1639.01. (a) Notwithstanding Section 1639, the state department shall adopt, on or before July 1, 2004, rules and regulations governing licensed tissue banks engaged in the collection of human musculoskeletal tissue, skin, and veins for transplantation in humans. The regulations shall be substantially based upon the criteria used by tissue bank trade associations in their respective accreditation processes including, but not limited to, those of the Eye Bank Association of America and the American Association of Tissue Banks, and the scientific and technical data submitted by individual tissue banks.
(b) Regulations adopted by the state department, pursuant to subdivision (a), shall include minimum standards for all of 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) On or before July 1, 2003, the department shall report to the appropriate policy and fiscal committees of the Legislature regarding the status of the proposed regulations.
(Added by Stats. 2002, Ch. 929, Sec. 1. Effective January 1, 2003.)
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