§1271.50. How do I determine whether a donor is eligible? — Inbound Citations

(10) Requirements relating to donor eligibility determinations, donor screening, and donor testing in §§ 1271.50, 1271.75, 1271.80, and 1271.85.

(a) You must keep an HCT/P in quarantine, as defined in § 1271.3(q), until completion of the donor-eligibility determination required by § 1271.50. You must quarantine semen from anonymous donors until the retesting required under § 1271.85(d) is complete.

(a) You are not required to make a donor-eligibility determination under § 1271.50 or to perform donor screening or testing under §§ 1271.75, 1271.80 and 1271.85 for:

(1) Cells and tissues for autologous use; or

(2) Reproductive cells or tissue donated by a sexually intimate partner of the recipient for reproductive use; or

(3) Cryopreserved cells or tissue for reproductive use, other than embryos, originally excepted under paragraphs (a)(1) or (a)(2) of this section at the time of donation, that are subsequently intended for directed donation, provided that:

(i) Additional donations are unavailable, for example, due to the infertility or health of a donor of the cryopreserved reproductive cells or tissue; and

(4) A cryopreserved embryo, originally excepted under paragraph (a)(2) of this section at the time of recovery or cryopreservation, that is subsequently intended for directed or anonymous donation. When possible, appropriate measures should be taken to screen and test the semen and oocyte donors before transfer of the embryo to the recipient.

(i) When the donor-eligibility determination under § 1271.50(a) is not performed or is not completed; or