Are fingertip sampling and surface sampling required in CAIs and CACIs?
Yes. Sampling should be incorporated into an overall Quality Improvement Program that measures the competency of the worker and the effectiveness of the cleaning and disinfection process. 89. For initial sampling, 3 samples with 0 CFU are required but the table for Microbiological Action Levels sets the action level as >3. Can you clarify the requirements for glove finger tip sampling? The initial sampling is to demonstrate the training and garbing competency of personnel training prior to compounding. Compounding personnel must be able to don sterile gloves without contaminating them. The action level of 3 is the maximum allowable CFUs on gloves during actual compounding activities. 90. A pressure gauge is required to monitor the pressure between the buffer area and the ante-area, and also between the ante-area and the main pharmacy room. Does this mean that we need two pressure gauges for the IV room? Yes.
