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Compliance News: CMS Guidance for AEM Tracers

| David Stymiest

By now many hospital facility directors have reviewed the Hospital Equipment Maintenance Requirements contained within the current CMS Alternate Equipment Management (AEM) program rules being enforced by CMS and all of its deemed accrediting organizations.  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.

However many hospitals have not fully reviewed the guidance contained within the Survey Procedures §482.41(c)(2) at the end of that publication.  These CMS survey procedures could be considered a blueprint for AEM-related tracers by state CMS surveyors.  The listed survey procedures include but are not limited to the following summary:

Surveyors are advised to interview personnel in charge of facility, supplies and equipment maintenance: The procedures include reviewing maintenance and storage of supplies, as well as verifying that supplies and equipment needed during an emergency situation are identified and also that the hospital has made adequate provisions to ensure the availability of those supplies and equipment when needed.

The CMS letter states “Concerning facility and medical equipment:

  • Interview equipment users when surveying the various units/departments of the hospital to determine if equipment failures are occurring and causing problems for patient health or safety.
  • Determine if there is a complete inventory of equipment required to meet patient needs, regardless of ownership.
  • Is critical equipment readily identified?
  • If the hospital employs an AEM program, is equipment in this program readily identified?
  • Determine if the hospital has documentation of the qualifications (e.g., training certificates, certifications, degrees, etc.) of hospital personnel responsible for the AEM program (if one is being used by the hospital) as well as for those performing maintenance.
  • Determine if the hospital is able to demonstrate how it assures contractors use qualified personnel.”

Note the phrase “critical equipment” above.  This is what TJC calls High-Risk Equipment via the same definition as the CMS definition for critical equipment.

With respect to the requirements that dictate when adherence to manufacturer recommendations is required, CMS states “If the hospital is following the manufacturer-recommended equipment maintenance activities and frequencies:

  • In addition to reviewing maintenance records on equipment observed while inspecting various hospital locations for multiple compliance assessment purposes, select a sample of equipment from the hospital’s equipment inventory to determine whether the hospital is following the manufacturer’s recommendations….”

CMS further stated “for the sample selected, determine if:

  • The hospital has available manufacturer’s recommendations (e.g., manufacturer’s operation and maintenance manual, standards, studies, guidance, recall information, service records, etc.);
  • Maintenance is being performed in accordance with manufacturer’s recommendations.”

With respect to the equipment where a hospital decides to use its alternate equipment management (AEM) program, CMS states that surveyors should verify that the AEM-managed equipment is not on the prohibited list.  CMS also advises surveyors to:

  • “Determine if the hospital’s development of alternate maintenance activities and frequencies for equipment in the AEM program as well as AEM activities are being performed by qualified personnel.
  • Verify the hospital has documented maintenance activities and frequencies for all equipment included in the AEM program.
  • Verify the hospital is evaluating the safety and effectiveness of the AEM program. If there is equipment on the inventory the hospital has identified as having such a very low level of risk that it has determined it can use a broad interval range or departmental ‘sweeps,’ ask the hospital for the evidence used to make this determination. Does it seem reasonable?”

Note that a metric for assessing reasonableness could not be found within the document.

CMS also stated “Select a sample of equipment in the AEM program. The majority of the sample must include critical equipment which poses a higher risk to patient safety if it were to fail, such as ventilators, defibrillators, robotic surgery devices, etc. For the sample selected:

  • Ask the responsible personnel to explain how the decision was made to place the equipment in an AEM program. Does the methodology used consider risk factors and make use of available evidence?
  • Ask the responsible personnel to describe the methodology for applying maintenance strategies and determining alternative maintenance activities or frequencies for the sampled equipment. Can they readily provide an explanation and point to sources of information they relied upon?
  • Determine if maintenance is being performed in accordance with the maintenance activities and frequencies defined in the AEM program.
  • Verify the hospital is evaluating the safety and effectiveness of the AEM maintenance activities for this equipment and taking corrective actions when needed.”

Although the critical equipment examples above were limited to medical equipment, it is clear from the overall document that the requirements also apply fully to utility systems components.

Based upon the above, our suggestion is to review all of these published CMS survey procedures when developing both the AEM program, preparing its policies & procedures, and establishing the required documentation processes.  Granted the survey procedures are not the requirements; however it does not appear to make sense to establish a new program without at least taking into account the types of questions that CMS surveyors are being advised to ask during surveys.

Future newsletters will address other aspects of these new requirements.

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