Designing systems-focused simulation for healthcare quality and safety: integrating quality improvement and human factors methods during transition to a newly expanded emergency department

Abstract Background Healthcare simulation is increasingly used to identify latent safety threats (LSTs), yet standardized approaches for designing system-focused simulation projects, prioritizing findings, and translating results into healthcare quality and safety work remain unclear. We describe the application of a Simulation-based Clinical Systems Testing (SbCST) process integrating quality improvement methods and human factors frameworks during transition to a newly expanded emergency department. Methods This single-site methodology paper describes a systems-focused SbCST process used during pre-opening operational-readiness work. Seventeen in situ simulations were conducted across four high-acuity emergency care pathways: trauma, stroke, ST-elevation myocardial infarction, and pediatric emergencies. The process integrated modified Promoting Excellence and Reflective Learning in Simulation (PEARLS) debriefing to elicit and clarify LSTs, Systems Engineering Initiative for Patient Safety (SEIPS) classification to organize findings across work-system domains, Healthcare Failure Mode and Effect Analysis (HFMEA) consensus scoring to prioritize risk, and Plan-Do-Study-Act (PDSA)-informed iteration to refine scenarios, clarify processes, address low-complexity LSTs when feasible, and escalate unresolved or higher-risk threats for leadership review. Results Across all scenarios, 277 LSTs were identified. Fifty-three were classified as high risk, 57 as moderate risk, and 167 as low risk. Generalized work-system patterns included travel distance, wayfinding, and resource access; segmentation, visibility, and shared situational awareness; communication infrastructure and cross-service coordination; doors, access points, and transport friction; and safety and security conflicts during urgent care. The integrated process translated scenario-specific observations into structured, risk-informed recommendations for quality, safety, operational, and leadership review. Conclusions A systems-focused SbCST process integrating modified PEARLS debriefing, SEIPS classification, HFMEA-based prioritization, and PDSA-informed iteration identified, organized, and prioritized LSTs during emergency department transition. The value of this approach was not limited to threat identification; it provided a structured method for generating safety intelligence to inform healthcare quality and safety decision-making. Future applications should include formal mitigation tracking, accountable ownership, retesting, and documentation of residual risk. Trial registration Not applicable.