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Relabelling modified components


VACASE

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We are a transfusion service. When we receive our blood components from our supplier each one has the sticker that states where the blood was collected and processed and their FDA registration number. We have barcoded labels that state, "Modified by:" with our facility name, address and our FDA Reg # that we use when we modify a component (e.g. thaw a frozen plasma unit or pool platelets). Does anyone know if we can place our barcoded label over the collecting facility's label or do both FDA registration numbers have to be visible on the modified unit?

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We are a non-FDA, non-AABB accredited hospital-based transfusion service. (We receive all of our blood products from our blood supplier.) I'm wondering, what is the minimum necessary RELABELING requirements for thawing plasma and pooling platelets? Do we need a "modified by" label too? (We have a digitrax printer, barcode readers, etc for when the computer is working, but I'm worried about fuctioning during a computer downtime.)

So, we're looking into pre-printed labels for the new product codes "pooled plts" and "thawed plasma." But what else would need to be pre-printed for RELABELING during a computer downtime? It looks to me like only certain aspects of the unit label must be "machine readable" (and for our purposes, those should already be taken care of from the collection facility). Will we be ok hand labeling the thawed/pooled expiration date and time?

Thanks for your help!!

Heather

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