Allow Historical Antigen Phenotypes on tie tag

[trondint]

Hello,

Is anyone aware of any specific regulation/FDA guidance that requires a donor center to retype donor antigens in order to include them in the unit's tie tag/label? Can historical antigens be included on the label if they have not been retyped with the current donation? (I know that it's a better business practice to confirm the type; just looking for any regulation that REQUIRES that retyping of donor antigensbe done by the donor center.)

Thanks!

[Malcolm Needs ☆]

It is is most certainly a rule that only current typing is allowed on the pack in the UK.

The MHRA would go bananas if we put historical grouping on the packs (unless the typing has been done twice by DNA).

[khalidm3]

Here no historical antigens/grouping are allowed to label, Historical records are to verify current testing, to avoid repeat sample or procedure.

[adiescast]

I could not find a requirement, but I would think it would be misbranding if the label did not state that the result was based on historical records and not current testing. Otherwise, a rational person reading the label would assume that it was based on testing from the current unit.

[heathervaught]

I have been looking for a reference...I have this statement in an e-mail, but I can't find it anywhere online.

"Please see below for Q & A from ATAG meeting.

Question: May historical RBC antigen phenotypes be listed on tie tags?

FDA Response: No, historical RBC antigen phenotypes may not be included on the tie tag. The tie tag should only be used to include test results from the current donation. In addition, listing historical RBC antigen phenotypes on a tie tag is not consistent with the labeling regulations in 606.121©(12) and 606.121(j). Additionally, the blood bank must have a way to convey the historical RBC antigen phenotypes to the consignee."

[khalidm3]

I have been looking for a reference...I have this statement in an e-mail, but I can't find it anywhere online.

"Please see below for Q & A from ATAG meeting.

Question: May historical RBC antigen phenotypes be listed on tie tags?

FDA Response: No, historical RBC antigen phenotypes may not be included on the tie tag. The tie tag should only be used to include test results from the current donation. In addition, listing historical RBC antigen phenotypes on a tie tag is not consistent with the labeling regulations in 606.121©(12) and 606.121(j). Additionally, the blood bank must have a way to convey the historical RBC antigen phenotypes to the consignee."

Thanks for references.

[trondint]

Thanks Heather...I have the exact same email from the ATAG meeting. I just wish I could find some more concrete information.