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

| David Stymiest

Many hospitals are struggling with the AEM risk assessments required by both the CMS Survey & Certification Letter and the TJC July 2nd revisions.  This newsletter discusses the AEM risk assessment requirements.

Compliance News 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.  In our January 2015 article we discussed the CMS written guidance to state survey personnel for conducting AEM tracers.

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.”

Note that The Joint Commission’s phrase “high-risk equipment” means the same thing as the CMS phrase “critical equipment.”

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.”

The TJC requirements are similar but not identical to the CMS requirements.  TJC’s Standard EC.02.05.01, Element of Performance 6 requires that hospitals include the following topics within its criteria supporting the determination whether it is safe to permit operating components of utility systems to be maintained in an alternate manner:

  • How the equipment is used, as well as the likely consequences of equipment failure or malfunction. For both factors hospitals are required to consider both the seriousness of harm and the prevalence of harm.
  • Availability of alternative or back-up equipment – we also recommend that hospitals consider the timeliness (speed) of this availability as well as the degree of operator involvement required to make it function properly.
  • Incident history of identical or similar equipment
  • Maintenance requirements of the equipment – this criterion sounds similar to a criterion used in past utility system risk assessments.

These risk assessment factors are generally not the same as the more commonly-used factors that hospitals have used either in past utility system or medical equipment risk assessments. A new risk assessment framework appears to be required to support AEM-inclusion decisions.

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