(a) Determination based on screening and testing. If you are the establishment responsible for making the donor-eligibility determination, you must determine whether a donor is eligible based upon the results of donor screening in accordance with §1271.75 and donor testing in accordance with §§1271.80 and 1271.85. A responsible person, as defined in §1271.3(t), must determine and document the eligibility of a cell or tissue donor.

(b) Eligible donor. A donor is eligible under these provisions only if:

(1) Donor screening in accordance with §1271.75 indicates that the donor:

(i) Is free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases; and

(ii) Is free from communicable disease risks associated with xenotransplantation; and

(2) The results of donor testing for relevant communicable disease agents in accordance with §§1271.80 and 1271.85 are negative or nonreactive, except as provided in §1271.80(d)(1).