APPENDIX B: Evaluation of Medical Suitability of Potential Donor
Medical and Behavioral History
OPTN requires that the medical history includes each of the following: 1) laboratory tests and results used to identify transmissible disease, treated and untreated, that if transmitted will adversely impact the recipient; 2) factors that are associated with increased risk of infectious disease transmission including HIV, HBV and HCV; and 3) prior exposure to Human Pituitary Derived Growth Hormone to determine the risk of prion disease. In addition, obtaining information on vaccination status, residence or travel to disease endemic areas, drug use, risky sexual behavior and incarceration are also recommended . Identified infections, if any, do not automatically preclude transplantation in all cases and in all infections. The urgency of the recipient’s need and the recipient’s infection status are also factored in while making a decision to accept or reject the organ. For instance, if the donor is HIV positive and the recipient is negative, the organ is rejected. But if the donor and recipient are HCV positive, the organ can be accepted for transplant. The medical and behavioral history is obtained from the patient’s medical records and from interviewing close associates. For donors less than 18 months old, history of the potential donor and the mother is recorded.
All donor serological screening tests must be performed on non-hemodiluted samples to preclude altered serological test results. The extent of hemodilution is determined from the medical record detailing all blood products and intravenous fluid transfusions that the potential donor has received since admission. In addition, the OPO assesses all blood samples obtained for serology screening for the extent of hemodilution using a U.S. Food and Drug Administration (FDA) approved hemodilution calculation. For infants younger than 3 months old with diluted blood, serology tests can be performed using the blood from the biological mother.
Serology Screening and Blood Typing
Most OPOs operate an in-house laboratory to run serology tests and blood typing on potential donors. Given the uncertainty about when a potential donor may become available and the short timeframe within which medical evaluation must be completed, laboratories involved in potential donor serological screening are operated 24 hours. Blood samples from the potential donor are tested for blood type and subtype. In order to prevent donor-recipient blood type mismatch, OPTN employs stringent reporting requirements on blood typing. These include primary reporting and secondary reporting (by an individual other than the one who entered the primary reports) to UNet. There is consensus among the transplantation community that routine serological screening of potential organ donors should include testing for HIV, human T lymphotropic virus, hepatitis B virus, hepatitis C virus, and cytomegalovirus .