CAP standard TRM.40130 is a new standard that deals with alternative control procedures. It states "If the laboratory performs test procedures for which control materials are not commercially available, there are written procedures for an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be recorded."
We use the Ortho Confidence system for gel. We also use AB Plasma (we aliquot one unit of expired FFP and use it until gone) for our reverse type in confidence cell 1, to test the buffer part of the card and also to test our screening cells in the IGG card to make sure they come up negative.
If you use the Ortho system, do you test your buffer cards (or last 2 cells in the ABO RH Reverse card) and IGG cards in the same way?
It sounds like this new standard applies to what we are doing, correct? We don't have a procedure, but we do monitor and review. We even do a 20 sample crossover before it is put in use.