Temperature and Humidity Log

Q: How often are we required to log the room temperature, humidity levels, and air changes in our OR’s? Is this required daily, each shift, hourly? What about the other rooms like Sterile Processing and others, how often do we need to log them?

A: It depends on your accreditation organization, and to a lesser extent, the surveyor.

For Joint Commission, their standard EC.02.05.01, EP 15 says in critical care areas (i.e. operating rooms, special procedure rooms, isolation rooms, sterile supply rooms, etc.) the ventilation system must provide appropriate temperature, humidity, air-pressure relationships, and etc., based on the edition of the FGI guidelines used at the time of design. This standard does not say how often these factors need to be checked. But there are some other professional organizations such as AORN and CDC that offer opinions on how frequent. Joint Commission surveyors will expect the hospital to have adopted some frequency that is consistent with these other professional organizations, or at least have conducted a risk assessment to determine how frequent these issues need to be checked and logged.

For non-critical care areas, such as soiled utility rooms and clean utility rooms, incorrect air pressure relationships would be scored under EC.02.06.01, EP 1, but this standard is like EC.02.05.01 in that it also does not say how frequently these rooms need to be checked. Again, surveyors would expect you to follow professional organization guidelines or your own risk assessment for testing frequency.

If you’re HFAP accredited, standard 11.07.03 covers all temperature, humidity and air-pressure relationship requirements, and similar to Joint Commission, HFAP does not specify the frequency of checks. They also identify AORN and FGI Guidelines as standards to follow, but they will accept a facility-based risk assessment to determine testing frequencies, within reason.

It is up to the individual surveyors to determine if your risk assessment is acceptable and reasonable. If they believe it is, then you should be fine. If they do not feel it is acceptable, they may discuss this issue further and a finding may be cited.

As far as DNV goes, I believe they are similar to the above.

Temperature & Humidity Monitoring

Q: Where do I find in the code that tells me where required temperature and humidity must be monitored? We have our accreditation organization here, and they mentioned our Sterile Processing and Clean Utility rooms require this monitoring. I have looked at the FGI manual and looked at AHSRAE 170-2008 table which have the guideline perimeters, and this list has several locations with temperature and humidity perimeters. Are these all required to be monitored? I haven’t found any specific reference in the Life Safety Code that says which areas are required to be monitored. Any help would be appreciated.

A: You won’t find it in the Life Safety Code, because it does not directly regulate air temperature, humidity, or air pressure relationships. This is left to other standards, guidelines and regulations. For instance; CMS has a standard for acute-care hospitals under §482.41(c)(4) that says “There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas.” In the Interpretive guidelines section for this standard it says acceptable standards such as AORN and FGI should be incorporated into hospital policy. The accreditation organizations will have standards of their own that compliment what CMS is saying. So, some sort of standard must be used by the hospital. If not the FGI Guidelines (which references the ASHRAE 170 standards on design of ventilation), then some other standard must be used. This means if the state or local AHJ had more restrictive requirements you would have to comply with those requirements. It appears your AO is expecting the hospital to meet at a minimum, the FGI requirements for ventilation.  To answer your question, yes these other locations must be monitored to ensure you have the proper HVAC ventilation. If you don’t monitor them, then how do you know if they are correct? But you won’t find this information referenced in the Life Safety Code.

Temperature and Humidity Logs for Surgery Hallways

Q: During our mock inspection this week at our hospital, they are asking for temp and humidity checks in the surgery hallways. We do monitor the surgery rooms and center core room, along with sterile storage and clean rooms. Is there a regulation or code to monitor the hallway in any part of a hospital?

A: While there are no direct and specific standards that require the monitoring of temperature and humidity in a surgery hallway, it could be an issue that the mock surveyor is concerned about. If you’re Joint Commission accredited, they do have a couple of standards that address this issue:

EC.02.06.01, EP 13

This standard requires the hospital to maintain proper ventilation, temperature and humidity levels suitable for the care, treatment, and services provided. If the mock surveyor believed the temperature or humidity levels in the surgery hallway were not suitable then that would be a legitimate finding. But, this standard does not require the hospital to maintain logs that they are constantly monitoring the temperature or humidity levels.

EC.02.05.01, EP 15

This standard requires the hospital to ensure the ventilation system provides the appropriate air-pressure relationships, air-exchange rates, and filtration efficiencies in areas designed to control airborne contaminants. A note underneath this standard explains that areas designed for the control of airborne contaminants include operating rooms, special procedure rooms, delivery rooms, etc. It does not specially include surgery hallways as an area designed for the control of airborne contaminants, but it would fall under the provisions of air-pressure relationships to the ORs and clean or dirty utility rooms.

It all falls back on what the mock surveyor saw, and why they cited it. If there was a serious deficiency with temperature or humidity in the surgery hallway then the finding appears to be legitimate. However, if the mock surveyor’s opinion is you should be monitoring and logging the temperature and humidity in the surgery hallway just because the mock surveyor thinks it is a good idea, then that does not seem to be a legitimate finding. I suggest you appeal this finding.

Humidity Control in Sterile Storage Rooms

Q: What supplies qualify as having to be stored in a “sterile storage” room? The 2014 FGI Guidelines for Design and Construction of Hospitals and Outpatient Facilities requires these rooms to control humidity levels to not exceed 60% relative humidity (RH). While one can presume a “sterile storage” room is where sterile supplies are stored, what constitute as a sterile supply?

We had a consultant onsite from a large and prestigious healthcare consulting organization that said sterile supplies include purchased supplies such as band-aids and IV kits. We have these types of supplies on every nursing unit and if we have to control our RH in every nursing supply room, that would be very costly and unreasonable.

What would you recommend?

A: First let me say that the opinion of a consultant no matter where the consultant is from is the opinion of that consultant and not of any authority having jurisdiction (AHJ). Therefore, what a consultant says is pretty much his/her own opinion; not that his/her opinion is necessarily wrong, but it doesn’t mean it is gospel.

The Centers for Medicare & Medicaid Services (CMS) standard 482.41(c) (4) states, “There must be proper ventilation, light, temperature controls in pharmaceutical, food preparation and other appropriate areas.” In this standard there is no reference to sterile storage, although it does say ‘other appropriate areas”, In the Interpretative Guidelines section of the CMS standard, they refer to the FGI guidelines as being “acceptable standards”.

The Joint Commission standard EC.02.06.01, EP 13 just says the hospital maintains the ventilation levels for the suitable care, treatment, and services provided. It says even less about humidity levels than what CMS standards say, although the next standard (EC.02.06.05) does reference the FGI guidelines for new construction.

The expectation is the accreditation organization and the state agency surveying on behalf of CMS would expect the hospital to maintain the ventilation parameters that were required at the time the room, area or building was designed, or last renovated.

Looking at the 2010 and 2014 FGI guidelines, sterile storage is a sub-heading of “Central Medical and Surgical Supply”, and requires humidity levels to not exceed 60% RH. In the 1996-1997 edition, the 2001 edition, and the 2006 edition of the guidelines the humidity levels for ‘sterile storage’ was listed as “maximum 70% RH”.

The term ‘sterile storage’ is not defined in the FGI guidelines as far as I can see, so in cases like this when the standards are not well defined, it is up to the AHJ to define them. It is my opinion that common supplies such as bandages, and IV kits would not qualify for ‘sterile storage’ applications, but then my opinion doesn’t count either.

Sterile storage is typically defined as an area which processes, disinfects and sterilizes multi-use surgical equipment. Monitoring and controlling the humidity of every storage location within a facility for routine medical supplies (e.g., band-aids), seems to be excessive and an unreasonable hardship.

I would suggest that you ask your accreditation organization how they define ‘sterile storage’. Do they consider bandages and IV kits to be required to be stored in humidity controlled areas? I would think they would not since it would be such a financial burden on healthcare organizations.

Humidity and Temperature in Central Supply

Q: I’m working with a hospital on their temperature and humidity monitoring in their Central Supply area, and was wondering what specific parameters they should follow in the two different areas of Central Supply/Storage; and Decontam Area? Should the FGI Guidelines be followed or should the AAMI guidelines be followed?

A: If the organization is CMS certified, all CMS requires on the subject is found in standard §482.41(c)(4) which says “There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas.” In their Interpretive Guidelines section, they identify the FGI Guidelines as an acceptable standard to incorporate. While they do reference other standards, such as AORN, OSHA, CDC, and NIH, they do not mention AAMI. So, it would seem acceptable to use the FGI Guidelines in this application. Could your client use AAMI guidelines instead? Yes, but they may have to defend this decision (through the use of risk assessments) to surveyors and inspectors.

The interesting thing with CMS is their standard §482.41(c)(4) does not specifically state that the use of the FGI Guidelines are for new construction and renovation only. This has led to some erroneous findings by state agencies performing validation surveys on behalf of CMS whereby surveyors have cited existing conditions that did not meet the more restrictive current edition of the FGI Guidelines. Even in the preface to the current FGI Guidelines, it states that their standards only apply to new construction and renovation, and is not retroactive to existing conditions. CMS has since issued informal communications that the FGI Guidelines only apply to new construction and renovation.

Moving to the Joint Commission standard EC.02.06.05, EP 1, we find that they require compliance with the 2014 FGI Guidelines for new, altered or renovated spaces only; not for existing conditions. HFAP standard 11.07.03 is a repeat of CMS standard §482.41(c)(4) and also references the current edition of the FGI Guidelines. So, it would seem the FGI Guidelines wins by popular affirmation.

When it comes to monitoring, there are differences because the two rooms are not considered to be the same. The Central Supply/Storage is considered a clean room and the Decontam Area is considered a dirty room. If there is an opening between the two rooms, there must be a positive air flow from the clean side to the dirty side.

For new construction:

  • The Sterile Supply/Storage room is required to have a positive air pressure, with a minimum of 4 total air-changes per hour that includes 2 outdoor air changes per hour; and a maximum relative humidity of 60% (no minimum requirements), and a design temperature of 72° – 78° F.
  • The Decontam Area is required to have a negative air pressure, with a minimum of 6 total air-changes per hour that includes 2 outdoor air changes per hour; and there is no maximum or minimum relative humidity required, and a design temperature of 72° – 78° F.

It is important to remember that the current FGI Guidelines are in fact guidelines and not standards. It is very possible that older existing hospitals may not be able to meet these ventilation requirements for new construction. In those cases, it is important to verify what guidelines or standards the ventilation requirements were designed to, and whether or not they are still meeting those original design requirements.

As far as frequency of monitoring… There is not much stated in writing, but Joint Commission seems to expect daily monitoring of air-pressure requirements, which can be easily accomplished through various methods. The least expensive approach is to use a tissue at the bottom of the door to observe whether the air pressure is positive or negative. Other methods utilize inexpensive manual indicators (ball-in-tube, flappers) mounted in the wall near an entrance door, to more elaborate electronic monitoring equipment that would send messages to plant operators when the air pressure is non-compliant.

The air changes per hour rate is much more difficult to monitor, and usually requires manually measuring the air flow at each supply and return/exhaust diffuser with bulky flow-hoods. This is usually done annually, or more often if there have been problems in the past.

Humidity monitoring can be done manually with sling psychrometers; small inexpensive portable battery-operated humidity monitors; or electronic monitoring through the building automation system. The beauty of the building automation system doing the monitoring is it is automatic and there is a record (log) of the measurements; and if there is a reading out of the acceptable range, it automatically notifies the plant operator. The frequency of monitoring temperature and humidity is not stipulated, but it would be reasonable that a surveyor would expect the hospital to have the frequency identified through a risk assessment. I suggest the hospital monitor and log the temperature and humidity daily. Again, it must be documented through a risk assessment to have any validity with a surveyor. If there are other guidelines that recommend more frequent monitoring (such as AORN, AAMI or CDC) then those should be followed.