Section 1639.01 Of Article 2. Regulation Of Tissue Banks From California Health And Safety Code >> Division 2. >> Chapter 4.1. >> Article 2.
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.