RESUMEN
BACKGROUND: Fundamental changes in critical systems within hospitals present safety risks. Some threats can be identified prospectively, others are only uncovered when the system goes live. Simulation and Healthcare Failure Mode and Effect Analysis (HFMEA) can be used together to prospectively test a system without endangering patients. The research team combined iterative simulations and HFMEA methodologies to conduct simulation-based clinical systems testing (SbCST) to detect and mitigate latent safety threats (LSTs) prior to opening a hospital helipad. METHODS: This study was conducted in three phases. In Phase I, an interprofessional team created a process map and conducted a tabletop exercise, identifying LSTs that could theoretically occur during patient transfer from the new helipad. Using HFMEA methodology, steps predicted to be affected by the new helipad were probed. Identified LSTs were assigned a hazard score. Mitigation solutions were proposed. Results from Phase I were used to plan Phase II, which used low-fidelity simulation to test communication processes and travel paths. High-fidelity simulation was used in Phase III to test previously identified LSTs. RESULTS: Over three testing phases, 31 LSTs were identified: 15 in Phase I, 7 in Phase II, and 9 in Phase III. LSTs fell under the categories of care coordination, facilities, and equipment, and devices. Eighteen (58.1%) were designated "critical" (hazard score ≥ 8). CONCLUSION: A three-phase SbCST program using HFMEA methodology was an effective tool to identify LSTs. An iterative approach, using results of each phase to inform the structure of the next, facilitated testing of proposed mitigation strategies.
