Prevent Safety Threats in New Construction through Integration of Simulation and FMEA

Introduction: The built environment may impact safety and decisions made during the design phases can have unintended downstream effects that lead to patient harm. These flaws within the system are latent safety threats (LSTs). Simulation-based clinical systems testing (SbCST) provides a clinical context to examine the environment for safety threats postconstruction. Integration of Failure Mode Effect Analysis (FMEA) with SbCST provides a framework to identify, categorize, and prioritize LSTs before patient exposure. Methods: We implemented SbCST in a newly constructed pediatric subspecialty outpatient center before opening. We used in-situ simulations to evaluate both routine and high-risk clinical scenarios pertinent to each clinical area. FMEA was used as a methodology to assign risk, prioritize, and categorize LSTs identified during the simulation. Results: Over 3 months, we conducted 31 simulated scenarios for 15 distinct subspecialty clinics involving 150 participants and 151 observers. We identified a total of 334 LSTs from 15 distinct clinics. LSTs were further classified into process/workflow, facility, resource, or clinical performance issues. Conclusions: Integration of SbCST and FMEA risk assessment is effective in evaluating a new space for safety threats, workflow, and process inefficiencies in the postconstruction environment, providing a framework for prioritizing issues with the greatest risk for harm.