ISBT and yes Thawed Plasma again

[JMunden]

We are a transfusion service that currently relabels thawed FFP as "Thawed Plasma"

with a Thawed Plasma Sticker after 24 hours and a 5 day outdate. When ISBT is mandated, can we continue to overlabel, or is this considered a modification requiring a new facility identifier (ISBT unit number)...and if so, why is it ok to thaw FFP-a modification-and not require the same?? Both utilize the same "process".

Thanks for any input!

[Franklyn]

Bloody good question - I wish I had an answer... The same question applies to thawed cryo and pre-pooled cryo, upon thaw the label doesn't change.

Does anyone use a "fresh plasma" label to relabel thawed FFP?

[DHarts]

ICCBBA codes are defined according to the exact type of plasma you are thawing. Fresh Frozen Plasma can be re-labeled as Thawed Fresh Frozen Plasma with a 24 hour outdate. If you choose to extend the outdate on an un-used unit, you can re-label at the end of the first 24 hours to Thawed Plasma with a 5 day expiration. Example CPDA-1 FFP path: E0707 > E0785 > E2702. The DIN number does NOT change.

If your facility pools single cryo units, the new label will contain YOUR facilities unique DIN because now you have modified (thawed) AND created a "new" (pooled) product. The new DIN number must be machine readable and your facility information will now be located beneath the DIN in the upper left quadrant.

If your facility receives Pre-Pooled cryo from your supplier, the modified (thawed) product retains the DIN of the supplier.

In both cryo situations above, the correct product code will reflect "open" pooling or "closed" pooling.

Hope this all makes sense!

[bbbirder]

If I remember correctly (and maybe I don't), Thawed Plasma is not an FDA licensed product so the facility's FDA license number should be crossed off. It probably doesn't matter if you use it in house, but we sometimes ship thawed plasma to a local smaller hospital, so we cross off the number.

[heathervaught]

When relabeling a thawed product (or irradiating any product), you should have a label 2 inches tall by 4 inches wide with the new product code on the left and the new expiration (if it changes) on the right. The lower right quadrant should also contain the 'Further Processing By' label identifying your facility. See Pages 29 and 31 of the US Industry Consensus Standard.

What I have done (and what I recommend) is I created an "ISBT Bible". I took a binder and printed out the FDA Guidane for Industry, the ICCBBA US Consensus Standard, the ICCBBA Technical Specification, and the Product Code Map and placed it in a binder. Thus far, it has been able to answer most of my questions. For questions that I still cannot answer with those 4 documents, I e-mail Pat Distler.

[VACASE]

Does anyone have a quote or a standard that states the information about ISBT 128 labeling of thawed plasma. Before ISBT 128 (and actually still as we have not received any ISBT-128 labelled FFP units yet) we would modify and relabel a FFP unit as FFP, THAWED when we first thawed it. We would then change to THAWED PLASMA after 24 hours if it hadn't been used yet. Our blood supplier is telling us that with ISBT 128 we will only have to relabel with the new product code after the first 24 hours (when it changes to THAWED PLASMA). There are ISBT-128 codes for FFP, THAWED. Why would they have them if we don't need them? Thanks.

[Mabel Adams]

Some of us don't make "thawed plasma" and need those codes for our 24 hr. exp. products.

[ANORRIS]

So if we relabel Thawed FFP and use only for 24 hrs., do we need an ISBT code on the label or just out modified Thawed FFP label with the new 24 hr exp. date?

[estiner]

Has some regulation changed? ISBT told me that I can thaw FFP or FP24 and use within 24 hours without relabeling - only crossing out the expiration and writing in the new 24hr expiration date and time. Now, if I change to THAWED PLASMA, then I would have to relabel the unit.

[Linda0623]

When I set my ISBT product code trees up, I emailed them to Pat Distler and one of her assistants verified that my code changes as I modified products were correct.

I specifically confirmed with them that if we only thaw FFP and discard within 24 hrs, that we did not need to relabel. She said no, that the only allowable handwritten change on an ISBT label was to edit the date/time of expiration. If you take the FFP and extend the outdate for 5days thawed, you no longer have what is considered to be thawed FFP. Once it becomes thawed plasma, it becomes a modified product which requires appropriate relabeling under ISBT, even though you physically have only thawed the product.

Hope this helps,

Linda

[Pat Distler]

Linda is correct. If you thaw and use FFP (or Plasma, Frozen Within 24 Hours After Phlebotomy) within 24 hours, all that is required is changing the expiration date and time. This can be a handwritten change. If you opt to, you can re-label it as THAWED FRESH FROZEN PLASMA (or THAWED PLASMA, Frozen Within 24 Hours After Phlebotomy). But changing the product code is entirely optional.

If you extend the dating to 5 days, however, it is a different product (no longer has the same level of labile clotting factors). This new product, THAWED PLASMA, requires re-labeling with a new product code and appropirate expiration.

Reading back through this thread, I think everyone has it right--I think there may just be some confusion on what is meant by THAWED PLASMA. I think this term is used by some to describe Thawed FFP or Thawed Plasma, Frozen within 24 hours after phlebotomy. ??