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Let’s raise a toast to the qualified individuals—you know who they are (don’t you?)

There’s been a fair amount of discussion in the trenches about the changing dynamics relative to the maintenance of medical equipment and utility systems equipment in the face of all the changes in Joint Commission standards, invocation of CMS as the supreme authority, etc. And while I’m absolutely convinced that this is a conversation that is likely to evolve/mutate over time (the topic of relocatable power taps springs to mind as an example of some fairly rapid-cycle change in approach), I figure we can at least start the conversation and see what happens.

From a compliance standpoint, I think the critical dynamic is how much, if any, of your medical equipment and/or utility systems equipment inventory is being maintained through the application of an alternative maintenance strategy, which effectively means any maintenance strategy that is not in strict adherence to what is recommended by the original equipment manufacturer (OEM). I know a lot of folks are using a database system for managing preventative maintenance activities, but I will admit to not being sufficiently familiar with each system’s capabilities, so I may go somewhat far afield in this portion of the program. Please feel free to issue an e-dope slap if I get things going sideways.

If you are fortunate enough to have a system that is (or is capable of) keeping track of the inventory as a function of whether it is being maintained under an alternative maintenance strategy, then that becomes the basis of any discussion in this regard during a survey. Once you’ve done that initial “sort” (if it is applicable; if you’re maintaining everything in accordance with the OEM, then you really only need to state that in the applicable management plan), then I would recommend a second sort for each category (you could call one category OEM and the other AEMS—Alternative Equipment Maintenance Strategy) to determine what high-risk equipment resides in each of those categories, if any. Ideally (at least from a strict compliance approach), you are not managing any high-risk equipment through an alternative strategy; that will make things potentially less contentious during survey. If you do find that you have some high-risk equipment in the AEMS bucket, then you’re probably going to have to move those processes into the OEM bucket—hopefully a minimally disruptive task.

I guess the other piece of this that could end up being a pain in the butt is if folks had elected not to include all of the medical and/or utility system equipment components, in which case you’re going to have to “capture” anything you might have left out of the inventory to start with. As an editorial aside, every time I think about this whole thing, the more peeved I become because while I understand what they’re getting at from the larger perspective of ensuring safety and operational reliability, I can’t escape the thought that the focus on this whole thing is completely in inversion to the performance of this process over time. In general, we are not hurting people through our medical equipment/utility systems, but it is what it is, I guess. Still, I can’t help but think they must have better things to do than worry about this stuff.

At any rate, the next step depends on whether you’re managing any of this equipment through an alternative maintenance strategy/system. If that is the case, you need to go through the list of equipment being managed in this fashion and provide support the determination whether it is safe to permit medical equipment to be maintained in an alternate manner, based on criteria that includes:

  • How the equipment is used, including the seriousness and prevalence of harm during normal use
  • Likely consequences of equipment failure or malfunction, including seriousness of an prevalence of harm
  • Availability of alternative or back-up equipment in the event the equipment fails or malfunctions
  • Incident history of identical or similar equipment
  • Maintenance requirements of the equipment

 

The other piece of this is that the above analysis has to be performed by a “qualified individual(s)” (and, as with the responsibility for maintaining the SOC, there is no specific direction in regards to what constitutes a qualified individual–I would recommend making that determination and running it through the EOC Committee for their knowledge/approval. At the end of the day, the complexities all grow out of the use of alternative maintenance strategies for medical/utility systems equipment, with the end game being (as is noted under both EC.02.04.01 and EC.02.05.01) “the strategies of an AEM program must not reduce the safety of equipment and must be based on accepted standards of practice” (they specifically cite AAMI/ANSI EQ56: 2013 Recommended Practice for a Medical Equipment Management Program).

Unfortunately, I think this is mostly going to be grunt work unless you’ve never gone down the AEM road (which would make little or no sense; I don’t think anyone has enough resources to absolutely manage every piece of medical and/or utility system equipment in accordance with OEM). It’s getting everything into the correct categories and moving on from there.

You may need to reset your compliance calendar

As the trees turn over their colors, it (sometimes) gives me time to go back over stuff we’ve covered out here in the blogosphere, with the intent of trying to capture some things of note that I think are worth mentioning, even if they are not quite “hot off the presses.”

One of the interesting shifts is the subtle redefining of several of the compliance time frames invoked throughout the standards and performance elements. Not all of the definitions changed, but in the interest of full disclosure, I think we should include the lot of them:

  •           Every 36 months/every three years = 36 months from the date of the last event, plus or minus 45 days
  •           Annually/every 12 months/once a year/every year = one year from the date of the last event, plus or minus 30 days
  •           Every six months = six months from the date of the last event, plus or minus 20 days
  •           Quarterly/every quarter = every three months, plus or minus 10 days
  •           Monthly/30-day intervals/every month = 12 times per year, once per month
  •           Every week = once per week

 

A particularly curious impact of this shift is the abandonment of the time-honored “not less than 20 days and not more than 40 days” intervals for emergency power testing activities. Now we have “at least monthly” for those very same activities, which probably means that you may want to consider scheduling your generator tests earlier in the month so if you have to postpone/delay the testing of your generator(s) to work around patient care activities, etc. You don’t want to run out of “month.” It will be interesting to see how this translates into the survey process.

The other thing that I’m “watching” is how that definition of quarterly is going to dovetail with how you would conduct fire drills. Is there going to be yet another “counting” vulnerability? I know the Conditions of Participation indicate that fire drills are to be conducted at “unexpected times under varying conditions,” which somehow seems to fly in the face of an every three months plus or minus 10 days. Maybe that’s a big enough window to keep things unexpected; I guess we’ll see how things unfold.

Sometimes miracles really do happen…BREAKING NEWS!

In what is clearly one of the busiest years for regulatory upheaval in the healthcare safety world (at least in recent memory), CMS has, yet again, turned things on their ear—and to what all appearances seems to be a most positive potential outcome—in its ongoing series of categorical waivers. And this on a topic that has caused a ton of gnashed teeth and much sorrowful wailing: the use of relocatable power taps.

You will recall (it seems no more than minutes ago) that back in June (2014), George Mills, director of The Joint Commission’s Department of Engineering, was tasked with the dubious honor of announcing to the world that, basically, the use of relocatable power taps to power medical equipment in patient care areas was on the no-no list. Since then, many (okay, probably just about everyone to one degree or another) facilities and safety folks have been spending countless hours trying to figure out how to make this happen. So I guess this means that CMS has decided that Mr. Mills doesn’t have to get painted with the “bad guy” brush any longer as they have issued a categorical waiver that provides a fair amount of flexibility for the presence of RPTs in the patient care environment.

Now history has taught us, if nothing else, that that flexibility is going to vary quite a bit depending on your facility and the results of the inevitable risk assessment; but presumably you’ve already started the risk assessment process like good little girls and boys, yes? There is a lot of fairly useful (at least at first blush—we also have learned how useful can become useless in the blink of an eye) information to be had in the memo, which you can find here. If you have not yet had a chance to look this over, I would encourage you to do so before you make any “big” decisions on how you’re going to manage these pesky little items (hopefully, this “relief” is not coming too late to avoid having undo sweeping seizures of power strips, etc.).

Maybe it’s Christmas come a bit early (or maybe we just power-shifted into winter), but I would encourage you to unwrap this present very carefully (some assembly required) and try not to break it on the first day…

No doubt there will be questions, so please use this forum as you wish.

How many plans must a response planner plan before he is called a response planner?

Recently I fielded a question regarding the requirements for organizations to have department-level emergency response plans and what those requirements might represent in terms of specific elements, etc.  I have to admit that my initial reaction was that I really didn’t see much rationale in the creation of detailed department-level response plans;  to be honest, it sounded very much like busy work, but that may just be me. But upon reflection of what is actually required (at least for the moment—still waiting on the Conditions of Participation “version” of emergency response—I’m sure that will result in some interesting conversation), while I can’t make a completely unassailable case for department-level plans (with some exceptions, but those may pivot on an organization versus department assessment), there may be some value in at least looking at the concept (in recognition that there is nothing in the requirements that specifies department-level plans; department level planning is certainly in the mix, but written plans, not so much).

By parsing the response elements to the tried and true Joint Commission model, we’d want to account for communications, management of resources and assets, management of staff roles and responsibilities, management of safety and security, management of utility systems and capacities, and the management of patient care and support activities (is that six elements? Yes!).  My thought is that the critical infrastructure needs would “live” in the organization’s response plan and that most of the department-level plans would be along the lines of “consult with incident command” during a response activation—and isn’t that kind of the purpose of IC anyway?

Which leads me to the question of how much a department-level plan is going to deviate from/bring value to what is already included in the organizational response plan? I’m having a very difficult time convincing myself that what any organization “needs” when it comes to emergency response is yet another layer of plans. For all intents and purposes, the more layers you have underneath the command function, the more intricate the communications lines, etc. and to my way of thinking, intricacy is not necessarily a hallmark of effective emergency response. When I think of the command function/structure, while you certainly want to have some “distance” between the deciders and the doers, I would think that (at least at the organization level) you would want an org chart that is reasonably “flat” (precipitous command structures make me nervous; they just seem to be less flexible in the moment).

So, dear audience, have any of you folks gone down this road of developing department-level response plans (recognizing that there are certain departments, like materials management and food services, that have a role in supporting the entire organization’s response capabilities)? If you have, has it been worth the efforts to do so? Or did you look at it and decide, from a prioritization standpoint, that the value in doing so did not represent a worthwhile investment? Any feedback/discussion would be very much appreciated.

May you live in interesting times…no duh!

Well, now that we are well and truly ensconced in the post-July 2014 world, perhaps things will quiet down a bit on the updated standards front. It’s been a very busy first half of 2014 relative to The Joint Commission’s ongoing alignment with the CMS Conditions of Participation and perhaps they’ll allow the smoke to clear a bit so we can get down to figuring out how much impact the changes to the standards will have in the medical equipment and utility systems management pursuits. Kind of makes you wonder what’s left to update/align, but let’s hold that card for another day.

So, the last salvo in June saw some fairly interesting edits of (to? you be the judge) the medical equipment and utility systems management standards and performance elements (visit here for details). As near as I can tell, the most eventful changes relate to the change of the life support and non-life support equipment categories to a somewhat more expansive (or at least it seems that way to me) categorization of high-risk (which includes life support medical and utility systems equipment) and non-high-risk (which includes pretty much everything else). To be honest, most (probably all, but I don’t want to use too big a blanket for this) of the programs I’ve had the privilege to review/evaluate have moved to the high-medium-low-no risk strategy for assigning preventive maintenance activities and frequencies, so I’m not sure that this will require any fundamental changes to how folks are administering their programs. But (and there’s always, always, always one of those when there is an official change in the standards), I am curious to see how these changes will be applied during accreditation surveys. I expect the life safety surveyors to have a good grasp on the practical impact of the changes, but what about the rest of the survey team as they wander around the corridors of healthcare organizations across the country. It’s not unheard of for standards changes to “drive” an increase in findings in those particular areas as surveyor knowledge expands/contracts/evolves/mutates so it will be interesting to see what types of findings may fall out of the changes.

I guess my best advice at the moment is to do a careful assessment of where your program is relative to the “new” standards, particularly if you have adopted an “alternative equipment maintenance” (AEM) program (this must be that alternative lifestyle I keep hearing about…). I suspect we are all going to need to be prepared to make full use of the post-survey process (especially the clarification process) to demonstrate the “compliance-ness” of our programs. As I tell folks at virtually every stop on my never-ending tour of hospitals, there will always be surveyors that will disagree with programmatic decisions that you’ve made. Your task/responsibility is to have a very clear understanding of how your program meets the intent and the spirit of the standards, regardless of how something might “look” to a surveyor. At the end of the day, it’s about supplying to our customers safe and reliable medical and utility systems equipment—and as long as we can demonstrate that within the confines of the standards –then we have fully honored that obligation. And that, my friends, is what compliance-ness is all about.

Tiptap through the tulips

In what has turned out to be one of the busier periods when it comes to changes in regulatory oversight of the physical environment, we have George Mills, senior engineer at The Joint Commission, announcing a considerable shift relative to the use of power strips/relocatable power taps with medical equipment in patient care areas. According to the press release from the Association for the Advancement of Medical Instrumentation (AAMI)’s 2014 annual conference (at which Mr. Mills was a featured speaker), we should consider the following areas as being included in “patient care areas”: operating rooms, patient rooms, and “areas devoted to recovery, exams, and diagnostic procedures.” That looks like a pretty inclusive list from where I’m sitting. What say you? BTW, if you want to see the whole press release, you can find it courtesy of the AAMI.

At any rate, from wherever you’re sitting, this is going to be a pretty big freaking deal for way more organizations than not. All that said, at least at the moment (as of June 13, 2014), I’ve not seen anything in writing from CMS (generally, when a change of this magnitude comes down the pike, they’ll send out a letter to inform their surveyors how to enforce new requirements); my hope is that perhaps things will have smoothed out a bit when that missive arrives.

A couple other items from the AAMI conference include the announcement that CMS has made the determination that ultrasound equipment is considered radiologic equipment and can’t be included in any alternative equipment management program. The long and short of that is that ultrasound devices will have to be inspected, tested, and maintained in accordance with manufacturer recommendations. Not sure how many folks have strayed from that path, but if you have, you need to stray back.

The final bit of word from the conference (and feel free to make your own determination as to whether its good news or bad news) is that, effective July 1, 2014, all hospitals that use TJC for accreditation must maintain a written inventory of all medical equipment and identify “high-risk” medical equipment, which would include (as you would probably be able to guess), but is not limited to, life support equipment. And by way if revisiting the whole alternative equipment management program concept, if you are indeed managing any of the equipment in your inventory through the graces of an alternative equipment management program, then those devices must be identified as such. As we’ve seen in the past, requirements for written information/documentation can result in a fair amount of scrutiny, so I think we can expect the same thing to happen with these changes.

Is this evidence of a refocusing of the survey process on all things medical equipment (don’t forget to keep clinical alarm safety on the front burner too!) during the survey process? Tough to say, but past practices would seem to indicate perhaps, yes. Beyond that, only time will tell…

Paperwork, shmaperwork!

One interesting thing to note during a recent CMS validation survey up here in the Northeast: there was a fair amount of interest on the part of the CMSers on life safety system testing documentation for patient care locations other than the main hospital sites. Fire alarm testing (and sprinkler testing for those locations having sprinkler protection) documentation for physician practices and other free-standing service locations was requested (and in some instances not quite produced in full). I know that generally speaking we tend to focus on stuff that occurs within the “four walls” of the hospital, but once you get outside those walls, you can encounter an increasingly complicated set of conditions. There may be patient care services being provided in leased space, in which case you may have to deal with a landlord to access testing the needed testing documentation (unless, of course, you have taken responsibility for managing that process, but I’m going to guess that folks with multiple sites may not have the “luxury” of taking complete responsibility for those types of activities). I don’t know if this signals a sea change in what documents might be expected, but it’s certainly something worth considering—and perhaps testing within your own sphere of influence. I know I’m going to be asking about these types of processes a little more frequently…

News flash: Vacuum cleaner sucks up budgie!

Actually, the news is even bigger than that: it appears that the CMS machine is churning inexorably towards adoption of the 2012 edition of NFPA 101, Life Safety Code. While the last year or so has seen plenty of tidbits (in the form of waivers) tossed our way, the day we’ve been waiting for is finally upon us. There will be plenty of opportunities for in-depth analysis (minimally, TJC is going to have to reconfigure the accreditation manuals to reflect the changes; just when I had memorized the standard and EP numbers…drat!), but I think the main focus for folks is to weigh in on how this is all going to shake out over the next 12 to 18 months.

Fortunately, the powers that be are allowing a two-month comment period that is scheduled to end on June 16, 2014 (everything should be finalized for CMS in about a nine to 12-month timeframe following the close of the comment period). The proposed rule is available for viewing, at which point you can download the proposed rule in its entirety (and it is, as one might suspect, a pretty entire entirety, which is not so very far from decomposing composers, but I digress). There is much information to digest, and again, we’ll have some time to watch how this whole thing comes to fruition. But once again, it’s important to do the reading ahead of time. Confab with your engineering colleagues at the local, state, regional, and national levels; this may very well be the most sweeping change we’re likely to see in the practical application of the Life Safety Code in our hospitals and other healthcare facilities. Make sure everyone with a voice can be heard in the discussion!

Get ready, ’cause here I come!

I’m still trying to get my head around the driving forces behind the pending CMS rules regarding all things emergency management. I don’t think I will ever understand why the requirements are quite as complex as they appear to be. My take has always been that the requirements could be distilled down to having a NIMS-compliant incident command structure, establishing a process for credentialing practitioners during an emergency, and a standard set of requirements for conducting exercises—everything that you need to be able to do, I think, fits very nicely into those couple of items. Would your actual plan be a complicated undertaking? Absolutely. The all-hazards approach has to be both flexible and comprehensive, so the mere physics of such an undertaking would tend away from small dense structures to larger, more fluid structure. But I’d not convinced that the overarching requirements need to be quite so (insert adjective here).

I also have a hard time thinking that hospitals and other healthcare organizations don’t take emergency management concerns seriously. As I pen this on the eve of the first anniversary of the Boston Marathon bombing, I continue to reflect on how well the hospitals in the Boston area responded to that horrific event. Were the lessons learned? Opportunities identified? You betcha! But when it comes down to getting the job done in real life/time, last April was a sterling example of how well hospitals plan and cooperate and respond to emergencies. No CEO wants their hospital to be on the front page of the local paper/web page because their organization dropped the ball during an emergency. That kind of publicity, no one needs.

So now we’re faced with another set of requirements—not particularly dissimilar from what we already have—and another set of interpretations by yet another set of authorities having jurisdiction. And the question I have yet to find a really good answer for is this: how is this going to make hospitals better prepared to respond to an emergency? If anyone has figured that one out, please share!

You haff ze papers?

On March 4, 2014, The Joint Commission unveiled the new EC prepublication standards, which have been created at the behest of CMS (oh boy, oh boy, oh boy!). The new standards are based on a Survey and Certification letter (S&C 14-07- Hospitals) issued in December 2013 (you can find the details of that little puppy here).

In the Survey & Certification letter, CMS is basically allowing for medical and/or utility systems equipment to “adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment by qualified personnel.” There are the usual caveats invoking the Conditions of Participation and other federal or state laws; the example given is that all imaging/radiologic equipment must be maintained per manufacturer’s recommendations (I could be fresh and say that this means that the radiological equipment lobby might be more influential than the hospital lobby, but I guess I just did). Likewise, medical laser devices must be maintained in accordance with manufacturer’s recommendations. The third category of exclusions is “new equipment without a sufficient amount of maintenance history has been acquired.” The whole ball of wax concludes with the statement that “hospitals electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their Alternate Equipment Management (AEM) program. They must adhere strictly to the AEM activities and/or frequencies they establish.

Apart from the birth of a kicky new acronym, the new Joint Commission standards pretty much reflect the requirements from the S&C letter, with the inclusion of a pretty nifty clarifying note regarding what can constitute an equipment history: records provided by hospital contractors; information made public by nationally recognized sources; and records of the hospital’s experience over time. I should mention at this point that the new standards apply equally to hospitals and critical access hospitals.

I think the one thing that gives me the most pause (I’m sure there will be other pauses as these start to show up during survey) is the whole concept of the “qualified” personnel doing the risk assessment. Methinks that this will end up driving some sort of accounting/definition of qualified to be determined by each hospital. I guess the questions I have for you folks are:

–          How far into the AEM world have you drifted?

–          How solidly crafted are your policies and procedures in this regard?

–          How well do you think you’ll endure the “qualified personnel” component of the requirement?

I think this is a topic worthy of some discussion. I invite you all to weigh in.