Can a regular plasma donor donate their tissues and organs if they participate in a red cell immunization program?

An e-Network member has written that her facility collects plasma from compensated individuals, some of whom have anti-D in their plasma. In fact, her facility is licensed to inject small quantities of D positive red blood cells into selected individuals who have anti-D, in order to boost the anti-D titer, so that the anti-D containing plasma can be manufactured into Rh Immune Globulin. This process is done with informed consent and by following regulatory guidelines. The D positive 'booster' red cells are obtained from highly selected donors, per FDA rules, and have been frozen in quarantine for at least one year pending the testing of the red cell donor for seroconversion to relevant infectious diseases before the red cells are released for use. Based on the above situation, the inquiring e-network member asks if it would be permissible for an individual who has received a D positive 'booster' shot of red cells to become a tissue or organ donor (in the event they died).

I asked this inquiring member to contact Mr. Clint Venable, at the California Department of Health Services, since Mr. Venable is the tissue bank guru for California. His e-mail address is: cvenable@dhs.ca.gov.The inquiring member reports that she telephoned Mr. Venable, and was told the only universal requirement is that the tissue donor must test negative for current infectious diseases at the time of tissue donation. For tissue donation there is no California State regulated deferral for one year after red cell exposure, as is the case for blood donation. However, local regulations may apply.

ADDENDUM April 19, 2001

1. According to a high ranking physician in the plasma industry, the FDA has removed restrictions about such individuals becoming blood donors. If the booster cells are properly pedigreed it is not considered to be a transfusion.
   
   In addition, according to another experienced worker in the field, due to the scarcity of tissue and organ donors, decedents cannot be automatically deferred for having received blood products in the past year. By accepting donors who have received multiple units of blood, tissue banks must depend on the screening of blood donors and the safety of blood transfusion. Otherwise a large percentage of tissue and organ donors would be lost since many are victims of trauma and have undergone resuscitation and transfusion. Because of the common transfusion history, every program must do a hemodilution assessment to determine whether a blood specimen obtained from a tissue donor can be tested reliably for infectious disease testing. Of course every tissue donor must be evaluated for a variety of risk factors much like blood donors.

Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org

Ira A. Shulman, MD
CBBS e-Network Forum Senior Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Editor & Moderator

Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator