On January 21, 2015, the American Society of Healthcare Engineering (ASHE), in coordination with the American Hospital Association (AHA) and the Association for Healthcare Resource & Materials Management (ASHRMM), issued a Joint Quality Advisory, offering new guidance on humidity levels in the OR. The short version is that the CMS waiver allowing hospitals to maintain humidity levels in operating rooms at a level down to 20% relative humidity (RH) is presenting some conflicts relative to the care and feeding of certain sterile supplies and surgical equipment that were designed to be in surgical environments with a humidity level of no less than 30% RH. Can I get an “Oh yeah!”?
One of the conversations I’ve bene having with greater frequency with clients relates to the storage of sterile supplies as a function of ASHRAE 170 Standard for Ventilation of Health Care Facilities, which has very clear design specifications for sterile storage (must have positive pressure, a minimum of two outdoor air exchanges, a minimum of four total air exchanges, a maximum of 60% RH (no identified minimum) and a temperature between 72 and 78 degrees F). The conversations generally grow out of thinking about all the areas in a hospital where sterile supplies can be found and whether all of those locations constitute “sterile storage” and thus would have to adhere to the design specifications listed in ASHRAE 170.
The upshot of those conversations is typically the need for a risk assessment of what supplies are being stored where (so to speak) and determining what locations and products need to be considered in the mix for “protection” in accordance with the ASHRAE standard. For all intents and purposes, the ASHE Joint Quality Advisory is recommending the same type of process (with the “net” being cast a little further afield to include equipment stored in these locations).
As we have learned over the past little while (and reinforced through TJC surveys pretty much everywhere), there is a concerted effort on the part of regulators to scrutinize the management of special environments with an ever-broadening list of locations to be included in those ranks. I believe that I have recommended using the table in ASHRAE 170 as a starting point for conducting a risk assessment of all the potentially applicable locations in each organization, so I’m just going to put it back out there—if you haven’t looked closely at how you are maintaining compliance with this stuff, I can only encourage you to do so. But please know that any lack of preparedness on this count can lead only to survey peril.
As I eagerly await the final numbers of the most frequently cited standards during the 2014 survey season, I can’t help but think that this may the point at which the findings relating to integrity of egress finally (blessedly?!?) take a back seat to findings relating to the management of environmental conditions in surgical/invasive procedure areas, and the associated support environments (sterile processing, sterile storage, decontamination areas) at the top of the food chain. I can’t think of very many survey reports that I’ve seen in 2014 in which the surgical/invasive procedure environment didn’t show up—and too many times that has resulted in condition-level RFIs for the organizations in question.
As you are more than familiar at this point, there are a ton of variables when it comes to this subject—design specifications for the HVAC equipment being used, “field modifications” by the end users (vents taped over, doors left open when they should be closed, etc.), the usual struggles with seasonal temperature and humidity fluctuations—the list almost seems endless. And these types of conditions have cropped up in places that have what I would consider outstanding programs for managing the care environment—attentive leadership, effective buy-in from point of care/point of service staff, reasonable access to capital funds, etc.—so it’s not necessarily symptomatic of the “have not” organizations. It can be as simple as a damper that’s closed, a belt on an air-handler that’s slipping, a filter that’s just, just getting to the point where it needs to be changed.
The key to this whole magillah is having a robust process in place that takes into account those instances in which the presence out-of-range values have been assessed to point where there is a very clear delineation between the design specifications (as outlined in ASHRAE 170), the actual performance of the systems throughout the year, and an oversight process (in close coordination with Infection Prevention) that allows some pushing of the envelope, particularly when the “desires” of occupants bump up against the design specifications. Clearly, we don’t want “rain” in any of these procedure/storage areas, but we must have a definitive sense of what conditions can be legitimately tolerated without putting patients at risk. Otherwise, you’ll find yourself dangling over the precipice of the survey process without a net. Not something I would wish on anyone!
I don’t know how many of you folks subscribe to The Joint Commission’s (TJC) e-notification products, but an interesting bit of news/info came across the airwaves that relates very clearly to some of the conversations we’ve been having (to one degree or the other) over the last, oh let’s say decade or so. Mark Pelletier, the COO of TJC, has taken on the task of “calling out” those healthcare organizations accredited by the Joint to clean up their acts as it relates to the preponderance of EC/LS findings during triennial and associated survey activities. If you’ve not yet seen it, it might be useful for you to be conversant in some of the details.
Now I think that we can absolutely pinpoint when this shift first manifested itself: way back in 2007 when the initial wave of Life Safety surveyors were introduced to the TJC survey process. Since then, there has been a steady increase in EC/LS findings, particularly as the remainder of the survey teams have also been tasked with observing conditions in the physical environment, which brings me back to the age-old dynamic of “Are they looking for it because that’s what they’re finding or are they finding it because that’s what they’re looking for?”
Having pondered this for quite some time, I believe that I fall squarely in the latter camp. One thing I’ve learned over the last 10+ years of working with hospitals is that there are no perfect buildings—and I really don’t think you need any more evidence than the number of findings generated in the survey of the physical environment to be convinced of that. Does this means that we are putting patients/staff/visitors at risk because of the poor conditions in our facilities? I don’t feel that the evidence supports such a draconian interpretation. Is there an opportunity for the management of the physical environment to better resourced, utilize technology better, etc.? I don’t think there’s anyone out there who would disagree that there have always been, and always will be, opportunities to make improvements in the physical environment.
TJC has not yet revealed the final results of most frequently cited standards during 2014 (I have no reason to think that the January to June 2014 results aren’t a good indicator of what we can expect), though I get the sense from Mr. Pelletier’s blog posting that findings relative to the integrity of egress may finally be taking a back seat to findings relating to the management of the surgical procedure environment (temperature/humidity/air pressure relationships). But that said, from the survey results that I’ve seen and the facilities with whom I’ve done on-site work, it is debatable (at least in my mind) that the findings are representative of a significant systems issue. My experiences indicate that the findings are generally related to what I would euphemistically refer to as transient conditions. Sometimes there are legitimate problems that need to be addressed; I recall one decontamination room that had never had an exhaust installed, but that is indeed an exception. But a majority of the time, we are talking about the sundry imperfections that can be encountered in any facility inspection. At this point, you should have a pretty good idea of how long you’d have to tour your building to find a condition that is not quite as it should be. Do you think if you toured for two or three days in a concerted fashion that you wouldn’t be able to find anything at all? Buildings are never more perfect than the moment before you put people in them—and apparently that perfection has somehow become the expectation. Jeez!
By now I’m sure you’ve seen information regarding the CMS report that weighs in on hospital response during Superstorm Sandy and the challenges faced by hospitals during that October 2012 event.
Now, some of the media reports covering this particular issuance from CMS have painted kind of a bleak picture, but I don’t know if that is strictly the case. Certainly, there were, and likely will continue to be, challenges relating to response to any emergencies, but in looking at the data contained in the report, I ultimately can’t help but think the response efforts on the part of the hospitals in the New York metropolitan area and adjacent areas were pretty darn good.
Again, some of the coverage seems to highlight the 89% of hospitals that “reported experiencing critical challenges during Sandy, such as breakdowns in infrastructure and community collaboration” and equate “experiencing critical challenges” with “not being prepared.” Now I will freely admit that I have not exercised operational responsibilities in a hospital for about 13 or so years, but my recollection about such things is that one of the things that makes emergencies, like, emergencies, is that you experience critical challenges that could include breakdowns in infrastructure, etc. For me, the most important nuggets that are presented in the report are that:
- Only 7% of the hospitals involved had to fully or partially evacuate (and yes, I do indeed recognize that evacuation is an entirely acceptable and appropriate response if the conditions dictate)
- Only one hospital indicated that its emergency plan was not useful
- No patient perished as the result of a hospital’s inability to appropriately respond to the disaster
Of course, there were a number of instances of flooding out of infrastructure components and some challenges relating to the whole idea of clinical folks not being able to use powered equipment to deliver IV fluids, etc., (I think it’s probably a good idea to look at those pesky clinical interventions in the case of utility systems or medical equipment failures; something tells me that this might become a wee bit more of a focus during your next TJC visit), but I will direct you back to #3. To me, this means that there was definitely some rough sledding as Sandy came and went, but the folks on the ground were able to keep things together, which is a pretty good measure of preparedness. If nothing happens, how do you know for sure you really were prepared?
Again, if you haven’t had a chance to read through the report, it’s a pretty interesting read (even for the Feds) and I think that some of the stories regarding somewhat rocky interactions with the community might sound at least a little familiar to folks. As with any emergency, there are lessons to be learned and there is much in this report to think on for just about everyone involved with hospital emergency management.
But perhaps the most instructive thing of all is the “tenor” of the conclusion and recommendations section, which doesn’t really point any fingers at the hospitals involved in responding to Sandy. Sure, there are some rather generic references to findings during previous Joint Commission surveys that could have had an impact on response capabilities, but to me it appears nothing more than a classic case of post hoc ergo propter hoc (for those of you not “down” with Latin, that translates roughly as “after this, therefore because of this”). They really don’t seem to be able to tie any survey findings to what happened, but I guess they have to tie the survey process in somehow—such is life.
At The Joint Commission’s Executive Briefings conference in September, another question that I found of some interest/horror (and please remember—that’s horror with a small “h”) continued the charge into the realms of environmental compliance.
Q: What areas need to be monitored for humidity and temperature? Does this include ICU patient rooms?
A: There are multiple areas in a hospital that require humidity and temperatures be monitored. Recovery rooms, Critical Intensive Care, and procedure rooms all require 30% to 60 % humidity and temperatures ranging from 70-75 degrees Fahrenheit. Other areas can have the same humidity levels but varied temps like the newborn nursery suite, which should have temperatures from 72-78 degrees Fahrenheit and Endoscopy would have temperatures from 68-73 degrees Fahrenheit. A very good reference is the AIA Guidelines for Design and Construction of Hospitals and Healthcare Facilities.
So I’ll ask you: How many folks out there are monitoring your Intensive Care Unit rooms for temperature and humidity? By the way, apparently the “faculty” in this instance were not quite familiar with the categorical waiver relating to humidity levels down to 20%. Actually, I suppose invocation of the American Institute of Architects Guidelines might be an indication that they were using an older edition of the Guidelines, since we all know that they’re the Facilities Guidelines Institute (FGI) Guidelines now.
I think minimally we can take this as further indication of an expansion of survey scrutiny into other areas of the hospital when it comes to the management of environmental conditions. I still think the best thing you can do is to get a copy of the 2010 FGI Guidelines, turn to the section at the end of this mighty tome that deals with the ventilation standards, start making a list, and check it twice.
We’ll cover the remaining questions and answers over the next little while; nothing quite as raucous as these first two, but nonetheless instructive.
This is another plucked from the oblivion of the mailbag…
Back towards the end of September, I received an email from an acquaintance out in California who had attended The Joint Commission’s Executive Briefings conference, which included a session on CMS compliance, presented (or so it would seem) jointly by TJC and Joint Commission Resources. In their never-ending pursuit of encouraging customer participation, the audience (or learners as they are identified on the slide sheet) got to submit some questions to the faculty (who shall remain nameless … primarily because I don’t have that information), for which responses were prepared and shared with the group (there were 6 questions asked, based on the document I’ve seen).
At any rate, there are two questions asked for which the responses were somewhat illuminating, albeit in a rather frightening way:
Q. Does temperature and humidity need to be done/recorded daily in procedural areas even if they are closed (i.e., operating room closed on a Sunday or holiday)?
A. Indoor air quality testing that includes directional air flow, humidity, and temperatures should be done daily when in use, however, it is only recommended monthly when the rooms are not in use. So if the rooms are closed they need not be tested unless they are closed for more than one month, but tested when they are put back in use.
The question I have for the studio audience is this (and it’s not like we’ve had this conversation before in various permutations): Where in the regulations does it require daily performance of “indoor air quality testing that includes (which by extension can be interpreted as “not limited to”) directional air flow, humidity and temperatures”? Now it may very well be that this is an extension of the whole magillah regarding the maintenance and testing of critical utility systems components in accordance with manufacturer recommendations (and I don’t have nearly enough knowledge of the OEM guidance on the various and sundry HVAC systems there are out in TV land to be able to speak to that piece of it). Maybe this is destined to show up on TJC’s FAQ page (I see we’re getting a little acronym-heavy here, so I will try to refrain from further acronymization), but this one seems a little beyond the pale. My advice for the moment is that you really ought to look at this as a risk assessment and make the determination of frequencies, etc. for this kind of stuff. Which brings me to the other question of note, but let’s leave that for next time…
Season’s Greetings to you all and please accept my very best wishes for a safe and fulfilling New Year.
And speaking of the holiday season (please excuse my tardiness on this one—probably should have come up with this before Halloween came and went—oh well…), I was wondering how folks had been coming to grips with the allowances contained within the CMS Categorical Waiver on combustible decorations, now that we are in the midst of our third end-of-the-year-holiday-timey-wimey period since the waiver was issued back in March 2012.
I can anecdotally speak to a fair amount of reluctance on the part of safety and facilities folks in running too far with the decoration waivers (or, to be a wee bit more precise, running too far in terms of communicating the changes to frontline staff; to a degree, I share the horror of what might happen, but I also believe that there is a therapeutic value in making the place look festive during the holidays, but I digress).
So has anybody come up with some creative decorating ideas or are you still embracing your inner Scrooge? You know me, I’m always curious about such things…
As the flu season commences, the specter of Ebola Virus Disease (EVD) and its “presentation” of flu-like symptoms is certainly going to make this a most challenging flu season. While (as this item goes to press) we’ve not seen any of the exposure cases that occurred in the United States result in significant harm to folks (the story in Africa remains less optimistic), it seems that it may be a while before we see an operational end to needing to be prepared to handle Ebola patients in our hospitals. But in recognition that preparedness in general is inextricably woven into the fabric of day-to-day operations in healthcare, right off the mark we can see that this may engender some unexpected dynamics as we move through the process.
And, strangely enough, The Joint Commission has taken an interest in how well hospital are prepared to respond to this latest of potential pandemics. Certainly, the concept of having respond to a pandemic has figured in the preparation activities of hospitals across the country over the past few years and there’s been a lot of focus in preparations for the typical (and atypical) flu season. And, when The Joint Commission takes an interest in a timely condition in the healthcare landscape, it increases the likelihood that questions might be raised during the current survey season.
Fortunately, TJC has made available its thoughts on how best to prepare for the management of Ebola patients and I think that you can very safely assume that this information will guide surveyors as they apply their own knowledge and experience to the conversation. Minimally, I think that we can expect some “coverage” of the topic in the Emergency Management interview session; the function of establishing your incident command structure in the event of a case of EVD showing up in your ED; whether you have sufficient access to resources to respond appropriately over the long haul, etc.
Historically, there’s been a fair amount of variability from flu season to flu season—hopefully we’ll be able to put all that experience to work to manage this year’s course of treatment. As a final thought, if you’ve not had the opportunity to check out the latest words from the Centers for Disease Control and Prevention (CDC) on the subject, I would direct your attention to recent CDC info on management of patients and PPE.
I suppose, if nothing else, the past few weeks of our encounter with Ebola demonstrates something along the best laid plans of mice and men: it’s up to us to make sure that those plans do not go far astray (with apologies to Robert Burns).
There’s been a fair amount of discussion in the trenches about the changing dynamics relative to the maintenance of medical equipment and utility systems equipment in the face of all the changes in Joint Commission standards, invocation of CMS as the supreme authority, etc. And while I’m absolutely convinced that this is a conversation that is likely to evolve/mutate over time (the topic of relocatable power taps springs to mind as an example of some fairly rapid-cycle change in approach), I figure we can at least start the conversation and see what happens.
From a compliance standpoint, I think the critical dynamic is how much, if any, of your medical equipment and/or utility systems equipment inventory is being maintained through the application of an alternative maintenance strategy, which effectively means any maintenance strategy that is not in strict adherence to what is recommended by the original equipment manufacturer (OEM). I know a lot of folks are using a database system for managing preventative maintenance activities, but I will admit to not being sufficiently familiar with each system’s capabilities, so I may go somewhat far afield in this portion of the program. Please feel free to issue an e-dope slap if I get things going sideways.
If you are fortunate enough to have a system that is (or is capable of) keeping track of the inventory as a function of whether it is being maintained under an alternative maintenance strategy, then that becomes the basis of any discussion in this regard during a survey. Once you’ve done that initial “sort” (if it is applicable; if you’re maintaining everything in accordance with the OEM, then you really only need to state that in the applicable management plan), then I would recommend a second sort for each category (you could call one category OEM and the other AEMS—Alternative Equipment Maintenance Strategy) to determine what high-risk equipment resides in each of those categories, if any. Ideally (at least from a strict compliance approach), you are not managing any high-risk equipment through an alternative strategy; that will make things potentially less contentious during survey. If you do find that you have some high-risk equipment in the AEMS bucket, then you’re probably going to have to move those processes into the OEM bucket—hopefully a minimally disruptive task.
I guess the other piece of this that could end up being a pain in the butt is if folks had elected not to include all of the medical and/or utility system equipment components, in which case you’re going to have to “capture” anything you might have left out of the inventory to start with. As an editorial aside, every time I think about this whole thing, the more peeved I become because while I understand what they’re getting at from the larger perspective of ensuring safety and operational reliability, I can’t escape the thought that the focus on this whole thing is completely in inversion to the performance of this process over time. In general, we are not hurting people through our medical equipment/utility systems, but it is what it is, I guess. Still, I can’t help but think they must have better things to do than worry about this stuff.
At any rate, the next step depends on whether you’re managing any of this equipment through an alternative maintenance strategy/system. If that is the case, you need to go through the list of equipment being managed in this fashion and provide support the determination whether it is safe to permit medical equipment to be maintained in an alternate manner, based on criteria that includes:
- How the equipment is used, including the seriousness and prevalence of harm during normal use
- Likely consequences of equipment failure or malfunction, including seriousness of an prevalence of harm
- Availability of alternative or back-up equipment in the event the equipment fails or malfunctions
- Incident history of identical or similar equipment
- Maintenance requirements of the equipment
The other piece of this is that the above analysis has to be performed by a “qualified individual(s)” (and, as with the responsibility for maintaining the SOC, there is no specific direction in regards to what constitutes a qualified individual–I would recommend making that determination and running it through the EOC Committee for their knowledge/approval. At the end of the day, the complexities all grow out of the use of alternative maintenance strategies for medical/utility systems equipment, with the end game being (as is noted under both EC.02.04.01 and EC.02.05.01) “the strategies of an AEM program must not reduce the safety of equipment and must be based on accepted standards of practice” (they specifically cite AAMI/ANSI EQ56: 2013 Recommended Practice for a Medical Equipment Management Program).
Unfortunately, I think this is mostly going to be grunt work unless you’ve never gone down the AEM road (which would make little or no sense; I don’t think anyone has enough resources to absolutely manage every piece of medical and/or utility system equipment in accordance with OEM). It’s getting everything into the correct categories and moving on from there.
As the trees turn over their colors, it (sometimes) gives me time to go back over stuff we’ve covered out here in the blogosphere, with the intent of trying to capture some things of note that I think are worth mentioning, even if they are not quite “hot off the presses.”
One of the interesting shifts is the subtle redefining of several of the compliance time frames invoked throughout the standards and performance elements. Not all of the definitions changed, but in the interest of full disclosure, I think we should include the lot of them:
- Every 36 months/every three years = 36 months from the date of the last event, plus or minus 45 days
- Annually/every 12 months/once a year/every year = one year from the date of the last event, plus or minus 30 days
- Every six months = six months from the date of the last event, plus or minus 20 days
- Quarterly/every quarter = every three months, plus or minus 10 days
- Monthly/30-day intervals/every month = 12 times per year, once per month
- Every week = once per week
A particularly curious impact of this shift is the abandonment of the time-honored “not less than 20 days and not more than 40 days” intervals for emergency power testing activities. Now we have “at least monthly” for those very same activities, which probably means that you may want to consider scheduling your generator tests earlier in the month so if you have to postpone/delay the testing of your generator(s) to work around patient care activities, etc. You don’t want to run out of “month.” It will be interesting to see how this translates into the survey process.
The other thing that I’m “watching” is how that definition of quarterly is going to dovetail with how you would conduct fire drills. Is there going to be yet another “counting” vulnerability? I know the Conditions of Participation indicate that fire drills are to be conducted at “unexpected times under varying conditions,” which somehow seems to fly in the face of an every three months plus or minus 10 days. Maybe that’s a big enough window to keep things unexpected; I guess we’ll see how things unfold.