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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…

When things really start to add up (and not in a particularly nice way…)

Our continuing coverage of the survey wars brings us to the June 4 edition of Joint Commission Online in which it was revealed that we can anticipate that Joint Commission survey reports are going to be bulking up over the next little while (you can determined whether that bulk is the result of banned substances). This “bulk” is being introduced as TJC strives ever harder towards alignment with the requirements (and expectations) of the folks at CMS, and I’m all a-tingle—not!

Henceforth (kind of makes it sound almost biblical), TJC will be adding a section to every survey report that will be entitled Opportunities for Improvement or OFI (to differentiate OFIs from PFIs and RFIs and any other FIs that might be swirling around the compliance world). The OFI section is going to be reserved for all those pesky little single instances of non-compliance that fall under “C” performance elements (you will no doubt recall that “A” performance elements are already balanced on a single instance of non-compliance—you either have it or you don’t. And if you don’t…).

In current survey practice, “C” performance elements, to generate an RFI, require the survey team to identify at least two instances of non-compliance. For example, during the facility tour, the LS surveyor finds a single door that does not close and latch properly. In the past, that finding would be absent from the final report, but now it will reside in the OFI section of the report. The good news here is that you will not have to submit an Evidence of Standards Compliance (ESC) for the items in the OFI section, you just have to fix them. Also, any open PFIs from previous surveys or PFIs approved by the surveyor during the survey visit will also be enumerated in the survey report. You’ll still be resolving them via the normal process, within six months of the projected completion date, etc., so that piece of it doesn’t change. I guess it’s just a means of keeping open PFIs on everyone’s radar (the likelihood of this being an offshoot of the number of overdue PFIs found in recent TJC review of eSOCs is anybody’s guess, but I’m betting… yeah, pretty much) I suppose another by-product of this “highlighting” of open PFIs is added impetus to make sure that you get things resolved prior to your triennial survey, but it is certainly not a requirement. You just have to adhere to your committed completion dates.

All that said, clearly we’ll be dealing with more “findings” on the report, which presumably means that TJC will have more evidence for CMS that it really is looking carefully at compliance issues and that it is identifying deficiencies during the survey process. I do believe that everyone in the process—the regulators and the regulated—are committed to providing safe quality care to the patients, but I guess how that care is going to be delivered is subject to interpretation. Same as it ever was…

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.

Time has come today—but you don’t have much of it!

One thing for your to-do list (if it’s not already on your done list) is to take a few moments (okay, maybe a couple more than a few moments) to look over the proposed changes to the way CMS is going to be requiring hospitals to undertake emergency management activities.

You can get the skinny here. The caveat in all this is that you only have until the end of this month to provide feedback on the requirements. Forgive me for being a doom and gloom kind of guy, but something tells me that this is not going to be merely a kind of realignment of resources, etc. I think there is a fair amount of potential for this to cause a lot of heartburn for facilities/safety folks.

Fortunately, the webpage lays out pretty nicely, with click-through links and such, which allows pretty slick navigation of the requirements. I don’t think I’m going to surprise anyone by saying that while there are some consistent concepts, etc., between the proposed requirements and the Joint Commission’s Emergency Management chapter, the two don’t necessarily dovetail seamlessly. For example, it kind of looks like there will be a mandated tabletop exercise (which is defined as a “group discussion led by a facilitator, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan”). In the Training and Testing section of the proposed rule, there are some click-through resources aimed primarily at assisting smaller facilities—those of you in smaller facilities like critical access hospitals and such—may want to pay very close attention to how this is going to impact your organizations. It sounds nice on paper, but only you folks know how workable these “solutions” might be.

Again, there are common elements—risk assessments, community involvement, emergency plans that reflect reality, etc.—but you and I both know that it doesn’t take a great deal of variable language to create almost insurmountable compliance challenges (note the “almost”; failure, as always, not an option on this wagon train). At this point, it’s impossible to say how much influence can be brought to bear on what’s going to come out of this magillah (and I know it can be very unhappy to weigh in and have one’s thoughts ignored), but I think it is most important to speak up when the opportunity is presented. This will take you to the comment page:

ASHE offered the following suggestions to those who are considering making their own comments:

The comments most likely to affect regulatory decisions are ones that are constructive and clear. Comments should be supported by sound reasoning, scientific evidence, or real-world examples of how your hospital or facility will be affected. Copying and pasting comments or information submitted by others decreases the effectiveness of both your comment and the comment of the original submitter. The best comments explain, in your own words, the positive or negative effects of the proposed rule on your facility and others like it. Remember that public comments are not votes—a single well-written public comment can pull more weight than thousands of form letters.

You may also find value in checking with your state hospital associations. I don’t think we can ever underestimate the impact on daily operations when the feds make changes of this nature and intensity and it’s getting towards the 11th hour. Make those comments count!

Where will you be when the lights go out?

Now I don’t think that there’s any here among us who would be inclined to disagree with that as a going concern. The question I have is how might these requirements come into play when CMS adopts the 2012 edition of the Life Safety Code®? We know that CMS is looking very carefully at all things relating to emergency management/preparedness, including a fair amount of focus on the subject of emergency power. I think we can safely intuit that the broad-ish concept of grandfathering is fast becoming extinct. Thus, the question becomes (or perhaps this is really representative of two questions) what could be done now (and perhaps mandated to be done now) to reduce any existing EPSS installations that could be considered at risk (I’m presuming that you’ve all completed your risk assessments in this regard—if you haven’t, I think it would be a wicked swell idea to be jumping on that bandwagon ASAP)? The second prong being, what due diligence has been brought to bear in relation to any pending installations? I’m pretty certain that I would not want to have a brand spanking new generator get flooded out during the next deluge. At any rate, I am interested in finding out more about what you folks have been up to in this regard. I can’t imagine any endeavors in this realm having an inexpensive price tag, so I’m thinking about how folks might have had to, or will have to, sell these “ideas” to organizational leadership.

Get the heck out of there!

Touching back on the proposed CMS rule regarding emergency preparedness and hospitals, within the torrent of verbiage, the Federal Register information refers to a hospital evacuation decision guide that’s available through the AHRQ website (just so you know, there is a fairly gloomy caution that the information may be out of date, etc. I’m extremely glad that CMS is using potentially outdated information to promulgate new requirements. Perhaps that’s a wee bit too ironic…). In looking over the materials, I don’t know that the contents are so woefully out of date as to be useless. On the contrary, I think there’s a lot of helpful stuff; while there have been some evacuation-worthy events since June 2011 when this information was last vetted for currency, I’m thinking that the historical precedents in place at the time (Katrina, etc.) would drive a refinement of planning and preparedness as opposed to a wholesale revamping of concepts relating to evacuation of hospitals in response to emergencies.

Have folks out there been using this information? If so, has it been of particular use? Inquiring minds want to know!

A cautionary tale

During a recent CMS survey, one hospital in the Northeast was cited during the inspection of the physical environment for a vent on the roof of the laboratory that was labeled “caution.” The problem—not enough information. As these folks were preparing their response, they asked me what the correct wording would be. And the answer (and I realize I haven’t used this one in a while)? It depends.

Strictly speaking, as a function of the Hazard Communication Standard, the nature of the risk of which one is being cautioned should be identified. In the case of the lab vent, it could be signage indicating that the exhaust is a biohazard or a poison, etc. When you think about it (or even if you don’t), a sign that just says “caution” doesn’t really tell enough of the story—at least in terms of how persons on the roof should be managing the risks. Many, if perhaps not most, OSHA surveyors would accept the biohazard symbol on the vent; or, alternatively, you could also include identification of rooftop hazards in your roof access protocol (I’m sure you have one of those). It sounds like there will probably have to be some follow-up discussion with the inspector to either ask him for some guidance (I’m guessing there may get some generic instruction, but not much in the way of specifics) or at least run by him what the plan of correction will entail. It would be most stinky to have your corrective action plan kicked back because they don’t like how you’ve worded the signage, etc. Fixing identified issues is one thing, but when it gets into the gray area of how you would effectively manage risk is a little bit more tenuous—way better to err on the side of caution.