Transplant Safety

Prior to 2009, the Tissue Program was under the oversight of our surgical centers. Following a recommendation from our Joint Commission Inspector, that oversight was transferred to the laboratory.  We audit:

• 100% of all Tissue tags to verify proper documentation of all regulatory items.


• tissue storage records for ambient, room temp, refrigerated and frozen storage areas


• generate new FDA Registration forms at the beginning of each year


• quarterly verify any tissue received in the previous three months was from a facility for whom we've verified FDA registration.  Any new vendors or vendor locations have registration forms printed and placed on file


• semi-annually, have departments that store tissue have not relocated tissue to an area not previously identified (probably should do this more often)


• Annually audit all handlers of tissue in the surgery centers to verify they have received both initial training and ongoing competency assessment.    


• these are the low hanging fruit I could  think of off the top of my head                                                                                                                                      

Aloha kakahiaka 

Greg

Our inspectors have been TJC, CAP, AABB, and PADOH. They have all put the tissue transplant oversight with the blood bank since blood is also considered a tissue. In addition to Greg's response, BB must also confirm the licensing of the company supplying the tissues.