Allograft Safety

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Quality assurance focus on meeting and exceeding the regulatory standards and other guidelines associated with the tissue banking industry, as well as ensuring tissues obtained from Bone Bank Allografts meet the exacting standards of the surgeons and patients we serve. The following information documents the QA processes in place.

To learn more about the various certifications of Bone Bank Allografts and Texas Human Biologics, please click here.

To download a PDF file of our catalog pages which discuss allograft processing, please click here.

Quality Assurance

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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 demonstrate SOP requirements have been met
    • Verification of Shipment parameters
    • Reconciliation of tissues shipped vs. received
  • Processing records
    • SOP requirements have been met
    • Supplies used
    • Visual product / packaging inspection
    • Traceability of tissues received
    • Irradiation sterilization parameters
    • Residual Moisture results acceptable
  • Completion of Quality Assurance investigations
  • Completion of Production technical review
  • Inventory data entry
  • Final labeling