A California physician asks how do Blood Donor Collection Centers (including hospital sites) manage donor consent for incompetent adults who present as prospective blood donors? For example, would it be sufficient for a prospective donor to be accompanied by a parent or legal guardian who helps with answers to the donor's eligibility questionnaire? For example, on the same day and at the same collection site a father and his son attempted to donate blood. The father and son live together at the same address. The son works in the father's business, which employs disabled individuals. The son is developmentally disabled, with limited understanding. The father wanted his son to donate blood and the son was proud to be considered a potential blood donor. However, because the son would not be able to answer the questions on his own, the father was willing to assist the donor center staff with his son's pre-donation questionnaire.

The aforementioned situation subsequently raised the question of the guardianship role during the determination of donor eligibility, and how that role could possibly apply. According to the 23rd Edition of AABB Standards: STANDARD 5.2.1 Donor Consent - The consent of all donors shall be obtained before donation. Elements of the donation procedure shall be explained to the prospective donor in understandable terms. The explanation shall include information about risks of the procedure and tests performed to reduce the risks of transmission of infectious diseases to the allogeneic recipient. The donor shall have an opportunity to ask questions about the procedure and to give or refuse consent for donation. In the case of a minor or a legally incompetent adult, consent shall be addressed in accordance with applicable law.

This issue was discussed with a representative of the California Department of Health / Laboratory Field Services who obtained input from a California Department of Health Servcies attorney to determine if a guardianship role would be permitted in this situation. The answer was "The Office of Legal Services (OLS) left it to the inquiring physician's center to handle.

The physician and staff of the center conclude that the guardianship role could be applicable in the autologous donor situation, but not in allogeneic donation. The Center asks 'what SOP do other centers have regarding legally incompetent adult and consent for blood donation?'"

ADDENDA Sept. 12, 2006

1. A transfusion medicine physician in Santander, Spain reports having first hand experience with the topic under discussion, because some years ago they evaluated a prospective blood donor with Down's syndrome. The donor worked and lived a fairly independent life, without further problems. In the Spanish physician's opinion, the subject of incompetent adults is complex, because of the different degrees and modes of disability. Sometimes the disability can be a cause for donor rejection, as is the case of the cardiovascular malformations which affect some Down's syndrome patients, or in an otherwise normal person with cerebral palsy, but who cannot control his limbs. Therefore, they deal with these cases in a case-by-case basis, based on:

• The data supplied by the legal representative, as to IQ, risk factors, etc.
• The prospective donor's physician's input as to the physical well being of the donor, and their capability to undergo a donation.
• An interview with the prospective donor in which the donor center personnel in charge of the collection must feel satisfied as to the person's capability to understand the questions being asked, without help. This is a key to a successful donation, and the collection of a product that is safe for transfusion.
• They do not apply the last criteria to all cases of therapeutic phlebotomies or autologous donation.

ADDENDA Sept. 28, 2006

2. Dr. Ronald E. Domen, Professor of Pathology, Medicine, and Humanities at Milton S. Hershey Medical Center of Penn State University College of Medicine (attribution used with permission) reports that in his opinion to allow an incompetent adult to donate blood raises several concerns. First, the history and direct questioning would be asked of a surrogate rather than the donor. This would be second-hand information and validity is always suspect in such a situation; thus, safety of the blood would be a concern. Second, if the donor is incompetent to understand what is being asked of him to do, and does not understand the questions being asked, how can it be assumed that the donor looks forward to being a blood donor? The motivation of the parent or guardian needs to be questioned in this case. Third, it is difficult to comprehend how blood donation would be of any benefit to an incompetent donor. Blood donation in this setting is not analogous to treating an incompetent patient with a healthcare issue where some benefit to the patient is expected following medical or surgical therapy. Despite the general safety of blood donation, Dr. Domen believes the question has to be asked, Why subject an otherwise healthy individual to any risk associated with blood donation when that person is incapable of giving informed consent? In summary, he would not accept a blood donor who is incompetent to give informed consent.

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