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Do you perform apheresis QC per instrument or per instrument type? 6 members have voted

  1. 1. Do you perform apheresis QC per instrument or per instrument type?

    • Per instrument type (e.g.- Trima, Alyxx, etc.)
    • Per instrument (e.g.- Trima#1, Trima#2, etc.)

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comment_14336

Wondering about your interpretation of the regulatroy requirements governing performance of QC on apheresis products. Do you interpret the standard to mean QC is to be performed per instrument or per instrument type (e.g.- Trima, Alyx, Haemonetics, etc.)? Please let me know what you think. Thanks.

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comment_14366

(Collection center answer) Do you mean for example, if we are to do 25 alyx QC per month, we do 25 per machine? If so...no we do not. If we are required to do 50 QC per month, we make sure that some of our units are from each machine. We do not want an inspector to later say "How do you know you have QC'd each machine". We start off each new period with the instructions to draw one from each machine. We are worried that someone may say we are "picking" our units, but the instructions are "The first unit of the day" from that machine so we will see in the future how that goes over. If we randomly pull units as they come in, we couldnt make sure each unit is being QC'd.....so what do you do? Nice to see other replies on this as we are not 100% happy with our solution. Hope this helps.

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