Guidance Document - American Association of Tissue Banks

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The processor is responsible for the implementation and maintenance of recordsthat provide for tissue traceability back to the original donor information andincludes the date/time of tissue receipt from the retrieval agency. If further oradjunct manufacturing will occur, the date/time and the method of shipment that isused to send the tissue to another tissue processor would be requireddocumentation.Receipt Records – The processing tissue bank should perform a documentedreceipt & inspection of all incoming donor cells/tissues and document acceptanceor rejection, date/time received, and personnel performing these significant steps.Distribution Records include but are not limited to: tissue ID number, expirationdate, type, quantity, date/time of shipment to manufacturer as well as the identity ofthe receiving facility.c) Tissue manufacturer to Distribution Intermediaries:Tissue manufacturer is responsible for the implementation and maintenance ofrecords that provide for tissue traceability back to the original donor ID numberfrom the date/time of tissue receipt from tissue bank sender (e.g. processing tissuebank) to date/time of shipment to Distribution Intermediary. This includes, but is notlimited to, receipt and distribution records.Receipt Records should contain evidence of documented receipt & inspectionperformed at the time of receipt of tissue by Distribution Intermediaries for storageand/or further transport & delivery to end-user. Inspection should note if shipmentand/or tissues were accepted or rejected. Documentation of all personnel involvedwith each step is advised.Distribution Records include but are not limited to: tissue ID number, expirationdate, type, quantity, date/time of shipment to and/or from Distribution Intermediaryand/or end-user locations as well as the identity of the receiving facility.Documentation of all personnel involved with each step is advised.d) Distribution Intermediary to End-user (consignee) location:A Distribution Intermediary is responsible for the implementation and maintenanceof records that provide for tissue traceability from the date/time of tissue and/ortissue device receipt to date/time of transport & delivery to end-user.This includesreceipt, storage and/or transport and delivery to end-user. This is accomplishedby:Receipt Records should contain evidence of documented receipt & inspectionperformed at time of receipt by agent for transport and delivery or receipt by agentfacility for storage and further transport & delivery. Inspection should note ifshipment and/or tissues were accepted or rejected. Distribution Intermediary isPage 36 of 44
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
Page 5 and 6: purpose of this Guidance Document i
Page 8 and 9: periodic reviews of the performance
Page 12 and 13: Q10. Does the sterilizer that is us
Page 14 and 15: eagents meet established specificat
Page 16 and 17: Section III.Donor Screening and Don
Page 18 and 19: enforcement. If a tissue establishm
Page 20 and 21: contractor has necessary elements o
Page 22 and 23: A17. No. Tissue processing-related
Page 24 and 25: IV. PACKAGINGQ1. Does the immediate
Page 26 and 27: V. LABELINGQ1. Given that new infec
Page 28: Q11. Must labeling operations, such
Page 31 and 32: distinct identification code in you
Page 33 and 34: Section VI.DistributionPage 33 of 4
Page 35: Q5. Is shipping container qualifica
Page 39 and 40: Section VII.ProcessingPage 39 of 44
Page 41 and 42: • Surface Monitoring - taking int
Page 43 and 44: Section VIII.StoragePage 43 of 44

Guidance Document - American Association of Tissue Banks

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