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For several years, there was a requirement in the TJC standards for organizations to conduct an annual proactive risk assessment referred to as a Failure Mode and Effects Analysis (FMEA). The requirements for proactive risk assessment have evolved over the past few years and we frequently get questions about whether a FMEA is still required. So, here is a summary of the current TJC requirements:

For Hospitals Accredited under the Hospital Accreditation Standards:

In the Leadership chapter, standard LD.04.04.05 EP 10 states: “At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment.” The standard then refers the reader to the section at the beginning of the Leadership chapter titled “Proactive Risk Assessment.” This section uses the FMEA model as one method for conducting a proactive risk assessment.

So, the bottom line for hospitals is that they must conduct some type of proactive risk assessment every 18 months.

For Organizations Accredited under the Behavioral Health Care Standards:

There is the same section at the beginning of the Leadership chapter titled “Proactive Risk Assessment.” However, under standard LD.04.04.05, there is no EP 10 requiring a FMEA every 18 months (as in the Hospital manual). Instead, EP 11 addresses the topic in the following manner: “To improve safety, the organization analyzes and uses information about system or process failures and, when conducted, the results of proactive risk assessments.”

So, the bottom line for BH organizations is that conducting a FMEA is not a requirement per se. It is one of the methods that an organization can use to analyze system or process failures.

Also, it’s important to keep in mind that if your organization does conduct a FMEA, it’s critical that you focus not only on identifying the failure modes but also on implementing a redesign that shows a measurable improvement to the process. It’s best to narrow your redesign actions to a critical few and actually measure the success of each one. As noted by Erik Stalhandske, MPD, MHSA of the VA National Center for Patient Safety: “It’s better to have fewer (redesign) actions that actually get implemented than a myriad of half-addressed or ignored actions.”

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