Guidance Document - American Association of Tissue Banks

VI. DistributionQ1. Why is a tissue expiration date important?A1. The expiration date is the maximum allowable storage period. Expiration datesare assigned by the tissue processor and should appear on labeling. Expiredtissue should not be transplanted. If possible, storage methods should be appliedso that tissue that will outdate first is arranged so it will be selected for distributionfirst.Q2. In general, how should a consignee store tissue?A2. Tissue must be stored in a secure area and in accordance with processor’s(manufacturer’s or “source facility’s”) instructions. Continuous monitoring would beexpected for tissues that require specific environments (i.e. refrigerated, frozen).Q3. What comprises a documented receipt and inspection of tissue?A3. Receipt and inspection is a visual check of incoming tissue. The inspection mayinclude visual inspection of the shipping carton as well as the tissue packaging.Criteria for acceptance or rejection of a tissue shipment must be defined inprocedures. If there are indications that contamination or cross-contamination ofthe tissue has occurred, the shipment should be rejected.Documentation may be performed by using a packing list, a checklist, or similardocument which identifies the sender, donor/tissue identification number(s) oftissues in the shipment, identity and quantity of tissues included in the shipment(e.g. femur, fascia lata, dowel, wedge, etc.), date/time of receipt, and acceptanceor rejection of the incoming tissue based on set specifications defined inprocedures.Tissue processors/manufacturers may require consignees to return rejected tissuefor final disposition. Final disposition of the rejected tissues must be documented.Q4. Who must document receipt and inspection of tissues?A4. Processors, Distribution Intermediaries and Consignees should document receiptand inspection of tissue and note acceptance or rejection of tissue usingestablished parameters. Refer to § 1271.265. You must evaluate each incomingtissue for the presence and significance of microorganisms and inspect for damageand contamination. You must determine whether to accept, reject, or place inquarantine each incoming tissue, based upon pre-established criteria designed toprevent communicable disease transmission. Tissue Consignees should refer toJCAHO standards section QC.5.300 and PC.17.10 pertaining to requirements forwritten procedures for documentation of receipt and storage conditions. Otherrecognized industry standards can also be used.Page 34 of 44