There are times when you need to put a fine point on a pencil and times when you need to put a fine point on a confusing issue because a part of it remains cloudy or unclear. Much like the Internal Revenue Code, that voluminous collection of rules and regulations that require interpretation by CPAs and tax attorneys, the rules in the health care setting are extensive. When it comes to ensuring the public’s safety, there has been a concerted effort to get it right and not overlook anything. As HTM professionals have sought to comply with evolving rules and regulations, some areas have remained vague, requiring clarification, and other areas beg for national standards.
There have been two parallel discussions that have existed for several years; frequency of preventative maintenance (PM) and completion rate requirements. With The Joint Commission’s new standard that became effective in January, the question of completion rates has effectively been put to bed. Most remaining questions about the standard concern devices in use and devices not located.
In 2010, The Joint Commission (TJC) and the Centers for Medicare and Medicaid Services (CMS) met. CMS asked that TJC surveyors scrutinize the effectiveness of maintenance strategies more closely.
The discussion continued past 2011 and questions about the frequency of PMs, approaches to alternative equipment maintenance (AEM) programs and putting a fine point on a few lingering uncertainties remained. Unlike the legal profession, where settled law describes a rule or doctrine that is clearly established, there is no settled equipment maintenance rule or doctrine that every CE department follows.
Despite the lack of a national standard template for every AEM program, the requirements for scheduled maintenance have become more straightforward and clear.
Setting the Record Straight
CMS made a pronouncement that rattled the HTM community in 2011 by stating that AEM methods were not permitted. Maintenance frequency for high risk and any new equipment had to follow manufacturer recommended maintenance schedules.
There was an immediate call from the HTM community for some clarification on the rule, in light of the real need for frequent attention to devices that don’t require it and the available resources for carrying out this routine preventative maintenance. In the same way that CPAs and tax attorneys occasionally have to ask the IRS for their opinion on a specific point in a “private letter ruling,” the HTM community asked TJC for some clarification on the revised CMS requirement.
Additional revisions followed in 2013 and 2014 and requirements were laid out for AEM programs. Change was afoot again in January of this year, when a new standard went into effect.
In an attempt to address concerns, The Joint Commission’s George Mills, MBA, FASHE, CEM, CHFM, CHSP, director of the Department of Engineering at The Joint Commission and Stephen Grimes, FACCE, FHIMSS, FAIMBE, managing partner and principal consultant for Strategic Healthcare Technology Associates LLC, gave a webinar presentation to about 1,000 members of the HTM community in January. The webinar “Clarifying the Changes to Joint Commission and CMS Standards,” is available online at university.aami.org/diweb/catalog/item/id/1431777.
According to an AAMI January 11 news article Mills said that the TJC has moved to a “much more aggressive, ‘see it-cite it’ practice.” Under the new elements of performance (EPs), hospitals are expected to complete all planned maintenance activities in line with manufacturer recommendations or an alternative equipment management (AEM) program 100 percent of the time.”
A Simpler Approach
In reality, the January webinar presented by Mills and Grimes, through AAMI, answered most questions about the new standard. It made clear that there is an expectation that 100 percent of both high risk and non-high risk medical equipment should be included in scheduled maintenance. The frequency of non-high risk maintenance can be determined by an AEM program. But, that AEM program must stand up to scrutiny. It must be defensible – whether or not it achieves this threshold will depend on the approach utilized and the effort to document everything.
The only exceptions for scheduled maintenance would be equipment/devices that are included in your AEM inventory, but are in use or not found. Equipment that is being used for a patient will need to be documented as such and tagged for later maintenance. Equipment that can’t be located should go through a process of discovery. These two areas have produced many of the remaining questions.
“Any equipment scheduled for routine maintenance but unavailable for that maintenance either because it is in-use or non-locatable should not be factored in meeting a ‘100 percent completion rate.’ However hospitals should establish policies that account for the likelihood that some equipment will not receive maintenance on schedule because it is either in-use or non-locatable,” Grimes explains.
“Those policies and associated procedures should provide methods for determining when equipment becomes available and for completing scheduled maintenance on the available equipment previously missed,” he says.
“Previously unavailable equipment may be found by informing operators and department owners of any equipment that was unavailable and requesting they notify HTM when it is no longer in-use or has been found. Policies/procedures should also provide that periodic area ‘sweeps’ by HTM personnel include searching for previously unavailable equipment and conducting any overdue maintenance,” Grimes adds.
Now, this topic can be put to bed and biomeds can do their job giving attention to the right devices, at the right intervals or supporting an AEM program that is based on a tried and trusted model – except the industry is not there yet.
There are lingering questions still being asked. Some of those questions have shown up on the TechNation listserv and members of the HTM community are helping each other understand the new requirements. Often it is webinar attendees helping those who did not attend.
A key takeaway after the January 9 TJC release, and the anticipated HTM community response is:
“Know and conservatively interpret the latest CMS and TJC requirements. Ensure that relevant policies and procedures are logical, consistent and thorough and that staff practices and documentation adhere to those policies/procedures,” Grimes says.
The good news is that TJC has streamlined and simplified some components of some standards that were deemed too complex by the organization.
Defensible AEM Program
Can you defend your AEM program and it’s precepts, assumptions and conclusions? Mills has stated that an AEM program that deviates from a manufacturer’s recommendations should be “defensible” when put to the test. If a biomed department can choose from metered maintenance, corrective maintenance, interval-based maintenance, reliability-centered maintenance or predictive maintenance, then the number of variables becomes very large without a national standard.
“Developing a ‘defensible’ AEM approach toward maintenance of a particular device category requires that HTM verify that the risk (i.e., severity and probability) of maintenance-related failure is sufficiently low that at least some of the manufacturers’ recommended activities and/or frequencies can reasonably be modified without significantly impacting patient safety,” Grimes says.
“Ensuring that the AEM program is defensible also requires HTM to periodically review the maintenance history of devices that have been placed in the AEM program and confirm they can remain in the program because there has been no significant increase in maintenance-related failures,” he says.
One of the challenges that many HTM departments have experienced recently is the retirement of baby-boom generation biomeds. This reduction in staff and/or a less experienced workforce creates challenges when it comes to meeting the new standards. How should HTM management approach this situation in light of updated requirements?
“If I have short resources, and I know that there are techniques available that can make me really look at the allocation of my resources, I can apply that strategy hopefully to be able to say that I don’t have to do the work to help me with my shortened resources,” Mills says.
“If I just said, ‘leadership has come to me and said I would be cutting three of my staff so I had to move all of my PMs from quarterly to semi-annually,’ that is not defensible. You’re responding to a lack of resources, but you are not telling me that the equipment is going to be safe and reliable and that it is the right decision to make,” Mills explains.
“However, if leadership came to you and said, ‘you have to cut three FTEs’ and you said, ‘let me re-evaluate my distribution of my workload,’ and then you started applying some of the strategies of Reliability Center Maintenace (RCM) or others, then you said, I can actually extend these PMs out safely, based on my history or my data or things that would be showing you that, then you are able to move that way, but it’s defensible,” he adds.
Mills points out that the difference is that with one, you are just reacting and you don’t have an assurance that it is the right decision, versus making a resource allocation based on, “yes, it’s defendable, it makes sense; it’s a good thing to do,” he says.
Grimes adds that this scenario will also require coordination and communication with leadership.
“HTM must understand that hospital HTM services are expected to know what resources are needed to ensure compliance with all relevant regulations and that it is HTM’s responsibility to inform the hospital’s leadership of the level of resources needed,” Grimes says.
“These resources will likely involve some combination of in-house HTM staff, service training, continuing education programs, test equipment and facilities, vendors services, etc. HTM may be judged based on how well a properly resourced service is managed to achieve compliance. But it is the hospital leadership that will be judged responsible by regulators and accrediting organizations if, after being adequately informed, they fail to provide those resources necessary for compliance.”
Some questions were answered in a Q&A session during recent webinars, but some are more specific and have been brought up in online forums, on the TechNation listserv and on social media sites.
One of those questions asked: When a hospital’s EOC committee is updating its guidelines, do they wait for a strict interpretation from CMS or is the standard clear currently? For example, if 95 percent of PMs on NHR devices is the hospital’s policy; will this fly?
“Technically CMS requirements take effect ‘upon issuance’ by CMS (i.e., immediately) and the most recent hospital equipment maintenance standards were published on December 20, 2013 (Ref: S&C: 14-07-Hospital). Updated TJC Environment of Care standards – those modified to align with new CMS requirements take place – were first published in July 2014 and additional EC revisions were published in January 2017 following some changes in TJC’s accrediting process,” Grimes says.
“Note that the January 2017 print and online versions of the hospital accreditation manual do not reflect the actual current (enforced) versions of EC.02.04.01 EP 4, EC.02.04.03 EP 2, and EC.02.04.03 EP 3. The corrected language for these three EPs can be found in the TJC newsletter Perspectives as well as in articles and presentations given by TJC staff,” Grimes says.
“Hospitals should be well versed with the most recent CMS requirements and the standards associated with their accrediting organization. Hospitals should not only have a process that ensures continual updating of hospital policies, procedures and practices to reflect compliance with the latest requirements/standards but also should ensure staff are sufficiently educated about the updates and that they act consistently with those practices,” Grimes says.
Grimes points out that current CMS requirements are for hospitals to “strictly” adhere to manufacturer recommendations or to their AEM policy requirements for scheduled maintenance activities and frequencies.
“In its latest standards, TJC interprets CMS’s strictly adhere requirement as a ‘100 percent completion rate’ for all equipment regardless of whether it is high-risk, non-high-risk, manufacturer’s recommended maintenance or AEM,” he says
As mentioned earlier, there are a number of approaches to managing an AEM program and evaluating the best maintenance schedule for each device.
Questions have arisen about devices that don’t have enough documented maintenance history. Will there be a national database that will be useful to all biomeds when using an approach that requires this big data?
“Industry experts define risk as a function of both the severity of consequence (e.g., serious to negligible impact on people, assets, etc.) and the probability of a failure (e.g., frequently, sporadically, rarely),” Grimes says.
“When considering the probability of failures related to maintenance or the lack thereof, examining maintenance history for an equipment category is one of the better predictors of future probability of maintenance-related failures,” he adds.
He goes on to say that an organization can determine what is a sufficient maintenance history through statistical analysis. It would be necessary to have enough maintenance history and an adequate number of “device-years” to calculate the history on each device. When this data is not available, there are other avenues.
“Organizations do not have to rely solely on their own maintenance histories when determining probability of maintenance-related failures,” Grimes says.
If available, they can use maintenance histories from groups of hospitals, from independent service organizations (ISOs), from manufacturers or from other reputable sources (e.g., ECRI, AAMI, etc.). AAMI has established a Reliability Center Maintenance (RCM) task force that is in the process of collecting and analyzing maintenance histories from a large group of hospitals and this could serve as an appropriate source of such histories sometime in the future,” Grimes adds.
Evidence-based maintenance has been evaluated by a number of people in the HTM community. In a 2011 TechNation cover story, it was stated that more people are considering “maintenance effectiveness” and that, starting a few years before that time, they had begun engaging in a grassroots effort through their own internal studies. Because of this, the approach has amassed some big data.
Predictive maintenance can save money and downtime, and more specifically targeted predictive maintenance, can pinpoint exactly what will need to be replaced and when. This is achieved through predictive analytics. Done correctly, it removes any guesswork. This is about proactively fixing a problem before it occurs. Knowing what is most likely to fail allows for the stockpiling of the right parts.
Cost benefit analysis is made easier and maintenance schedules can be adjusted to make the best use of available resources. Much of this is achieved through the learning systems on devices.
Still Have Questions?
Mills suggests that HTM professionals with questions visit The Joint Commission website (jointcommission.org).
The website suggests: “If you have access to The Joint Commission Connect, login and go to Resources-Standards Interpretation to submit your question. If you accessed this page via Resources-Standards Interpretation, close your browser and submit your question.”
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