TJC & CMS News Blog
Information for

In any healthcare setting, particularly in psychiatric hospitals and community behavioral health care environments, identifying and mitigating risks before they lead to adverse outcomes is crucial. Failure Modes and Effects Analysis (FMEA) is a proactive risk assessment tool that helps healthcare teams anticipate potential failures in processes and develop solutions to address them.

To enhance safety and reduce risk, the Joint Commission mandates that psychiatric hospitals perform a proactive risk assessment on one high-risk process every 18 months. While community behavioral health and human services providers are not subject to the same requirement, it is strongly recommended that they adopt this practice to safeguard the individuals they serve. In fact, it is advisable for all accredited and/or CMS-certified organizations—whether accredited or regulated by CMS, TJC, DNV, CIHQ, ACHC, CARF, Social Current (COA), and state agencies—to regularly conduct proactive risk assessments. This should be done either as stipulated by accrediting or regulatory agencies or as outlined in the organization’s own policies. Regular assessments ensure a consistent focus on minimizing risks and enhancing safety.

How to Conduct an FMEA

Here’s how to apply FMEA in a psychiatric hospital or a community behavioral health setting:

1) Assemble a Multidisciplinary Team

Begin by gathering a team of professionals from various disciplines, such as psychiatrists, licensed practitioners, clinical psychologists, mental health techs, nurses, administrators, quality professionals, pharmacists, safety officers, and others. A diverse team from across the organization ensures that all potential risk areas are considered from multiple perspectives, including patient care, operations, and safety protocols.

2) Identify Key Processes

Select a specific high-risk process to assess, such as patient elopement, high-risk for suicide or self-harm, high-risk for violence, seclusion and restraint, medication management, crisis intervention, discharge, legal risk, infection control, or other. Utilizing near miss data can be critical in identifying, prioritizing, and selecting high-risk processes.  

3) List Failure Modes

Select one high-risk process and identify possible ways in which each step of the process could fail. For example, in medication administration, failures could include incorrect dosage, missed doses, or medication given to the wrong patient. Each failure mode should reflect realistic scenarios that could impact patient safety or care quality.

4) Assess Risk Priority

Use the FMEA framework to evaluate each failure mode based on three criteria:

    • Severity: How serious would the consequences be if this failure occurred?
    • Occurrence: How likely is this failure to happen?
    • Detection: How likely is it that this failure would be detected before it causes harm?

Assign a numerical value to each factor and calculate the Risk Priority Number (RPN) by multiplying these scores. This helps prioritize which failures need urgent attention.

5) Develop Action Plans

For high-priority risks (those with high RPNs), develop action plans to either eliminate or mitigate the risk. Solutions might include changes to workflows, documentation, channels of communication, additional staff training, implementing new safety checks, or other interventions. 

6) Implement and Monitor Solutions

Once changes are implemented, continuously monitor their effectiveness. Risks can evolve over time, especially in mental health care where patient needs and behaviors may shift rapidly. Ongoing evaluation ensures that the strategies in place remain effective and adaptable. Use data on near misses and sentinel events to evaluate the effectiveness of the solutions on an ongoing basis.

Proactive risk assessment tools like FMEA enable behavioral health organizations to anticipate problems, reduce errors, and continuously improve their processes, creating safer, more effective environments for both patients and staff. By using FMEA, behavioral health environments can be proactive in identifying and addressing risks before they lead to negative outcomes. This improves patient safety and enhances the overall quality of care.

Additional Resources

Barrins & Associates

Barrins can help you to identify, prioritize, and select, a high-risk process to improve the safety and quality of the care, treatment, and services you provide to the individuals you serve. We will assist you in conducting an FMEA, developing and implementing your action plan, evaluating the results, and sustaining the improvements. Contact us today to learn more about our services.

Barrins & Associates – “Elevating Patient Outcomes: Empowering Healthcare Leaders to Achieve Excellence.”