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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!

Let’s begin again, begin the begin: CMS ligature risks codified!

While I have little doubt that we will yet again revisit the management of ligature risks and behavioral health patients, it would seem that chapter and verse are getting towards stone tablet form—but you have a chance to influence the future state. I suspect we will also be looking back to determine how much influence the field has on the final, final or whether the party line from Chicago holds sway (kind of looks like that at the moment, but there is still time):

  • Back on April 19 (and I do apologize for not picking up on this sooner—I need to get a better strategy for monitoring all these goings-on), CMS issued a draft clarification of the interpretive guidelines relating to ligature risk (you can find the skinny here). All things being equal, I suppose the “newest” thing is the formal introduction of the Ligature Risk Extension Request (LRER—just what we needed, another acronym), which outlines a process for correction of ligature risks that will take longer than the official 60-day turnaround time for the correction of deficiencies. One thing is very clear (well, maybe a couple of things): State agencies and/or accreditation organizations are not allowed to grant LRERs. They can, and in most instances, will act as intermediary between the organization seeking the extension and CMS, and will (basically) advocate for approval based on their analysis of the issues. This is not a Life Safety Code® waiver as ligature risks are not a compliance deficiency relative to life safety requirements. From the process outlined, it does appear that this is to be a reasonable process, (potentially) making allowances for obtaining approval of the governing body, engaging in competitive bidding, applying for funding, obtaining permits for physical changes, and lack of or delays in obtaining products and supplies needed for corrective actions. Needless to say, with the invocation of the LRER, there will be
    • Mitigation strategies to implement
    • Progress reporting to be done
    • A re-survey to verify that the deficiencies have indeed been corrected by the state agency or accreditation organization
  • As has been the case pretty much from the get-go, there are two assessment processes that need to dovetail (or perhaps they are concentric circles): An assessment of the environment and the assessment of patients to determine the level of risk for suicidal behaviors. I do believe that eventually we will be left with the latter upon which to focus, but I suppose there will need to be an ongoing due diligence relative to monitoring the environment. Ultimately, it seems to come down to striking the balance between seeing every aspect of the environment as a big hairy monster as opposed to an element in the environment that can be managed by appropriate means. At the very least, I am hoping that the survey focus returns to general patient care and infection control, with perhaps a side of medication management—I think that’s where the meaningful improvements are hiding (in plain sight).

As a final note, we do have until June 6, 2019 to weigh in on the proposed changes, so I would suggest you gather together a little working group, and if the spirit moves you, weigh right in. The data supports this being a whole bunch of ado about very little (approaching a whole bunch of doodoo), so the sooner we can refocus on the “real” challenges, the better.

 

Immediate Jeopardy: How much do you want to wager?

With best wishes to Alex Trebek!

Over the last couple of weeks, the folks at the Centers for Medicare & Medicaid Services (we know them by the cleverly acronymic CMS) have been busy generating lots of guidance for the folks in the field, healthcare organizations and surveyors alike. One of these missives covers the revision of Appendix Q of the State Operations Manual to provide guidance to surveyors and, (by extension) folks charged with compliance at the organizational level, for identifying Immediate Jeopardy (IJ) conditions during surveys. For those of you that have not had the dubious fortune of encountering an IJ in your organization (and I dearly hope that trend continues), it is difficult to describe the impact this can have on an organization. Short of shutting the place down, I cannot think of a more—oh I don’t know, words really seem to fall short in describing the sheer awfulness of an IJ finding.

But as they say, forewarned is forearmed (more on that delightful turn of phrase here). So let’s chat a bit about how one gets to an IJ.

The pieces that comprise an Immediate Jeopardy finding go a little something like this (the entire notification can be found here):

“To cite immediate jeopardy, surveyors determine that (1) noncompliance (2) caused or created a likelihood that serious injury, harm, impairment or death to one or more recipients would occur or recur; and (3) immediate action is necessary to prevent the occurrence or recurrence of serious injury, harm, impairment or death to one or more recipients.”

I think you could probably imagine any number of scenarios that might fit that particular bill; by the way, one of the revisions to this guidance was a change to (2). In the revision, the term “likelihood” replaced “potential.” While I do think “likelihood” is a somewhat higher bar to meet than “potential,” I still see a lot of room for surveyor interpretation. Hopefully, the administration of this judgment call will be more judicious than not. Time will tell…

Fortunately, we do have the opportunity to get a “leg up” on the process by visiting the CMS surveyor training page and working through the education materials provided there (the education is open to providers, so don’t be scared off by the link). I have not yet partaken of the education (it’s on my to-do list) and I will surely provide an update in this space once I have done so.

Keeping an eye on things: Managing behavioral health patients

What, again?!?

Recently, our friends in Chicago added a new FAQ to the canon, this time reflecting on the use of video monitoring/electronic sitters for patients at high risk for suicide (you can find the details here). For those of you paying attention over the years—and I think that’s everybody within the sound of my “voice”—the situational requirements are based on a clear invocation of the “it depends” metric. I think it is pretty clear (and pretty much the standard “problem” relative to the management of behavioral health patients at serious risk for suicide) that providing sufficient flexibility of staffing to be able to provide 1:1 observation of these patients is where folks are looking for that flexibility in technological monitoring and the FAQ pretty much puts a big stop on that front. I think the quote that comes into focus for this aspect is, “The use of video monitoring or ‘electronic-sitters’ would not be acceptable in this situation because staff would not be immediately available to intervene.” So, as a general practice, a 1:1 observation means that somebody (a human somebody) is “immediately available to intervene,” which means all the time, at any time.

At this point in the discussion, I think the important piece of this is (and is likely to remain so) the clinical assessment of the patient, inclusive of the identification of the risk level for suicide. I don’t think that the “reality” of having to deal with way more of these patients than we would prefer is going to change any time soon, and with it, the complete unpredictability of that patient volume as a function of staffing (full moons notwithstanding).

The FAQ goes on to discuss the use of video monitoring in those instances in which it is not safe for staff to be physically located in the patient’s room, but the use of video monitoring has to result in the same level of observation, immediacy of response, etc. It also indicates that video monitoring for patients that are not at high risk for suicide is at the discretion of the organization, indicating that there are no “leading practices” in this regard. I guess that means that you’re really going to have to make your own way if you chose the video monitoring route, which should include (as also noted in the FAQ) provisions for reassessment of the patient(s). Interesting times, my friends, interesting times…

As a final (and almost completely unrelated) note, I wanted to bring to your attention some discussion over at the Motor & Generator Institute (MGI) relating to recent CMS guidance regarding expected temperatures in the care environment during normal power outages and how, if you have a long-term care facility in your mix, a risk assessment might not be enough. You can find the details here and the folks at MGI are encouraging feedback, so I think it might be worth checking out and weighing in.

 

It’s been a long time: Revisiting an EOC perennial

Setting the wayback machine for the dark ages of safety (well, 2011 or so), we come to the last time we covered the monitoring of temperature and/or humidity in surgical spaces, etc. (if you want to revisit those halcyon days, you can head here). The funny thing about this most ancient of history is that, since then, while there have been changes in applicable codes and references, the “new” stuff comes up a little short when it comes to providing guidance relating to monitoring temperature and humidity, particularly as a function of frequency (I suppose we could call it the frequency function if we were being excessively alliterative). The baseline response (catty though it may be) is that you should be monitoring conditions on as frequent a basis as is required to ensure appropriate conditions, given due consideration of the systems you have in place, any manufacturers’ recommendations (which are also not particularly helpful in determining monitoring frequencies), and regulatory guidance (ASHRAE 170; state mechanical code) as applicable.

Ultimately, this all comes down (back?) to the requirements as outlined in the Conditions of Participation, which gives us:

  • 482.41(c)(4) – There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas.

So, you might well ask, what are those “other appropriate areas”? For that information, we need to head over to the State Operations Manual/Interpretive Guidelines, which is where the skeleton of the Conditions of Participation is fleshed out into the survey process.  And what do we find there? Take a look:

Interpretive Guidelines §482.41(c)(4) – There must be proper ventilation in at least the following areas:

  • Areas using ethylene oxide, nitrous oxide, glutaraldehydes, xylene, pentamidine, or other potentially hazardous substances;
  • Locations where oxygen is transferred from one container to another;
  • Isolation rooms and reverse isolation rooms (both must be in compliance with Federal and State laws, regulations, and guidelines such as OSHA, CDC, NIH, etc.);
  • Pharmaceutical preparation areas (hoods, cabinets, etc.);
  • Laboratory locations; and
  • Anesthetizing locations. According to NFPA 99, anesthetizing locations are “any area of a facility that has been designated to be used for the administration of nonflammable inhalation anesthetic agents in the course of examination or treatment, including the use of such agents for relative analgesia.” NFPA 99 defines relative analgesia as “A state of sedation and partial block of pain perception produced in a patient by the inhalation of concentrations of nitrous oxide insufficient to produce loss of consciousness (conscious sedation).” (Note that this definition is applicable only for Life Safety Code® purposes and does not supersede other guidance we have issued for other purposes concerning anesthesia and analgesia.)

Interesting to note that the list here does not quite match up with the totality of issues for which The Joint Commission is citing folks (clean and soiled utility rooms being first and foremost, though I know that it is merely an extrapolation of the ASHRAE 170 requirements). Also interesting to note that, sterile supply and processing is not specifically mentioned, but (again), I think we can see where the importance of maintaining those spaces drives out of ASHRAE 170.

But what’s the endgame when it comes down to the survey process? The general unhelpfulness of the answer will not surprise you:

  • Review monitoring records for temperature to ensure that appropriate levels are maintained
  • Review humidity maintenance records for anesthetizing locations to ensure, if monitoring determined humidity levels were not within acceptable parameters, that corrective actions were performed in a timely manner to achieve acceptable levels

So (still!) if you follow the temperature and humidity rabbit all the way back to the Interpretive Guidelines, we see that the surveyors are instructed to ask to see “records,” so it all comes down to what you can produce in terms of a deliverable that reflects that temperature and humidity levels are appropriate/acceptable and levels that were not within acceptable parameters (which they do not define, so you better have a sufficiently flexible definition) were dealt with in a “timely manner” (again, not defined, so it’s up to you, based on your risk assessment).

As a closing thought on this (for now), apparently there are some folks that have determined that they don’t have to monitor both elements (temperature and/or humidity) and if there is nothing else that you derive from this week’s missive, it is this: You gotta do both! You can determine the frequency (though I would recommend at least daily—if you recall, the question that started this conversation in 2011 was whether quarterly monitoring was sufficient), but you clearly want to be able to use performance data to make that determination (and from whence comes that data—regular monitoring). You can determine what is acceptable/appropriate (based on utilization, types of procedures, preference of surgical staff, etc.); you can determine what is a timely timeframe for corrective action (Timely Timeframe—that sounds like a name Stan Lee would’ve loved). But you gotta do the monitoring; to do otherwise risks too much if the CMSers darken your door (which is becoming a much more common occurrence).

One last quick note for this week: There seems to be a bit of a groundswell of survey findings relating to hand sanitizer dispensers not having drip trays. It would seem that there must have been some recent mention of this in surveyor education as there are some surveyors indicating that this is a new requirement, but the overarching requirement has been in place for rather a while. To whit (and, again, the State Operations Manual becomes then go-to resource):

  • 482.41(b)(9) (ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls; with the associated Survey Procedure being: “Determine whether the hospital maintains the ABHR dispensers in accordance with the manufacturer’s guidelines, or, if there are no manufacturer’s guidelines, that the hospital has adopted policies and procedures to ensure that the dispensers neither leak nor the contents spill.”

Now, nowhere in the regulatory canon does it discuss drip trays (though, when you come right down to it, how else are you going to manage the threat of leaks/drips, especially over hard-surface flooring?). But apparently drip trays have become the “gold standard” for leak/drip control, so you might want to keep an eye on this for the future. These things do tend to spread and who wants to be chasing this during a (or post) survey? Not me.

Making a checklist, making it right: Reducing compliance errors

As you may have noticed, I am something of a fan of public radio (most of my listening in vehicles involves NPR and its analogues) and every once in a while, I hear something that I think would be useful to you folks out in the field. One show that I don’t hear too often (one of the things about terrestrial radio is that it’s all in the timing) is called “Hidden Brain”, the common subject thread being “A conversation about life’s unseen patterns.” I find the programs to be very thought-provoking, well-produced, and generally worth checking out.

This past weekend, they repeated a show from 2017 that described Dr. Atul Gawande’s (among others) use of checklists during surgical (and other) procedures to try to anticipate what unexpected things could occur based on the procedure, where they were operating, etc. One of the remarks that came up during the course of the program dealt with how extensive a checklist one might need, with the overarching thought being that a more limited checklist tends to work better because it’s more brain-friendly (I’m paraphrasing quite a bit here) than a checklist that goes on for pages and pages. I get a lot of questions/requests for tools/checklists for doing surveillance rounds, etc. (to be honest, it has been a very long time since I’ve actually “used” a physical checklist; my methodology, such as it is, tends to involve looking at the environment to see what “falls out”). Folks always seem a little disappointed when the checklist I cough up (so to speak) has about 15-20 items, particularly when I encourage them not to use all the items. When it comes to actual checklists that you’re going to use (particularly if you’re going to try and enlist the assistance of department-level folks) for survey prep, I think starting with five to seven items and working to hardwire those items into how folks “see” the environment is the best way to start. I recall a couple of years ago when first visiting a hospital—every day each manager was charged with completing a five-page environmental surveillance checklist—and I still was able to find imperfections in the environment (both items that they were actually checking on and a couple of other items that weren’t featured in the five-pager and later turned out to be somewhat important). At the point of my arrival, this particular organization was (more or less) under siege from various regulatory forces and were really in a state of shock (sometimes a little regulatory trouble is like exsanguination in shark-infested waters) and had latched on to a process that, at the end of the day, was not particularly effective and became almost like a sleepwalk to ensure compliance (hey, that could be a new show about zombie safety officers, “The Walking Safe”).

At any rate, I think one of the defining tasks/charges of the safety professional is to facilitate the participation of point-of-care/point-of-service folks by helping them learn how to “see” the stuff that jumps out at us when we do our rounds. When you look at the stuff that tends to get cited during surveys (at least when it comes to the physical environment), there’s not a lot of crazy, dangerous stuff; it is the myriad imperfections that come from introducing people into the environment. Buildings are never more perfect than the moment before occupancy—after that, the struggle is real! And checklists might be a good way to get folks on the same page: just remember to start small and focus on the things that are most likely to cause trouble and are most “invisible” to folks.