By John Bethune

George Mills

George Mills

When the Centers for Medicare & Medicaid Services (CMS) revised its guidelines for preventive maintenance in December 2013, the health technology management community breathed a collective sigh of relief. Relaxing its much stricter guidelines proposed in December 2011, the new CMS approach now allows hospitals to deviate from manufacturers’ recommended maintenance procedures and frequencies for certain categories of equipment.

While the more flexible rules are welcome, they nonetheless will bring a significant change in policies and procedures for most HTM departments. At a session at the June 2014 annual AAMI conference, George Mills outlined the new realities of preventive maintenance. (See also the related article on a subsequent AAMI session on preventive maintenance by Steven Grimes of ABM Healthcare Support Services.)

Set in Stone

In his AAMI session, Mills, director of engineering for The Joint Commission, stated that he did not expect CMS to make any further changes to preventive maintenance rules. For many types of equipment, hospitals may now depart from the maintenance schedules and procedures recommended by manufacturers. After qualified personnel conduct a risk assessment, hospitals may instead use a documented Alternate Equipment Management (AEM) program. Exceptions to this flexibility remain, however: Medical lasers, imaging equipment, and new equipment (for which insufficient maintenance records exist) may not be included in an AEM program.

Mills said that after the December 2013 CMS announcement, the matter seemed settled. But CMS was not quite through. In May, he said, the agency sent The Joint Commission a letter stating that the JC standards on maintenance weren’t “complete enough.” As a result, he said, “we had to respond with new elements of performance” (EPs).

The Joint Commission has updated its guidelines accordingly. The new or revised EPs include requirements 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. In addition, all equipment maintained under AEM procedures must be identified, and the hospital must show that the person setting up the AEM system is an appropriately qualified BMET or clinical engineer.

The first step in compiling the inventory of medical equipment, Mills said, is to define what qualifies as “medical equipment.” He urged his listeners not to go overboard by being overly inclusive: “I would not include tongue depressors!” As part of the process, hospitals must also identify high-risk equipment, which he defined as “equipment for which there is a risk of serious injury or death to a patient or staff member if the equipment should fail.” High-risk equipment, he added, should include life-support equipment. (In a subsequent question-and-answer period, Jim Keller of the ECRI Institute said that his organization will soon publish a list of equipment that should be considered high risk for preventive maintenance purposes.)

Mills also offered some clarifications about what equipment might or might not be eligible for an AEM program. For new medical equipment, he said, hospitals should follow the manufacturer’s maintenance recommendations until they can gather enough history to vary the procedure. New equipment, he added, is that where there is no available knowledge, such as hospital records, public data from recognized sources, or information from vendors.

For CMS, Mills noted, the category of imaging equipment includes all types of products, not just radiation-emitting systems. The agency specifically told him, he said, that all ultrasonic devices are considered imaging or radiologic equipment and are therefore not eligible for alternate maintenance.

HTM-Focused Surveys

As a result of these changes, Mills said, biomeds can expect to receive much more attention from The Joint Commission. “Your next JC survey,” he told his audience of HTM professionals, “will be focused a lot more on your world than it ever has in the past.” 24×7

John Bethune is 24×7 editorial director. Contact him at [email protected].