anonimmuno

Thanks Malcom. What does CAPA stand for? I'm mostly referring to adding this to our quality indicators list that is internally reported to the hospital's highest level quality oversight committee. When this was discussed, we were really curious how many of these events happen at other US hospitals before we started letting others know exactly how often these were happening in our blood bank. Any others from the US have any comments or willing to share some numbers?

How many other other institutions track number of non-conforming events that require reporting to accrediting/regulatory agencies as a quality indicator? What is the benchmark that you determined......? 0..? Will FDA/CAP provide statistical information relating to reporting if requested?

We do pretty much the same thing that R1R2 does. We do a stress test for funsies: we toss in a bunch of room temp or refrigerated cold packs and see how long it takes to fall back into acceptable range to determine if it matches the curve that the manufacturer provided.

Thanks everyone for posting your perspectives! I discussed these cases with the people at my blood bank and found the deeper meaning of why they didn't really see the first two situations as reportable. If the second situation was discovered at your hospital (no record of phenotyping info for units transfused to antibody patient) would you actually report it? Or would there be a brief counseling, correction of information, maybe a process change (different method of documentation, review all problem patients full record before issue, etc) and call it a day? Is reporting something like this being unreasonable/nitpicky?

Yes but debating with you in that vein, if you crossmatch and issue a unit based on a mislabeled specimen and find out about it later on, that is reportable. The information that it was a mislabel was not within the control of the blood bank/transfusion service at the time of issue, but it falls under the unexpected events side. Are there any other viewpoints out there? Ironically others have looked at the first two as questionably/doubtfully reportable and the third case as reportable.

I'm familiar with the algorithm, seems like so many things can be interpreted a dozen different ways. Wouldn't the 3rd scenario fall under the "unexpected or unforseeable" event side seeing that it was something unforseeable that may have affected the safety purity or potency of the product?

Hi, I am researching case studies and I came across three that I wanted some opinions on: 1) Type and screen testing was performed with expired A1 and B cells. A unit of blood was crossmatched with this type and screen and issued for a patient's transfusion. Is this reportable? Or are expired typing reagent errors reportable for blood donor centers only? The patient had a previous history with the transfusion service and the blood type from the expired reagents matched the patient's history. 2) An antibody patient required Jk(a) negative units. The technologist phenotyped two units for transfusion but did not document the lot #, manufacturer or expiration date of the typing sera. The products were labeled, crossmatched and issued for transfusion. Is this reportable? Would this be considered a minor clerical error? 3) A transfusion service has a sickle cell patient policy where they all receive Rh/Kell matched Hgb S-negative units. A patient comes in through the ED but the transfusion service is never notified that the patient has a history of Sickle Cell disease. The patient receives a blood product from the general population which is later found to be antigen positive. Is this reportable to the FDA? If any of these are reportable, why? Thank you for your help !!!