qualified cord blood bank

(4) Definition The term “qualified cord blood bank” means a cord blood bank that— (A) has obtained all applicable Federal and State licenses, certifications, registrations (including pursuant to the regulations of the Food and Drug Administration), and other authorizations required to operate and maintain a cord blood bank; (B) has implemented donor screening, cord blood collection practices, and processing methods intended to protect the health and safety of donors and transplant recipients to improve transplant outcomes, including with respect to the transmission of potentially harmful infections and other diseases; (C) is accredited by an accreditation entity recognized by the Secretary under subsection (b); (D) has established a system of strict confidentiality to protect the identity and privacy of patients and donors in accordance with existing Federal and State law; (E) has established a system for encouraging donation by a genetically diverse group of donors; and (F) has established a system to confidentially maintain linkage between a cord blood unit and a maternal donor.


42 USC § 274k(d)(4)

Scoping language

None identified, default scope is assumed to be the parent (part I) of this section.
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