CMS Dismisses the Evidence-Based Maintenance Approach
By: Lanier Norville, Editor, MD Publishing
123 Sometimes, elegant medical theories disregard even the best evidence. Practices passed down through the medical canon can trump knowledge gleaned from empirical data, even when it is to the contrary. Emergency room doctors continue to treat heart attack patients with beta-blockers, though evidence from 26 studies has shown that beta-blockers administered immediately after a heart attack cause an increase in heart failure, noted emergency room physician David H. Newman, in a New York Times Well blog post. Though beta-blockers are commonly used to treat heart attack patients post discharge, evidence shows they can be detrimental when administered in the ER. “Treatment based on ideology is alluring,” Newman explained, but it isn’t an effective way to allocate resources or advance medicine.
“The critical question that looms for health care reform is whether patients, doctors and experts are prepared to set aside ideology in the face of data,” Newman said.
The same question applies to hospital biomed departments, who when faced with severely restricted budgets, began to embrace data. Evidence consistently showed that for many devices, routine preventive maintenance checks were not necessary. They were, the data showed, a waste of time and resources – time and resources that could be used for competing technology management activities.
But last December, those departments were stopped in their tracks, when the U.S. Centers for Medicare and Medicaid Services (CMS) issued a directive that required them to follow manufacturers’ suggested preventive maintenance schedules. The directive applies to critical devices and any equipment that lacked a sufficient maintenance history – in other words, any new equipment. Only non-critical devices with a recorded, successful evidence-based approach could remain on the hospital’s schedule.
The update stated: “Equipment that is critical to patient health and safety is not a candidate for an alternative, less frequent maintenance activity schedule.” According to CMS, critical devices were to adhere to at least the frequency of maintenance prescribed by the manufacturer. A general outline of what constitutes these devices was included: “At a minimum such critical equipment includes, but is not limited to, life-support devices, key resuscitation devices, critical monitoring devices, equipment used for radiologic imaging and other devices whose failure may result in serious injury to or death of patients or staff.”
The directive also included all new equipment, regardless of classification, within the scope of the equipment that should adhere to manufacturer service recommendations. This schedule must be maintained for non-critical equipment “until a sufficient amount of maintenance history has been acquired to safely adjust the maintenance frequency below that recommended,” though what constitutes a sufficient amount is not specified.
The requirements for “non-critical” equipment allow for an alternative method, but solid documentation is essential. The update spells this out with some specificity. “If a hospital is adjusting non-critical equipment maintenance frequencies to be below those recommended by the manufacturer, such adjustments must be based upon a systematic, evidence-based assessment. The hospital must document the assessment for all equipment with less frequent maintenance than what the manufacturer recommends, including the selected maintenance strategy that led to the lower adjusted frequency, and supporting evidence.”
Because CMS deems health care facilities eligible for government reimbursement, the implications of the directive are grave. Failing to meet these requirements could mean a facility would fail to meet inspection requirements and no longer be endorsed as a CMS-accredited facility. Without CMS endorsement, a hospital would lose a substantial portion of its income. Removing this income stream could shut the doors of many hospitals that rely on it.
PREVENTIVE MAINTENANCE VS. EVIDENCE
Kenneth Maddock has found that some manufacturers prescribe maintenance checks at unnecessary frequency. “We have seldom varied from manufacturer inspection methods; where we have varied is with the frequency of inspections,” says Maddock, who is vice president of Clinical Engineering and Telecom Services at Baylor Health Care System. “We believe in evidence-based maintenance and have used the evidence from our large database to drive the frequency of our inspections. Perhaps fortunately, we hadn’t gotten to the point where we used evidence-based maintenance to drive the content of our inspections to any great extent.”
The directive’s lack of a concrete definition of the devices to which it applies presented a challenge for Maddock’s department. “We checked with CMS to see if they had a specific definition for what this means, and they pointed us back to the update. As the update doesn’t define “critical monitoring devices” beyond that phrase, we had to define what we feel are critical monitoring devices. This did lead to an increase in preventive maintenance for us.”
“For most people, preventive maintenance is synonymous with getting an oil change for their car, explains Tim Ritter, BA, CBET, CCE. Ritter is program manager for the Accident and Forensic Investigation group at ECRI Institute. “However, there are relatively few medical devices that require true preventive maintenance,” Ritter says. “Therefore, my impression is that there is a misperception by people outside the industry that if manufacturers’ maintenance recommendations are not followed, there will be less reliability of devices and maybe patient safety issues.”
Although biomeds frequently say they “PM” their equipment, they’re usually referring to maintenance checks, Ritter says, and inspecting equipment doesn’t do anything to prevent failure. “When people are doing evidence-based maintenance, they’re saying, ‘Why are we inspecting the device? Are we finding anything wrong with these devices? Is there really a need to do exactly what the manufacturer says, as often as the manufacturer says to do it?’”
“The manufacturer has to make a recommendation for all devices at all locations for the life of the device,” Ritter says. It seems that in some cases, what they are recommending may be unnecessary or could be reduced. This has a big impact on workload, to do exactly what the manufacturer says, [and] may result in a lot of unnecessary work, where clinical engineers could be doing other things that have a larger impact on patient safety and healthcare technology management efficiency.”
ECRI Institute’s position is that the CMS directive, as handed down, should be revised. “This is not an entirely new position. CMS has always had this position,” Ritter says. “It was just not very public and it had not been coming up in inspections of hospitals on a regular basis. CMS has always said that if you receive money from us for Medicare and Medicaid patients, you will maintain your equipment per manufacturer recommendations. That was not new.”
“Unless your group has always religiously followed manufacturer recommended procedures and PM frequency, those responsible for setting your group’s PM procedures and frequency for medical equipment need to do a gap analysis ASAP,” says Alan Lipschultz, CCE, PE, CSP, president of HealthCare Technology Consulting, LLC. “From experience, I know that this can be a major job.”
Lipschultz recommends first defining critical care devices. “Identify what types of equipment you consider to be critical to patient health and safety. While the list of devices should include what The Joint Commission has designated as “Life Support Equipment,” (e.g. anesthesia machines, defibrillators, heart lung machines, ventilators), do not ignore other equipment that may be considered critical to patient health and safety (e.g. infusion pumps, X-ray equipment, dialysis machines),” says Lipschultz, who is also co-chair of the Association for the Advancement of Medical Instrumentation’s (AAMI) standards board.
Lipschultz says biomeds should compare the nature and frequency of manufacturers’ recommended PM procedures to their department’s current practices. “Enter every manufacturer/ model combination checked as rows in a spreadsheet,” he suggests, “or figure out a way to document your progress directly in your CMMS program. Every time you identify an instance where your internal practice is less stringent than what the manufacturer recommends (you don’t do some steps in manufacturer recommended procedure, or you don’t do it as often as recommended), make a notation as to what is the discrepancy.” Lipschultz suggests including a reference in the manufacturer’s service manual for future reference.
“Unless something strikes you as requiring immediate action, I recommend not trying to correct these issues at this time,” he says. “Keep on going with this process to try to get an overall sense of where you stand. Once you have a sense of where you stand with regard to this issue, you need to have a conversation with the risk manager and/or someone in administration on the subject. Decisions need to be made, and they go beyond the scope of the person responsible for managing the medical equipment.”
A FORM OF JOB SECURITY?
Some biomeds interpret the CMS directive as job security. As hospitals’ budgets have tightened, careful equipment maintenance has become critical for keeping some facilities in business. A proven, evidence-based approach has enabled them to save money by reducing the frequency of PMs and allocating only the appropriate resources to maintenance. Sometimes that means there are less traditional jobs for a biomed to do.
“Regulations are requirements. Requirements translate to employment. Hospitals spend money to meet regulations,” says Gene Mitchell, D.S.M, CBET. “For instance, when regulations require a certain license or level of education, hospitals will spend more to hire someone who meets those requirements when they could have gotten a capable employee who could do the job for less but maybe hadn’t finished the educational level.”
Mitchell extends this line of reasoning to the CMS update. “So I see the directive saying, in effect, the hospital must have someone overseeing this directive, which in effect says I still have a job.”
But some clinical engineers fear the job security that strictly enforced regulations provide is only temporary. It’s true hospitals spend money to meet regulations – it’s what guarantees they’ll continue receiving reimbursements. But when it comes to equipment, many C-level managers see manufacturer service contracts as the paramount guarantee for regulatory compliance – and for following their own recommended maintenance practices. And more service contracts mean fewer in-house clinical engineers.
MANAGING THE DIRECTIVE’S IMPACT
In May, The Joint Commission posted a request to clinical engineering departments across the country to complete a simple seven-question survey. The goal was to share the survey results with CMS. The Joint Commission concurrently surveyed facilities managers through the American Society for Healthcare Engineering (ASHE). Through the accumulated results, TJC hopes to take the nationwide experience of healthcare technology management shops and facilities managers back to CMS to seek change in the directive.
According to The Joint Commission website, the survey “includes questions on a hospital’s size, number of devices, and whether there were any patient injuries or deaths caused by adjusting equipment maintenance schedules.”
George Mills, MBA, FASHE, CEM, CHFM, CHSP, director of engineering at The Joint Commission, presented a series of webinars for clinical engineers and facilities managers in May, providing a review of EC.02.04.01 and EC.02.05.01 standards. Mills also outlined how surveyors for TJC assess a PM program. Mills said that while equipment is under warranty, manufacturer suggested PMs are the way to go. But he said that an estimated increase in FTEs by 25 percent and an increase in contracts with service companies would potentially cost healthcare technology management between $2 billion and $4 billion. That figure could run as high as $12 billion, according to Mills, if it includes the costs of equipment purchased to replace equipment taken out for service.
Mills took the concerns of members of the healthcare technology management field to CMS in a meeting in April.
The Joint Commission accredits more than 19,000 hospitals and health care facilities. The TJC accreditation makes those facilities eligible for Medicare and Medicaid reimbursement, which accounts for a substantial amount of a hospital’s income.
“For the industry overall, the impact is going to vary from no impact on those who have followed manufacturer’s recommendations exactly to extensive for those who have delved deeply into the realm of evidence-based maintenance,” says Maddock.
“Many have protested this update due to the potentially large increase in costs at a time when the industry cannot afford it, with minimal impact on patient safety. I agree with this perspective, as I feel that any look at the available evidence makes it clear that you can’t point to ineffective equipment maintenance as a significant cause of incidents involving patient injury or death.”
“And the problem is, clinical engineering departments have had talented people who can do many things that impact patient safety,” says Jonathan A. Gaev, MSE, CCE, HEM, PMP, business line manager of ECRI Institute’s Biomedical-Benchmark product. “One of those is maintenance of medical equipment, but there are other things such as selecting the right equipment in the first place – or helping educate the clinicians about how to use the equipment. Those are meaningful activities. So if because of this directive I have to spend extra time performing maintenance activities that don’t contribute to patient safety, I’m either going to take that time from activities that do contribute to patient safety, or I’ll have to hire additional staff which increases costs. None of that is a happy combination.”
Gaev says that through its Biomedical-Benchmark product, ECRI Institute is able to view and track hospitals’ medical equipment maintenance patterns. “We did a quick study of the data we have and we were surprised that we found that in quite a few cases, hospitals may be maintaining equipment more frequently than the manufacturer requires.”
“That was a surprising result for us, and we think that one of the reasons might be that when a clinical engineering department sets a maintenance interval, they may have set that interval based on their view of the technology at one point in time, and as time marches forward, that technology may no longer require that frequency of maintenance. Gaev says some manufacturers don’t specify a recommended maintenance interval. For that equipment, it’s left up to each department to determine the appropriate frequency.
“So I think that the advice that I would give clinical engineering departments, especially with this new directive, is to look carefully at the service manual and see if a maintenance interval is in fact prescribed by the manufacturer,” Gaev says. Like Lipschultz, he suggests comparing manufacturer recommendations to current practices. “In other words, don’t necessarily maintain this every six months. If you look at the manual and it doesn’t say to do that, then use your judgment.”
“CMS should consider obtaining outside opinion,” Ritter says. “The Joint Commission may try to provide a study of equipment where manufacturers’ recommendations were adhered to, versus the same equipment where those recommendations have been deviated from, to demonstrate that there was no difference in failure rate.”
“Remember this: Recommendations have to be made for the device under all circumstances. Recommendations are made for a service manual that has to be prepared before that device even ships for the first time. The manufacturer has no field experience at that point. Frequently, it seems they just repeat what they have done in the past, failing to recognize that the newer equipment has automated self-tests and is, in fact, more reliable.”
TechNation is the primary monthly magazine and ultimate resource guide for over 12,000 medical equipment service professionals. It’s diverse editorial and information helps Biomeds/CE, Imaging and I.T. professionals keep their finger on the pulse of the healthcare technology community, helping advance their careers and further their profession.