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I'm working with our surgical service on a policy to improve bone/tissue/biological handling and oversight. We aren't a large facility, but have a surprisingly large number of types of bone/tissue/biological materials available for use. After going through the latest JC checklist, surgery realized that there was a big need for improvement in policies they had in place. We are going to place everything bone/tissue/biologicals related under the oversight of the blood bank medical director. As part of this process, we are writing several policies that will be used by both blood bank (frozen bone/tendons) and surgery (everything else) - to make sure that we are all following the same game plan. Our medical director has been reviewing our proposed new policies and has a couple of questions that I need help with. Which is where you all come in. I'd appreciate any help you can give me. 1. Lookback and notification - will someone please point me to the part of the CFR that deals specifically with lookback and notification for tissues? Is there a separate section or is it the same as used for blood products? 2. My medical director says he remembers reading somewhere (sorry - he can't remember where) that anyone who has been diagnosed with HIV/HCV within 6 months of receiving a bone/tissue implant should be physician reported for investigation. Is there a specific citation for this in the CFR? I've based the lookback section on a blood lookback policy that has passed a CLIA inspection because that's what I (blood bank) know, but maybe that's not the best approach? What is missing/different for tissue? We are CAP and JC inspected, but not AABB inspected. (I think one of the things I need to do - pronto - is order a copy of the AABB Tissue Standards.)