A question from Jojie Acosta:
After a lab inspection we are required to perform normal whole blood controls each day of testing for our PFA-100. Previously we only did the daily self-test on the PFA, though we ran QC on every shipment of cartridges.
We currently have difficulty finding normal donors for the required daily QC during off shifts or on weekends. Also the number of suitable normal donors are limited. Any suggestions on how to address the required daily QC for the PFA-100? Normal donors are hard to find.
Dear Jojie Acosta, thank you for your question. You don’t identify who performed your lab inspection, but I think the assessor may have been working from a missed or obsolete communication. The package insert for the PFA-100 specifies “wet QC” on new lots only, thus you were doing your QC correctly. You may wish to contact your Siemens representative in case you need additional documentation. Good luck with the inspection team! Geo.