[MT-L] Blood Bank ISBT Labels

[Denise Woodruff]

We are struggling with new CAP standard TRM.43605 Component Labeling - Final Inspection that requires a validated process where each barcode quadrant of the component label is scanned and compared to the electronic record of the laboratory computer system by one BBK person or a system using 2 BBK persons to verify the information on the component. We are a small blood bank and only create one component - thawed FFP from frozen FFP. Of course in the thawing process, the product code and expiration date is changed. We really do not want to purchase a Hematrax printer at a price tag of $5000.00+ and all the up keep that software requires. Has anyone resolved the issue of just printing an ISBT label for the thawed product and the new expiration date outside of purchasing the Hematrax printer? thanks, Denise Woodruff

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[Leah Dungo]

How long do you keep your thawed plasma (after thawing)? Do you still use it after 24 hours?
We do not have a Hematrax printer either, we do not change the product, we issue it as FFP, but the expiration has to be within 24 hours.

You may want to check KB article 42130 if this will help.
Article ID: 42130
Date: 2/23/2012
Published: 4/17/2012 Application: BBK
Subject: Hardware Requirements
Platform: ALL
Relabeling FFP Without a Hematrax Printer for ISBT Labels
Sites using ISBT unit labels may run into issues with relabeling component products if they do not want to purchase a Hematrax printer.

Joint Commission standards refer to the Food and Drug Administration (FDA) regulations for blood product labeling requirements. Effective July 2, 2012, the FDA regulations will allow the infusion of thawed fresh frozen plasma for up to 24 hours after thawing. The need for a variance from the FDA to transfuse plasma beyond the original six-hour limit will no longer be required. The scheduled regulation change was published in the Federal Register, Vol. 77, No. 1, Tuesday January 3, 2012/Rules and Regulations 7.

When frozen plasma is thawed, the product is still considered to be fresh frozen plasma for up to the 24 hours. After 24 hours, the product should be labeled as thawed plasma. The license number should be struck, because this is no longer a licensed product according to the FDA. For more information on product modifications, an excellent resource is found on the AABB website.


Consequent to these regulations, thawed FFP does not necessarily need to be relabeled. However, if sites are using TAR and LAB does change the product, then it will not be recognized by TAR. In this case, site will need to purchase a Hematrax printer and relabel with ISBT. Another option would be to generate a .CODABAR barcode component for the new product and expiration date. The site should check with their inspection agency to ensure that this workaround will be compliant. It is important to note that the Unit Number is not changed in the process.

Thank you ,

Leah Dungo, CLS, ASCP, AMT
INFORMATION SYSTEM SPECIALIST-LAB
P:(830)278-6251 ext. 1143
Uvalde Memorial Hospital * 1025 Garner Field Road * Uvalde, TX 78801 * www.umhtx.org

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