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  • Pat Distler
    Pat Distler

    Looking back at the orginial question: Yes, FDA in 21 CFR 606.121 © (13) requires machine readable (bar codes) for certain information: This includes ABO/Rh, product code, unit number and a facility

  • Pat Distler
    Pat Distler

    To answer a couple of the questions above: If we only thaw/pool and rarely aliquot RBC's, do we need to add a "modified by" label to the product? For pooling and aliquoting, yes. Does it need to

comment_7733

I think what kdal meant is that the LIS assigns a number for the pool and that number is not in the ISBT-128 DIN format. I know Misys/Sunquest and Soft both do that now. There is no way the system will let you assign an ISBT-128 DIN when you pool so buying preprinted DIN numbers won't work. A messy workaround is to pool and let the LIS assign the "Pxxxx" or "POOLxxxxx" number to the pool then in a unit comment record the DIN you are going to assign. Then "ship out" the product to a bogus location (call it something like "Pooled products" and re-deliver it back with the ISBT-DIN adding a unit comment with the original LIS number. I am hoping our blood supplier (Red Cross) will provide pre-pooled cryo when they finally convert to ISBT-128. If not, and our LIS still does not allow DIN numbers for pools, I just may continue to use the barcoded LIS number. The workaround is too cumbersome and will make it difficult to handle a unit recall.

comment_7739

Yes, that is what I meant. We have decided to do just what you described. Let Sunquest give us a P#### for our pool, then we will ship out that pool for an "ISBT workaround". Then we will re-deliver the pool into the system using the pool# in an ISBT format-ex. if our pool is P1234 we will create a new unit number of W####08001234CRP with our site number as the W#### and CRP is what Sunquest calls pooled cryo. We started doing this yesterday and so far seems to work ok. By following the same format each time we pool a lookback will not be a problem because we can determine the original pool number from the new number. We can also put the original pool number as a comment on the new one and vice-versa so there's no detective work involved.

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