About a month ago, a patient had a workup done by our reference lab and found to have a warm autoantibody. I gave “least incompatible” units but forgot to give the nurse doing the pickup an emergency release form to have the doctor sign. Is this an error that’s reportable to the FDA? Where can I find this information?

Edited August 15, 20204 yr by Flygrrrrl

It certainly merits an occurrence report as it was a Deviation from SOP.  The only possible BPDR code that I could see using would be QC-97-13, but I defer to superior knowledge.

Yes, this does need to be reported.  There are specific time intervals for reporting, I believe.

I would say no as not sendng a high risk form doesn't affect the potency, safety or purity of the product. One could say not having the doctor sign the form affects the safety  because perhaps they won't watch the transfusion more closely than usual but should the transfusion still be monitored ? Anyway you could always submit a deviation just to cover the BB behind, if it isn't  reportable the FDA will  let you know. This I know as I have filed reports that were questionable to file or not to file and received notification that it wasn't .

But  the non-conformance (not following the SOP) should be reported in whatever way the lab reports their errors internally. 

QC-97-13 - procedure for issuing not performed or documented in accordance with specifications. If your policy states the form needed to be signed prior to issuing, this is a general code to cover that.  As stated above, they will let you know if it isn’t necessary.