07-13-2011 01:04 PM - edited 07-13-2011 01:51 PM
Thanks for joining our webinar, "Who Says You're Competent to Compound CSPs? Evaluating Your Sterile Compounding Training and Competency Program" with Eric Kastango.
Have a question for Eric? Post it here and he will do his best to answer your question.
07-13-2011 01:34 PM
What's the best process for glove fingertip sampling if using CAI? We only have one set of sterile gloves that are changed daily and attached to hood. We can't wear a 2nd pair of gloves because they "stick" together. Our current process is to do sampling at end of day, but several people could have been in hood so I don't feel like it adequately reflects the specific person's technique.
07-13-2011 01:52 PM
Here are question from our live presentation:
Q: What if you have isolator hoods, when do you perform glove fingertip sampling?
Q: We utilize a MIC for IV preparation, how can the glove tip testing be accomodated in this situation?
Q: Is there a process for doing fingertip sampling in a CAI? Is it necessary to don sterile gloves in a CAI?
Q: Why do you prefer plates over paddles for GFT?
Q: Please clarify when 3 CFU's are allowed during testing. It should be ZERO CFU's x3 for fingertip testing, so when is it allowed to have 3 CFU's??
Q: Baxa star training, who should go?
07-14-2011 11:24 AM
The slide detailing "ongoing basis" indicates that sample is obtained during preparation of personnel medial fill units. Does this mean that the individual being evaluated places her hand in the plate prior to beginning the first manipulation of the media fill test? How does one reconcile this with the chapter that states ".......and after completing the media fill preparation (without applying sterile 70% PIP) in order to assess the adequacy of aseptic work practices......"
07-14-2011 01:38 PM
The fingertip sampling is done after the media fill but before spraying the gloved hands with sterile IPA. Not sure if I misspoke or there is a misunderstanding.
07-14-2011 01:47 PM
Great questions and working with an isolator requires a couple of additional considerations. Not sure why the gloves are sticking together but you should be donning a second pair of sterile gloves over the ones on the gauntlet. Typically going up 1/2 to one full size will make the double-gloving process easier and comfortable for the operator. Isolators need to be treated like a laminar airflow workbench. You wouldn't have employees take of their sterile gloves and leave them for the next person working in the hood to put prior to compounding. You should be put on a pair of stationary (sterile or nonsterile) gloves that will be changed daily but a second pair of sterile gloves that are dedicated to the person working in the isolator. This way you will be able to see how good the person's technique is donning a second pair of gloves when you do your gloved fingertip sampling.
07-15-2011 08:53 AM
I must be misunderstanding. I though the intent of sampling was to assess competency in hand hygiene and garbing procedures? Doing it after the media fill doesn't assess this but rather it assess how well you were able to sanitize your components (vials, syringes, needles) that you bring into the hood to prepare your product i.e aseptic work practice.
07-15-2011 11:28 AM
There are two phases to this assessment. First is the hand hygiene and garbing procedure. This is done through direct observation and documentation using the checklists (if you like) in the Appendix of the chapter. During this first phase, you assess the operator's ability to perform proper hand washing skills along with garbing skills which includes aseptically don a pair of sterile gloves without any CFUs. Once an operator has demonstrated this proficiency, then the ongoing gloved fingertip sampling can be incorporated as part of the operator's media fill.
Having disinfected vials and surfaces and handling them properly and avoiding touching unclean surfaces (hair nets, face masks, chairs and other surfaces) during an aseptic media fill is a core metric of proper and ongoing aseptic technique and the status of your gloved hands after you have done a lot of handling and manipulating will be a robust measurement of aseptic technique in my opinion. Let me know if this clarifies your question. Thanks.