Donor Screening and Testing

Donor Screening

It is important to determine if the potential donor  has an infection that could be transmitted to recipients through the transplanted organs and/or tissues.  The Organ Procurement and Transplantation Network (OPTN) policy (for OPOs) and FDA regulations (for tissue and eye banks) require a medical and social history interview to be conducted with the deceased donor’s next-of-kin, and may include other persons who knew the potential donor, to gather information about 1) behaviors that may have exposed the potential donor to certain diseases and 2) the potential donor’s past medical history.  This interview is one of several ways the donor’s risk for having an infectious disease is assessed, its usefulness depends on how well the person being interviewed knew the potential donor.

Laboratory Testing for Infectious Diseases

OPTN policy requires OPOs and living donor recovery centers to perform the following tests to see if the potential donor may have certain infections: human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus, syphilis, cytomegalovirus (CMV) and Epstein Barr Virus (EBV).  Living potential kidney donors at increased risk for tuberculosis are also tested for this infection.

According to federal law, transplant centers are only prohibited from accepting and transplanting organs from donors infected with human immunodeficiency virus (HIV).  Because the number of donor organs is not sufficient to meet the need, intentional transplantation of organs from HBV – and HCV – infected donors is accepted medical practice. These organs are typically offered to transplant patients known to have the same infection, or in rare circumstances, to uninfected patients in cases of urgent medical need.

FDA regulations require tissue and eye banks to test donors for HIV, HBV, HCV, and syphilis.  Tissues that may contain live white blood cells, such as skin, are also tested for human T-lymphotropic virus (HTLV) and cytomegalovirus (CMV).  Donors with positive test results for any of these infectious pathogens, but not necessarily CMV, are not eligible to donate.

Additional steps are taken to rid tissue of pathogens that might be present on or within the tissue. Corneas are stored in a solution to reduce bacterial growth.  Other tissues go through a disinfection process.  Some tissues, such as corneas, blood vessels, heart valves and skin cannot be sterilized because the treatment could damage the tissue.  The medical director, or designated person, of the tissue or eye bank performs a final review of the documents, such as records on donor eligibility, test results and tissue processing, before deciding if tissues from a particular donation are safe to be released for transplantation.