Temperature and Humidity - Monitoring Requirements for Sterile Supply Storage Areas

What are the requirements for temperature and humidity monitoring in areas in which sterile supplies are stored ?

Centralized sterile supply storage, in procedural areas where large volumes of sterile supplies are kept, require a program for management of proper temperature and relative humidity (RH) levels in accordance with the Facilities Guidelines Institute (FGI) Guidelines for Design and Construction of Hospitals and Outpatient Facilities.  Examples of these centralized sterile storage areas include surgery suites, C-section suites, endoscopy suites and cardiac catheterization suites. Some emergency departments may perform high-level trauma cases that would require a significant storage of sterile supplies.

Examples of large volume centralized locations are sterile processing areas and central stores. Examples of temperature and RH management include electronic monitoring through a building automation system and manual monitoring by observation of a measurement device at the site, with some established process to contact facilities management personnel to correct deficiencies (alarming, staff feedback).

Decentralized locations where small quantities of sterile items are stored close to treatment/procedure areas that are outliers to areas described above can be managed through staff surveillance during the regular course of performing their duties. Examples of these decentralized locations could include labor and delivery areas without C-section procedures, imaging areas, emergency department (small storage), etc. Staging of sterile items outside of procedure room (like an operating room) for a limited period of time would also apply.

Knowledgeable staff should examine sterile supplies before use, and should contact facilities management personnel if space temperature and RH levels are determined to be inadequate. A process method for temperature, relative humidity (RH) and sterile product management is required, but specific measurement/documenting of temperature and RH is not prescriptive for decentralized sterile product deployment.

For consistency, temperature and relative humidity management process decisions should be made based upon the criteria stated above, not the type of sterile items stored or the packing method of sterile items stored. However, if the organization assesses that the type of decentralized storage requires a more robust management and monitoring process based on criticality, then methods described for centralized storage should be implemented.

Deficiencies relating to temperature and relative humidity management are scored at EC.02.05.01 EP 15 (based on the FGI edition used at the time design) for critical care areas designed to control airborne contaminants and at EC.02.05.01 EP 16 for non-critical areas.

Organizations should determine the appropriate temperature and humidity (and ventilation) parameters based on the design criteria at the time of construction (see also the note in EC.02.05.01 EP 15) For new, renovated, or altered spaces, organizations that use the Joint Commission for deemed status purposes must use ASHRAE 170-2008 as referenced in NFPA 99-2012, Chapter 9, effective July 5, 2016. This document is included in the 2010 FGI Guidelines for Design and Construction of Health Care Facilities. Organizations that do not use the Joint Commission for deemed status purposes would use ASHRAE 170-2013 as referenced in the 2014 FGI Guidelines for new, renovated, or altered spaces.
 
Last updated on February 22, 2018
Manual: Hospital and Hospital Clinics
Chapter: Environment of Care EC

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