Relabelling Thawed Ffp

[MARINA]

We are a small blood bank that supplies only one type of FFP to the patients in our facility. Is is necessary to have another tech check the product before permanently placing the Thawed FFP label over the original frozen plasma label? We are CAP, but not FDA or AABB inspected.

[LaraT23]

We do not have second tech as our policy. We are a bit larger and keep all blood types of FFP in inventory. We change the date in the computer system and put a new label over the old expiration date. I have found not CAP standards for second tech verification.

[David Saikin]

If you are transfusing the plasma within 24 hrs you do not need to relabel it, only change the expiration date. If you use it as thawed plasma with a 5 day expiration, you do need to relabel. You only need a 2nd tech involved if that is your policy . . . there is no standard demanding such (AABB or CAP).

[LaraT23]

We relabel as the expiration date on the bag initially is for the 12 month period from collection. We put a sticker on it to reflect the 24 product from FFP to thawed.

[Mer]

We skip the whole "24 hour" process and simply thaw all our plasma to a 5 day FFP...We are a very large, busy hospital, in which the Med Directors here made that choice, as it is acceptable, and a big time saver for us!

[bbbirder]

If you modifiy a label, you need to have a process to ensure accuracy [check AABB standards 5.1.6.3.1 #5) and #6)]

"5) If a component is modified and new labels are applied, the labeling process shall include a method to ensure the accuracy of all labels includging the donation identification number, ABO/Rh, expiration date (as appropriate), and component labels.

6) The labeling process shall include a second check to ensure the accuracy of affixed label(s) including hte correct donation identification number, ABO/Rh, and expiration date (as appropriate)."

We do a second check of thawed (expiration date), pooled (everything), and split/aliquoted products. If labeled wrong and you issue it, reportable to the FDA. Some computer systems have a good way to check this using the computer, ours does not, so we do a manual check.

Linda Frederick

[LaraT23]

I would think that the unit ID " assignment" card with the new expiration date is a good second check. That has the same information on it that the sticker label does. They both should match.

[bpkelly]

The second label check does not imply that a second person check the label- only that you have a process to verify the label for accuracy a second time before the label is placed on the unit. We accomplish this by pulling the number up in the computer and checking the label against the computer screen before we place the label on the unit.

[Eagle Eye]

We have a second check for aliquots and pooled cryo. Once first tech modify and place label on product, second tech has to verify labels(for pool cryo I have 4 labels) and sign off on the form.

[NedB]

In a Q&A document on the ICCBBA site, the agency responds to a question about re-labeling thawed units. The question and response are:

1. I am a transfusion service that only thaws Fresh Frozen Plasma. Will I be required to relabel that unit and do I have to register with ICCBBA?

If your facility thaws Fresh Frozen Plasma and transfuses it within 24 hours, then you are not required to relabel the unit and can just hand write the new expiration date/time. However, if your facility does not transfuse it and keeps it over the 24 hours (up to 5 days), then you will have to relabel the unit as Plasma.

If you apply an ISBT 128 label (i.e., 5 day Plasma), then you would have to register with ICCBBA. Otherwise, if you are just thawing units, registration is not required.

The highlights were mine to someone with whom I was arguing (The IS department at our mother hospital).

So if you only need to change the expiration date, isn't that the safest thing to do? Also the minimalist. With changing the date on the bag and in the computer

you would have a check built in for when the product is setup and issued.

And actually the FDA could come in to inspect any time; maybe not; it has been many years since I heard of one coming around.