Donor Screening and Testing
It is important to determine if the donor has an infection that could be transmitted to recipients through the transplanted organs and/or tissues. The Organ Procurement and Transplantation Network (OPTN) policies (for organ procurement organizations [OPOs]) and FDA regulations and guidance (for tissue and eye banks) require a medical and social history interview to be conducted with the deceased donor’s next of kin or another knowledgeable person. These interviews gather information about 1) risk behaviors that may have exposed the donor to certain diseases, 2) the donor’s past medical history, and 3) relevant travel history, which can be important for exposure to certain pathogens. This interview is one of several ways to assess the donor’s risk for having an infectious disease; its usefulness depends on 1) how well the person being interviewed knew the donor and 2) the interviewee’s comprehension of the meaning of the questions
Laboratory Testing for Infectious Diseases
OPTN policy requires OPOs and hospitals that recover living donor organs to perform the following tests to see if the donor may have certain infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, cytomegalovirus (CMV), Epstein Barr Virus (EBV), Chagas disease (for heart donors), and toxoplasmosis (for deceased donors only). Living potential kidney donors at increased risk for tuberculosis are also tested for this infection.
In the past transplant centers were only prohibited from accepting and transplanting organs from donors infected with HIV. In 2013, the HIV Organ Policy Equity (HOPE) Act was passed, enabling transplantation of solid organs from HIV-positive donors to HIV-positive recipients when following specified research protocols established by the Department of Health and Human Services under the direction of the National Institutes of Health. 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 some circumstances, to uninfected patients in cases of urgent medical need.
FDA regulations require tissue and eye banks to adequately and appropriately test donor specimens for risk associated with HIV, HBV, HCV, and syphilis. Living tissue donors must also be tested for West Nile Virus (WNV). Donors of tissues that may contain live white blood cells, such as semen and hematopoietic stem/progenitor cells (e.g., umbilical cord blood), are also tested for human T-lymphotropic virus (HTLV) and CMV). A donor with positive test results for any of these infectious pathogens, but not necessarily CMV, is not eligible.
When possible, additional steps may be taken to rid tissue of pathogens that might be present on or within the tissue. For example, corneas are stored in a solution containing antibiotics to reduce bacterial growth. Other tissue types can be cleaned and disinfected, and may be irradiated. Some tissues, such as corneas, blood vessels, and heart valves cannot be sterilized because such treatment could damage the tissue. The medical director, or designated person, of the tissue or eye bank performs a final review of available records to determine donor eligibility, such as communicable disease test results, an autopsy report and tissue processing treatments when applicable, before deciding if tissues from a particular donor are safe to be released for transplantation.