Our donor tracking, documentation, tissue processing, allograft packaging, storage and shipping processes ensure the availability of safe, high quality allografts. A three-level pre-processing review is performed by our highly trained Quality Assurance staff and Medical Director. The following items are carefully reviewed and documented:

• Donor qualification
• Review of consent/authorization to recover tissues for transplantation
• Medical/behavioral risk profile
• Review of recovery process/time frames/reconciliation of refrigeration times/recovery site assessment/recovery sequence
• Completion of recovery record
• Receipt/reconciliation of tissue recovered
• Supplies/materials used in recovery/ lot numbers and expiration dates
• Blood sample assessment/qualification
• Infectious disease testing results
• Procurement microbiology results
• Information sharing with other agencies who participated
  in recovery or receipt of recovered tissues
• Pathology/autopsy results if performed
• Tissue receipt records so SOP requirements have been met
  o Verification of Shipment parameters
  o Reconciliation of tissues shipped vs. received
• Processing records
  o SOP requirements have been met
  o Supplies used
  o Visual product / packaging inspection
  o Traceability of tissues received
  o Irradiation sterilization parameters
  o Residual Moisture results acceptable
• Completion of Quality Assurance investigations
• Completion of Production technical review
• Inventory data entry
• Final labeling

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