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Compliance News: CMS Requirements for AEM Inclusion Risk Assessments

| David Stymiest

CMS changed the rules for both inventories and equipment inspection, testing and maintenance (ITM) requirements in December 2013.  The CMS changes require that, where law and regulations do not stipulate ITM, manufacturer ITM recommendations must be followed unless the organization has a compliant AEM Program and uses a risk-based process to determine how and when to deviate from manufacturer ITM recommendations.  This article presents the CMS AEM inclusion risk assessment requirements.

The CMS-issued Survey & Certification (S&C) Letter S&C:14-07-Hospital (entitled Hospital Equipment Maintenance Requirements) dated 12/23/2013 includes both requirements and state agency survey guidelines.  That CMS S&C Letter is available at Among many other related topics, the 11 pages of surveyor guidance in “Appendix A interpretive guidelines §482.41(c)(2)” also discuss the following requirements for AEM inclusion risk assessments.

  • “… Adequate provisions to ensure the availability and reliability of equipment …”
  • Typical health and safety risks
  • Identify “critical equipment” (TJC’s “high-risk” phraseology is the same)
  • Different types of equipment presenting different combinations of severity of potential harm and likelihood of failure
  • How the equipment is used and the likely consequences of equipment failure or malfunction – including whether it is used for life support, infection control, or life safety purposes
  • Patient care setting within the hospital
  • Healthcare setting(s) impacted by equipment failure of malfunction – types of areas, patient acuity, how widespread, entire hospital, etc.
  • How serious is the harm likely to be?
  • How widespread is the harm likely to be?
  • Manufacturer’s maintenance recommendations, including rationale
  • Maintenance requirements of the equipment: simple or complex?
  • Timely availability of alternate devices or backup systems
  • Service history is also considered, including the number, frequency and nature of previous failures and service requests. Incident histories of identical and 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.”

Hospitals should carefully reconsider using an approach based on only decades-old historical utility risk assessment factors that do not comply fully with the above current CMS AEM inclusion risk requirements.

The CMS AEM inclusion risk assessment requirements go beyond the more commonly-used factors that hospitals have used either in past utility system or medical equipment risk assessments. Based upon all of this, a new risk assessment framework is recommended to support utility equipment AEM-inclusion decisions.

The short discussion above is from the July 2018 Health Facilities Management Magazine article entitled “Conducting alternate equipment-maintenance assessments” available here.  Readers may want to review the HFM Magazine article for a more complete discussion of this complex issue.

The two below-listed ASHE Annual Conference white papers on AEM and related requirements are available to ASHE members at ASHE’s online MyASHE All Member Community Library.  The MyASHE library can be accessed via the ASHE website’s > Member Corner > MyASHE online community section.  These two white papers (under the July 17,2018 heading AEM WHITE PAPERS FROM PREVIOUS ANNUAL CONFERENCES) delve much further into the CMS AEM compliance issues.

  • AEM Program Compliance (originally delivered at the 2015 ASHE Annual Conference)
  • AEM Risk Assessments (originally delivered at the 2016 ASHE Annual Conference)

Questions related to this article may be directed to the author, David Stymiest, PE, CHFM, CHSP, FASHE, at