectation misalignment. These elements formed a comprehensive methodology to proactively assess safety threats. Results: Based on our application of the assessment methodology, 16 system safety vulnerability themes were identified (table below) and 44 recommendations were generated to address them. From the recommendations, 26 improvement projects were proposed to prevent the occurrence of safety events. To date, 15 projects addressing 13 safety vulnerabilities have been initiated. Conclusions: Vulnerabilities uncovered through our methodology can inform the development of projects to proactively reduce risk and improve system resiliency in any clinical setting. Preliminary data indicate longer average days between safety events in the Research Pharmacy as projects triggered by the assessment are implemented. Further analysis is underway. [Table: see text]
Systems‐theoretic process analysis (STPA) is a prospective safety assessment tool increasingly applied in healthcare. A problem hampering STPA proliferation is the difficulty of modeling systems for analysis by creating control structures. In this work, a method is proposed to use existing process maps—commonly available in healthcare—when creating a control structure. The proposed method entails (1) extract information from the process map, (2) determine the modeling boundary of the control structure, (3) transfer the extracted information to the control structure, (4) add additional information to complete the control structure. Two case studies were conducted: (1) ambulance patient offloading in the emergency department and (2) ischemic stroke care with intravenous thrombolysis. The amount of process map‐derived information in the control structures was quantified. On average, 68% of the information in the final control structures was derived from the process map. Additional control actions and feedback were added from nonprocess map sources for management and frontline controllers. Despite the differences between process maps and control structures, much of the information in a process map can be used when creating a control structure. The method enables the creation of a control structure from a process map to be done in a structured fashion.
Purpose Advanced technologies have led to improvements in modern radiotherapy over the years. However, adoption of advanced technologies can present challenges to existing clinical operations and negatively impact safety. The purpose of this work is to perform an assessment of modern radiotherapy for the operational objectives of safety, efficiency, and financial viability. Methods This work focuses on external beam radiotherapy (EBRT). The operational assessment included department management, treatment planning, treatment delivery, and associated workflows for three equipment configurations of Ethos, Halcyon, and TrueBeam with the ARIA information system, Eclipse treatment planning, and IDENTIFY surface guidance. Systems‐theoretic process analysis (STPA) was used to analyze the related workflows. Control actions, unsafe contexts of those control actions, and associated causal scenarios that can lead to unsafe radiation and non‐radiation physical injury (safety objective), reduced treatment capacity (efficiency objective), and costs that exceed budget (financial viability objective) were identified. Results The number of control actions (and causal scenarios) were 18 (254), 18 (267), and 20 (267) for the equipment configurations of Halcyon, TrueBeam, and Ethos, respectively. The extent that safety, efficiency, and financial viability were impacted is similar across the different equipment configurations, but there were some noteworthy differences related to information transfer and workflow bottlenecks potentially impacting access to care. Seventy‐five percent of the scenarios across all three configurations were related to safety. Overall, 29% of the scenarios impacted more than one operational objective and 48% were related to human decisions during the process of care. Planned or unplanned process changes were responsible for 8% of the causal scenarios. Conclusions Broad‐based clinical improvements may be realized by addressing causal scenarios that impact multiple objectives. Redesigning the roles and responsibilities of the clinical team and some aspects of the radiotherapy workflow may be helpful to fully realize the benefits of advanced technologies. Radiotherapy may benefit from additional tools to improve the consistency between decisions and actions when system or process changes occur.
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