RSSAll Entries Tagged With: "ASHRAE 170"

It’s been a long time: Revisiting an EOC perennial

Setting the wayback machine for the dark ages of safety (well, 2011 or so), we come to the last time we covered the monitoring of temperature and/or humidity in surgical spaces, etc. (if you want to revisit those halcyon days, you can head here). The funny thing about this most ancient of history is that, since then, while there have been changes in applicable codes and references, the “new” stuff comes up a little short when it comes to providing guidance relating to monitoring temperature and humidity, particularly as a function of frequency (I suppose we could call it the frequency function if we were being excessively alliterative). The baseline response (catty though it may be) is that you should be monitoring conditions on as frequent a basis as is required to ensure appropriate conditions, given due consideration of the systems you have in place, any manufacturers’ recommendations (which are also not particularly helpful in determining monitoring frequencies), and regulatory guidance (ASHRAE 170; state mechanical code) as applicable.

Ultimately, this all comes down (back?) to the requirements as outlined in the Conditions of Participation, which gives us:

  • 482.41(c)(4) – There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas.

So, you might well ask, what are those “other appropriate areas”? For that information, we need to head over to the State Operations Manual/Interpretive Guidelines, which is where the skeleton of the Conditions of Participation is fleshed out into the survey process.  And what do we find there? Take a look:

Interpretive Guidelines §482.41(c)(4) – There must be proper ventilation in at least the following areas:

  • Areas using ethylene oxide, nitrous oxide, glutaraldehydes, xylene, pentamidine, or other potentially hazardous substances;
  • Locations where oxygen is transferred from one container to another;
  • Isolation rooms and reverse isolation rooms (both must be in compliance with Federal and State laws, regulations, and guidelines such as OSHA, CDC, NIH, etc.);
  • Pharmaceutical preparation areas (hoods, cabinets, etc.);
  • Laboratory locations; and
  • Anesthetizing locations. According to NFPA 99, anesthetizing locations are “any area of a facility that has been designated to be used for the administration of nonflammable inhalation anesthetic agents in the course of examination or treatment, including the use of such agents for relative analgesia.” NFPA 99 defines relative analgesia as “A state of sedation and partial block of pain perception produced in a patient by the inhalation of concentrations of nitrous oxide insufficient to produce loss of consciousness (conscious sedation).” (Note that this definition is applicable only for Life Safety Code® purposes and does not supersede other guidance we have issued for other purposes concerning anesthesia and analgesia.)

Interesting to note that the list here does not quite match up with the totality of issues for which The Joint Commission is citing folks (clean and soiled utility rooms being first and foremost, though I know that it is merely an extrapolation of the ASHRAE 170 requirements). Also interesting to note that, sterile supply and processing is not specifically mentioned, but (again), I think we can see where the importance of maintaining those spaces drives out of ASHRAE 170.

But what’s the endgame when it comes down to the survey process? The general unhelpfulness of the answer will not surprise you:

  • Review monitoring records for temperature to ensure that appropriate levels are maintained
  • Review humidity maintenance records for anesthetizing locations to ensure, if monitoring determined humidity levels were not within acceptable parameters, that corrective actions were performed in a timely manner to achieve acceptable levels

So (still!) if you follow the temperature and humidity rabbit all the way back to the Interpretive Guidelines, we see that the surveyors are instructed to ask to see “records,” so it all comes down to what you can produce in terms of a deliverable that reflects that temperature and humidity levels are appropriate/acceptable and levels that were not within acceptable parameters (which they do not define, so you better have a sufficiently flexible definition) were dealt with in a “timely manner” (again, not defined, so it’s up to you, based on your risk assessment).

As a closing thought on this (for now), apparently there are some folks that have determined that they don’t have to monitor both elements (temperature and/or humidity) and if there is nothing else that you derive from this week’s missive, it is this: You gotta do both! You can determine the frequency (though I would recommend at least daily—if you recall, the question that started this conversation in 2011 was whether quarterly monitoring was sufficient), but you clearly want to be able to use performance data to make that determination (and from whence comes that data—regular monitoring). You can determine what is acceptable/appropriate (based on utilization, types of procedures, preference of surgical staff, etc.); you can determine what is a timely timeframe for corrective action (Timely Timeframe—that sounds like a name Stan Lee would’ve loved). But you gotta do the monitoring; to do otherwise risks too much if the CMSers darken your door (which is becoming a much more common occurrence).

One last quick note for this week: There seems to be a bit of a groundswell of survey findings relating to hand sanitizer dispensers not having drip trays. It would seem that there must have been some recent mention of this in surveyor education as there are some surveyors indicating that this is a new requirement, but the overarching requirement has been in place for rather a while. To whit (and, again, the State Operations Manual becomes then go-to resource):

  • 482.41(b)(9) (ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls; with the associated Survey Procedure being: “Determine whether the hospital maintains the ABHR dispensers in accordance with the manufacturer’s guidelines, or, if there are no manufacturer’s guidelines, that the hospital has adopted policies and procedures to ensure that the dispensers neither leak nor the contents spill.”

Now, nowhere in the regulatory canon does it discuss drip trays (though, when you come right down to it, how else are you going to manage the threat of leaks/drips, especially over hard-surface flooring?). But apparently drip trays have become the “gold standard” for leak/drip control, so you might want to keep an eye on this for the future. These things do tend to spread and who wants to be chasing this during a (or post) survey? Not me.

There’s no such thing as someone else’s code: Infection control and the environment (again…)

Periodically, I field questions from folks that require a little bit (well, perhaps sometimes more than a little) of conjecture. Recently, I received a question regarding the requirements in ASHRAE 170-2008 regarding appropriate pressure relationships in emergency department and radiology waiting rooms (ASHRAE 170-2008 says those areas would be under negative pressure, with the caveat that the requirement applies only to “waiting rooms programmed to hold patients awaiting chest x-rays for diagnosis of respiratory disease”).

Right now, that particular question is kind of the elephant in the room from a regulatory perspective; there is every indication that The Joint Commission/CMS are working their way through ASHRAE 170-2008 and have yet to make landfall on this particular requirement—as far as I know—feel free to disabuse me of that notion. The intent of the requirement (as I interpret it) is to have some fundamental protections in place to ensure that an isolated respiratory contagion does not have the capacity of becoming a legitimate outbreak because of inadequate ventilation. Now, you could certainly use the annual infection control program risk assessment to identify whether your waiting rooms are “programmed to hold patients awaiting chest x-rays for diagnosis of respiratory disease” based on the respiratory disease data from the local community (and you might be able to obtain data from a larger geographic area, which one might consider a “buffer zone”).

Best case scenario results in you being able to take this completely off the table from a risk standpoint, next best would be that you introduce protocols for respiratory patients that remove them from the general waiting rooms (depending on the potential numbers, you may not have the space for it), worst case being that you have to modify the current environment to provide appropriate levels of protection. The notation for this requirement does provide some relief for folks with a recirculating air system in these areas, which allows for HEPA filters to be used instead of exhausting the air from these spaces to the outdoors, providing the return air passes through the HEPA filters before it introduced into any other spaces.

Knowing what I do about some of the ventilation challenges folks have, I suspect that it may make more sense to pursue the HEPA filtration setup than it would be to try to bring each of the spaces under negative pressure, but (going out on a limb here) that might be a question best answered by a group of knowledgeable folks (including an individual of the mechanical engineering persuasion) as a function of the (wait for it…) risk assessment process.

Ultimately, it comes down to what the Authority Having Jurisdiction chooses to enforce; that said, it might be worth having someone work through your state channels or by putting the question to the Standards Interpretation Group at Joint Commission (I suspect that their response would not be not particularly instructive beyond the usual “do a risk assessment” strategy, but there is a new person running the Engineering group at TJC, so perhaps something a little more helpful might be forthcoming). At any rate, as noted above, I’ve not heard of this being cited, but I also know that if there’s an outbreak tied to inadequate ventilation somewhere, this could become a hot topic pretty quickly (probably not as hot as ligature risks at the moment, but you never know…).

Try not to breathe

I know that we’ve visited (and revisited) this topic once or twice over the last little while, but it continues to be (at least in my mind’s eye), the most significant vulnerability for every healthcare organization that uses The Joint Commission (TJC) for accreditation services: the management of temperature, humidity, and air pressure relationships (THAPR—How’s that for an acronym? It’s pronounced “thapper” or, if you’re from Boston, “thappah”) in the care environment. Folks continue to be cited for issues in this regard; other folks are jumping on board (a little late, but better than never) but are in the closing section of their survey window; and others still have not quite grasped the importance of having a stranglehold (if you will) on those areas for which there are THAPR requirements. Those of you who’ve accompanied me in the blogosphere for a while know that I do not do a lot of product marketing (even my own product), but I will encourage you once again: if you do not have a copy of ASHRAE 170—2008 Standard for Ventilation of Health Care Facilities, you are not in possession of what may be (at least at the moment) the single most important slab of information in the physical environment pantheon (yes, we will always have a place in our hearts for the 2000 edition of NFPA 101 Life Safety Code®; probably for too long, based on the ever-so-slow-to-adopt new things track for the 2012 edition).

While I’m not suggesting that you memorize ASHRAE 170 (it is fairly brief and those of you with eidetic memories probably won’t be able to keep yourselves from doing so), I am suggesting that you need to go to the table on pages 9-11 and start identifying the areas in your organization that have specific requirements and start figuring out where you stand in relation to those requirements, and perhaps more importantly, come to some sort of sense as to how reliably your systems can support those requirements. And you really need to go through the entire table; TJC certainly is. Just last week, I heard of pressurization issues in lab and pharmacy areas (labs are to be under negative pressure; pharmacies under positive) that added up to condition-level survey results.

Make sure you know where you have sterile storage in your organization; sterile storage areas are to be under positive pressure and should be monitored for temperature and humidity. But the reality of the situation is that you have sterile supplies in locations throughout your organization, so you have to define what does and what does not represent sterile storage (my best advice is to coordinate with your infection control and surgical folks on this one—it’s beginning to look a lot like a risk assessment—everywhere you go!). That way, you have a solid foundation for determining what needs to be managed from an environmental standpoint; it’s the only thing that will keep you out of the hottest water during survey.

Two final thoughts before signing off for this week; make sure that routine bronchoscopies are being performed under negative pressure (urgent or emergency bronchoscopies may not have quick enough access to the appropriate environment, so make sure that folks know what protective measures need to be considered to protect themselves and the patient when they’re aerosolizing potential bugs). There are still instances in which this is being cited during survey, so I think my best advice is to go and check with your respiratory therapy folks, as well as the folks in surgery, critical care, infection control, etc., and ask the question: Are bronchoscopy procedures being performed, and if so, where are they being performed? Then you can start walking it back to a point where you can be assured that they are being done in an appropriate environment.

The last thing is a brief reminder that the process for the survey of the physical environment (again, as it is currently being administered) involves all of the survey team – when it comes down to this are of concern, there is no more “clinical” versus “non-clinical”; everything that occurs within the four walls of your organization are patient care activities, direct or indirect (you may have noticed TJC has been splitting its performance elements using that very same language). Coordination of the various hospital services, etc., has never been more heavily scrutinized and never been found more wanting during survey. There is a paradigm shift afoot, my friends, and we need to get on the good foot.