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A. Based on observations, staff interviews and review of documentation for immediate use sterilization (formerly known as "flash sterilization", a sterilization process designed for use in the Operating Room for emergent and immediate use of a forgotten or unanticipated instrument or one that was accidentally dropped on the floor), the Hospital failed to consistently enforce hospital policies that governed the control and prevention of infection, specifically the implementation of policies for immediate use sterilization.

1. Observation in the Operating Room (OR) and the Central Supply (CS) Service on 5-16-12 between 11:30 A.M. and 1:15 P.M., revealed that immediate use sterilization was used to reprocess selected surgical instruments. According to the recommendations of the Association of Perioperative Registered Nurses (AORN) and Association of Medical Instrumentation (AAMI) immediate use (flash) sterilization should only be used if there isn't enough time to process medical devices by the preferred wrapped or container method and the item is needed for immediate use. Flash sterilization should not be used as a substitute for insufficient instrument inventory.

According to the hospital policy titled "Documentation & Procedure for Testing Immediate use/Pre-vacuum Autoclaves in the OR", documentation of the immediate use load cycle must contain 9 specific documented parameters to ensure complete record-keeping for each immediate use load. Review of the immediate use print-out tapes for May 2012 on autoclave "A" revealed that neither the contents of the load cycle nor the biological indicator result was recorded as required by the hospital policy and industry standards.

B. Observation in the OR on on 5-16-12 between 11:30 A.M. and 1:15 P.M, revealed that two Liquid Chemical Sterilant Processing Systems were used to reprocess select items. According to the manufacturer's recommendations, a chemical indicator (a monitoring strip that verifies the minimum recommended concentration of the sterilant has been met to achieve liquid chemical sterilization) is used with each load cycle. When the bottle of chemical indicators is opened, it must be dated for use up to six months after opening or until the manufacturer's expiration date, whichever occurs first.

It was noted that two opened bottles of chemical indicators bottles used for sterilant monitoring had not been labeled with the date of opening.