Or. Admin. Code § 333-080-0040

Current through Register Vol. 63, No. 11, November 1, 2024

Section 333-080-0040 - Definitions

(1) As used in this section of Oregon Administrative Rules:

(a) "Entity" means an individual, corporation, business trust, partnership, limited liability company, association, joint venture or an instrumentality of an entity.

(b) "Eye bank" means an entity that is licensed or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage or distribution of human eyes or parts of human eyes.

(c) "Health care facility" has the meaning given that term in ORS 442.015.

(d) "Organ procurement organization" means an entity designated by the United States Secretary of Health and Human Services as an organ procurement organization.

(e) "Tissue bank" means an entity that is licensed or regulated under federal or state law to engage in the recovery, screening, testing, processing, storage or distribution of tissue for transplants.

(2) Tissue banks and eye banks must be registered with and regulated by the United States Food and Drug Administration.

(3) A health care facility that performs organ transplants must:

(a) Be a member of the Organ Procurement and Transplantation Network established by the National Organ Transplant Act of 1984;

(b) Be regulated by the United States Department of Health and Human Services; and

(c) Use an organ procurement organization to obtain organs for transplants.

(4) A health care facility that performs tissue or corneal transplants must obtain the tissue or corneas from a tissue bank or an eye bank that is registered with and regulated by the United States Food and Drug Administration.

Or. Admin. Code § 333-080-0040

PH 5-2008, f. 3-7-08, cert. ef. 7-1-08

Stat. Authority: ORS 441.015

Stats. Implemented: ORS 183.745, ORS 441.015, ORS 441.079, ORS 441.082