Crash Course in United States Pharmacopeia Standard 797 (USP 797): Investigation of Positive Sterility Cultures from a Hospital Pharmacy Preparation

Clean Room Observations Inconsistent use of scrubs, head and shoe covering, mask, gloves, cuffed Increase traffic in and out of room gown Frequent personnel conversations during preparation Reeducate staff on proper use of attire Reduce traffic in and out of room Limit conversation Review aseptic technique Utilize mask and aseptic technique competency videos Cleaning and Disinfection Routine cleaning procedures; frequency and type Consider use of ultra violet C light disinfection machine Environmental Quality Control Air exchanges not verified Recommended temperatures periodically exceeded Humidity readings not obtained by automated system Settle plates utilized for environmental sampling Outside agency performs air sampling Initiate routine parameter testing and adjustment by engineering for air exchanges, temperature/ humidity Discontinue use of settle plates Purchase volumetric air sampling device for inhouse testing to facilitate increased testing when needed Sterility Testing Growth media requirements and incubation periods not updated by laboratory Laboratory reviewed and made adjustments to media type, incubation temperature and incubation period Communication Protocols Policies lacked communication protocol for positive test results of routine sampling and sterility testing Notify Infection Control and Prevention for all positive environmental and sterility testing Notify Risk Management when patients have Poster Abstracts / American Journal of Infection Control 41 (2013) S25-S145 S143