Unused Autologous Blood
Why Is It Not Made Available for General Use?

1. Liberal eligibility criteria to maximize patient participation
   In order to enable as many patients as possible to donate blood for their planned surgery we deliberately relax the medical eligibility criteria. For example, we lower the acceptable hemoglobin/hematocrit level and accept persons with serious medical conditions (e.g., cancer and heart disease) that would ordinarily disqualify them from donating for general use.
2. Unexpected conditions diagnosed after surgery (e.g., cancer) may render a donation unsuitable, requiring a recall
   In this situation, if the unit had been designated for general use and transfused to another person, an FDA-mandated recall would have to be initiated. Because blood banks would then have to notify recipients of recalled units and their physicians, and considerable expense and anxiety would result, we feel it best to have a single uniform set of criteria for donors of blood intended for general use.
3. Since most autologous donations are unsuitable for general use, any savings from releasing these donations for general use would be outweighed by the administrative costs of subjecting the donors to a full medical history.
   In view of this, and because these patients are usually making repeated donations over a short time, we limit the medical history to those questions addressing the safety of the donor. This reduces the time patients must take to make their donations.
4. Safety concerns:
   Some patients, fearful that mention of certain information may disqualify them from donating for themselves, may not fully disclose their medical history, thus increasing the possibility their blood could transmit an infection to others.
   Studies of the incidence of positive test results for infectious agents show higher rates among autologous donors than volunteer donors. Since a negative test result may occur in the presence of infection (= "false-negative"), this higher incidence of positive test results suggests that their blood may be less safe than that of volunteer donors.
   If autologous blood were made available for general use, hospitals would have to maintain two inventories of this blood. This increases the possibility for erroneous release, with an unsuitable autologous unit being transfused to another person.
5. Legal liability
   Excluding unused autologous donations from general use has become the standard of care throughout the United States. If a "crossed over" autologous unit led to disease transmission, legal liability for the hospital and the physician could be considerable.

(Adapted from a position statement by the Blood Centers of California, 1994)