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klsmith

FDA reportable?

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Hi Blood Bankers!

So I am wondering, if your facility misses a positive antibody screen, and fails to identify it, then fails to long crossmatch  the units and gives one that is antigen positive (and it is transfused to the patient), is that an FDA reportable?  Please inform if you can!

Thank you!

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Yes, I would think so, as a unit was released from blood bank that was not compatible based on your own P&Ps.  But you should check with the FDA!

Scott

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11 hours ago, klsmith said:

Hi Blood Bankers!

So I am wondering, if your facility misses a positive antibody screen, and fails to identify it, then fails to long crossmatch  the units and gives one that is antigen positive (and it is transfused to the patient), is that an FDA reportable?  Please inform if you can!

Thank you!

I'm curious, can you possibly detail what you mean by "misses a positive antibody screen"?  

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I think missing the antibody screen depends why it was missed?  Was it negative this time?  Was that an error? 

If the pt has a hx of an antibody, ag negative rbcs should always be provided (regardless of the absc result).

Since the unit was transfused without an ahgxm, without ag typing,  Biological Product Deviation report is required.

 

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Yes, re-portable. It the only exception is during an emergency release. Since it most like is not part of your SOP to overlook the positive AB screen, it is re-portable. contact them and they are very helpful about providing  you with the correct info.

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