For those of you out there who collected apheresis platelets (leukocyte reduced), regulations state you should QC test 4 units per month for WBC count. Is it 4 units per machine or 4 units per month total (machine doesn't matter)?

We used to have Trima and Spectra and we did 10 products from each. Now we have just Trima and do 10 products from those.

I don't feel it's necessary to QC each instrument. We validated each intrument with 20 products before we put thme into use.

The baseline from the 21 CFR 640.25 is four collections/month. I believe that was refined into (from the FDA Guideline for the Collection Platelet Pheresis 10/88 and other) 4 collections per machine type, per collection site and per product type.

I work at a Blood Center and both the FDA and AABB looked at our QC practice and were satisfied with them.