jlphunn Posted August 15, 2012 Share Posted August 15, 2012 Here is another questionable scenario: Suppose an incorrect blood type was reported on a patient. The order was for a type and screen only and no rbc's were transfused - The error was caught and corrected before any product was issued. Would this error be reportable and if so, would FDA form-3486 (Biological Product Deviation Report) be the correct on to use? Link to comment Share on other sites More sharing options...
tbostock Posted August 15, 2012 Share Posted August 15, 2012 I believe not, since a blood product was never involved that left the Blood Bank. I would consider it a near miss though, and do a full root cause analysis to try to prevent it from happening again.What does everybody else think...reportable or not? Link to comment Share on other sites More sharing options...
R1R2 Posted August 15, 2012 Share Posted August 15, 2012 No, it is not reportable. R1R2 Link to comment Share on other sites More sharing options...
Justina Posted August 15, 2012 Share Posted August 15, 2012 No, it is not reportable. R1R2I agree Link to comment Share on other sites More sharing options...
David Saikin Posted August 16, 2012 Share Posted August 16, 2012 Ditto Link to comment Share on other sites More sharing options...
AMcCord Posted August 16, 2012 Share Posted August 16, 2012 DittoAgree. Link to comment Share on other sites More sharing options...
bmarotto Posted August 16, 2012 Share Posted August 16, 2012 Agree. Link to comment Share on other sites More sharing options...
L106 Posted August 17, 2012 Share Posted August 17, 2012 Agree; Not reportable. Link to comment Share on other sites More sharing options...
SMILLER Posted August 18, 2012 Share Posted August 18, 2012 Don't think so either. And i am glad i agree with all these people here!Scott Link to comment Share on other sites More sharing options...
Mabel Adams Posted August 19, 2012 Share Posted August 19, 2012 Nothing is reportable to FDA under BPDs unless blood product was issued or otherwise left your control. Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted August 19, 2012 Share Posted August 19, 2012 It would certainly be reportable to SHOT in the UK, but as a near miss. Link to comment Share on other sites More sharing options...
carolyn swickard Posted August 20, 2012 Share Posted August 20, 2012 It would probably be reportable here too on the new Hemovigilence programs, if you are participating in them. But not to the FDA. Link to comment Share on other sites More sharing options...
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