During a packed Monday session at AAMI, Stephen Grimes, chief technical officer for ABM Healthcare Support Services, covered the latest updates from the Centers for Medicare & Medicaid Services (CMS) and The Joint Commission (TJC) on preventive maintenance (PM) procedures.

The new CMS guidelines, which restored some flexibility to the organization’s December 2011 directive, now allows hospitals to deviate from manufacturers’ recommended maintenance procedures and frequencies for certain categories of equipment. Based on a risk assessment by qualified personnel, hospitals may maintain some equipment through a documented Alternate Equipment Management (AEM) program. Medical lasers, imaging equipment, and new equipment (for which insufficient maintenance records exist) are ineligible for participation in an AEM program.

TJC is in the process of updating its guidelines accordingly, which will include requiring that hospitals maintain a written inventory of all equipment, identify high-risk equipment, and keep written documentation of the activities and frequencies associated with maintaining, inspecting, and testing all equipment in inventory.

(For more information on the December 2013 directive and reactions from the biomedical community, see 24×7’s March 2014 feature.)

In order to comply with the new regulations, Grimes recommended several steps to demonstrate “a good-faith effort” toward preparation:

  • Prepare a complete inventory of all medical equipment, including loaned, leased, and rented equipment.
  • Request written guidelines for the recommended maintenance frequencies and methods from the original equipment manufacturer (OEM) for all equipment. Be sure to document these requests, as well as any response or non-response received.
  • In your complete medical equipment inventory, flag:
    • Critical or high-risk equipment
    • Life support equipment
    • Equipment ineligible for an AEM program, such as medical lasers, imaging, or therapeutic radiology equipment
    • Equipment maintained through an AEM program
  • In corrective maintenance records, be sure you have the ability to: 
    • Categorize the degree of equipment failure
      • “major,” resulting in a hard down
      • “minor,” cases in which the equipment was still operational and did not compromise safety
    • Categorize the type of equipment failure
      • wear-and-tear-related failure, which is maintenance-preventable
      • spontaneous failure, which no amount of PM would have prevented
      • user- or process-related failure, unrelated to the equipment itself
  • Establish policies and procedures that:
    • Describe hospital guidelines for deviating from OEM guidelines
    • Identify the team that will create those guidelines, such as clinicians, clinical engineering, risk management, and safety officers
  • Document sources of the service histories used to conduct the risk assessment, including in-house records and organizations like ECRI and AAMI.
  • Document the credentials of those involved in the risk assessment, including degrees, certifications, training, etc.
  • In service contracts, include language requiring vendors to:
    • Follow OEM guidelines pertaining to maintenance frequencies and methods
    • Document all service performed
    • Demonstrate the qualifications of vendor staff
  • Designate a staff member responsible for monitoring compliance with CMS and TJC standards and document that person’s qualifications.

Jenny Lower is the associate editor for 24×7. She can be reached at [email protected]