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CMS provides yet a little more flexibility for the management of the physical environment

In the ever-unfolding saga of pandemic response, the folks at CMS have issued another couple of waivers relating to the physical environment. Of course, these continue to be published with rest of the granted waivers, so I’ve copied and pasted the new stuff here:

  • Alcohol-based Hand-Rub (ABHR) Dispensers: We are waiving the prescriptive requirements for the placement of alcohol based hand rub (ABHR) dispensers for use by staff and others due to the need for the increased use of ABHR in infection control. However, ABHRs contain ethyl alcohol, which is considered a flammable liquid, and there are restrictions on the storage and location of the containers. This includes restricting access by certain patient/resident population to prevent accidental ingestion. Due to the increased fire risk for bulk containers (over five gallons) those will still need to be stored in a protected hazardous materials area. Refer to: 2012 LSC, sections 18/19.3.2.6.  In addition, facilities should continue to protect ABHR dispensers against inappropriate use as required by 42 CFR §482.41(b)(7) for hospitals; §485.623(c)(5) for CAHs; §418.110(d)(4) for inpatient hospice; §483.470(j)(5)(ii) for ICF/IIDs and §483.90(a)(4) for SNF/NFs.
  •  Fire Drills: Due to the inadvisability of quarterly fire drills that move and mass staff together, we will instead permit a documented orientation training program related to the current fire plan, which considers current facility conditions. The training will instruct employees, including existing, new or temporary employees, on their current duties, life safety procedures and the fire protection devices in their assigned area. Refer to: 2012 LSC, sections 18/19.7.1.6.
  •  Temporary Construction: CMS is waiving requirements that would otherwise not permit temporary walls and barriers between patients.

I’m going to guess that some folks have already “taken advantage” of these items (with the possible exception of the fire drills, more on that in a moment). It would seem more than likely that some additional hand sanitizer dispensers have sprouted up all over your facility (hopefully you’ve been keeping reasonable track on these locations). Once this is over, you’ll probably need to either do an analysis of how much you’ve got floating around or remove them before you run afoul of allowable amounts. I also can’t imagine that temporary walls haven’t sprouted up (lots of sprouts this week!) in all sorts of spots. Those are probably a little simpler to track, but there is one instructive element to this allowance, that being the interpretive difference between TJC and CMS when it comes to temporary barriers: While TJC allows them to be smoke-tight, the feds are really looking for temporary barriers to be fire-rated, particularly for construction separations. Something about which to be mindful when things get back to “normal.”

As to the fire drill waiver, I absolutely understand the first part of the statement—inadvisable is as good a descriptor for trying to conduct fire drills at the moment, particularly as a function of moving and massing staff together. But I’m not exactly sure what they mean by the latter portion, but I think we can parse this for a bit. Especially if the physical space has been altered in efforts to provide “new” pressure relationships for some units, then, in all likelihood, there are elements of egress that have been impacted and, in some instances, that impact is to a degree that probably requires modification of existing unit-based fire response plans. I think it’s good to be able to alert folks to the “reality” that if the alarm goes off “this is not a drill,” but how do we make sure that folks can take full advantage of the compartmentalization features of our facilities? And then, how do we “document” that education? I don’t think it needs to be particularly complex (in fact, I suspect the less complex, the better) and could perhaps be communicated through whatever lines of communication are in place with your incident command structure. If anyone has any thoughts they’d be inclined to share, that would be delightful.

And for you folks who might be interested in what’s happening in the fulcrum of state and federal response, you can find your state’s waiver requests, etc., here.

I won’t say it’s good reading, but one can never have too much insight into the process during times of chaos.

Stay well and take care!

In the grand scheme of things, this helps—but how much?

A few weeks back we chatted about efforts to engage the 1135 Waiver process as a function of fire and life safety systems inspection, testing & maintenance, particularly as a function of ASHE’s efforts to facilitate a coordinated response. Apparently, this part of the waiver picture was not a priority for the folks at regional CMS, so there were a number of rejection notices sent to folks.

I’m not exactly sure what may have transpired (other than the passing of time, but if there were folks with access to CMS ears that continued to advocate, a debt of gratitude is owed), but some items related to certain inspection, testing & maintenance activities have finally made it to the slate of blanket waivers. You can find the information here, on page 23 of the linked document. Unfortunately, it appears that the blanket waiver announcement is being released in cumulative form, so you have to dig a little bit to find the applicable passage. Because of that, I’ve copied and pasted the information below.

As near as I can tell, the areas of greatest concern for the moment are those activities for which waivers were not granted:

  • Sprinkler system monthly electric motor-driven and weekly diesel engine-driven fire pump testing.
  • Portable fire extinguisher monthly inspection.
  • Elevators with firefighters’ emergency operations monthly testing.
  • Emergency generator 30 continuous minute monthly testing and associated transfer switch monthly testing.
  • Means of egress daily inspection in areas that have undergone construction, repair, alterations, or additions to ensure its ability to be used instantly in case of emergency.

In looking at the list, I think that it is both reasonable and very practical from a safety perspective. Clearly, as busy as it is, there are critical processes/protections that need to be assured, so hopefully you haven’t missed any of those noted activities and, if you have, you probably need to start working on preparing your organizational leaders for some likely survey findings.

As a closing thought, lately while walking I’ve been checking out some new (to me) podcasts, one humor-based (Conan O’Brien Needs A Friend—generally pretty good—a couple of good “laughs out loud” per episode) and one not so much so, which is my shareable moment for you. Lately, the Freakonomics Radio podcast has been covering subjects relating to the pandemic, with the episode I listened to today being “How Do You Reopen A Country?” One of my favorite aspects of this program is their tendency to come at topics in a calm, measured fashion, but generally from a somewhat unusual angle, but I don’t want to spoil it for you be jabbering too much. If you’re interested in something thoughtful, but not crazily scary, you might enjoy the episode.

Hope this finds you safe and well – until next time…

CMS Blanket Waiver Information

Inspection, Testing & Maintenance (ITM) under the Physical Environment Conditions of Participation: CMS is waiving certain physical environment requirements for Hospitals, CAHs, inpatient hospice, ICF/IIDs, and SNFs/NFs to reduce disruption of patient care and potential exposure/transmission of COVID-19. The physical environment regulations require that facilities and equipment be maintained to ensure an acceptable level of safety and quality.

CMS will permit facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment.

  • Specific Physical Environment Waiver Information:

o 42 CFR §482.41(d) for hospitals, §485.623(b) for CAH, §418.110(c)(2)(iv) for inpatient hospice, §483.470(j) for ICF/IID; and §483.90 for SNFs/NFs all require these facilities and their equipment to be maintained to ensure an acceptable level of safety and quality. CMS is temporarily modifying these requirements to the extent necessary to permit these facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment.

o 42 CFR §482.41(b)(1)(i) and (c) for hospitals, §485.623(c)(1)(i) and (d) for CAHs, §482.41(d)(1)(i) and (e) for inpatient hospices, §483.470(j)(1)(i) and (5)(v) for ICF/IIDs, and §483.90(a)(1)(i) and (b) for SNFs/NFs require these facilities to be in compliance with the Life Safety Code (LSC) and Health Care Facilities Code (HCFC). CMS is temporarily modifying these provisions to the extent necessary to permit these facilities to adjust scheduled ITM frequencies and activities required by the LSC and HCFC. The following LSC and HCFC ITM are considered critical are not included in this waiver:

  • Sprinkler system monthly electric motor-driven and weekly diesel engine-driven fire pump testing.
  • Portable fire extinguisher monthly inspection.
  • Elevators with firefighters’ emergency operations monthly testing.
  • Emergency generator 30 continuous minute monthly testing and associated transfer switch monthly testing.
  • Means of egress daily inspection in areas that have undergone construction, repair, alterations or additions to ensure its ability to be used instantly in case of emergency.

o 42 CFR §482.41(b)(9) for hospitals, §485.623(c)(7) for CAHs, §418.110(d)(6) for inpatient hospices, §483.470(e)(1)(i) for ICF/IIDs, and §483.90(a)(7) for SNFs/NFs require these facilities to have an outside window or outside door in every sleeping room. CMS will permit a waiver of these outside window and outside door requirements to permit these providers to utilize facility and non-facility space that is not normally used for patient care to be utilized for temporary patient care or quarantine.

Rock on: Where do we go from here?

It would seem that the subtext to all we are experiencing/dealing with now is how long we can anticipate this “siege” to last, and (as is typical of these types of events) we probably won’t have a clear sense of the timing until the clouds break and the “sun” comes out. From a practical standpoint, the current situation is a very robust test of each organization’s continuity of operations plan (COOP), as well as the opportunity to witness the intricacies of the 1135 Waiver process as it unfolds. Of course, the other element that is unfolding is the number of COVID-19 cases worldwide (I’ve found the Johns Hopkins University case map of particular use in watching the spread of cases, both worldwide, but particularly in the United States; if you haven’t “found” it yet, it’s definitely worth a look).

At any rate, from a planning perspective, we’ve gotten to the point where some preparations need to be made to ensure sufficient capacity in the event regions are not successful in their attempts to “flatten the curve.” And those preparations will probably involve real-life/real-time actions to be ready to establish alternate care sites (to see what that looked like 100 years ago, you can scroll down this page to see my old stomping grounds at Brockton Hospital). To aid in that pursuit, just yesterday (March 30), CMS unveiled a number of regulatory changes to encourage thoughtful expansion of capacity, including provisions for what is described as “hospitals without walls.” I would encourage you to review these new materials as they do have some restrictions (mostly checking to make sure your planning dovetails with your state’s planning for alternate care sites).

From a practical standpoint, our friends at the American Society for Health Care Engineering have included with their COVID-19 resources some guidance (including links to other materials) on options for establishing/converting alternate care sites. Again, looking at the COVID-19 map, it is fairly easy to discern where bed capacities are likely to be in greatest demand and hopefully those most dire of conditions will not spread everywhere, but there’s no reason to delay consideration of what can be done in advance to be able to flex up capacity at your facility. I know there’s a lot going on right now and the struggle to attain some level of normalcy is all too real, but it is clear that we are in the process of redefining the magnitude of planning and preparation activities. Anything we can do to stay at least a couple of steps ahead is worth our time and energies.

Stay safe until next time!

Time I had some time alone: How negative do we need to be?

Just a quick couple of items this week. Don’t want to take you too far away from your primary focus!

First up, I’ve been working with some folks for whom there’s been something of a disconnect relative to the general concept of a room being under negative pressure versus an Airborne Infectious Isolation (AII) room. While all AII rooms are negative, all rooms under negative pressure (and there is a certain inescapable logic to this) are not AII rooms. It would seem that there are clinical folks that use the terms interchangeably (albeit in good faith) and sometimes, for example, when reporting isolation capacities to authorities, that interchangeability could put people at risk. Fortunately, the current state of affairs with COVID-19 does not require the use of AII rooms for holding patients, but it’s probably a good time to make sure that everyone is on the same page relative to your organization’s “true” isolation capabilities. It’s probably also a good time to keep a close eye on performance of these spaces—current events really highlight the need to be sure of which way the wind is blowing in your critical spaces.

For further reading, you might find the following information useful:

  • This Compliant Healthcare Technologies blog post covers some of the particulars relating to negative pressure considerations; might be familiar territory, but a refresher never hurts.
  • This Stericycle article covers some of the particulars relating to the management of waste during the current conditions; a lot of useful information from my perspective and perhaps yours, too.

As a final note, I suspect there’s been a fair amount of discussion in the background as to how the current state of emergency is going to impact the survey process once it re-emerges from the swamp. Right now, it’s not clear if any of the existing waiver processes is going to result in any flexibility relative to the various and sundry compliance activities that might be delayed, particularly those activities for which you’ve contracted with external vendors (fire alarm and sprinkler system inspection, testing and maintenance being a good example). At this point, it’s anyone’s guess, but past survey experiences in the aftermath of emergencies would seem to indicate that surveyors will feel bad about citing you for missing a timeframe (and will absolutely understand how it happened, etc.), but will still write the finding. I’ve been keeping a close eye on all the issuances from CMS, TJC, etc., and I haven’t seen anything relating specifically to all the stuff we worry about.

That said, my best advice at the moment is to document any compliance challenges manifesting themselves during this implementation of your emergency response plan and have a risk assessment for the impact on the life safety of building occupants in your back pocket, with perhaps some implementation of education initiatives, etc., to ensure nobody is put at an additional risk. Certainly, there are internal processes that could still be administered, but probably there are some that are not—might not be a bad idea to take a few moments to figure out what compliance (and any gaps) might look like if this goes to the end of April, or May, or even June. I’m hoping that you got all your quarterly stuff done early this quarter (don’t forget to check fire drills—some folks will wait until the end of the quarter—don’t want to miss anything), so it will be a question of keeping an eye on the longer-term future.

Stay safe and keep in touch as you can!

Logic doesn’t always prevail…a luxury you can’t afford!

By my observations over time, I’ve found that, all-too-often, logic finishes a distant third behind self-interest (which sometimes manifests itself as crimes of convenience) and panic. Unfortunately, if you currently work in the healthcare industry, you must cling to the bastion of logic as those “other” winds threaten to pull you under.

But sometimes even bureaucracies manage to act judiciously; the good folks at the Centers for Medicare & Medicaid Services (CMS) have elected to curtail some of their “regular” survey activities to afford healthcare organizations the opportunity to focus on COVID-19 preparedness (you might want to bookmark the CMS FAQ page—they’ll be updating frequently). While this doesn’t mean CMS is going to halt all survey activity, it outlined how it would be prioritizing survey activities over the next little while:

Effective immediately, survey activity is limited to the following (in priority order):

  • All immediate jeopardy complaints (cases that represent a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death or harm) and allegations of abuse and neglect
  • Complaints alleging infection control concerns, including facilities with potential COVID-19 or other respiratory illnesses
  • Statutorily required recertification surveys (Nursing Home, Home Health, Hospice, and ICF/IID facilities)
  • Any revisits necessary to resolve current enforcement actions
  • Initial certifications
  • Surveys of facilities/hospitals that have a history of infection control deficiencies at the immediate jeopardy level in the last three years
  • Surveys of facilities/hospitals/dialysis centers that have a history of infection control deficiencies at lower levels than immediate jeopardy

While that does narrow down the field somewhat, those last two possibilities might be well-served by digging out any survey reports from the past couple of years to see if there are any IC-related issues lurking in the weeds.

According to the information provided to surveyors, the aim is to keep on-site survey time to no more than two days, with a particular focus on (you guessed it!) infection control, particularly as it relates to COVID-19 preparedness. You can see the meat and potatoes of the CMS memos to providers here:

https://www.cms.gov/files/document/qso-20-12-allpdf.pdf-1

https://www.cms.gov/files/document/qso-20-13-hospitalspdf.pdf-2

https://www.cms.gov/files/document/qso-20-14-nhpdf.pdf

As a final note for this week’s entertainment, our friends at ASHE have dedicated a webpage to provide COVID-19 information and resources; some of the materials require membership to access, but this is probably another page you’ll want to visit regularly as the next few weeks unfold.

On your marks, get set, sweat!

But hopefully not a Billy Idol kind of sweat…

Our friends in Chicago are once again tweaking the survey process, with the result being less time for surveyors to wait for organizations to muster their troops at the outset and pretty much no time at all before they are out and about doing tracers. Basically, what used to be the surveyor planning session in the morning of the first survey day is now being flipped and combined with the special issue resolution session at the end of the day. For organizations to adapt their process to the changes, folks should be prepared to do the following:

  • Prompt alert of/to the leadership team of any on-site survey to facilitate their availability for a prompt opening conference (I can’t think of too many folks who are not already doing this)
  • Prepare all required documentation and deliver those documents to the survey team immediately after the team is escorted to their “base” (the list of required documents is available in the Survey Activity Guide, although it begs the question as to whether this includes the life safety documentation…)
  • Gather the scribes together so they are ready to hit the pavement as soon as the (ever-so-brief) opening conference is completed

Somehow I think this may all tie across with the folks from CMS accompanying the Joint Commission folks as part of the validation process—anyone who has dealt with a state and/or CMS survey will tell you, there’s not a lot of time (or indeed, inclination) for pleasantries. The job of being prickly requires a lot of inflexibility, which does seem to be the hallmark of the current survey process.

These changes to the survey process are effective March 2020.

Don’t get soaked by your water management program!

I don’t know about you, but lately I’ve been finding the most interesting stuff being published in Perspectives are the articles entitled “Consistent Interpretation” because I am fascinated by the data they are collecting that drives taking particular note of the standard or performance element being featured. For example, the January 2020 issue covers the intricacies of managing the risks associated with waterborne pathogens, a topic that I’ve been keeping an eye on if only because of the attentions paid to that topic by our friends at CMS (if you’ve lost track of where they are in the fray, feel free to make the jump—but don’t forget to come back!). I figure there are just enough peculiarities involved for this to wreak some havoc during accreditation surveys, and while there are ways for survey findings to be generated, it would appear (based on the just under 4% citation rate during the first half of 2019) that you folks out there in the field are making pretty good headway.

So, where things can go awry include: Not having a water management plan to deal with waterborne pathogen risks (not sure how someone would have missed that, but perhaps it was a question of a slower than normal implementation track); failing to include a new piece of equipment (for instance, a brand new cooling tower) in the program (I should think the time for risk assessment and inclusion is during the commissioning of new equipment); failing to maintain the water in the system in accordance with the levels called for in the water management plan; failing to document scheduled testing and monitoring; and failing to establish acceptable ranges and/or control measures to be taken when levels are out of range.

It would seem that decorative water features, ice machines, and water dispensers were in the mix as well, including issues with equipment not being maintained in accordance with the manufacturers’ instructions for use, but in looking at all the different ways water management concerns could be cited, I suspect a lot of the cited conditions (you can find more specifics in the January Perspectives) were not widely observed.

That said, since a lot of the nuts and bolts implementation of water management programs may be accomplished by “others,” I think that going forward, the surveyors will be especially attentive to reviewing your water management plan and any deliverables from testing and monitoring activities. There are a lot of moving parts in this endeavor; best to be ahead of the curve and keep a close eye on those reports.

In a world of magnets and miracles: Shifting the sands of compliance

At the risk of engaging in non-sequiturial (which autocorrect keeps insisting should be non-equatorial) content, I want to touch on a couple of short items that came across my desk over the last couple of days. I don’t know that they specifically relate to each other, but I can imagine a sufficiently powerful pattern recognition program that could link the two (think really, really big picture).

First up, we have some conversation relative to CMS’ efforts to increase the validity of the process by which CMS oversees (or validates) the work of the various accreditation organizations (AO) as they engage in the deemed status survey process. Until recently, the CMS validation process involved a survey visit close on the heels of the AOs (typically within 60 days or so) to see how closely the completed survey met the expectations of CMS vis-à-vis the Conditions of Participation. Historically, there have always been gaps between what was found by the AOs and what was found by CMS, with a lot of pushback on the part of the AOs relative to the timing of things—healthcare organizations are, if nothing else, fluidity personified. So, in response to the timing pushback, CMS has started co-surveying with TJC in real time; so, instead of dealing with your usual complement of TJC surveyors, you also get to host—at the same time—a group of CMSers. Ostensibly, the purpose of the CMS team is to observe the survey efficacy of the Joint Commission team,  but I think you can see where what has never been a “pleasant” experience could really go sideways. I personally have not heard any tales of folks having experienced this type of event, but I feel certain that someone I know will be able to share some stories of daring do and horror-filled antics. Any takers? It would seem (based on a blog post from TJC) that some organizations have expressed gratitude for not having to go through two separate survey events, and there’s a general sense that the CMS/AO survey findings are of a piece, so I guess that’s a good thing. But somehow…

At any rate, at the moment, if your organization is going to have this extra special survey experience, there will be prior notification, but there appear to be plans afoot to end up at a point in which these extra special surveys will be completely unannounced. It also appears that moving in that direction will require some modification to the language in the Conditions of Participation that authorize the validation surveys. According to the blog, the current process is in place through federal FY 2020 (October 1, 2019 through September 30, 2020), so I guess we’ll have to wait and see how things go.

To take this in a completely different direction (well, maybe not completely…) I came across an article providing some advice on conducting one-on-one meetings with staff. As a consultant, it’s been rather a while since I’ve had to administer one-on-one staff meetings, so this may be old hat to you folks with current operational oversight of line staff, but it did prompt me to think about past practices and I can see where this might be helpful in a lot of different ways. I am a firm believer in trying to make every encounter more useful and I think this might be a strategy worthy of your consideration. So, if you need something to read as we start the wind-down of summer (it’s the last week of August—how did that happen?!?), I think this would be worth your time (and please let me know if you think otherwise—any and all feedback is most appreciated!).

Have a safe and festive Labor Day!

People get ready: There’s a (survey) train a-coming!

When it comes right down to it, I think it is nigh on impossible to have access to too many resources or, indeed, to have access to too many perspectives on the various and sundry processes that make up our little EOC world (OK, maybe not so little), so I’m always on the lookout for stuff that I think might be worth sharing with you folks. (It’s one way I’ve managed to not run out of things to say over the past 600+ weeks since I started this journey.)

Our good friends over at ASHE’s Health Facilities Management magazine recently published an article describing some of the ways facilities and safety professionals can effectively manage the accreditation process, primarily as a function of survey preparedness/readiness. I don’t know that there was anything of great surprise contained therein (with the important note that surveying hospitals is pretty much my life’s work, at least at the moment), but I think the authors did a nice job of providing an overview of the survey process with some key information points that may give you a “leg up” on your next survey.

The one thing we “know” is that we really don’t know when they’re coming next, so the general concept of continuous survey readiness is one that really needs to be taken to heart. But one of the key components of which you need to be mindful is that CMS is definitely ratcheting up on the “looking over the shoulder” aspect of the validation survey process. Where previously, CMS would conduct a validation of survey of the various accreditation organizations within 60 days of the accreditation survey activity, now CMS resources are observing the accreditation organization process as it happens. At the moment, any organization encountering the “enhanced” (my characterization) survey process are notified ahead of time, so you can do a little planning (not sure how much notice is given—if anyone out there can shed some light, based on experience, I’d love to hear from you). But there will come a time when it will be a (more or less) complete surprise!

At any rate, if you want to read about the opening salvo in this little endeavor, you can find it here, and the latest news on this front can be found here, which includes a link to the proposed rule change that deals with changes of ownership, etc. of accreditation organizations. Not very exciting stuff…yet! But I think the pendulum is going to continue swinging in the direction of more oversight (and probably, intervention) for the next little while…

He held his head in his hands: Outpatient/Offsite Vulnerabilities

Being something of a quiet week on the compliance front (as we embrace the “dog days” of summer—and spring’s got 10 or so days to go), I wanted to use a recent Joint Commission announcement relative to Environment of Care standards relating to fluoroscopy as they apply to outpatient/office-based surgery practices (which seems rather more logical than not, particularly when one reflects on the Conditions of Participation requirements relating to the management of imaging equipment). You can find the particulars here, but I don’t think that there’s anything that’s going to come as a surprise. To my mind, why would the expectations be any different based on where the equipment “lives”? Just as there must be continuity of care, there must also be continuity of compliance.

Now one could certainly disagree as to how much of a sea change this represents relative to the survey process, but (and I’m going out on a limb here, but it’s a very, very stout one) I think the next significant survey “beachhead” (mixing all sort of metaphors today) is going to be all those pesky little physician practices and clinics and such that dot the landscape and are covered by the “umbrella” of hospital operations (you know, offsite locations that have become “departments of the hospital”). If we accept the premise that the primary goal of the survey process is to generate as many findings as possible (and I accept that premise—the evidence doesn’t really point to much else), then the likelihood of the regulatory folks looking for areas with greater levels of vulnerability seems, again, rather more logical than not.

At any rate, my best advice to those of you with these types of sites is to really kick the tires when you’re rounding. As you are no doubt aware, there can be a lot of resistance when compliance comes to the hinterlands (think about how much angst fire drills can generate!), but the stakes for non-compliance have never been greater and, for the record, one can never be too safe…or too compliant!