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Compliance News: Alternate Equipment Management (AEM) Requirements Alter Existing Processes

| David Stymiest

The new AEM program requirements can represent a sea change in hospital utility system management. The new requirements can affect a multitude of existing processes as laid out in a hospital’s current Plans, Policies or Procedures (PPPs). This article briefly discusses a few of those processes.

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. For TJC-accredited organizations, the changes related to equipment inventories and equipment maintenance entail six new and revised EPs within the medical equipment standards; and eight new and revised EPs within the utilities standards.

Starting at the top, consider your Utility Systems Management Plan and your Medical Equipment Management Plan. Both will likely require changes because they may contain statements that are no longer allowable or applicable under the new AEM Program rules.

It is already clear that many hospital equipment inventories will need to change, probably being expanded and/or clarified.

It is important to understand clearly where mandated inspection, testing & maintenance (ITM) requirements will exclude certain medical equipment and utility system ITM from AEM applicability. For example, the CMS S&C Letter contains the following statement regarding some of those exclusions:

“Other CoPs require adherence to manufacturer’s recommendations and/or set specific standards. For example:

  • The National Fire Protection Association Life Safety Code (LSC) requirements incorporated by reference at 42 CFR 482.41(b) has some provisions that are pertinent to equipment maintenance, and compliance with these requirements are assessed on Federal surveys.
  • Imaging/radiologic equipment, whether used for diagnostic or therapeutic purposes, is governed by 42 CFR 482.26(b)(2) and must be maintained per manufacturer’s recommendations.”

The changes will likely require additional risk assessments based upon, for example the CMS critical equipment / TJC high-risk equipment definitions and related requirements. The outcomes of these activities can affect some existing processes.

Organizations will need to have PPPs established to define how and when they monitor, determine and report the AEM Program effectiveness, including degradation of performance that “may not be readily apparent to staff using the equipment” according to the CMS letter. Existing forms may need to be augmented to capture whether equipment failures were a result of the AEM program and how that determination was made.

Future newsletters will address other aspects of these new requirements.

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