Guidance Document - American Association of Tissue Banks

esponsible for notifying the tissue bank and/or tissue manufacturer if shipmentand/or tissues are damaged.Inventory-in-storage records include but are not limited to: tissue ID numbers,expiration date, date/time of receipt into inventory and by whom as well asdate/time removed from inventory and by whom.Distribution Records include but are not limited to: tissue ID numbers, identity oftissue type, quantity, date/time of transport & delivery, end-user facility to whichtissues or tissue devices were delivered, identity of person transporting tissues andidentity of person at end-user facility accepting tissue. Distribution Intermediariesshould also provide documentation for ALL final dispositions (i.e. not implanted dueto expiration or contamination, etc.).If tissue is returned to the manufacturer for any reason, distribution records shoulddocument that tissue was returned to the manufacturer per manufacturer’sinstruction, date/time of return, and the reason for return.Q9. What records must Distribution Intermediaries (such as independent salesagencies or representatives) maintain?A9. Applicable records include:a) Receipt, inspection and acceptance or rejection of tissue,b) Storage temperature records, if applicable, andc) Disposition records documenting the identification number, tissue type andquantity, date of shipment and identity of consignee (if shipped) or date ofdestruction (if applicable).Q10. How should a consignee participate in tissue tracking?A10. At or before the time of distribution of tissues, the tissue establishment distributingthe tissue must inform the consignee in writing describing expectations andrequirements for tissue tracking. The consignee is responsible for documentingdisposition of the tissue while it is in their possession and providing tracking to thenext destination or final disposition.Q11. Are tissue returns permitted?A11.Each tissue facility should establish a procedure regarding return of tissue. Ifreturns are not permitted a simple policy stating that the facility does not accepttissue returns is all that is required.If returns are permitted, the facility must have a policy that states that tissuereturns are permitted and identify the conditions under which the return may bePage 37 of 44