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Carbon-dating compliance: What happened when…

…and how responsible are you for the sins of the past (turns out, quite a bit).

Kind of a mixed bag of things this week, so please bear with me.

First up, in looking back over the last little while of survey activity, I keep looping back around to one (possibly unanswerable) question: How many of the survey findings being generated are the result of conditions that pre-existed the prior survey? I think we can all agree that there are noncompliant conditions lurking throughout our buildings (including that pesky loaded sprinkler head we talked about a couple of weeks ago), some of which (and perhaps quite a few) are the result of actions or inactions occurring a long time ago (in a galaxy almost too close to home). I’m going to guess there are few of us that have not encountered the angst of having a surveyor pop a ceiling tile or wriggle into some crawl space and find some condition that had previously escaped prying eyes (I suspect that the most common previously undetected finding relates to things attached to sprinkler piping and supports, which supports LS.02.01.35 being the most frequently cited Joint Commission standard). And, as onerous as it may be on the face of it (and every other aspect), we are on the hook for all of it (grandfathering of conditions can help in very limited ways, but there’s really very little in the way of grandfathering noncompliant conditions and practices).

For better or worse (likely more the latter than the former), in these increasingly resource-challenged times, it is almost impossible to ferret out every little imperfection. Particularly in the sense that noncompliance happens in three dimensions—square footage just doesn’t work for this process. So, the questions I ask of you, dear readers, are these:

  • Do you proactively attempt an exhaustive search of your facility from top to bottom (and all the nooks and crannies)?
  • Do you “roll the dice” and correct deficiencies as they appear and if there’s stuff out there, let the surveyors find them?

I’m keen to see how this is going to “split.” I know if we could we would take the higher road of proactivity, but not everyone is in that position.

One other item I’ve been hanging on to for probably longer than I should relates to the management of medical gas and vacuum systems. I would hardly think that this blog is the only resource for information, commentary, etc. (though I do like to think it’s an entertaining and perhaps randomly enlightening one), there is one dedicated to the management of medical gas systems, etc., that I think you’ll find useful (and since it doesn’t publish as often, it’s an easy one to add to your bloggy queue) is sponsored by Compliant Healthcare Technologies (CHT). Recently, Tim Richards at CHT penned a blog post on upcoming changes in NFPA 99 relative to medical gases, etc. As I’ve noted once or twice in the past, I really see NFPA 99 compliance as a likely source of heartburn for facilities and safety folks in the coming survey cycles, so any resource that can increase our operational understanding of what is actually required, etc. gives us a leg up on the survey front. I encourage you to check out the information.

As a final note, it appears that we are gearing up for another wild summer of weather and I wanted to take a moment to send best wishes to those in areas already in the throes of severe weather and those that may find themselves in the same. I do believe that, as an industry, we have done some extraordinary work in the practical preparations to deal with emergencies (I would feel better if appropriate preparedness would “drive” regulatory compliance a little more closely, but perhaps in time) and I trust that we all manage the coming season with minimal impact and disruption.

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!

We are hope, despite the times: Steve Mac’s top 10 most troublesome EC challenges

First a quick (moderately revelatory) story: While traveling last week, I had the opportunity to see Creed II on the plane (I found it very entertaining, though somewhat reminiscent of another film—but no spoilers here). Interestingly enough, the image that stayed with me was during a scene on a maternity unit in a hospital where I observed a nicely obstructed fire extinguisher (there was some sort of unattended cart parked in front of the extinguisher). I guess that means I can never turn “this” (and you can call it what you will) off… but enough digression.

About a month or so ago, an organization with whom I had not worked before (they’re on the upcoming schedule) asked for a top 10 list of what I’ve seen as the most challenging physical environment standards, etc. I will admit to having been taken off guard a wee bit (I usually depend on others for top 10 lists), but then I figured it was probably about time that I put a little structure to all the various and sundry things that I’ve seen over the last decade or so.

To that end, here are Steve Mac’s Top 10 Things that will get you in the most trouble in the quickest amount of time (I don’t think there are any surprises, but feel free to disagree…):

Top 10 Critical Process Vulnerabilities – Physical Environment

  1. Inadequately mitigated ligature/safety risks in behavioral health environments
  2. Management of surgical and other procedural environments (temperature, humidity, air pressure relationships)
  3. Construction management process—lack of coordination, inconsistent implementation of risk management strategies
  4. ILSM policy/assessment/implementation—including “regular” LS deficiencies
  5. Management of hazardous materials risks, particularly those relating to occupational exposure (eyewash stations, monitoring, etc.)
  6. Life safety drawings (accuracy, completeness, etc.)
  7. Management of infection control risks in the environment (non-intact surfaces, expired product, high, intermediate and low-level disinfection)
  8. Management of contractors/vendors (documentation, activities, etc.)
  9. Effectiveness of surveillance rounds; integration of work order system, etc., to address compliance concerns
  10. Stewardship of the environment—participation of point-of-care/point-of-service staff in management of the environment.

Now I don’t know that there’s anything here that we haven’t covered in the past, but if you folks would like a more in-depth analysis of anything in the list above (or, indeed, anything else), please let me know. I suspect that I will be returning to this list from time to time (particularly during slow news weeks).

One of your sprinkler heads is loaded: Can you find it before they do?

And now, to the recap of the 10 most frequently cited standards during all of 2018 (in hospitals; other programs are a little more varied), as chosen by somebody other than you (or me): the survey troops at TJC.

The top 10 are as follows:

  • EC 02.01.35—The hospital provides and maintains systems for extinguishing fires (88.9% noncompliance percentage).
  • EC 02.05.01—The hospital manages risks associated with its utility systems (78.7%).
  • EC 02.06.01—The hospital establishes and maintains a safe, functional environment (73.9%).
  • LS 02.01.30—The hospital provides and maintains building features to protect individuals from the hazards of fire and smoke (72.9%).
  • IC 02.02.01—The hospital reduces the risk of infections associated with medical equipment, devices, and supplies (70.9%)
  • LS 02.01.10—Building and fire protection features are designed and maintained to minimize the effects of fire, smoke, and heat (70.7%).
  • LS 02.01.20—The hospital maintains the integrity of the means of egress (67.4%).
  • EC 02.05.05—The hospital inspects, tests, and maintains utility systems (64.7%).
  • EC 02.02.01—The hospital manages risks related to hazardous materials and waste (62.3%).
  • EC 02.05.09—The hospital inspects, tests, and maintains medical gas and vacuum systems (62.1%).

The ongoing hegemony of the top 10’s EOC-centric focus (and I still consider IC.02.02.01 the point upon which infection control and the physical environment intersect—sometimes with spectacular results) leaves little to the imagination (both ours and the surveyors). While you can still get into some significant trouble with certain processes, etc. (more on that next week—I figure if they can have a Top 10 list, then so can I…), the reason that these particular standards continue to jockey for position is because they represent the kinds of conditions (to some degree, I hesitate to call them deficiencies) that you can find literally any (and every) day in your organization. Just think about LS.02.01.35 for a moment: How far would you have to go before you found schmutz on a sprinkler head, something within 18 inches of a sprinkler head, a missing escutcheon (or an escutcheon with a gap), or even something (likely network cabling) lying atop, wire-tied to, somehow “touching” sprinkler piping or supports? I’m going to intuit that you probably won’t have to range too far afield to find something that fits in that category. The only thing I can say is whoever was surveying the “other” 11.1 % of the hospitals in 2018 must not have felt like poking around too much.

At any rate, I don’t know that there is a lot to glean from the 2018 results (same as it ever was…), but if someone out there has a question or concern that they’d like to share, I’m all ears!

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.

Don’t bleed before you are wounded, and if you can avoid being wounded…

…so much the better!

Part of me is wondering what took them so long to get to this point in the conversation.

In their latest Quick Safety utterance, our friends in Chicago are advocating de-escalation as a “first-line response to potential violence and aggression in health care settings.”  I believe the last time we touched upon this general topic was back in the spring of 2017 and I was very much in agreement with the importance of “arming” frontline staff (point of care/point of service—it matters not) with a quiver of de-escalation techniques. As noted at the time, there are a lot of instances in which our customers are rather grumpier than not and being able to manage the grumpies early on in the “grumprocess” (see what I did there?!?) makes so much operational sense that it seems somewhat odd that we are still having this conversation. To that end, I think I’m going to have to start gathering data as I wander the highways and byways of these United States and see how much emphasis is being placed on de-escalation skills as a function of everyday customer service. From orientation to periodic refreshers, this one is too important to keep ignoring, but maybe we’re not—you tell me!

At any rate, the latest Quick Safety offers up a whole slate of techniques and methods for preparing staff to deal with aggressive behaviors; there is mention of Sentinel Event Alert 57 regarding violence and health workers, so I think there is every reason to think that (much as ligature risks have taken center stage in the survey process) how well we prepare folks to proactively deal with aggressive behaviors could bubble up over the next little while. It is a certainty that the incidence rate in healthcare has caught the eyes and ears of OSHA (and they merit a mention in the Quick Safety as well as CDC and CMS), and I think that, in the industry overall, there are improvements to be made (recognizing that some of this is the result of others abdicating responsibility for behavioral health and other marginalized populations, but, as parents seem to indicate frequently, nobody ever said it would be fair…or equitable…or reasonable…). I personally think (and have for a very long time, pretty much since I had operational responsibilities for security) that de-escalation skills are vital in any service environment, but who has the time to make it happen?

Please weigh in if you have experiences (positive or negative are fine by me) that you’d feel like sharing—and you can absolutely request anonymity, just reach out to the Gmail account (stevemacsafetyspace@gmail.com) and I will remove any identifying marks…

E to the E to the E to the E: Next step(s) towards a reporting culture

Thinking that this may have gotten lost in the year-end shuffle, I wanted to take a moment to cover a little ground relative to Sentinel Event Alert (SEA) #60: Developing a reporting culture: Learning from close calls and hazardous conditions. I believe (I was going to say “know,” but that’s probably a little more hyperbolic than I can reasonably venture, but I’m basing it on your “presence” here—you folks are all about getting better and on the off chance that I provide something useful to that end, I’m pleased to have you along for the ride) that you folks are committed to ongoing evaluation of performance, occurrences, funky happenstance, etc. and so little of this will come as anything resembling revelation. That said, I think we do need to prepare ourselves for the wild and wacky world of surveyor overreach and draconian interpretation. Part of my “concern” (OK, perhaps most of it) revolves around the innate simplicity of the thrust of SEA #60. It’s straightforward, cogent, and all the things you would want through which to develop a compliance framework:

  • Establish trust
  • Encourage reporting
  • Eliminate fear of punishment
  • Examine errors, close calls and hazardous conditions

But, how do you know when you’ve actually complied with this stuff? Is this more of an activity-driven requirement: We’re going to do A, B, and C to “establish” trust, then we’ll do D, E, F, G, and H to encourage reporting? (Aren’t we already encouraging reporting?) And the whole “eliminate fear” thing (I’ve had one or two bosses that would have a hard time not administering some sort of retributory action if you messed up)…how do you pull that off? Likely, the examination of errors and close calls is a normal part of doing business, but the examination of hazardous conditions seems less of a fit in this hierarchy. My own tendency when I find a hazardous condition is to try and resolve it (I do love a good session of problem-solving), but maybe it’s more of an examination once someone reports the condition as hazardous. Not quite sure about that.

At any rate, there’s lots of information available on the subject, including an infographic on the 4E methodology, as well as the usual caches of information, etc. which you can find here and here and here.

I am a big fan of encouraging the reporting of stuff by the folks at the point of care/point of service, so to the extent that this moves healthcare in that direction, I’m all for it. So, my question to you is: Does  this represent a shift for the way in which you practice safety in your organization or perhaps gives you a little bit more leverage to get folks to “say something if they see something”? Does this help or is it just so much “blah, blah, blah”?

Philo-safety: Improving our practice in 2019

In case it has not become abundantly clear over the last decade or so of penning this blog, there is something about this time of year that sets me to pondering the enormity of just about anything and everything (if I’m not doing onsite work, my morning routine is to get my first 10K steps in before breakfast—plenty of time to contemplate, ruminate, and various other solipsistic activities). To enhance the “environment” of the morning walk, I listen to podcasts that tend to cover other folks’ life experiences. One of my favorites is the Nerdist podcast, which tends to lean towards tech and entertainment coverage, but lately there’s been a conversational thread relating (to various degrees) to the philosophy of stoicism (please bear with me: I’ll loop this back around in a minute).

For those of you not familiar with the roots of stoicism, it goes back to the times of the ancient Greeks and, if I may steal a passage from Epictetus (bet you never expected to find him here—and neither did I!), the foundational notion geos a little something like this: “In life our first job is this, to divide and distinguish things into two categories; externals I cannot control, but the choices I make with regard to them I do control. Where will I find good and bad? In me, in my choices.” (if you’re interested in finding out more about the particulars of Epictetus and the philosophy of stoicism, you can find a bunch of stuff here).

So in looking at that dynamic, I started to think about the importance of how we, as safety professionals, interact with our “charges.” By that, I mean: Do we react to circumstances or do we respond to them? While there is a case to be made for react and respond as synonyms, I think that there is a subtle (OK, maybe not that subtle) shift from a “reaction” to a “response.” To me, “response” tends to be the result of a more thoughtful, measured consideration of whatever issue, concern, etc., we might be facing. Framing this in this age of social media, I think we need only glance at Twitter (and sometimes the various newscasts) if you’re looking for some reactive materials, but “response” seems rather more in short supply than is good for any of us. At any rate, my personal challenge for this year is to work towards the “response” side of the equation and to reduce the level of reactivity (including while driving in Massachusetts!).

One of the things that can (and does, to one degree or another) influence our reactive versus responsive nature is the presence of what can euphemistically be referred to as “implicit social cognition,” which manifests itself as hidden or unconscious bias. One could certainly debate how much impact implicit social cognition has on our individual lives, practices, etc., but there is a group at Harvard University that is trying to collect data on just this topic with anonymous testing and other activities. I’ve always been fascinated by the various psychologies that influence the workplace environment and I think the folks at Project Implicit are looking at some really interesting stuff. I haven’t done a deep, deep dive into their materials yet, but I did take the first Implicit Association Test and I can definitely see how this process might help each of us understand some of our inner workings. I do believe that the more we can learn about ourselves and how we interact with others can only help the “quality” of those interactions. To that end, I would encourage you to check out the materials noted here and if you do (no pressure), please let me know (you can share it with the group or with me directly at stevemacsafetyspace@gmail.com).

And here’s to a safe, healthy and productive 2019!

Last Call for 2018: National Patient Safety Goal on suicide prevention

While I will freely admit that this based on nothing but my memory (and the seeming constant stream of reasons to reiterate), I believe that the management of behavioral health patients as a function of ligature risks, suicide prevention, etc., was the most frequently occurring topic in this space. That said, I feel (reasonably, but not totally) certain that this is the last time we’ll have to bring this up in 2018. But we’ve got a whole 52 weeks of 2019 to look forward to, so I suspect we’ll continue to return to this from time to time (to time, to time, to time—cue eerie sound effects and echo).

If you’ve had a chance to check out the December 2018 edition of Perspectives, you may have noticed that The Joint Commission is updating some of the particulars of National Patient Safety Goal (NPSG) #15, which will be effective July 1, 2019, though something tells me that strategies for compliance are likely to be bandied about during surveys before that. From a strategic perspective, I suspect that most folks are already taking things in the required direction(s), so hopefully the recent times of intense scrutiny (and resulting survey pain for organizations) will begin to shift to other subjects.

At any rate, for the purposes of today’s discussion, there is (and always will be) a component relating to the management of physical environment, both in (and on) psychiatric/behavioral health hospitals and psychiatric/behavioral health units in general hospitals (my mother-in-law loves General Hospital, but I never hear her talking about risk assessments…). So, the official “environmental risk assessment” must occur in/on behavioral health facilities/units, with a following program for minimizing the risks to ensure the environment is appropriately ligature-resistant. No big changes to that as an overarching theme.

But where I had hoped for a little more clarity is for those pesky areas in the general patient population in which we do/might manage patients at risk to harm themselves. We still don’t have to make those areas ligature resistant, with the recommendation aimed at mitigating the risk for patients at high risk (the rest of the NPSG covers a lot of ground relative to the clinical management of patients, including identification of the self-harm risks). But there is a note that recommends (the use of “should” in the note is the key here, though I know of more than a handful of surveyors that can turn that “should” into a “must” in the blink of an eye) assessment of clinical areas to identify stuff that could be used for self-harm (and there’s a whole heck of a lot of stuff that could be used for self-harm) and should be routinely removed when possible from the area around a patient who has been identified as high risk. Further, there is an expectation that that information would be used to train staff who monitor these high-risk patients, for example (and this is their example, but it’s a good ‘un), developing a checklist to help staff remember which equipment, etc., should be removed when possible.

It would seem we have a little time to get this completed, but I would encourage folks to start their risk identification process soon if you have not already done so. I personally think the best way to start this is to make a list of everything in the area being assessed and identify the stuff that can be removed (if it is not clinically necessary to care for the patient), the stuff that can’t be removed (that forms the basis of the education of staff—they need to be mindful of the stuff that can’t be removed after we’ve removed all that there is to be removed) and work from there. As I have maintained right along, in general, we do a good (not perfect) job with managing these patients and I don’t think the actual numbers support the degree to which this tail has been wagging the regulatory dog (everything is a risk, don’t you know). Hopefully, this is a sign that the regulatory eyeball will be moving on to other things.