Quality

All donor tissue is recovered, processed, and distributed according to standards established by the American Association of Tissue Banks. Donor screening exclusion criteria is performed via donor physical inspection, interview with a person who knew the donor, review of available medical records, and a review of autopsy findings (when applicable). Individuals considered to be at high risk for AIDS or hepatitis as defined by the FDA and CDC are excluded from donation. Using FDA licensed, approved, or cleared test kits in a laboratory registered with the FDA and certified under CLIA or equivalent requirements, a serum sample from the donor has passed a hemodilution review and tested non – reactive for the following:

• Human immunodeficiency virus antibody (anti -HIV1 and anti -HIV2)
• Nucleic acid test (NAT) for HIV- 1
• Hepatitis B surface antigen (HBsAg)
• Total antibodies to Hepatitis B core antigen (anti – HBc-total, IgG/ IgM)
• Antibodies to the Hepatitis C virus (anti -HCV)
• Nucleic acid test (NAT) for HBV and HCV
• Rapid plasma reagin (RPR) or serological tests for syphilis (STS).

Additional tests, including but not limited to HTLV I / II, may have been performed and were found to be acceptable for transplantation. All required communicable disease tests must be negative or nonreactive. Communicable disease testing is performed by laboratories that are registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS).

Based on all the screening and testing results all donated human tissues will be determined to be suitable for transplant by the Medical Director and Quality Assurance.