QC for Apheresis Platelets (Leukocyte Reduced)

[Keystone]

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)?

[Cliff]

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.

[Art]

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.