The new CMS position on preventive maintenance for hospital equipment has satisfied many critics, but it leaves many questions unanswered.

By Jenny Lower

Five days before Christmas last year, when the Centers for Medicare and Medicaid Services (CMS) delivered its long-anticipated clarification superseding its December 2011 directive on preventive maintenance (PM), the HTM community breathed a collective sigh of relief.

While not perfect in the eyes of most observers, the latest memo from CMS (PDF), identified as S&C 14-07, addresses what observers see as many of the worst faults of its predecessor, S&C 12-07. Citing the ongoing need to “ensure an acceptable level of safety and quality,” the directive permits hospitals to adopt an Alternate Equipment Maintenance (AEM) program following “a risk-based assessment by qualified personnel.” In many cases, hospitals may establish testing methods and frequencies deviating from specifications set by the original equipment manufacturer (OEM). Exceptions to this flexibility remain for imaging equipment, medical laser devices, new equipment without sufficient maintenance history, and devices governed by other federal or state laws.

In the February 2014 newsletter for the Association for the Advancement of Medical Instrumentation (AAMI), George Mills, director of engineering at The Joint Commission, said he was pleased with the clarification. “On first review, this appears to be very in line with the current Joint Commission process.”

Similarly, says Jonathan Gaev, business line manager at ECRI Institute, “It’s a delightful big step in the right direction of restoring flexibility to the health technology management department.” But while ECRI is pleased that CMS revised its policy, Gaev adds, “it still doesn’t bring us completely back to the pre-2011 days.”

A prominent opponent to the December 2011 directive was Binseng Wang. In an April 2013 piece he coauthored for 24×7, he noted that the new policy was expected to cost between $1 and $5 billion per year. Now, he says that the December 2013 memo does reduce the financial burden, by as much as 50% “if the hospitals are smart enough to do the right things using the latitude that’s given.”

However, he believes that the new memo still imposes “a lot of burdens that are unnecessary and unjustified, especially when CMS is significantly reducing reimbursement. You are taking the money away and then asking people to do more with no significant benefit.”

Other professionals have cited remaining confusion over terminology and noted that the document doesn’t address some of the persistent obstacles to implementing effective and efficient preventive maintenance (PM), such as the unavailability of high-quality service manuals from OEMs. But for now, it seems, the profession is counting its blessings.

Caught Off Guard

It’s unclear precisely what conditions led to the original directive being issued, but Karen Waninger, a member of the AAMI Technology Management Executive Council, speculates it had to do with a gradual divergence between the CMS understanding of equipment maintenance practices and the de facto methods endorsed by The Joint Commission, the field’s only accrediting organization for many years. As CMS became aware of the discrepancy, it sought to clarify standards for inspectors.

The original letter, released December 2, 2011, to state survey agency directors, allowed hospitals to adjust the maintenance, inspection, and testing frequencies—but not the methods—recommended by manufacturers for equipment maintenance. Alternative frequencies were not permitted for critical equipment and any new equipment lacking sufficient maintenance history.

According to Waninger, CMS believed it was providing leeway by specifying when alternative frequencies could be used. Instead, the organization sparked a firestorm. “They were absolutely caught off guard,” she said. “They thought they were doing the world a huge service.”

In 2012, representatives from AAMI and the American Society for Healthcare Engineering (ASHE) met with CMS in an effort to convince the agency that further clarification would be helpful. Concerned that the agency lacked critical information, AAMI prepared a 244-page document aggregating data on evidence-based PM programs. The CMS panel appeared receptive. “They wanted to understand why their clarification was received so negatively, and then wanted to understand what other pieces of information could be incorporated to help them come to a different recommendation,” says Waninger, who helped lead the meeting.

Initial reaction to the December 2013 revision has ranged “from neutral to positive,” says AAMI president Mary Logan. “In the end, I thought their final memo showed how hard they worked. It was a reasoned, clear, data-based memo.”

Gray Areas

At Grande Ronde Hospital, a 25-bed critical access facility in Eastern Oregon, biomedical technician Michael Shepherd oversees maintenance scheduling. Prior to the 2011 memo, he and his colleagues relied on a combination of manufacturer recommendations, professional experience, device history, and risk assessment to establish PM methods and frequencies.

When the 12-07 directive appeared, he began reviewing each device’s maintenance procedures on a monthly basis and comparing them to manufacturer recommendations. As the latest clarification was released, he was working on purchasing a $5,000 flow meter—a brand that hospital staff had previously used and disliked, but that was specified in OEM maintenance guidelines for a certain ventilator. The new memo allowed him to abandon that plan.

“It will allow us to move back to a strategy we’d used previously,” Shepherd says. He adds, however, that “because some of their specifications are a little vague, it means I’m going to have to approach it very methodically.”

He notes the ambiguity of terms like critical equipment, qualified personnel, and sufficient history. His colleagues are all CBET certified, but he questions whether the new regulations will require training in specific devices from individual OEM schools. He’s also uncertain just how long constitutes sufficient history. Unlike the 2011 directive, the 2013 version requires a more considered approach. “I feel like they’re going to be reasonable about it, but nobody likes that insecurity of not knowing if they’ve covered all their bases,” Shepherd says.

Others share his concerns. Unlike the more commonly understood term life-support equipment, the term critical equipment may be open to interpretation, Gaev says. While the previous memo defined the term, the 2013 version overrides that language. It now identifies critical equipment as “biomedical or physical plant equipment for which there is a risk of serious injury or death to a patient or staff person should the equipment fail.” New examples could help eliminate any potential misunderstanding.

Exceptions to the Rule

One of the sticking points in the 2013 document is CMS’ special consideration of imaging equipment and medical laser devices, which remain ineligible for an AEM program.

“I wasn’t surprised to see the exception for imaging equipment, because the imaging community was putting a lot of pressure on them,” Logan says. “There were a lot of letters sent.” The American College of Radiology (ACR) and the Medical Imaging & Technology Alliance (MITA) were among 30 signatories to a November 2013 letter asking CMS to reconsider the expected upcoming clarification as it pertained to imaging equipment.

Some confusion stems from the devices’ inclusion under the heading of Conditions for Participation. “We have not been able to find any federal law that requires that manufacturer recommendations for preventive maintenance be followed for any class of equipment,” Gaev says. “So we’re not sure what CMS wanted us to take away from their calling out these two classes of equipment.” CMS has since clarified to The Joint Commission that the AEM exception applies to all imaging equipment, even for modalities that don’t emit radiation such as ultrasound and magnetic resonance.

The exclusion appears rooted in a desire to err on the side of safety. But according to Waninger, “That’s still a little bit of a false perception. Through experience, as the device is used, you sometimes find steps that can be taken that the manufacturers didn’t include in the recommendations.”

As for medical lasers, Wang doesn’t believe there is anything inherently more dangerous about that equipment than any other. The most important step is to consider whether an evidence-based reason exists for treating certain equipment differently. He doesn’t think so. “Equipment is being used every day with many, many patients in many, many hospitals. So if there was a significant problem with how people maintain equipment, it would have appeared already.”

By the Book

When it comes to creating and evaluating effective AEM programs as specified in the CMS clarification, several professionals argue that a persistent problem is the unavailability of quality OEM service manuals—a conflict CMS couldn’t address in its memo regardless, since such requirements fall under the purview of the FDA. How can hospitals build up enough maintenance history to transition equipment into an AEM program, the argument goes, if they don’t have access to the OEM recommendations in the first place?

It’s not uncommon for an OEM technician’s service report to specify the number of hours worked, confirm the equipment now functions properly, and little else, professionals say. That makes it challenging for in-house technicians to identify proper PM procedures. It’s possible some of this caution has to do with protecting proprietary information. But it’s also difficult to ignore the enormous financial incentives for preserving the existing system.

“If they don’t train us to do any service on their equipment, then they have total latitude with what price they charge for their service and whether they will even do service without a contract,” Waninger says. “So they are guaranteeing their revenue stream regardless of whether the equipment ever fails or not.” At Community Health Network in Indianapolis, where she oversees the clinical engineering department, they spend $750,000 annually on service contracts to maintain a single specialty device in the surgery unit at three hospitals.

At the same time, Gaev says, OEMs are under no obligation to provide evidence to the FDA supporting the PM schedules they establish. Even OEM technicians sometimes don’t strictly follow the manufacturer’s own guidelines. As technicians gain more experience with a particular device, they may replace inefficient procedures with those that add more value. But even when this happens, it’s rare for a manufacturer to go back and update the manual. If OEMs discover they’re overmaintaining, that information doesn’t necessarily get back to their customers.

Looking Ahead

Now that the HTM community has gotten mostly what it wanted, will the 2013 memo introduce another dramatic policy reversal as hospitals swing back toward pre-2011 days?

Though formal data is unavailable, anecdotal evidence suggests many facilities chose to hold their breath and await a revision rather than implement sweeping changes. “It’s my impression that hospitals generally took a thoughtful wait-and-see approach, prepared to change if they had to, and ready to explain with data why they shouldn’t have to,” Logan says.

At Broward Health in Fort Lauderdale, Fla, the 2011 directive didn’t cause much flurry, says executive director of clinical and biomedical engineering Marcos Mantel. “We didn’t pay much attention to it. We had numerous state inspections, and there were really no issues at all.”

That changed when a recent inspection held before the 2013 update penalized the facility for failing to uphold an unfamiliar set of standards. Surveyors for Florida’s Agency for Health Care Administration (AHCA) could enforce the Automated Survey Processing Environment (ASPEN) regulations because of the CMS allowance for other state and federal regulations. Meeting those requirements will cost approximately $140,000 to hire three additional full-time employees. “Even though what CMS has done is definitely much better, there is still a tremendous disconnect between us here in the state of Florida and CMS,” Mantel says.

At Washington Hospital, a 359-bed district hospital in Fremont, Calif, the 2011 memo didn’t have a major impact on existing practices. Due to California’s Title 22 code, in most cases staff were already meeting or exceeding manufacturer guidelines, says director of biomedical engineering Paul Kelley.

He was involved behind the scenes with the 2012 AAMI/CMS meeting and cochairs the AAMI Medical Equipment Management standards committee. He helped develop ANSI/AAMI EQ 56, Recommended Practice for a Medical Equipment Management Program, which was cited in the 2013 memo as a reference for running a quality department. He’s also at work on a new standard about devising an in-house AEM program, EQ 89, though it’s still 2 years away from completion.

Kelley says he’s pleased that CMS incorporated the feedback it received into the revised clarification. “I’m very happy with it. They took verbiage right out of our standard, made the verbiage theirs, and issued it. I think once we get EQ 89 finished, it would be nice if they could adopt that.”

Such a standard should help provide a thoughtful framework for biomeds looking to make changes. As Wang notes, “The solution is to let people prove what they do is the right thing. Let’s try different things, and prove what we do is safe and effective.”

Jenny Lower is associate editor for 24×7. For more information, contact jlower@allied360.com.