Chapter 334 Oregon Laws 2007

 

AN ACT

 

SB 341

 

Relating to transplants.

 

Be It Enacted by the People of the State of Oregon:

 

          SECTION 1. (1) As used in this section and section 2 of this 2007 Act:

          (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.

 

          SECTION 2. (1) The Department of Human Services shall adopt by rule standards and a system of registration for every organ procurement organization, tissue bank and eye bank doing business in this state.

          (2) An organ procurement organization, tissue bank or eye bank may not do business in this state unless it has registered with the department.

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

          (4) The department 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 department;

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

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

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

 

          SECTION 3. Each organ procurement organization, tissue bank and eye bank doing business in this state must register with the Department of Human Services within 30 days after the operative date of section 2 of this 2007 Act.

 

          SECTION 4. Section 2 of this 2007 Act becomes operative on July 1, 2008.

 

Approved by the Governor June 11, 2007

 

Filed in the office of Secretary of State June 13, 2007

 

Effective date January 1, 2008

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