Labeling changed expirations

[Mabel Adams]

Would it meet regulatory requirements if an attached tag stated the new expiration of FFP after thawing but the original expiration wasn't changed or covered up on the bag label? I was thinking I could word it so it would establish that this was a changed expiration for the transfusion-ready product, but my computer uses the same tag format for red cells as for FFP so it would have to be a statement applicable to all products.

I will not be able to print new labels after the ISBT conversion. I understand that we can just change the expiration if we are only thawing FFP for our own use, but I am afraid techs will occasionally forget to change it and I wanted to make it pop out with the tag we already attach to the unit.

I'm guessing this is a pipe dream but I thought I would ask.

[Lcsmrz]

I would have difficulty with two different expiration dates affixed to a unit at any one time. It would be confusing for the nurses to know which one to use, since it would change with the product, and may lead to an expired unit inadvertently being infused.

We will not be printing new ISBT labels, but plan to continue with the currect practice of lining-out the original (frozen) date and adding an amended expiration label above it, the accuracy of which is verified when issued and again at the bedside. I would strengthen the visual check of the expiration date/time as part of the issue process.

This situation is analogous to irradiation, when the expiration date is shortened. While some sites affix a tag with the new expiration date, the original one is always somehow crossed-out. The process must be usable during computer downtime, as well.

[John C. Staley]

If the two expiration dates are visible and easy to read, in a small facility like Mabel's, it should not be too tough to train everyone that the shortest date/time always wins. I don't see a problem with what you want to do especially with the tag being computer generated.

If someone asks explain that the longer outdate was for the frozen product the short outdate was applied when thawed. That way you can prove you didn't thaw an already outdated product.

[Franklyn]

I would have to agree with Lcsmrz. A product can only have one valid expiration date and if the expiration date changes it needs to be changed on the label. Procedurally defining "take the shorter date" is not acceptable. This can be done a variety of ways (like striking the incorrect date as stated previously) but it must be done to be compliant with AABB and, more importantly, FDA standards.

[Mabel Adams]

Thanks for trying John. I guess I knew this was impossible. I think I have figured out a way to make the new expiration print an extra time on our compatibility label on a small extra label so it will be harder for the techs to forget to use it to cover up the original exp., more legible and not prone to tech's not knowing what day it is.

My current techs are more reliable than some of the dregs of techdom we were forced to hire a few years back so maybe I should be more trusting.

[John C. Staley]

Mabel, I can still disagree with the opinions expressed above because that's what they are. Even the inspectors are expressing their opinion/interpretation of things and I've seen a number of discrepencies between individual inspectors and their opinions. Everything is a crap shoot and depends on if your interpretation is in line with the current inspector's. So, we do the best we can with what we have to work with. Heaven forbid if logic and common sense ever gets in the way.

The opinions expressed here are mine and mine alone and usually shared by very few if anyone. But hey they are mine and all I have.