In 2012, there was an intense focus in the HTM community about evidence-based PM versus a manufacturer’s recommended maintenance schedules. The issue moved front and center when CMS declared that a manufacturer’s schedule had to be followed in late 2011. This threw the proverbial fly in the ointment for many who had developed well-reasoned alternative methodologies.
The evidence-based approach, much like its counterpart in medicine, was scientific in application, and a realistic option to the more standardized approach. The community waited on clarification after many questions arose as a result of the CMS directive. It took two years to receive a clarification. The decision was made to give the HTM community a little more rope, but it was incumbent on each HTM department not to hang itself.
With that clarification came the separation of equipment classifications into those eligible for alternate PM schedules and those that must adhere to its manufacturer’s recommendations. It also required that alternate methods be constantly monitored to evaluate their reliability, their methodologies and a process for discarding non-functional equipment. The rules further require that an alternate equipment maintenance (AEM) program, and its processes, must be in writing and qualified personnel must administer the program.
Today, health care facilities have adopted their own approach to workable AEM programs. The programs must meet strict requirements that include procedures to regularly evaluate the approach and a determination about how malfunctioning equipment is identified. A health care organization must keep an updated inventory of all medical equipment.
The approach used to determine maintenance schedules, and how it relates to patient safety, is the nexus of any discussion about AEM programs.
The importance of getting an AEM program right is as crucial as determining a hospital’s continued eligibility to receive Medicare and Medicaid reimbursements. Creating metrics by which devices can be rated for reliability and developing concise maintenance reports are components as well.
“The latest CMS and The Joint Commission requirements call for health care organizations to identify high-risk medical equipment. The Joint Commission uses the term ‘high-risk’ whereas CMS uses the term ‘critical,’ but the definitions are identical,” says Matthew Baretich, P.E., Ph.D., president of Baretich Engineering Inc. in Fort Collins, Colorado. Baretich presented on this topic at the 2015 CABMET Symposium.
“These definitions are somewhat expanded versions of the ‘life-support equipment’ terminology that the Joint Commission has been using for several years. Health care organizations should have a policy that includes a list of equipment it considers to be high-risk medical equipment. These should be flagged in the CMMS inventory,” Baretich says.
When a TJC surveyor drops in to review your program, it must meet muster. In order to be compliant, the program needs to be based on accepted standards of practice. During his 2014 presentation at the AAMI annual conference, George Mills, from The Joint Commission, alerted the HTM community to the additional scrutiny that these requirements would place on them.
Presently, is there any one standard of practice that is better or worse than others as far as TJC is concerned?
“It really depends on the device and suggested frequencies that are being evaluated,” Mills says. “Each has a specific advantage and disadvantage. For example, interval based maintenance is easy to schedule, but may not be the best for alternative strategies.”
“From my experience with dealing with different regulatory agencies as of late, the two keywords during any inspection are ‘risk’ and ‘mitigation,’ ” says Anthony J. Coronado, biomedical engineering manager and account manager for Renovo Solutions LLC working at Methodist Hospital of Southern California.
“In 2014, Alternate Equipment Maintenance Program’s written guidance was established by The Joint Commission and CMS to help health care facilities constructively develop a Medical Equipment Management Program. If you review the TJC’s Elements of Performance (EC.02.04.01 EPs 6 and 7, and EC.02.05.01, EPs 6 and 7) details and the CMS State Operations Manual, proper risk assessment is the primary focus,” he continues.
“Utilizing tools to define risk can help an organization develop an alternate equipment maintenance program that is cost effective, promotes uptime, and focuses on streamlining practices,” Coronado says. “The goal is not only to meet the requirements from these regulatory agencies, but to provide best practice for the future.”
Malcolm Ridgway, Ph.D, CCE, FAIMBE, the retired former chief clinical engineer of Aramark Clinical Technologies, points out that one of the major misunderstandings is that overall equipment failure rates are a reasonable indicator of the effectiveness of PM programs. He says that this is not the case.
“It is particularly important to remember that the only failures that can be prevented by performing PMs are: Those that result from inadequate restoration of the device’s non-durable parts (MR 1 type failures, as well as instances of serious physical deterioration), and those that result from a failure to detect and repair some kind of hidden deterioration that is affecting the performance or safety of the device.”
Ridgway says that in order to make that work properly, everyone would have to change over to a new way of documenting maintenance findings. He points out that this would be no small challenge.
“All of the regulatory ‘instructions’ about performing some kind of ‘risk assessment’ seem to have many people puzzled and I get the impression that many are just going along with performing PMs on all of their equipment according to the manufacturer’s recommendations,” Ridgway says. “What a tragic step backwards! This takes us back to the Stone Age and leaves us far worse off than we were before TJC introduced the Fennigkoh Smith process back in 1989. It is going to be a major challenge just getting copies of all of those manufacturer recommendations.”
Maintaining all equipment, as the manufacturer recommends, flies in the face of the realities of current day hospital budgets and HTM resources as well.
There are various alternate approaches to handling PM. Some acceptable methodologies might include metered maintenance, corrective maintenance, reliability-centered maintenance or predictive maintenance.
If equipment doesn’t have enough documented maintenance history, if it is a medical laser or imaging or radiologic equipment, it cannot be included in an AEM program.
The old adage about knowledge being power has great application at the core of this discussion. The accumulated evidence and/or data, from a multitude of HTM sources, could be shared, condensed and formatted in a way to provide a roadmap to a reliable and workable alternate maintenance strategy based on evidence.
An amalgamation of data has been the approach used in medicine to provide guidance in treatment decision making. This model has been trusted and relied upon to determine the course of treatment in medicine for many years. With this in mind, an alternate maintenance approach that would satisfy regulators, could be derived in the same way.
Standardization is not here yet, but it could be a reality in the near future, as useful and relevant methodologies are being reviewed and some of the best minds in the field are offering ideas from an impressive brain trust.
The aforementioned approaches are all potential candidates for an AEM program. AAMI and ANSI’s EQ56 also outlines the criteria for an AEM program. It covers the creation of alternative maintenance procedures, maintenance strategies and documenting findings and repairs, along with a lot of other useful information. It is a standard that Mills has recommended.
One methodology that has emerged as a potential viable choice for some type of standardization is reliability-centered maintenance (RCM), which is used in a number of industries and has a proven track record. Malcolm Ridgway brought the approach, and its history, to the attention of AAMI. Ridgway has proposed that RCM should be considered as a standard for AEM programs because if its success in other industries.
In November, AAMI kicked off a project to explore RCM, to determine if it is a “feasible strategy that could be adopted on a wide scale throughout the field of healthcare technology management (HTM).”
The project is under the guidance of HTM consultant Ken Maddock.
“What we need to ask is why more organizations aren’t taking advantage of the flexibility offered by the AEM program. It is important for organizations to fully embrace the AEM program and take advantage of it to develop a program that is not only safe but efficient,” Maddock says.
He says that the hope is to promote a methodology that not only fits within current regulatory guidelines, but supports the universal goal of cutting health care costs while maintaining an appropriate level of quality.
“Ultimately the hope is that we can achieve a goal which would be a real turning point for our industry; the universal adoption of an effective best practice. I believe that the lack of a consistent approach to maintenance practices within our industry leads some outside of the industry to believe that we need stricter guidance on how best to support medical technology,” Maddock adds.
“While the classic definition of reliability-centered maintenance (RCM) varies depending on the source, it is fundamentally a structured process for identifying the best maintenance practices for a given technology or group of technologies,” says Larry Fennigkoh, Ph.D., P.E., professor of biomedical engineering at the Milwaukee School of Engineering.
Fennigkoh says that in this context, the “best” practice is one that maximizes equipment availability (or uptime), reliability, and safety while it minimizes costs.
“As RCM may be applied to a group of technologies, what is ‘best’ may be a combination of maintenance practices, i.e., conventional and periodic ‘preventive maintenance’ may be needed for some, interval or real-time monitoring for others, and simply run-to-failure for others,” Fennigkoh says.
“In this regard, HTM has been doing this and in essence a (very loose) form of RCM for decades. What we haven’t done – as Malcolm and others are so painfully aware of – is brought or developed any structure and standardization to our maintenance practices,” he adds
Fennigkoh points out that “one of the reasons RCM works so well in other maintenance-intensive industries has been due, in part, to their ultimate and effective use, and proper analysis of equipment failure modes, mechanisms, and frequencies.”
It is only with such data, he says, that an organization or industry then determines optimum PM intervals — if any — [and] optimum inspection procedures (if any).
“The continuing lack of standardized maintenance procedures, recording, and data validation techniques – combined with no meaningful, centralized, and substantial database – remain some of HTM’s greatest obstacles and challenges in bringing a true RCM approach to medical devices,” Fennigkoh adds.
Tweaking what Works
When Joshua Virnoche, MBA, CBET, came on board as a clinical engineering manager with JPS Health Network in Fort Worth, Texas, the situation was that all equipment with a risk score higher than seven was serviced at least annually.
“All equipment less than seven was run until fail; this accounted for a significant portion of our overall equipment. Risk score greater than seven accounted for roughly 6,000 items, while risk score less than 7 accounted for about 17,000 items,” he says.
Virnoche says that the hospital’s AEM program was set up using a risk assessment that put a risk number on each piece of equipment based on the ECRI formula E+A+[(P+F+U)/3], where equipment function is E, clinical application is A, preventive maintenance requirement is P, likelihood of failure is F, and environmental classification is U.
“The current process has been revised to be in line with regulatory requirements. We still use the same risk score calculation, but have revised the layers,” Virnoche explains.
“Anything that is risk score 15+ is considered ‘high risk’ equipment, and is maintained by manufacturer’s specs. If we don’t have the service manual or the test equipment to maintain this equipment in house it is maintained by the manufacturer. All imaging, lasers, and equipment subject to federal or state law, or Medicare Conditions of participation, is maintained at this level as well,” he says.
“Additionally, all new devices with insufficient maintenance history is maintained at this level. Risk scores less than 15 now receive a performance, functional, and electrical safety check on, at minimum, an annual basis. If this equipment fails any of these tests it’s repaired, and then a manufacturer’s recommended PM is performed.”
Virnoche says that a year into the new maintenance plan has revealed some benefits, as well as some drawbacks.
“Overall, expanding scheduled maintenance to all of our equipment has been a daunting and on-going task. We’ve seen great results in the functionality and reliability of the equipment, with less overall failures of the equipment, since we catch problems before equipment fails, in most cases,” he says. “Less downtime has definitely increased our positive feedback from our customers, and our working relationships have improved all around.”
On the other side, there has been a significant investment in time to ensure that the department has the right manuals, strategies, test equipment and manpower to cover the added work load, Virnoche says. The original AEM program took six biomed techs and two imaging techs, along with a significant investment in service contracts and time-and-materials and labor-hour contracts (T&M labor).
“Today, we’re budgeted for four imaging technicians and 20 biomed technicians,” he says. “We rely much less on contract and T&M labor, which has offset the cost of the new employees. The FY2015 budget offset was initially net neutral, offsetting $1 dollar of contract cost for $1 dollar of in-house labor, but by the end of the year we had saved an additional $300,000+ in contract labor over expectation.”
Virnoche says he expects additional savings in FY2016 over FY2015.
“I’d like to reiterate, that while we have saved budget dollars, our quality of work has significantly increased since we began this journey,” he says.
In the meantime, Maddock and AAMI are working behind the scenes on assessing how RCM might fit into the equation.
“Organizations are being solicited that would be willing to adopt RCM practices and record the data so we can verify the effectiveness of this methodology,” Maddock says.
“At the recent Supportability Summit, there was very good cooperation between manufacturer representatives and HTM professionals, so we hope to engage manufacturers on how they might get involved in this effort,” he says.
“The plan does include a shared database that would start small, but over time could expand to become a national database,” he adds. “Any database would be used as supporting documentation rather than part of a live support system, so recovery would be more appropriate than full redundancy.”
He says that the current draft plan is to write a series of articles and/or white papers that would explain how to use the process and how it fits within current regulatory guidelines.
Working within the regulatory framework, the task of running an effective alternate equipment maintenance program is an important step in allocating human resources, maintaining safe equipment and watching the budget. The day may come when the implementation and management of such a plan includes some degree of standardization and readily accessible online resources.
“I do agree that using an RCM based approach is the best way out,” Ridgway says. “It also provides a very solid case for reducing the amount of PMs that we would have to do very substantially.”
There are four parties at the table of any AEM discussion. There are the patients, the regulators, the HTM community and the manufacturers. All three of the other parties are interested in the well-being and safety of the patients. The regulators have the final say. The manufacturers have their recommended schedules and the HTM community has limited resources. Finding a path that is practical for the HTM community is a work in progress.
This year should see the development of an AAMI RCM task force, as well as the possibility of a database. Those things are still preliminary at this point, but would certainly move the ball forward.
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