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 (Civil penalty procedures).
Rule 333-080-0050 — Registration and Civil Penalties,