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.

Statutory/Other Authority: ORS 441.015
Statutes/Other Implemented: ORS 183.745, ORS 441.015, ORS 441.079 & ORS 441.082
History:
PH 5-2008, f. 3-7-08, cert. ef. 7-1-08

333-080-0050
Registration and Civil Penalties

(1) An organ procurement organization, tissue bank or eye bank may not do business in Oregon unless it has registered with the Oregon Health Authority. Registration with the Authority must be completed within 30 days after the implementation of these rules on July 1, 2008.

(a) The Authority shall develop a registration form and the transplant organizations shall, at least 30 days prior to implementation, obtain and mail the required form to the Authority.

(2) Each organ procurement organization, tissue bank and eye bank shall provide to the Authority, at least every three years, current documentation of designation, certification and inspection as evidence of compliance with national standards and requirements under federal law.

(3) The Authority may impose a civil penalty not to exceed $1,000 against an organ procurement organization, tissue bank or eye bank doing business in this state for failure to:

(a) Register with the Authority;

(b) Report loss of designation, accreditation or certification within 60 days of the loss; or

(c) Supply the Authority with requested current documentation of designation, certification and inspection.

(d) For the first violation the civil penalty shall be $250;

(e) For the second violation the civil penalty shall be $500;

(f) For the third and any subsequent violations, the civil penalty shall be $1000.

(4) Civil penalties under this section shall be imposed in the manner provided under ORS 183.745.

Statutory/Other Authority: ORS 441.015
Statutes/Other Implemented: ORS 183.745, ORS 441.015, ORS 441.079 & ORS 441.082
History:
PH 5-2008, f. 3-7-08, cert. ef. 7-1-08