Yet another mixed bag this week, mostly from the mailbag, but perhaps some other bags will enter into the conversation. We shall see, we shall see.
First up, we have the announcement of a new Joint Commission portal that deals with resources for preventing workplace violence. The portal includes some real-world examples, some of the information coming from hospitals with whom I have done work in the past (both coasts are covered). There is also invocation of the Occupational Safety & Health Administration (lots of links this week). I know that everyone out there in the listening audience is working very diligently towards minimizing workplace violence risks and perhaps there’s some information of value to be had. If you should happen to uncover something particularly compelling as you wander over to the Workplace Violence Portal, please share it with the group. Bullying behavior is a real culture disruptor and the more we can share ideas that help to manage all the various disruptors, we’ll definitely be in a better place.
And speaking of a better place, I did want to bring to your attention some findings that have been cropping up during Joint Commission surveys of late. The findings relate to being able to demonstrate that you have documented a risk assessment of the areas in which you manage behavioral health patients; particularly those areas of your ED that are perhaps not as absolutely safe as they might otherwise be, in order to have sufficient flexibility to use those rooms for “other” patients. Unless you have a pretty significant volume of behavioral health patients, it’s probably going to be tough to designate and “safe” rooms to be used for behavioral health patients only, so in all likelihood you’re going to have to deal with some level of risk. I suppose it would be appropriate at this juncture to point out that it is nigh on impossible to provide an absolutely risk-free environment; the reality of the situation is that for the management of individuals intent on hurting themselves, the “safety” of the environment on its own is not enough. Just as with any risk, we work to reduce the risk to the extent possible and work to manage what risks remain. That said, if you have not documented an assessment of the physical environment in the areas in which you manage behavioral health patients, it is probably a worthwhile activity to have in your back pocket. I think an excellent starting point would be to check out the most recent edition of the Design Guide for the Built Environment of Behavioral Health Facilities, which is available from the Facilities Guidelines Institute. There’s a ton of information about products, strategies, etc. for managing this at-risk patient population. And please keep in mind that, as you go through the process, you may very well uncover some risks for which you feel that some level of intervention is indicated (this is not a static patient population—they change, you may need to change your environment to keep pace), in which case it is very important to let the clinical folks know that you’ve identified an opportunity and then brainstorm with them to determine how to manage the identified risk(s) until such time as corrective measures can be taken. Staff being able to speak to the proactive management of identified risks is a very powerful strategy for keeping everybody safe. So please keep that in mind, particularly if you haven’t formally looked at this in a bit.
As a closing thought for the week, I know there are a number of folks (could be lots) who purchased those customizable EOC manuals back in the day and ever since have been managing like a billion policies, which, quite frankly, tends to be an enormous pain in the posterior. I’m not entirely certain where all these policies came from, but I can tell you that the list of policies that you are required to have is actually fairly limited:
- Hazard Communications Plan (OSHA)
- Bloodborne Pathogens Exposure Control Plan (OSHA)
- Respiratory Protection Program (OSHA)
- Emergency Operations Plan (CMS & Accreditation Organizations)
- Interim Life Safety Measures Policy (CMS & Accreditation Organizations)
- Radiation Protection Program (State)
- Safety Management Plan (Accreditation Organizations)
- Security Management Plan (Accreditation Organizations)
- Hazardous Materials & Waste Management Plan (Accreditation Organizations)
- Fire Safety Management Plan (Accreditation Organizations)
- Medical Equipment Management Plan (Accreditation Organizations)
- Utility Systems Management Plan (Accreditation Organizations)
- Security Incident Procedure (Accreditation Organizations)
- Smoking Policy (Accreditation Organizations)
- Utility Disruption Response Procedure (Accreditation Organizations)
Now I will freely admit that I kind of stretched things a little bit (you could, for example, make the case that CMS does not specifically require an ILSM policy; you could also make the case that it is past time for the management plans to go the way of <insert defunct thing here> at the very least leaving it up to the individual organizations to determine how useful the management plans might be in real life…). At any rate, there is no requirement to have any policies, etc., beyond the list here (unless, of course, I have left one out). So, no policy for changing a light bulb (regardless of whether it wants to change) or policy for writing policies. You’ll want to have guidelines and procedures, but please don’t fall into the policy “trap”: Keep it simple, smarty!
Earlier this week, I received a question regarding the need to do a risk assessment that would allow (or prohibit) the use of toasters in break rooms, etc., due to the open heating element. I should probably mention that this “finding” was not at the hands of The Joint Commission, but rather one of the other acronymic accreditation agencies, but these things do tend to travel across agency boundaries, so it may be a topic of conversation for your “house.” At any rate, the request was aimed more at identifying a format for documenting the risk assessment (an example of which follows), as the surveyor who cited the toasters indicated that a risk assessment supporting continued use of the toasters would be sufficient. Special survey hint: If a surveyor indicates that a risk assessment would be an acceptable strategy for whatever practice or condition might be in question, you should consider that a pretty good indication that there is no specific regulatory guidance in any direction for the subject at hand. Though I will also note that if a surveyor does not “bite” on a risk assessment, it doesn’t mean that there is a specific regulation/statute/etc. that specifies compliance, so even if there appears to be no relief from a risk assessment, a thorough review of what is actually required is always a good idea. Which probably represents a good point to discuss the risk assessment components:
- Issue Statement. Basically a recap of what the condition or practice that has been identified as being problematic/a vulnerability, etc.. Using this week’s topic—the use of open element appliances in break rooms, etc. (no reason to confine the discussion to toasters; might as well include toaster oven, grills, and other such appliances)
- Regulatory Analysis. Reviewing what is specifically indicated in the regulations: CMS Conditions of Participation; Accreditation Agency standards and performance elements; state and local laws and regulations should definitely be discussed, as well as any other Authorities Having Jurisdiction (AHJ) that might weigh in on the topic. For the open element appliance discussion, I always encourage folks to check with their property insurer (they are a very important, and frequently overlooked, AHJ); they might not tell you that you can or can’t do something (again, based on whether there is an actual regulatory requirement), but they might tell you that if you do X and have a fire, etc., they might elect not to cover damages.
- Literature Review. Review any manufacturer recommendations or information from specialty society or trade associations. Staying with our friends the toasters, most of the devices in use in your organization are probably manufactured “For Household Use Only”; you might be hard-pressed in the risk assessment to be able to indicate definitively that the devices are being used in accordance with that level of use (I mean I love toast as much as the next person, but I don’t toast a whole loaf every day…). As a consultative aside, my philosophy has always been to encourage (okay, mandate, but only when I was in a position to make the call) the use of commercial-grade toasters. Yes, they are more expensive, but they are also less likely to self-immolate, which (in my book) is rather a good thing. We definitely don’t need things bursting into flames in our break rooms, etc.
- Review of Safety, Quality and Risk Management Data. Check your records. You know you’ve had accidental activations of the fire alarm system (though I do believe that toaster events have faded to a distant second behind microwave popcorn). Is there evidence that your organization is not doing an appropriate job of managing these devices/appliances. I suppose you could take into consideration anecdotal data, but I would be very careful as that can be tricky.
- Operational Considerations and Analysis. Discuss how things are being managed now; how often are the appliances being cleaned, serviced, etc. Is that often enough? Is there sufficient smoke detection, suppression, etc.? Do you need to have “official” guidelines for safe toaster use (no sticky, gooey toaster strudels, etc.)? If you’re going to allow something (recognizing that a prohibition is the easiest thing to police from a surveillance perspective), you may find that folks will require a bit of sensible direction to manage the risks effectively.
- Organizational Position and Policy Statement/Approval and Adoption. Once you’ve figured out what you want to do, just outline the position you are adopting, make sure that what you’re doing is not in opposition to any existing policy or plan, and then run it through the appropriate committees for final approval and adoption by the organization. In most instances, there is absolutely no reason to establish a specific policy for these things; set it up as a guideline or a protocol or a standard operating procedure (SOP). There are really very few policies that are required by law or regulation. Please don’t feel the need to populate your EOC manuals with a million and one incidental policies (I think this might be a good topic of future conversation).
There are many ways to “skin” a risk assessment and the methodology indicated above may not be suitable for all audiences, but it is a very good way to document the thoughtful analysis of an issue (be it identified during a survey or during your own surveillance activities), particularly when logic does not immediately prevail. (And believe me, logic doesn’t prevail as often as it used to. It makes me sad to think about all the gyrations that have been “committed” because we’ve been forced to deal with something that is “possible” as opposed to “probable” or “actual.” And if you’re thinking that the management of cardboard is somewhere in that equation, you would indeed be correct…) It all goes back to the subtle dynamics between what you “have” to do versus what you “could” do—to a very large extent, at least in terms of the regulations, we get to make our own way in the world. But that world is full of surveyors who are perfectly willing to disagree with any decision we’ve ever made; and they tend not to allow us to do the risk assessment math in our heads (pity, that). This is a pretty straightforward way to get your work on paper. I hope you find it useful.
In the interest of time and space (it’s about time, it’s about space, it’s about two men in the strangest place…), I’m going to chunk the EM and LS risk areas that are now specifically included in the Focused Standards Assessment (FSA) process (previously, the risk areas were only in the EC chapter). Next week, I want to take one more chunk of your time to discuss now the FSA process (particularly as a function of what EPs the folks in Chicago have identified as being of critical importance/status). But for the moment, here are the add-ons for 2016:
- participation of organizational leadership, including medical staff, in emergency planning activities (you need to have a clear documentation trail)
- your HVA; (interesting that they’ve decided to include this one—they must have found enough folks that have let the HVA process languish)
- your documented EM inventory (I think it’s important to have a very clear definition of what this means for your organization)
- participation of leadership, including medical staff, in development of the emergency operations plan (again, documentation trail is important)
- the written EOP itself (not sure about this addition—on the face of it, it doesn’t necessarily make a lot of sense from a practical standpoint)
- the annual review of the HVA (my advice is to package an analysis of the HVA with the review of the EOP and inventory)
- annual review of the objectives and scope of the EOP
- annual review of the inventory
- reviewing activations of the EOP to ensure you have enough activations of the right type (important to define an influx exercise, as well as, a scenario for an event without community support)
- identification of deficiencies and opportunities during those activations—this means don’t try to “sell” a surveyor an exercise in which nothing went awry—if the exercise is correctly administered, there will always, always, always be deficiencies and/or opportunities. If you don’t come up with any improvements, the you have, for all intents and purposes, wasted your time… (Perhaps a little harsh, but I think you hear what I’m saying)
- Maintenance of documentation of any inspections and approvals made by state or local fire control agencies (I think you could make a case for having this information attached to the presentation of waivers, particularly if you have specific approvals from state or local AHJs that could be represented as waivers)
- Door locking arrangements (be on the lookout for thumb latches and deadbolts on egress doors—there is much frowning when these arrangements are encountered during survey)
- Protection of hazardous areas (I think this extends beyond making sure that the hazardous areas you’ve identified are properly maintained into the realm of patient spaces that are converted to combustible storage. I think at this point, we’ve all see some evidence of this. Be on the lookout!)
- Appropriate protection of your fire alarm control panel (for want of a smoke detector…)
- Appropriate availability of K-type fire extinguishers (this includes appropriate signage—that’s been a fairly frequent flyer in surveys of late)
- Appropriate fire separations between healthcare and ambulatory healthcare occupancies (a simple thing to keep an eye on—or is it? You tell me…)
- Protection of hazardous areas in ambulatory healthcare occupancies (same as above)
- Protection of fire alarm control panels in ambulatory occupancies (same as above)
I would imagine that a fair amount of thought goes into deciding what to include in the FSA (and, in the aggregate, the number of EPs they want assessed in this process has gotten decidedly chunkier—I guess sometimes more is more), so next week we’ll chat a bit about what it all means.
I apologize for not having gotten to this sooner, but sometimes the wind comes out of nowhere and you find yourself heading in a rather unexpected direction (I’ve never spent so much time in Texas!).
With the advent of each new year, our three-lettered friends in Chicago unveil the changes to the accreditation standards for the upcoming cycle. Most of the changes in the EC/LS/EM world (with a couple of fairly notable exceptions—more on those in a moment) have to do with a shift in focus for the Focused Standards Assessment (FSA) process as a function of the various specific risk areas (I will freely admit that this is a wee bit convoluted, but should not necessarily come as a surprise). At any rate, as part of the accreditation process, each organization is supposed to evaluate its compliance based on specific areas of concern/risk identified by The Joint Commission. Thus for 2016, some of the risks to be evaluated have gone away (at least for the moment) and other have been added to the mix:
Please remember: These are not going away entirely, they just don’t have to be included in your organization’s FSA process!
So, we bid adieu to specific analysis of the safety, hazardous materials, medical equipment, and utility systems management plans (leaving security and fire safety in the mix) and we say bonjour to the identification of safety and security risks (as you may have noted, I’m not indicating the specific standard and EP numbers—our friends get a little protective of their content, but if you really need to check out the numbers, please see your organization’s accreditation manual).
We say goodbye to implementing our hazardous material and waste spill/exposure procedures, the monitoring of gases and vapors, and proper routine storage and prompt disposal of trash; and say hello to the hazardous materials and waste inventory, the actual written hazmat and waste spill/exposure procedures, minimization of hazmat risks, ensuring that you have proper permits, licenses, etc., for hazardous materials, and labeling of hazardous materials.
We say howdy to a focused look at fire drills, including the critiques.
We greet a focus on the testing documentation relating to duct detectors, electromechanical releasing devices, heat detectors, manual fire alarm boxes and smoke detectors, as well as the documentation relating to fire dampers.
We say auf wiedersehen to focusing on the selection, etc., of medical equipment, the written inventory of medical equipment, SMDA reporting, inspection, testing and maintenance of non-high risk medical equipment, and performance testing of all sterilizers.
We say guten tag to the written utility components inventory, written frequencies for maintenance, inspection and testing of utility system components, written procedures for utility system disruptions, and minimization of pathogenic, biological agents in aerosolizing water systems.
We say konichiwa to a focus on the provision of safe and suitable interior spaces for patients and the maintenance of ventilation, temperature and humidity in all those other pesky areas (e.g., soiled utility rooms, clean utility rooms, etc.).
We say hola to a focus on whether or not staff (including LIPs) are familiar with their roles and responsibilities relative to the environment of care (I predict that this is one is going to start showing up on the top 10 list soon unless there is a dramatic shift in survey focus).
And we say “Hey-diddly-ho, good neighbor” to the use of hazard surveillance rounds to identify environmental deficiencies, hazards, and unsafe hazards, as well as ensuring that you have a good mix of participants in your EC Committee activities, particularly the analysis of data—clinical, administrative, and support services have to be represented.
Now, there are three standards changes that went into effect on January 1, 2016: one a shift to a different spot in the standards, one a fairly clarifying clarification, and one about which I am not quite sure what to make, though I somehow fear the worst…
The requirement for the results of staff dosimetry monitoring (CT, PET, nuclear medicine) to be reviewed at least quarterly shift from Safety to Hazardous Materials. The EP number remains the same (and I can give you 17 reasons for that…), but it’s only a shift in where it would be scored (another important reason for making sure that you have a solid relationship between your EOC Committee and your Radiation Safety Committee—I’m a great believer in having compliance information in a location where surveyors are more likely to encounter it: EOC Committee minutes).
The requirement for managing the risks associated with smoking activities was clarified to indicate that the risks have to be managed regardless of the smoking types (e-cigarettes and personal vaporizers are officially in the mix); I’m presuming that this is helpful to folks who have perhaps faced some resistance in this area.
And finally (we’ll cover the EM and LS changes next time—nothing particularly scary, but a little too voluminous for this rather dauntingly wordy blog post), the requirements based around the inspection, testing and maintenance of non-high-risk utility system equipment components has gone from a “C” Element of Performance (EP) to an “A” EP (they did remove the Method of Success requirement for a deficient finding in this area—I suspect that was as much for their own sanity as anything else. Plus, it never really made a great deal of sense to figure out how to monitor something over four months’ time that frequently occurs every six or 12 months). My sense is that they are making the change to increase the “cite-ability” of managing utility systems equipment; now they only need to find one instance of noncompliance for a finding. I don’t know that I’ve seen a ton of findings in this area, but I can’t honestly say that I’ve been doing a close count of the OFI section of the reports, so it may be that they’re seeing a trend with the non-high-risk utility equipment that makes them think we’re not doing as good a job managing as we should, but that is wholly and completely conjecture on my part. I will, of course, be keeping a close eye on this one; I have a sneaking suspicion that the focus on utility systems equipment is going to continue into the immediate future and this might just become another pressure point.
As a closing thought relative to the FSA and risk area discussion, I think we can reasonably intuit that (particularly since the FSA process, represents a process for self-reporting) the expectation is for folks to be looking very carefully at the requirements contained within the above-noted areas and that your compliance plans relative to those requirements will be well in hand come survey. For some reason, this shift “smells” like an approach that’s going to be that much more focused on organizational leadership when there are gaps (and ask anyone who’s had a bumpy survey these past couple of years—leadership gets dragged into the fray on a regular basis). The fact of the matter is that they will find something deficient in your facility—if they don’t, they didn’t look hard enough. It’s about having processes in place to recognize and manage those deficiencies appropriately (and yes, I recognize that I am running the risk of repeating myself). This is big-time crazy focus on this stuff—and we need to be continuously improving how we go about doing it (whatever “it” might be).
Back next week to cover the EM/LS stuff. Arrivederci for now!
Recently, the AORN Journal published an editorial penned by Kelly Putnam, the managing editor, highlighting the role nurses play in preventing surgical fires (see here for detail). The piece raises a lot of interesting points about some of the operational considerations that come into play when it comes to appropriately managing fire risks in the surgical environment. But what really caught my eye—and my imagination—was the conclusion, which goes a little something like this: “Perioperative nurses are integral to a team approach to fire safety. Nurses are responsible for performing preoperative risk assessments and informing other team members of the risks associated with each procedure, identifying potential fire hazards, helping to find system fixes that improve patient safety, and conveying the details of fire-related incidents to other stakeholders at the institution.”
Now those of you who’ve been following this space for a while will no doubt note the presence of one of my favorite (okay, pretty much #1 on the hit list) phrases: risk assessment. And not only does the risk assessment get a shout out, it’s within the framework of a team approach to managing fire safety in surgery. As I pondered this, I was thinking, wouldn’t it be cool if we could use this as a jumping off point for nursing involvement in a team approach to risk assessment that focuses on the management of the whole darn care environment? I’ve been yammering at just about every opportunity my “sense” that one of the desired end products of the current focus on the care environment by regulatory surveyors is the demolition of the “barrier” that exists (in smaller doses than formerly, to be sure, but not entirely gone) between the “clinical” and “non-clinical” functions of any healthcare organization. It is my firm belief that the organizations that will most effectively manage the survey process are those organizations that have developed a true collaboration of staff across the care continuum. In a very real sense, everyone in your organization is taking care of patients—directly or indirectly, everyone influences the “patient experience.” And at the end of the day (and yes, I recognize that the Urban Dictionary refers to that little turn of phrase as a “rubbish phrase used by many annoying people…”): CARING FOR THE PATIENT IS CARING FOR THE ENVIRONMENT!
Start printing up the t-shirts and bumper stickers…
In preparation for our journey into the restrooms of your mind (sorry—organization), you might consider a couple of things. Practicing this during surveillance rounds is probably a good thing; increasing folks’ familiarity with the potential expectations of the process is a good thing. But in practicing, you can also consider identifying an organizational standard for responding to restroom call signals, that way you can build at least a little flexibility into the process, maybe enough to push back a little during survey if you can allow for some variability.
Another restroom-related finding has had to do with the restrooms in waiting areas in clinic settings (ostensible restrooms that can be used by either patients or non-patient who may be in the waiting area). There is a requirement for a nurse call to be installed in patient restrooms, but there is no requirement for a nurse call to be installed in a public restroom. So what are these restrooms in waiting areas? I would submit to you that, in general, restrooms in waiting areas ought to be considered public restrooms and thus not required to have nurse calls. Are there potential exceptions to this? Of course there are—and that’s where the risk assessment comes into play. Perhaps you have a clinic setting in which the patient population being served is sufficiently at risk to warrant some extra protections. Look at whether there were any instances of unattended patients getting into distress, etc. (attended versus unattended is a very interesting parameter for looking at this stuff). Also, look at what the patients are being seen for; maybe cardiac patients are at a sufficiently high enough risk point to warrant a little extra.
At the end of the process, you should have a very good sense of what you need to have from a risk perspective. That way if you have a surveyor who cites you for not having a nurse call in a waiting area restroom, you can point to the risk assessment process (and ongoing monitoring of occurrences, etc.) as evidence that you are appropriately managing the associated risks—even without the nurse call. In the absence of specifically indicated requirements, our responsibility is to appropriately manage the identified/applicable risks—and how we do that is an organizational decision. The risk assessment process allows us the means of making those decisions defensible.
One of the more common questions that I receive during my travels is “When do you need to do a risk assessment?” I wish that there were a simple response to this, but (as I have learned ad nauseam) there are few things in this safety life that are as simple as I’d like them to be. But I can give you an example of something that you might be inclined to look at as a function of your risk assessment process: restrooms (oh boy oh boy oh boy)!
While I can’t honestly characterize this as a trend (I suspect that, at the moment, this is the provenance of a handful or so of surveyors), there seems to be an increasing amount of attentions paid to restrooms—both public and patient—during surveys. These attentions have included nurse call alarms (or lack thereof), the ability of staff to be able to “enter” restrooms to assist someone in distress, the length of the nurse call cords, etc. Now you might not think that there was a whole heck of a lot of trouble that could result from this type of scrutiny, but I can tell you that things can get a little squirrelly during survey (mostly the rescuing someone from the restroom) if you don’t have your arms around these spaces.
For example (and I think we’ve talked about this as a general observation a while back), there are some surveyors that will almost delight in locking themselves in a restroom, activating the nurse call system and wait to see how long it takes for staff to respond to–and enter!—the restroom (there is a Joint Commission performance element that requires hospitals to be able to access locked, occupied spaces; this would be one of those). Although there is no specific standards-based timeframe for response in these situations, the tacit expectation is that staff will be ready to respond, including emergency entry into the restroom, upon their arrival on the scene. This means that they would either immediately possess the means of entering the restroom or would have an immediate means at their disposal. This, of course, would be subject to the type of lock on the restroom door, etc., but for the purposes of this situation, we must assume that the patient is unable to unlock the door on their own. So, this becomes both a patient safety risk and a potential survey risk.
Stay tuned for some thoughts on how best to manage these types of situations.
One of the things I frequently share with folks when I’m doing client engagements is that (at least when I, or they, are doing the looking) it is a very good thing to find things: deficiencies, inconsistent practices, etc. My experience has been that the folks in the field will tell you that (insert deficiency/practice here) could “never happen,” and my experience has also been that pretty much everything happens eventually (never being a very, very long time, indeed). You can have the best systems, processes, education, staff that ever has been, but, inevitably, something within those systems, processes, education, staff, will break down or otherwise not quite make the mark. I guess the management of safety and risk in the physical environment boils down to the management of imperfections. Other than certain things in nature (Old Faithful, the sun), the list of things that work perfectly every time is pretty short and I suspect that there’s nothing on the perfect list that is wrought by human hands.
At any rate, I think the underlying subtext is to take full advantage of as many opportunities to poke around as you can make available. The Joint Commission requires surveillance rounds at a set frequency (twice per year in patient areas, at least once everywhere else), but that has to be considered the baseline. The more often you can look, the greater your chances of finding something you’ve not seen before (and presumably had been told could “never happen”). People make mistakes all the time. It is, after all, the nature of humans.
One thing for your to-do list (if it’s not already on your done list) is to take a few moments (okay, maybe a couple more than a few moments) to look over the proposed changes to the way CMS is going to be requiring hospitals to undertake emergency management activities.
You can get the skinny here. The caveat in all this is that you only have until the end of this month to provide feedback on the requirements. Forgive me for being a doom and gloom kind of guy, but something tells me that this is not going to be merely a kind of realignment of resources, etc. I think there is a fair amount of potential for this to cause a lot of heartburn for facilities/safety folks.
Fortunately, the webpage lays out pretty nicely, with click-through links and such, which allows pretty slick navigation of the requirements. I don’t think I’m going to surprise anyone by saying that while there are some consistent concepts, etc., between the proposed requirements and the Joint Commission’s Emergency Management chapter, the two don’t necessarily dovetail seamlessly. For example, it kind of looks like there will be a mandated tabletop exercise (which is defined as a “group discussion led by a facilitator, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan”). In the Training and Testing section of the proposed rule, there are some click-through resources aimed primarily at assisting smaller facilities—those of you in smaller facilities like critical access hospitals and such—may want to pay very close attention to how this is going to impact your organizations. It sounds nice on paper, but only you folks know how workable these “solutions” might be.
Again, there are common elements—risk assessments, community involvement, emergency plans that reflect reality, etc.—but you and I both know that it doesn’t take a great deal of variable language to create almost insurmountable compliance challenges (note the “almost”; failure, as always, not an option on this wagon train). At this point, it’s impossible to say how much influence can be brought to bear on what’s going to come out of this magillah (and I know it can be very unhappy to weigh in and have one’s thoughts ignored), but I think it is most important to speak up when the opportunity is presented. This will take you to the comment page:
ASHE offered the following suggestions to those who are considering making their own comments:
The comments most likely to affect regulatory decisions are ones that are constructive and clear. Comments should be supported by sound reasoning, scientific evidence, or real-world examples of how your hospital or facility will be affected. Copying and pasting comments or information submitted by others decreases the effectiveness of both your comment and the comment of the original submitter. The best comments explain, in your own words, the positive or negative effects of the proposed rule on your facility and others like it. Remember that public comments are not votes—a single well-written public comment can pull more weight than thousands of form letters.
You may also find value in checking with your state hospital associations. I don’t think we can ever underestimate the impact on daily operations when the feds make changes of this nature and intensity and it’s getting towards the 11th hour. Make those comments count!
Recently I received a question regarding the use of the risk assessment process to determine whether an environmental condition was being appropriately managed. During survey, these folks were cited for not actively monitoring temperature and humidity in a sterile storage supply room adjacent to the OB surgical procedure room (this is one location that I’ve seen cropping up in recent surveys—please remember to keep an eye on sterile storage locations). The physical layout of the space, including the HVAC equipment, basically provides the “same” environment for the procedure room (where they had been monitoring humidity and temperature), so the question became whether the risk assessment process could be used to indicate that if the temp and humidity in the procedure room had been fine, then the sterile storage room would be fine as well.
Now if we’d been having this discussion prior to the survey finding, we might have had a little bit of leverage, but I still think it would be a tough sell, both during survey or as part of the clarification process, because up to this point, there was no performance data to support that determination (which doesn’t mean it isn’t the case, just means there’s no supporting data—a very important and useful thing to have). My advice, especially since they’d taken the hit during survey, was to collect data for 12 months (this particular facility is located in an area that has four seasons—if you’re looking at a similar situation, but you only have, say, two seasons, you might be able to get away with fewer than 12 months of data) and then make the determination that monitoring only need be occurring in one location in this space. As an additional protective measure, I also suggested they might consider submitting data to the folks at the Joint Commission Standards Interpretation Group and query whether the consistency of data supports the monitoring conditions in the entire suite and not having to monitor in each space. Surveyors are more frequently arriving with past survey results, so it’s important to make sure you are appropriate and consistently managing past findings—you don’t want to be in a position in which previously noted conditions have not been corrected.