Quality and Regulation

Donor suitability, selection and testing meet stringent requirements established by the Food and Drug Administration (FDA) and American Association of Tissue Banks (AATB). Donor mothers are screened at delivery for infectious, malignant, neurological and auto-immune diseases and other exposures or social habits to determine the suitability for human tissue donation. All tissue is procured from a donor determined to be suitable based on the results of screening and testing.

A blood specimen, drawn within ± 7 days of donation, undergoes serological testing by a laboratory registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the 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). Donors are screened for the following infectious diseases to confirm that results are non-reactive:

  • HIV-1 & HIV-2 Antibody
  • HIV-1 (RNA-NAT)
  • Hepatitis B Surface Antigen (HBsAg)
  • Hepatitis B Core Antibody (HBcAb)
  • Hepatitis B (HBV, DNA-NAT)
  • Hepatitis C Antibody (HCVAb)
  • Hepatitis C Virus (HCV, RNA-NAT)
  • Syphilis (RPR)
  • HTLV I & II Antibody (HTLV I/II Ab)
  • West Nile Virus (WNV, RNA-NAT)
  • Zika Virus

Microbial testing is also performed on the final product to ensure no growth of aerobic, anaerobic or fungal cultures. The cell activity in the tissue is inactivated using our CryoTek cryopreservation process to reduce the possibility of graft rejection, while retaining the natural biologic properties.

All tissue is deemed suitable for transplantation based on acceptable screening, serological and microbial test results.  A Certificate of Compliance regarding the manufacturing, storage, shipping and tracking controls for products is available upon request.