ISBT Final Content Modifier

[MsDuffy]

We have run into a situation that is causing us a big headache and I'm looking for feedback and assistance, if possible, in determining the correct answer.

A blood supplier is labeling divided products intended for pediatric use with Final Content volume modifier information that is not consistent with the volume of the final product that is distributed.

Specifically, they are manufacturing an Apheresis Fresh Frozen Plasma (E0940 - Apheresis FRESH FROZEN PLASMA|NaCitrate/XX/<=-18C|>=200mL<400mL) and then further manufacturing it into four divisions intended for pediatric transfusion.

They are labeling and distributing the four divisions as E0940VA0, E0940VB0, E0940VC0 and E0940VD0. Our computer system will not process these units as the volume of the product that is shipped to us is <200mL and the Final Content volume modifier associated with E0940 is >=200mL<400mL. The system is balking at the discrepancy between the actually content of the unit received and Final Content volume modifier. The computer system vendor states that the blood supplier is labeling the products incorrectly and that the divided product must be labeled with E0938 - Apheresis FRESH FROZEN PLASMA|NaCitrate/XX/<=-18C|<200 mL or E0909 - Apheresis FRESH FROZEN PLASMA|NaCitrate/XX/<=-18C. The blood supplier is say that they are labeling the product correctly and that this is an issue with our computer system vendor. In the meantime we and the patients are stuck in the middle!

So who is right? How should the products be labeled?

[kate murphy]

As I understand ISBT, the blood supplier is correct. The original plasma is E0940V00 >=200ml<400ml. The pedi bags are divisions of the parent unit and are E0940VA0, B0... You would only use the E0938 if the original plasma was actually <200ml.

Your computer system if set up correctly for divisions should be able to handle A0, B0... What computer system are you using?

[MsDuffy]

As I understand ISBT, the blood supplier is correct. The original plasma is E0940V00 >=200ml<400ml. The pedi bags are divisions of the parent unit and are E0940VA0, B0... You would only use the E0938 if the original plasma was actually <200ml.

Your computer system if set up correctly for divisions should be able to handle A0, B0... What computer system are you using?

Thank you for your response. Could you share your reference for your answer? The United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, Version 3.0.0 Draft R (March 2011) seems to allow for either practice, but all of the examples are of product codes NOT utilizing volume Final Content modifiers. Everything that I've read thus far suggests that if a blood supplier is going to utilize the volume Final Content modifier, and it isn't required that they do so, than the label must reflect the accurate volume of the product that is in the unit that is distributed.

[MsDuffy]

Hi Everyone! I emailed my post to ICCBBA for their answer on my conundrum and here it is for those of you who are interested.

"The Final Content attribute (e.g., >=200mL<400mL) refers to the volume of the final product. So if the final product is an aliquot less than 200mL, then this attribute must either be omitted OR it can be replaced with another Final Content attribute that is consistent with the final volume of the aliquot (e.g., <200mL, <50mL, etc.). Your vendor and its system are correct.

The product code itself that your blood supplier is using can be a correct code only if the actual volume of the unit is consistent with the Final Content attribute. So if the A0 unit had just over 200mL and the B0 unit had just under 200mL, then the B0 unit cannot have the “>=200mL<400mL” attribute but the A0 unit would be fine. The bottom line is that the attributes must be consistent with the final contents of that unit. Please let me know if you have any further questions. Thank you.

Regards,

Erwin Cabana

Information Standards Specialist

ICCBBA"