DONOR SELECTION & SCREENING

DONOR SELECTION & SCREENING FULL REQUIREMENTS

Donor eligibility is determined by a thorough screening and testing process to identify any relevant communicable diseases or disease agents (RCDADs). To ensure the safety and suitability of a all donors, comprehensive medical and social histories assessments are conducted. These include:

  • Behavioral Risk Assessment

  • Physical Assessment

  • Donor Medical History

Tissues approved by these assessments are procured, processed and tested to exceed FDA requirements to minimize potential risks of disease transmission to recipients. Infectious disease testing is performed at a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493.

  • Human Immunodeficiency Virus, Types 1 and 2 (HIV-1/2)

  • Hepatitis B Virus (HBV)

  • Hepatitis C Virus (HCV)

  • Human T-Lymphotropic Virus, Type I and Type II (HTLV-I/II)

  • Human Transmissible Spongiform Encephalopathy (hTSE), including Creutzfeldt-Jakob Disease (CJD)

  • Cytomegalovirus (CMV)

  • Chlamydia Trachomatis (CT)

  • Neisseria Gonorrhea (NG)

  • Treponema Pallidum (Agent That Causes Syphilis)

  • Sepsis

  • Vaccinia

  • West Nile Virus (WNV)

  • Zika Virus (ZIKV)

  • Lyme Disease (ZEUS ELISA Borrelia)

DONOR SAFETY ASSURANCE

At One Biologics, we understand the importance of tissue donor safety. We have implemented rigorous safety protocols and procedures to ensure that all donated tissues are selected and screened in accordance with the highest standards of safety and quality. We use state-of-the-art technology and equipment to preserve the integrity of donated tissues and minimize the risk of incorrect selection.