Because healthcare processes are complex and often people-dependent, risks or deviation from what the process is expected to accomplish may result (International Organization for Standardization, 2015a). HFMEA is a prospective risk analysis system to identify, assess, and address vulnerabilities in high-risk processes. Failure Mode and Effect Analysis (FMEA) has its roots in the U.S. military, engineering, and aerospace industries, where steps are taken to minimize or eliminate the risk that an accident or failure will occur. In 2001, the U.S. Department of Veterans Affairs, National Center for Patient Safety, developed a hybrid model specific to, and ideal for, the healthcare environment (DeRosier et al., 2002). At the same time, TJC introduced a new leadership standard, still in effect today, that speaks to healthcare leaders ensuring a proactive risk assessment be conducted for identified high-risk processes (TJC, 2020b). Three basic questions are the focus of any proactive failure mode/risk analysis:

1.

What could go wrong?

2.

Why would the failures occur?

3.

What would be the consequences of each failure?