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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.

 

Like the dust that settles all around me: I got those low-down TJC FAQ blues

I don’t know if there’s anything to be inferred by the fact that the latest updates on the ligature resistance front are “buried” on p. 8 of the May 2019 Perspectives (after an onslaught of what I characterize as Joint Commission advertisements), but it would be nice to think that perhaps folks are going to be allowed to move on at their own “pace” as a function of risk assessments, abatement and mitigation strategies and monitoring for gaps in safety, but I guess we shall see what we shall see.

At any rate, the May Perspectives (on p. 8—imagine that!) provides two topics, one of which, video monitoring we discussed a few weeks back (I guess they like to repurpose content as much as anyone…) and a clarification on the (admittedly somewhat awkwardly worded) requirement that self-closing and self-locking (both, not one or the other) doors are required for the separation of areas required to be ligature resistant and those that are not, with the intent being to eliminate reliance on staff to close and lock those doors to prevent patient harm. The FAQ also prohibits the use of hold-open devices of any kind on these doors, so do keep that in mind. This applies to “staff controlled” areas on a behavioral health unit, like med rooms, utility rooms, consult rooms, etc. This is all based on Recommendation #1 published in the November 2017 Perspectives and the guidance that patient rooms, patient bathrooms, corridors, and common patient areas are to be ligature resistant. If this is news to you (I don’t know that we’ve discussed this particular piece of the puzzle), I can’t say that I am surprised as it really didn’t stand out at the time and really required too much in the way of cogitation to figure out what they were getting at, particularly the descriptor (“Nursing stations with an unobstructed view (so that a patient attempt at self-harm at the nursing station would be easily seen and interrupted) and areas behind self-closing/self-locking doors do not need to be ligature-resistant and will not be cited for ligature risks.”) as it was probably a little too all-inclusive. I think I would have separated them into two bullet points:

  • Nursing stations with an unobstructed view
  • Areas behind self-closing/self-locking doors

But hey, as long as we get there in the end, right? Yeah, sure, fine…

In other news, ASHRAE is in the public comment process relative to proposed changes to ASHRAE 170 Standard for Ventilation of Health Care Facilities (you can see the proposed draft here). Given that NFPA 99 defers to ASHRAE on the ventilation front, I can’t help but think that this is going to continue to be a cornerstone compliance document during survey activities. I don’t know that I noted anything particularly egregious, etc., in the proposed update, but I always try to encourage the folks in the field to review and weigh in when these things are open for comment. Before we got to ligature-resistant considerations, the management of procedural environments as it relates to temperature, humidity, air pressure relationships, etc. was the hot-button topic, so any changes might have a similar impact on the industry. Unfortunately, I just got wind of this last week and the comment period ends May 6, so act fast!

Ticking away the moments that make up a dull day: EOC orientation and ongoing education

Going to touch on a couple of things this week. First up? Ed-yoo-ma-cation!

A week or so back, I received an email encouraging me to list what educational competencies are most important relative to preparing for the survey process. Off the top of my head, the list (in no particular order) goes a little something like this (and I will stipulate that competency is the key focal point for these):

  • Fire response, including (and perhaps most importantly) department-level protocols
  • Emergency response, including how to summon assistance in an emergency
  • How to report an Environment of Care (EOC) problem or condition (I like to include “How to recognize an EOC problem or condition” as a subset of this one)
  • How to manage their own care environment (this is a bit of a stretch as it is not specifically mandated by code or regulation, but I will characterize this as something of a distillation of the general duty clause, kind of…)

After that, things get kind of gray, but if you look really closely at that last one, it comes down to everyone being able to demonstrate competency relative to what skills and knowledge are required for them to do their job appropriately (safely, timely, etc.). From knowing how long disinfectant has to keep a surface wet to appropriately disinfect whatever surface you’re disinfecting (say that 10 times fast!) to making sure that folks who are charged with providing on-to-one safety observation of at-risk patients are conversant with what to look for, how to summon assistance, when it is appropriate to intervene, etc. There does appear to be a growing focus on the processes involved in ensuring that folks are competent to administer their job responsibilities. While the list above gives you a sense of the “umbrella” under which organizationwide orientation provides a framework, the devil (as they say ) is in the details—and those details “live” at the department level.

To that end, it may be useful (if you are not already a participant in the department-level safety orientation) to “audit” some of the department programs to see if what folks are receiving matches up with what your expectations are of the entire orientation process. Most of the folks I’ve chatted with over time have found their “time” at orientation to be shrinking almost as quickly as those new pants in a hot water wash—it may be time to leverage some other opportunities to get the safety word out.

The other item for discussion relates to survey findings and the question of how much folks “expand” their surveillance in response to a survey finding. Minimally, you’re on the hook for resolving whatever the specific finding might be and now, with the submission of the corrective action plans to The Joint Commission (or whomever), there’s that whole concept of how you’re going to sustain the processes necessary to maintain compliance. Most of the action plans I’ve seen have a good framework for long-term monitoring, etc., but what about between right now and, say, next week? Or, even, next month? There seems to be a lot of follow-up surveying going on in the healthcare world and how far do you go to prepare for that potential “sooner than later” next visit. As with pretty much all of this stuff, there is very little in the way of guidance, but I was wondering if we could dig up some “best practices” in the name of (perhaps) introducing some non-EOC stuff into next year’s top 10 lists…just sayin’.

Have a most delightful week!

I’d like to know, can you tell me, please don’t tell me: Behavioral health and egress

In response to last week’s modified Top 10 list (there’s been a request for another list regarding point-of-care/point-of-service staff knowledge of EC stuff—coming soon to a blog near you…), I received a question from the Lone Star state that I wanted to chat about with the group at large (I’m never quite sure if folks go back and revisit past questions and I thought this one might generate some comments from folks in general).

The question comes from the folks at a large hospital in east Texas who are in the process of designating a behavioral health “safe room” adjacent to their ER, where they’ll be holding patients for evaluation and eventual transportation to a local behavioral health hospital. The room in question is approximately 900 square feet (30 x 30) and the question raised relates to installing a second door in the space for use in the event of an emergency. The problem (or at least the stated problem, a little more pondering in a moment) is that this second egress door would lead into a major egress corridor. The question resulting from this “problem” is whether, due to the nature of what’s going on in the behavioral health room, having the door swing out into the egress route would be permitted, based on a risk assessment, etc.

First off (and you could certainly look at this as a bit of shameless self-promotion), it would be much more effective to be walking/talking this through in the present physical space, etc., but since I’m not scheduled to visit east Texas any time soon, I’m going to have to work this from afar. To that end, I have one question for the general audience: Do any of you have a behavioral health safe room with more than one “portal”? Since I saw this question, I’ve been racking my brain to recall an instance in which there was a room (as opposed to a designated space within an ER, or indeed, a behavioral health ER) that had a second egress door (and if I’ve visited your “house” and you have a two-door arrangement and I have somehow forgotten, please let me know). Even before I get to the door swinging into the egress corridor (and I think there are ways of being able to do this, but more on that in a moment—though it will require some homework), I start thinking about how you would secure that second door in such a way as to appropriately limit escape by the patient occupant and still provide sufficient access to staff removing themselves from a dangerous situation. Talk about a tightrope. But then I’m thinking, is there a way to configure the space that reduces the potential for a staff person to become “trapped” even with only one way out? I’m intuiting that the request for the second door is based on an actual occurrence in which an entrapment occurred, but I keep coming up against the “reality” that I can’t think of a behavioral health room with multiple ways out and that staff education of appropriate techniques for dealing with patients in a “confined” space would be the way to go.

As to the second egress door itself, while there are instances in which doors do swing out into an egress corridor, I think probably the best way forward, once you have completed the risk assessment, is to seek out the opinion of the authority having jurisdiction (AHJ), which in this instance would be the Texas Department of Health. Having had some experience with CMS surveys conducted by the state in that part of the world (and, truthfully, in most parts of the world) is to embark upon a field modification without providing the AHJ with an opportunity to review the proposed change(s). I think the primary reason that I would encourage this route is that this appears to be a somewhat unusual (if not quite rare, though it may be) arrangement; I understand the safety implications of the second door, but I also understand the implications such an arrangement can have on egress for adjacent occupants and I am not convinced that you’ll get carte blanche from the regulatory folks solely on the basis of a risk assessment in hand.

That said, I suppose you could also investigate a modification to the space that creates enough of an alcove on the egress side of the space to provide room for door swing, though that would certainly reduce the number of folks you could safely manage in the space. It may be that you folks are on the cutting edge of healthcare design, but sometimes the cutting edge “cuts” in the wrong direction. Given the attention being paid to the physical environment at the moment, it is unlikely that such a modification would escape notice (particularly with CMS).

The pendulum may swing back at some point, but I don’t see it happening any time soon—there are so many potential findings that they’d be hard-pressed to turn away. It’s very much like finding buried treasure and then leaving some for somebody else to find—it is not in line with human nature to walk away while there are still riches to be had.

Wagering on a sewer thing: How are you managing wastes during an emergency?

Burn, bury, or dump it—apparently there is madness in the method—and your plan needs to reflect the methodologies.

I recognize that, particularly with newly introduced requirements, guidelines, etc., the rarified elements that we collectively (if not quite lovingly) refer to as “surveyor interpretation” are at their most diverse, maddening, arbitrary, capricious, and on and on and on. That said, there is one element relating to the recent CMS update relative to emergency preparedness that I touched upon in the blog a couple of weeks ago , but did not devote a lot of discussion time to it. And that element relates to waste management during an emergency response.

During CMS surveys as recent as March 2019, there has been much discussion about the particulars of how folks are poised to manage the various and sundry waste products generated by/through normal hospital operations, particularly during a prolonged emergency response condition. And while I can’t say I saw this coming (at least not in the first wave of scrutiny), it does appear that the CMSers (or at least some of ’em) are looking for fairly detailed planning in this regard: collection, holding/storage, short-term disposal, long-term disposal, pharmaceutical wastes, chemical wastes, etc. , inclusive of second and third-level backup plans. I suppose, like with just about anything and everything you could name, there is always the potential for external disruption that constricts the ability to remove waste materials from our campuses. And, while I think we tend to focus our preparatory activities on sustaining normal operations, it would seem that there might be some vulnerability relating getting rid of the stuffs that are the result of those normal operations.

At this point, I’m not entirely certain if the focus is more to the consultative than the compliance-related approach—the topic was discussed during survey, but no report has been issued as of this writing (if I hear more, I will certainly let you know), so it’s anybody’s guess. But I do know that these things tend to spread pretty quickly in the field, so it certainly wouldn’t hurt to kick the tires of your waste processes during your next emergency response exercise.

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.

Eat, drink, and be safe: Some guidance on the care and feeding of staff

One of the more universal conditions I find is the whole issue of where staff can grab something to eat or drink in the midst of busy periods, particularly when staffing levels don’t necessarily dovetail with leaving the work space to go to the cafeteria, etc. And there’s always the specter of someone, somewhere having invoked the “You can’t eat there, it’s against TJC regulations” or “You can’t drink there, it’s against regulations” and so forth and so on. And what better strategy than to use a regulatory presence from outside the organization to be the heavy.

Many’s the time I’ve tried to convince folks that, from a regulatory perspective (with some fairly well-defined exceptions, like laboratories), there is nothing that approaches a general prohibition when it comes to the how, when, and where of eating and drinking in the workplace (and yes, I absolutely understand that prohibition is the easiest thing to “police,” but I think prohibitions also tend to “drive” more creative workarounds). And in the March 2019 edition of Perspectives, our friends in Chicago provide a couple of clarifications for folks, and if you think that there’s a risk assessment involved, then you would be correct.

So, the clarifications are two in number:

  • There are no TJC standards that specifically address where staff can have food or drink in the work areas.
  • You can identify safe spaces for food and drink as long as those locations  comply with the evaluation (read: risk assessment) of the space and your exposure control plan as far as risks of contamination from chemicals, blood, or body fluids, etc.

The guiding light in all of this, if you will, are the regulations provided by the Occupational Safety & Health Administration, and while they have a lot to say about such things (Bloodborne Pathogens and Sanitation), a careful analysis should yield a means of designating some spaces. I have seen a lot of designated “hydration stations,” particularly in clinical areas, to help keep folks hydrated over the course of the working day, so clearly some folks are working towards providing some flexibility based on a risk assessment. This is a good thing both in terms of staff support, but also in not drawing a line in the sand that they don’t have to. Prohibitions can bring about some of your toughest compliance challenges, so if you can work with folks to build in some flexibility, it could mean fewer headaches during rounding activities.

Manage the environment, manage infection control risks

In looking back at 2018 (heck, even in looking back to the beginning of 2019—it already seems like forever ago and we’re only a week in!), I try to use the available data (recognizing that we will have additional data sometime towards the end of March/beginning of April when The Joint Commission (TJC) reveals its top 10 most frequently cited standards list) to hazard a guess on where things are heading as we embark upon the 2019 survey year.

First up, I do believe that the management of ligature risks is going to continue to be a “player.” We’re just about two years into TJC’s survey focus on this particular area of concern; and typically, the focus doesn’t shift until all accredited organizations have been surveyed, so I figure we’ve got just over a year to go. If you feel like revisiting those halcyon days before all the survey ugliness started, you could probably consider this the shot heard ’round the accreditation world or at least the opening salvo.

As to what other concerns lie in wait on the accreditation horizon, I am absolutely convinced that the physical environment focus is going to expand into every nook and cranny in which the environment and the management of infection control risks coexist. I am basing that prediction primarily on the incidence of healthcare-associated infections (HAI) and related stuff (and, as was the case with ligature risk, I suspect that having a good HAI track record is not going to keep you from being cited for breakdowns, gaps, etc.). We’ve certainly seen the “warning shots” relating to water management programs, the inspection, testing, and maintenance of infection control utility systems, management of temperature, humidity, air pressure relationships, general cleanliness, non-intact surfaces, construction projects, etc. Purely from a risk (and survey) management perspective, it makes all the sense in the world for the survey teams to cast an unblinking eye on the programmatic/environmental aspects of any—and every—healthcare organization. Past survey practice has certainly resulted in Condition-level deficiencies, particularly relative to air pressure relationships in critical areas, so the only question that I would have is whether they will be content with focusing on the volume of findings (which I suspect will continue to occur in greater numbers than in the past) or will they be looking to “push” follow-up survey visits. Time will tell, my friends, time will tell.

But it’s not necessarily just the environment as a function of patient care that will be under the spotlight; just recently there was a news story regarding the effects of mold on staff at a hospital in New York. TJC (as well as other accreditors including CMS) keeps an eye on healthcare-related news stories. And you can never be certain that it couldn’t happen in your “house” (it probably won’t—I know you folks do an awesome job, but that didn’t necessarily help a whole lot when it came to, for example, the management of ligature risks). Everything filters into how future surveys are administered, so any gap in process, etc., would have to be considered a survey vulnerability.

To (more or less) close the loop on this particular chain of thought (or chain of thoughtless…), the Centers for Disease Control and Prevention are offering a number of tools to help with the management of infection control risks in various healthcare settings, including ambulatory/outpatient settings. I think there is a good chance that surveys will start poking around the question of each organization’s capacity to deal with community vulnerabilities and these might just be a good way of starting to work through the analysis of those vulnerabilities and how your good planning has resulted in an appropriately robust response program.

That’s a Wrap! EPA’s Final Rule: Early present or gag gift?

Just a couple of brief items to close things out (I’m going to give you folks a break from my blathering next week—unless something of interest breaks—more on that in a bit), the first being the release of EPA’s Final Rule Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine. From where I’m sitting, although the promise is relatively good in terms of making things simpler to manage, particularly when it comes to the disposal of over-the-counter nicotine products, I’m still not certain how this will play out in the long run. I am (as always) hopeful that the Final Rule will blaze a trail towards a process in which doing the right thing is also relatively easy (that, my friends, should be the goal of all compliance activities—the more difficult the process to use, the greater the likelihood of noncompliant workarounds).

The notification I received from EPA characterized things thusly:

“The final rule provides tailored and streamlined standards for managing hazardous waste pharmaceuticals that reduce the cost and compliance burden for the healthcare sector, while ensuring the safe management of hazardous waste pharmaceuticals. Additionally, EPA is taking a common-sense regulatory approach to the disposal of FDA-approved over-the-counter nicotine replacement therapies (NRTs – i.e., gums, patches, lozenges), which will no longer be considered hazardous waste when discarded.

EPA has scheduled two webinars to discuss the contents of the final rule. The webinars, which are free and open to the public, are scheduled for 1 pm Eastern on the following dates:

  • Wednesday, January 9th
  • Wednesday, January 23rd

Both webinars will be the same, with a one-hour general presentation about the final rule, followed by a 30-minute question and answer session. See our website to register to attend one of the webinars: https://clu-in.org/conf/tio/HazWastePharmaceuticals/

Finally, if you would like to receive future updates from EPA’s Office of Resource Conservation and Recovery about solid and hazardous waste, sign up for our listserv by sending a blank email to: solid-and-hazardous-waste-subscribe@lists.epa.gov

I freely admit that that sounds like a pretty good deal, but I think I would advise you folks with some responsibility in this area to make some time in January to listen in to one (or both: the e-mail says the programs are the same, but you and I both know that last 30 minutes is much less likely to be the same, so maybe tune in for the Q & A). From a regulatory compliance perspective, there’s nothing like a “final rule” to get the accreditation organizations into a whirling maelstrom of interpretation, but I guess we’ll have to wait and see if this becomes a hot topic in 2019.

And so to the close of 2018: I’m not exactly sure what it is (though I suspect it’s mostly internal), I tend to find this time of year rather more reflective than not and this year seems to call for introspection more than some in the past. That said, I have no overarching words of wisdom, etc., beyond my hopes that you folks will have some time to power down from the onslaught of life as we know it and spend some time with family, friends, self—whoever makes you feel complete and happy. One of the big changes for me personally over the past year is embracing at least 10 minutes of quiet time every day (some would call it meditation, and I’m OK with that as a descriptor); I have found that it really makes a difference in being able to manage the many stressors of existence. I don’t know (and, in fact, I can’t know) if it would work the same for everyone, but I would encourage you to give it a try. And to that end, I’m going to provide you can opportunity to do just that—next week, please use the time you’d usually use to peruse this space—and I pledge to you that I will do the same.

A most joyous holiday and New Year to all of you and your families! Be safe, take good care, and I will see you in 2019!