In the July, 2011 issue of Transfusion, was the study entitled "Knowledge of food and drug administration reportable deviations". A bunch of scenarios were presented, all of which were reportable, I think. Two cases I didn't understand why they were FDA reportable. I am a generalist, so I don't know the FDA regs in depth. But I do understand the gist: if a specimen/product isn't fully tested or properly labeled per SOP, and the product is issued, (even if it's returned), then the case is reportable. So what's the deal with these two: Case 1: A patient is discharged from a hospital, but returns to the ER (same hospital) the next day wearing a blood bank armband. The specimen/band are from the previous admission and are not expired. A crossmatch was ordered, and the CLS used the old specimen to add on 2 units RBC. (Based on this, I have had 2 patients rebanded: First, an oncology patient who was banded Friday for a transfusion on Monday, but who came into the ER over the weekend. Second, an ER patient who left AMA, but who came back to the ER the next day wearing the same band. I don't know if this was necessary or not!) Case 2: (part of my copy got cut off, so I am missing the end) A patient's antibody screen was negative. The doctor ordered a DAT, which was positive. The CLS did not request a transfusion history because he thought all was fine with the negative screen. The patient had, in fact, been transfused at another hospital a few days earlier. An elution was not ordered by the doctor or the CLS. (This is where my copy ends. I think what happened next is that the patient was transfused.) Can anyone explain why these are reportable? Sorry about missing info on case 2. I don't have access to the article and am going off of a powerpoint I found off the internet. Thanks!