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Compliance News: Importance of Alternate Equipment Management/Maintenance (AEM) Risk Assessments

| David Stymiest

Many hospitals are still struggling with the AEM inclusion risk assessments required by both the CMS Survey & Certification Letter and Accrediting Organization (AO) requirements.  This newsletter revisits and updates a previous discussion of AEM risk assessment requirements.

TJC-accredited hospitals, for example, now face an even more important reason for having an effective AEM-inclusion risk assessment process since the official 1-9-2017 release of TJC’s updated Elements of Performance.  The broad utility system inspection, testing & maintenance (ITM) Standard EC.02.05.05 contains newly changed language concerning required utility ITM completion rates. The impacts of the updated EP language issued on 1-9-2017 basically require:

  • In EC.02.05.05 EP-4: 100% on-time compliance for all High Risk utility system components, whether done through the Alternative Equipment Maintenance (AEM) program or done in accordance with manufacturer’s recommendations;
  • In EC.02.05.05 EP-5: 100% on-time compliance for all Infection Control utility system components, whether done through the AEM program or done in accordance with manufacturer’s recommendations;
  • In EC.02.05.05 EP-6: down to not less than 90% on-time compliance for other Non-High Risk components done through the AEM program only if the organization’s policy (presumed to be the utility systems equipment AEM Program policy) permits such deferral.

In other words, TJC-accredited hospitals have some flexibility to mandated 100% on-time ITM compliance only for their non-high-risk and non-infection control utility system components that are managed through an acceptable AEM Program.

Hospitals accredited by other organizations may see similar movement or clarification since all AOs need to follow CMS guidance.

As background, we previously discussed the driving CMS 2014 Survey & Certification Letter S&C:14-07-Hospital and its enclosed Appendix A interpretive guidelines generally in our May 2014 article, related TJC July 2nd updates in our July 2014 article and some useful TJC inventory-related guidance in our September 2014 article. We also discussed some of the ways in which the new requirements require altering existing processes in our October 2014 article.  And in our January 2015 article we discussed the CMS written guidance to state survey personnel for conducting AEM tracers.  This information is also available in a 2015 ASHE Annual Conference white paper.

We also discussed AEM inclusion risk assessments in our March 2015 article.  That discussion and ongoing challenges reported by hospitals led to a more comprehensive treatment of AEM inclusion risk assessments in a 2016 ASHE Annual Conference white paper.

The CMS S&C letter states “In determining whether or not it is safe to include equipment in the AEM program, the hospital must take into account the typical health and safety risks associated with the equipment’s use. A hospital is expected to identify any equipment in its AEM program which is “critical equipment,” i.e., biomedical or physical plant equipment for which there is a risk of serious injury or death to a patient or staff person should the equipment fail. The guidance in Appendix A discusses the types of factors to be considered when hospitals make these determinations. Generally, multiple factors must be considered, since different types of equipment present different combinations of severity of potential harm and likelihood of failure. Note that the risk may vary for the same type of equipment, depending on the patient care setting within the hospital where it is used.”

Whether equipment is critical (TJC high-risk) equipment is one of the tests.  It may even be the most important factor to consider, but it is not the only factor.  Within The State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, A-0724 (Rev.); Interpretive Guidelines §482.41(c)(2), CMS states “Factors for a hospital to consider when evaluating the risks associated with a particular type of equipment include, but are not limited to:

  • How the equipment is used and the likely consequences of equipment failure or malfunction – would failure or malfunction of the equipment hospital-wide or in a particular setting be likely to cause harm to a patient or a staff person?”
    • “How serious is the harm likely to be?”
    • “How widespread is the harm likely to be?”
  • “Information, if available, on the manufacturer’s equipment maintenance recommendations, including the rationale for the manufacturer’s recommendations;”
  • “Maintenance requirements of the equipment:
    • Are they simple or complex?
    • Are the manufacturer’s instructions and procedures available in the hospital, and if so can the hospital explain how and why it is modifying the manufacturer’s instructions?
    • If the manufacturer’s instructions are not available in the hospital, how does the hospital assess whether the AEM uses appropriate maintenance strategies?
    • How readily can the hospital validate the effectiveness of AEM methods for particular equipment? For example, can the hospital explain how it ensures there is no reduction in the quality of the performance of biomedical equipment subjected to alternate maintenance methods?”
  • “The timely availability of alternate devices or backup systems in the event of equipment failure or malfunction”
  • “Incident history of identical or very similar equipment”

CMS also stated “Generally multiple factors must be considered, since different types of equipment present different combinations of severity of potential harm and likelihood of failure. The hospital is expected to be able to demonstrate to a surveyor the factors it considered in its risk assessment for equipment placed in its AEM program.”

Legacy computerized maintenance management systems (CMMS) generally do not adequately address these AEM inclusion risk assessment requirements with their original risk assessment programming.  This situation appears to be because the newly required risk assessment factors are generally not the same as the more commonly-used factors that hospitals have used in past utility system risk assessments.  A new risk assessment framework appears to be required to support AEM-inclusion decisions.

You may contact the writer at DStymiest@ssr-inc.com if you have questions on this content or if you would assistance with your AEM program.

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