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You cannot use E2121 for all of them. Each of those frozen products have a corresponding thawed 24hour and a thawed 5 day plasma code of their own. You have to use those. We go straight from frozen to 5 day thawed so we only use those two. Here is a screen shot of our database.

It drives me nuts when I go to a talk and the person speaking says we all make competency too hard. It is hard, it's really hard. I don't care if you have 5 staff or 50, it's hard. That said, we've tried to make it as simple as possible while still trying to make it a value-added process. First, follow the CLIA rules, period. (<-- link and attached) Next, follow the rules of all your inspectors / surveyors... We are FDA, AABB, and TJC, and DPH for NRC. For TJC they define annual and 6 months... Follow their rules. DPH says AABB is law in my state, follow their rules. When we created our competencies, we added a [1], [2],... after each element so we could show our inspector what element was being met by what. It was a little extra work one time but saves us during an inspection. If you're fortunate enough to have an electronic system (we recently moved to MediaLab), yay, otherwise, ensure you've reviewed the heck out of your completed forms. Try to design them so it's easy to see if you have any blanks. Inspectors have an easy time finding things that should have been signed. Again, it's far from easy. We, like many places, are understaffed and overworked, and we have a large Blood Bank, so it's hard. In a perfect world we'd have at least a 1/2 an FTE to manage this program, but like most other places, we need to absorb it as another task to be completed. CLIA_CompBrochure_508.pdf