BILL NUMBER: SB 617 CHAPTERED 09/22/03 CHAPTER 464 FILED WITH SECRETARY OF STATE SEPTEMBER 22, 2003 APPROVED BY GOVERNOR SEPTEMBER 20, 2003 PASSED THE SENATE SEPTEMBER 4, 2003 PASSED THE ASSEMBLY SEPTEMBER 3, 2003 AMENDED IN ASSEMBLY AUGUST 25, 2003 AMENDED IN ASSEMBLY JULY 9, 2003 AMENDED IN ASSEMBLY JUNE 18, 2003 AMENDED IN SENATE JUNE 3, 2003 AMENDED IN SENATE MAY 6, 2003 AMENDED IN SENATE APRIL 22, 2003 AMENDED IN SENATE APRIL 2, 2003 INTRODUCED BY Senator Speier FEBRUARY 20, 2003 An act to amend Section 1639 of, and to add Sections 1639.35 and 7158.3 to, the Health and Safety Code, relating to anatomical gifts. LEGISLATIVE COUNSEL'S DIGEST SB 617, Speier. Anatomical gifts: tissue banks: informed consent. (1) Existing law provides for the licensure and regulation of tissue banks by the State Department of Health Services. Existing law authorizes the department to adopt rules and regulations governing the administration and enforcement of these provisions. This bill would require the department to report to the Legislature by January 1, 2004, on the status of these regulations. This bill would also require that any person, when submitting an application for a license or renewal of a license to operate a tissue bank, submit, with the application, a copy of the applicant's standard informed consent form required pursuant to paragraph (2). (2) The Uniform Anatomical Gift Act, which is administered by the State Department of Health Services, establishes general requirements and procedures for the donation of human organs and tissue, and pacemakers, upon or after death. Existing law also includes related provisions regarding donation information and procedures. This bill would require specified donees of an anatomical gift to revise existing informed consent forms and procedures under the act to advise a donor or donor's representative of specified information regarding potential uses of donated tissue, including use of tissue by a for-profit tissue processor or distributor, use of skin for purposes of cosmetic or reconstructive surgery, as defined, or use of tissue for transplants outside of the United States. The bill would allow the donor to withhold consent for donated tissue to be used for these purposes. This bill would require the donee to offer to provide the donor or donor's representative with a copy of the completed consent form, or, if consent is obtained by telephone, to advise the donor or donor' s representative that the consent conversation will be tape recorded and to offer to provide the donor or donor's representative with a written copy of the recorded telephonic consent form. This bill would authorize a donor to bring a civil action for a violation of these provisions. The bill also would deem it unprofessional conduct for a health care provider to violate these provisions. These provisions would not apply to the removal of sperm or ova pursuant to a specified provision of existing law. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 1639 of the Health and Safety Code is amended to read: 1639. (a) The department may adopt rules and regulations governing the administration and enforcement of this chapter. (b) Regulations adopted by the department may include minimum standards for the following: (1) Safe preservation, transportation, storage, and handling of tissue acquired or used for transplantation. (2) Testing of donors to determine compatibility when appropriate. (3) Testing or assessment of donors to prevent the spread of disease through transplantation. (4) Equipment. (5) Methods. (6) Personnel qualifications. (7) Any other area concerning the operation or maintenance of a tissue bank, not inconsistent with this chapter, as may be necessary to carry out this chapter. (c) The department shall report to the Legislature by January 1, 2004, on the status of the regulations developed pursuant to this section. SEC. 2. Section 1639.35 is added to the Health and Safety Code, to read: 1639.35. Any person, when submitting an application for a license, including the renewal thereof, pursuant to this chapter, shall also submit, with the application, a copy of the applicant's standard informed consent form required pursuant to Section 7158.3. SEC. 3. Section 7158.3 is added to the Health and Safety Code, to read: 7158.3. (a) The following definitions shall apply for purposes of this section: (1) "Cosmetic surgery" means surgery that is performed to alter or reshape normal structures of the body in order to improve appearance. (2) "Donee" means a hospital, as defined in subdivision (f) of Section 7150.1, or an organ procurement organization, as defined in subdivision (j) of Section 7150.1, or a tissue bank licensed pursuant to Chapter 4.1 (commencing with Section 1635) of Division 2. (3) "Reconstructive surgery" means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (A) To improve function. (B) To create a normal appearance, to the extent possible. (b) For purposes of accepting anatomical gifts, as defined in subdivision (a) of Section 7150.1, a donee shall do all of the following: (1) Revise existing informed consent forms and procedures to advise a donor or, if the donor is deceased, the donor's representative, that tissue banks work with both nonprofit and for-profit tissue processors and distributors, that it is possible that donated skin may be used for cosmetic or reconstructive surgery purposes, and that donated tissue may be used for transplants outside of the United States. (2) The revised consent form or procedure shall separately allow the donor or donor's representative to withhold consent for any of the following: (A) Donated skin to be used for cosmetic surgery purposes. (B) Donated tissue to be used for applications outside of the United States. (C) Donated tissue to be used by for-profit tissue processors and distributors. (3) A donee shall be deemed to have complied with paragraph (2) by designating tissue that has been donated with specific restrictions on its use. Once the donee transfers the tissue to a separate entity, the donee's responsibility for compliance with any restrictions on the tissue ceases. (4) The donor may recover, in a civil action against any individual or entity that fails to comply with this subdivision, civil penalties to be assessed in an amount not less than one thousand dollars ($1,000) and not more than five thousand dollars ($5,000), plus court costs, as determined by the court. A separate penalty shall be assessed for each individual or entity that fails to comply with this subdivision. Any civil penalty provided under this paragraph shall be in addition to any license revocation or suspension, if appropriate, authorized under subdivision (c). (5) If the consent of the donor or donor's representative is obtained in writing, the donee shall offer to provide the donor or donor's representative with a copy of the completed consent form. If consent is obtained by telephone, the donee shall advise the donor or donor's representative that the conversation will be tape recorded for verification and enforcement purposes, and shall offer to provide the donor or donor's representative with a written copy of the recorded telephonic consent form. (c) Violation of this section by a licensed health care provider constitutes unprofessional conduct. (d) This section shall not apply to the removal of sperm or ova pursuant to Section 2260 of the Business and Professions Code. SEC. 4. (a) It is the intent of the Legislature that this act shall not increase the number of inspections of tissue banks made by the State Department of Health Services, and that existing initial and routine inspections incorporate a review of informed consent procedures within the policies and procedures already required for licensure under Section 1639.1 of the Health and Safety Code. (b) The implementation of this act shall be made through the existing resources of the State Department of Health Services.