A Simulation Systems Testing Program Using HFMEA Methodology Can Effectively Identify and Mitigate Latent Safety...

Area of Science:

• Healthcare Systems Engineering
• Patient Safety
• Risk Management

Background:

• Hospital system changes introduce potential patient safety risks.
• Some risks are identified before implementation, while others emerge during live operation.
• Prospective testing methods like simulation and HFMEA can identify and mitigate risks without patient harm.

Purpose of the Study:

• To evaluate the effectiveness of simulation-based clinical systems testing (SbCST) combined with Healthcare Failure Mode and Effect Analysis (HFMEA) for identifying latent safety threats (LSTs).
• To proactively detect and mitigate LSTs prior to the operational launch of a new hospital helipad.

Main Methods:

• A three-phase iterative approach was employed, integrating simulation and HFMEA.
• Phase I involved process mapping and tabletop exercises with HFMEA to identify theoretical LSTs and assign hazard scores.
• Phases II and III utilized low- and high-fidelity simulations to test communication, pathways, and previously identified LSTs.

Main Results:

• A total of 31 LSTs were identified across the three phases.
• LSTs were categorized into care coordination, facilities, equipment, and devices.
• Over half (58.1%) of the identified LSTs were classified as critical, requiring immediate attention.

Conclusions:

• The three-phase SbCST program, utilizing HFMEA, proved effective in identifying LSTs.
• An iterative testing methodology, where each phase informed the next, facilitated the evaluation of mitigation strategies.
• This approach offers a robust method for prospective risk assessment in healthcare systems.