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KerryBB

ISBT label for 5 day thawed plasma and validation

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Hello all! My facility has just now gone to 5 day thawed plasma. I am just starting as the BB supervisor here as well and I am unsure of what is supposed to be on the ISBT label for the 5 day. It is my understanding after researching that 5 day plasma is not a FDA licensed product. Should the FDA registration number and US license number print on the label for the plasma after it is thawed or should we remove that information? Also, what kind of validations did you do in your IS systems when changing from 24 hr to 5 day? I appreciate any help I can get with this,

Thank you!

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Hello Kerry,

I can help you with regards to the coding and labeling of your thawed plasma product.

The product must be relabeled with a different ISBT 128 Product Code that can be used for 5 day plasma. If you would like, I can help you find the code you need – just reply with your starting frozen code and I will provide the thawed code and the steps to find it.

Since thawed 5 day plasma is not a licensable product, the US License Number must not appear on the label. The FDA registration number would still appear.

Sections and 7.8.8, 7.8.10, and 7.8.18 in the United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 (IG-002) document provides more detailed coding and labeling guidance for thawed plasma products in the US. Figure 79 in the document provides an example of an updated Product Code portion (lower left quadrant) of the label for thawed plasma - I have attached the figure in this post.

I hope this helps! Please let me know if you have any additional questions.

Kind Regards,
Kaytee from ICCBBA (Organization that maintains and develops the ISBT 128 Coding and Labeling Information Standard)

 

IG-002_Figure79.png

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Thank you for replying! We have the appropriate code for the Thawed plasma. My main concern was if the FDA registration number should remain. Thank you for your help.

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