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An invitation to the regulatory dance—and the band keeps playing faster…

About a year ago, we chatted a bit about the likely changes to the regulatory landscape under a new administration, most of which (at least those related to the changing of the guard) never really materialized to any great extent. But one thing held true—and continues as we embark upon the good ship 2018—the focus on management of the physical environment is very much at the forefront of preparatory activities.

We also chatted a bit about The Joint Commission’s previous exhortations to healthcare leaders to focus more attention on the management of the physical environment (I was going to provide a link to TJC’s leadership blog regarding our little world, but it appears that the page is not so easily found, though I’m sure it has nothing to do with revisionist history…). But it does appear that there’s no reason to think that the number (and probably types) of survey findings in the environment are going to be anything but steady, though hopefully not a steady increase. Remember, we still have two years in the survey cycle before everyone gets to have undergone their first survey with the loss of the rate-based performance elements.

Which brings us squarely to 2018 and our continuing storm of regulatory challenges; I had made a list of stuff that I believed would play some role of significance in 2017 and (strangely enough) appear to be poised to do the same in the coming year (or two…or three?!?):


  1. Physical environment standards remain among the most frequently cited during TJC surveys (Nine of the 10 most frequently cited standards for the period January through June 2017). Please check out the September 2017 issue of Joint Commission Perspectives for the details! Just so you know (and I do believe that I’ve mentioned this in the past), I “count” IC.02.02.01 as a physical environment standard. Yes, I know it’s under the Infection Control chapter, but disinfection, the management of equipment and supplies? That all happens in the environment!
  2. CMS, in its report card to Congress, identified the physical environment as the largest “gap” of oversight during all accreditation organization surveys
  3. Also in its report card to Congress, CMS singled out TJC as lagging behind its competition when it comes to improving identification of deficiencies relative to the Conditions of Participation. I firmly believe that the report card to Congress was the proverbial “spark” that fanned the flames of regulatory focus in the environment. I don’t know when we can expect an updated edition of the report card (I suspect that it may be a while), but knowing that CMS is “concerned” can only mean continued focus…
  4. CMS adoption of the 2012 Life Safety Code® (effective survey date of November 1, 2016) definitely did create some level of confusion and uncertainty that always accompanies “change.” And 2017 demonstrated very clearly that it’s not just “us” that have to learn the practical application of the new stuff—the surveyors have to catch up as well! I am definitely starting to see the impact of the adoption of the 2012 Health Facilities Code (NFPA 99)—if you don’t have a copy in your library, it might just be time.
  5. TJC is in the process of revising its Environment of Care and Life Safety chapters to more closely reflect CMS requirements. January 2018 continues the rollout of the standards/performance elements updates—and they’re still not done. As we’ve discussed over the last few weeks, there’s still a lot of shifting requirements (some we always knew were in place, others merely rumored).
  6. Recent TJC survey reports indicate an increasing focus (and resulting vulnerabilities) on outpatient locations, particularly those engaging in high-level disinfection and/or surgical procedures. The physical environment in all areas in which patients receive care, treatment, and services are generating up to 60% of the total physical environment findings in recent surveys. That was just as true in 2017 as in 2016—each care location in the organization has to be prepared for multi-day scrutiny.
  7. CMS published its final rule on Emergency Preparedness (including Interpretive Guidelines, effective November 2016, with full implementation of requirements due November 2017). While organizations in compliance with current TJC Emergency Management standards will be in substantial compliance with the new rule, there will be some potential vulnerabilities relative to some of the specific components of the rule. The key sticking points at the moment appear to relate to the Continuity of Operations Plan (COOP) and the processes for delegating authority and leadership succession planning during extended events.
  8. Introduction of TJC’s SAFER matrix, which did indeed result in every deficiency identified during the survey process being included in the final survey report. Formerly, there was a section called Opportunities For Improvement for the single findings that didn’t “roll up” into a Requirement For Improvement. With the SAFER matrix, everything they find goes into the report. And there did seem to be a preponderance of findings “clustered” (make of that descriptor what you will) in the high risk sections of the matrix.
  9. As a final “nail” in the survey process coffin, effective January 2017, TJC will no longer provide for the clarification of findings once the survey has been completed. While this didn’t result in quite the devastation in the process as it might have first appeared (mostly because I think it forced the issue of pushing back during the survey), it also appears that clarification only during survey was not the hard line in the sand it appeared to be when this first “dropped.” That said, there very definitely seems to be a reluctance on the part of the folks at the Standards Interpretation Group (SIG) to “reverse the call on the field” once the survey team has left the building; just as there is a reluctance to vacate physical environment findings once the LS surveyor has hit the bricks. If you feel that a finding is not valid, there is no time like the present when it comes to the pushback.
  10. One unexpected “change” during 2017: The focus on ligature risks in the various environments in which behavioral health patients receive care, treatment, and/or services. We’ve discussed the particulars fairly extensively in this space and while I didn’t see it “coming,” it has certainly leaped to the top of the concern pile. The recent guidance from the regulators has (perhaps) helped to some degree, but this one feels a lot like the focus on the procedural environment over the past couple of years. I don’t think they’re done with this by any stretch…


In my mind, still working from the perspective of CMS calling out the physical environment as an area of concern, the stuff noted above indicates the likely result that the next 12-24 survey months will show a continued focus on the physical environment by the entire survey team (not just the Life Safety surveyor) and a likely continued plateau or increase in findings relating to the physical environment. I still believe that eventually the regulatory focus will drift back more toward patient care-related issues, but right now the focus on the physical environment is generating a ton of findings. And since that appears to be their primary function (generating findings), there’s always lots to find in the environment.

As I like to tell folks (probably ad nauseum, truth be told), there are no perfect buildings/environments, so there’s always stuff to be found—mostly fairly small items on the risk scale, but they are all citable. The fact of the matter is that there will be findings in the physical environment during your next survey, so the focus will shift to include ensuring that the corrective action plans for those findings are not only appropriate, but also can demonstrate consideration of sustained compliance over time. Preparing for the survey of the physical environment must reflect an ongoing process for managing “imperfections”—not just every 36 (or so) months, but every day.

What a long strange trip it’s been…

And we’re still in the first month!

As I’ve been working with folks around the country since November 8, there’s been a lot of thought/concern/etc. relative to how the new administration is going to be impacting the healthcare world and the end of January may have offered us a taste of what’s to come with the issuance of an executive order to reduce regulatory influence/oversight of the healthcare industry by establishing a plan that requires federal agencies to remove two existing regulations for every one new regulation that they want to enact (for the healthcare take on this, please check out the Modern Healthcare article here. As with pretty much everything that’s been happening lately, there appear to be widely (and wildly) disparate interpretations on how this whole thing is going to manifest itself in the real world (assuming that what we are currently experiencing is, in fact, the real world), so for the moment I am adopting a wait and see attitude about the practical implications of these moves (and acquiring truckloads of antacid). I don’t know of too many healthcare organizations that are so fantastically endowed from a resource ($$$$) standpoint to be able to endure further reimbursement reductions, etc. In fact, once you start looking at the pool of available cash for capital expenditures (and for too many, it’s more of an almost-dried up puddle), it hardly seems worth the effort to plan on expenditures that are likely never to come to fruition. Quick aside: section 482.12(d) of the Conditions of Participation requires each participating organization to have an institutional plan and budget, including a capital expenditure plan for at least a three-year period, though for far too many 3 x 0 is still a big fat goose egg, but still you must plan.

I would like to think that there’s a way forward that will result in greater financial flexibility for hospitals—in spite of some late-2016 chatter about allowing failing hospitals to do just that—fail! There were some closures last year. Hope nothing that impacted you; I couldn’t find anything that specifically indicated how many hospitals might have closed in 2015, so I can’t tell if last year was an aberration or business as usual. I do know that it is very tough when safety and facilities have to compete with some of the sexier members of the technology family; particularly those that generate revenue—growl! I couldn’t tell you the last time I saw an ad saying how clean and comfortable a hospital was (I think it would be a nice change of pace). And while I absolutely recognize the importance of wait times, technology advances, etc., if the physical environment is not holding up its end of the equation, it doesn’t really make for the best patient experience and that’s kinda where things are headed. It’s the total patient experience that is the measure of a healthcare organization—you’ve got to do it all and you have to do it good.

So, I guess we’ll have to keep an eye on things and hope that some logic (in spite of recent tendencies) prevails.



Ah, the fresh (de)scent of hell…

Two relatively disparate topics of conversation this week; one that I suppose could be characterized as good news, the other not so much…

First, the good news: The Joint Commission is continuing in its review and revision of the various and sundry accreditation programs and has earmarked a number of EC performance elements for the scrap heap, one of which is kind of interesting (and none of which is what I had really hoped for—the management plans, like the monster in some horror flicks, just keep coming back for more). So the requirements that are either redundant or will be left up to the decision of each organization are as follows:


  • The requirement to monitor and report all incidents in which medical equipment is suspected in or attributed to the death, serious injury, or serious illness of any individual. Reason: All required by the Safe Medical Devices Act of 1990.
  • The requirement to have procedures that address how to obtain emergency repair services. Reason: Issue should be left to organization discretion.
  • The requirement to provide emergency access to all locked and occupied spaces. Reason: Should be left to organization discretion.
  • Requirement for staff and LIPs to describe or demonstrate methods for eliminating and minimizing physical risks in the environment of care. Reason: Left to organization discretion.
  • Requirement for staff and LIPs to describe or demonstrate how to report EC risks. Reason: Left to organization discretion.
  • Requirement for semiannual environmental tours in patient care areas. Reason: Left to organization discretion.
  • Requirement for annual environmental tours in non-patient care areas. Reason: Organization discretion.
  • Requirement to use environmental tours to identify environmental deficiencies, et al. Reason: (all together now!) Organization discretion.
  • Requirement for representatives from clinical, administrative, and support services to participate in the analysis of EC data. Reason: You guessed it!
  • Requirement to evaluate changes to determine if they resolved environmental safety issues. Reason: not quite what you might be thinking—It’s because this element is implicit in the requirement for your organization to take action on the identified opportunities to resolve environmental safety issues. But wait: How are we going to identify opportunities if we are wicked discreet about the environmental tours? Hmmm…

So we lose 10 performance elements that will now become “ghost” standards (don’t get any ectoplasm on you…icky!) Clearly the expectation that these elements are going to be present somehow and/or somewhere in your EC program is not going away and, to be honest, I’m not convinced (at least at the moment) that you’ll be able to risk assess your way out of a lot of this stuff. I’m most disappointed (after the management plans—I really, really, really don’t have a whole lot of use for them—they bring no intrinsic value to the process and are naught but an exercise in paperwork) in the removal of the specific requirements for staff to be able to describe or demonstrate methods for eliminating risks and to be able to report EC risks. I suppose you could decide that folks don’t have to know that stuff, but I have spent a lot of time and energy beating the drum for the “spread” of safety to point of care/point of service folks. Safety does not live on a committee; it does not live on a periodic survey process. Safety lives everywhere in your “house” every moment of every day. Somehow removal of those two EP’s makes me a little verklempt…

But not as verklempt as some of the folks in Chicago might be of late. Quick background: Periodically, CMS is charged with notifying Congress as to how the various and sundry accreditation organizations are faring when it comes to surveying to the Conditions of Participation, which is pretty much the fundamental task of the deemed status process. At any rate, the information that CMS shared with those pesky Congresspersons can be found here. Of particular interest to this conversation is the information beginning at the bottom of p. 38 of the document, where you will find a table that outlines the disparity rate between Condition-level findings identified by the accrediting organizations (referred to as AOs in the report) and those found by CMS during validation surveys. While (and I don’t think it’s much of a surprise) CMS does ferret out things that were missed during the regular accreditation survey, of the “big three” accreditors of hospitals (AOA/HFAP, DNV, TJC), only TJC did not improve its disparity score in FY 2014 (as the only accrediting agency for psychiatric and critical access hospitals, it didn’t do real well there, either—see pp. 39-40).

But where things get kind of ugly for us is the table (lucky #13) on p. 44, which lists the types of findings missed most frequently in hospitals by the accreditation organizations as compared to CMS. And the most frequently missed Condition of Participation? Why, it’s our old friend, the Physical Environment! The environment fares somewhat better in psychiatric hospitals (which, to be honest, surprises me a little, but it may be a question of a small sample size; unless, of course, your sample size is HUGE!) and about the same in critical access hospitals. At this point, I think I’ve probably yapped enough for one week, but I would encourage you to check out the analysis of the physical environment findings starting on p. 49. It doesn’t paint a particularly bright picture, particularly if there were any of you folks anticipating a return to the clinical side of things during surveys. All signs point to even more scrutiny (happy, happy, joy, joy!) of the physical environment…imagine that.

Batten down the hatches, mateys—we’re in for quite a blow!

Are we there yet? Almost certainly not!

One of the fundamental purposes/charges of any high-reliability organization/program, etc., is to be able to identify improvement opportunities and to act upon those opportunities in a manner that actually results in sustained improvement. In the Boston area, we call that “making things bettah!” So, when it comes to the management of the physical environment, I think we can all agree that sustainable improvement is a good thing and, from an operational perspective, really makes a lot of sense. But it’s not necessarily good sense that drives your performance improvement efforts—it’s also a regulatory requirement.

If you look at the CMS Conditions of Participation, clearly there is an expectation of CMS for the management of the physical environment to be incorporated into the hospital’s QAPI program:

482.41 Condition of Participation: Physical Environment

The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community.

Interpretive Guidelines §482.41

This CoP applies to all locations of the hospital, all campuses, all satellites, all provider-based activities, and all inpatient and outpatient locations.

The hospital’s Facility Maintenance and hospital departments or services responsible for the hospital’s buildings and equipment (both facility equipment and patient care equipment) must be incorporated into the hospital’s QAPI program and be in compliance with the QAPI requirements.

Interpretive Guidelines §482.41(a)

The hospital must ensure that the condition of the physical plant and overall hospital environment is developed and maintained in a manner to ensure the safety and well being of patients. This includes ensuring that routine and preventive maintenance and testing activities are performed as necessary, in accordance with Federal and State laws, regulations, and guidelines and manufacturer’s recommendations, by establishing maintenance schedules and conducting ongoing maintenance inspections to identify areas or equipment in need of repair. The routine and preventive maintenance and testing activities should be incorporated into the hospital’s QAPI plan.

So, that sets things up fairly succinctly, but in looping back to what CMS is calling/looking for in terms of the indicated “QAPI requirements,” I think there may be opportunities to open things up a bit beyond merely tracking compliance rates (which, typically, perform up to/within regulatory/organizational expectations) and start to look at what those compliance rates mean in terms of demonstrating/verifying the effective management of the physical environment. For example, to my mind, monitoring fire drill compliance as a straight X number of drills per quarter, etc., really doesn’t make a great deal of sense, unless you are having difficulties meeting the requirement (and I should point out that if you are having difficulties conducting fire drills, that’s not going to play well with too many regulatory surveyors). Where I think the “gold” might be (continuing the fire drill example) is in working on figuring out how to demonstrate that the fire drills are effective in preparing folks to respond appropriately in the event of a fire, which leads us to the next piece of the CMS expectation:

482.21(a)(2) The hospital must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that assess processes of care, hospital service and operations.

 482.21(b)(2) The hospital must use the data collected to–(i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement and changes that will lead to improvement.

If you have indicators that are consistently performing at the 100% level, while someone is still going to be monitoring those programmatic aspects, it’s probably time to retire them from the active reporting structure to your EOC Committee. Now I know folks are usually loathe to focus too much on the negative stuff (nobody wants to get in trouble, etc.), but if I may make the suggestion—as a starting point, look at the stuff that you do pretty well, but not perfectly (and if we have learned nothing else over the past couple of years, it’s those things that are not perfect that can cause the biggest problems during a survey). For example, say you are tracking completion rates for non-urgent work order requests, and you are experiencing a pretty solid 90%-95% closeout rate. Now, I would call that a pretty good rate for the non-urgent stuff (presuming that this sterling completion rate is not getting in the way of completing urgent work order requests), but what about that 5%-10% of things that aren’t being completed? Are there any butt-biters in that grouping (things that later resurface to bite you on the backside)? In the interest of putting our best face forward, I think sometimes we focus too much on what has been done and not so much and what hasn’t been done. And I will tell you, the stuff that doesn’t get done will usually cause more trouble than the stuff that did get done.

So when it comes to performance improvement, while it is nice to reflect on the successes of the past, the key metrics “live” in the journey ahead: recognizing that compliance is a journey and not a destination. We ain’t never gonna be “done” with this little pursuit.

For those of you in the northern hemisphere, please enjoy these first days of summah! For those of you at the other end of the globe, wintah is nice, too!