Do you have to report a blood product fatality to your respective state? We are having AABB/CAP inspection, the assessor states that it needs to be reported to the state in addition to FDA, CBER and OCBQ. Anyone reporting to their state?

Yes, it’s required by my state, (NJ) to report.

And don't forget TJC if your facility is inspected by them.

We notify FDA, Mass DPH, TJC, and our hospital administrators and QA.

Thanks for the feed backs. Our facility risk management reports the fatalities to the state and the blood bank to the FDA, so we had to add to the blood bank policy that risk management would notify the state.