Design Requirements for Clean Area

Q: What are the ventilation, air exchange and air pressure standards for an area in a very old basement that is being used to sanitize equipment in a hospital facility? There is a very small area that is used for cleaning and sanitizing with disinfectants that is right next to the clean storage of these equipment pieces after they are cleaned. Is there also a certain type of flooring that should be used to prevent spores from harboring in cracks in the tile? There is no separation from clean to dirty, passing through the clean area with soiled equipment to get to the sanitizing area. How can this be corrected? I want this area to be compliant and my staff safe.

A: For design requirements, you would be expected to comply with your state and local authorities, as well as the 2010 FGI Guidelines, as applicable. I cannot tell you what your state and local requirements are (they often follow the FGI Guidelines), but here is what the 2010 FGI Guidelines require for ventilation for new construction:

Clean workroom or clean holding: 

  • Positive air pressure;
  • 2 minimum outdoor air changes per hour (ach);
  • 4 minimum total ach;
  • No requirement to exhaust air to the outdoors;
  • No restrictions regarding air recirculated by means of room unit;
  • No restrictions on design humidity thresholds;
  • No restrictions on design temperature thresholds.

Soiled workroom or holding area:

  • Negative air pressure;
  • 2 minimum outdoor ach;
  • 10 minimum total ach;
  • All room air must be exhausted to the outdoors;
  • No recirculating the air by means of room units;
  • There are no design RH thresholds;
  • There are no design temperature thresholds.

Sterilizer equipment room:

  • Negative air pressure;
  • 10 minimum ach total, without any outdoor air requirements;
  • All room air must be exhausted to the outdoors;
  • No recirculating the air by means of room units;
  • There are no design RH thresholds;
  • There are no design temperature thresholds.

The flooring would have to be cleanable with seams that cannot trap dirt, such as welded seams on VCT. There are other products available that would work as well. You have a real problem having soiled equipment pass-through the clean area. These different areas have to be separated physically, otherwise you will not be able to meet the ventilation requirements above. Sounds like you need the assistance of a design professional. I suggest you start with an architect who has experience with healthcare facilities.

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.