"Further processing by" statement

[bmarotto]

Can someone clarify when this statement in necessary? I assume it is required for modifications such as irradiating, freezing, and washing but what about thawing plasma and dividing a red cell unit into two aliquots for the same patient?

[Mabel Adams]

Thawing for in-house use does not require it, but pooling/aliquoting does is my understanding.

[lcubed]

We also have discussed where and when this statement is needed. It was determined by our Compliance Dept. that we did not need to use this statement at all unless we were pooling and not using a pool number with our facility information as a DIN. Or if we sent anything out of the institution. Can someone clarify is this is actually a REQUIRED statement at all?

Thanks!

[Eagle Eye]

As far as I know aliquoting doesn't require further processing label is not require.

[bmarotto]

Until an expert clarifies this, I guess the safest think is to use it whenever you do a modification that causes the product code to change, except maybe thawing plasma for in-house use. Aliquoting is a question since the base product code remains the same; it just has the division letters added.

[lcubed]

Funny, we came to the exact same conclusion yesterday afternoon. We are just going to add it until we hear something different (and concrete).

Thanks for your help!

[DHarts]

By ICCBBA standards, the product code for division does change if going from a "closed" to an "open" system. It only stays the same if using a sterile docking device. In both cases, the division characters would apply.

[bmarotto]

We sterile dock so our product code remains the same.