second check on modified products for aabb

[hughes]

Hello-

is a second check for lableing products required for thawed FFP where the only change would be the expiration date on the bag?

thanks

[lalamb]

What do you do w/ the thawed FFP after is expires?

Which expiration date - the original frozen one or the thawed one?

[goodchild]

What do you do w/ the thawed FFP after is expires?

Which expiration date - the original frozen one or the thawed one?

I'm not sure I'm following what you're asking.

To answer the OP I've certainly been under the impression it was unnecessary for a second person to verify something like an expiration time/date change due to thawing. If it was how would blood banks with only one tech on the night shift operate?

Edited June 29, 2010 by goodchild
grammar.

[bbbirder]

I would still think you would need a label review process, even if it is only one tech documenting that they checked it (unless you have some way to check this with a computer system.) Since you are only making the change by hand, I doubt a computer would help you.

You may be able to do this at the time of issue.

If the label was not changed to the correct expiration, and the unit then issued, this would be reportable to the FDA.

[Dr. Pepper]

Hello-

is a second check for lableing products required for thawed FFP where the only change would be the expiration date on the bag?

thanks

I believe that if the only change is the 24 hour outdate on thawed FFP, the standard does not apply, but does if you go beyond the 24 hour outdate and change the component from FFP to Thawed Plasma

[DPruden]

We had a couple of different FFP products that were not modified in the computer, so the tag and unit still had the original 1-year expiration when issued. Those were both FDA reportable because the expiration date was "extended". We chose to use the ISBT labels and change the product code when a unit is modified in the computer and made all of the frozen product codes non-transfusable so that a tech could not issue a product that was still listed as frozen in the computer. There is an electronic second check when a product is re-labeled in our computer system.

[kmh76]

we just had AABB inspection and that qustion came up. If you are only changing the expiration date and not the product code you do not need a second check.That according to our inspector.