klsmith Posted December 21, 2018 Share Posted December 21, 2018 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! Link to comment Share on other sites More sharing options...
SMILLER Posted December 21, 2018 Share Posted December 21, 2018 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 Link to comment Share on other sites More sharing options...
R1R2 Posted December 21, 2018 Share Posted December 21, 2018 yes, yes, yes, yes! Link to comment Share on other sites More sharing options...
Patty Posted December 21, 2018 Share Posted December 21, 2018 yes. Reportable once it leaves the BB. Link to comment Share on other sites More sharing options...
Cliff Posted December 21, 2018 Share Posted December 21, 2018 You can always email them for advice, Sharon and her team are awesome to work with. Link to comment Share on other sites More sharing options...
John C. Staley Posted December 21, 2018 Share Posted December 21, 2018 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"? Link to comment Share on other sites More sharing options...
Guest Posted December 21, 2018 Share Posted December 21, 2018 Yes, reportable based on missed antibody and the fact that the blood left your dept. I'm thinking RT 61-05. Brenda Hutson Link to comment Share on other sites More sharing options...
slsmith Posted December 24, 2018 Share Posted December 24, 2018 Since the unit was dispensed and transfused ,yes it is. David Saikin 1 Link to comment Share on other sites More sharing options...
David Saikin Posted December 27, 2018 Share Posted December 27, 2018 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. MOBB 1 Link to comment Share on other sites More sharing options...
seraph44 Posted January 30, 2019 Share Posted January 30, 2019 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. Link to comment Share on other sites More sharing options...
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