BILL NUMBER: SB 1135	CHAPTERED  09/26/02

	CHAPTER  929
	FILED WITH SECRETARY OF STATE  SEPTEMBER 26, 2002
	APPROVED BY GOVERNOR  SEPTEMBER 25, 2002
	PASSED THE SENATE  AUGUST 30, 2002
	PASSED THE ASSEMBLY  AUGUST 27, 2002
	AMENDED IN ASSEMBLY  AUGUST 25, 2002
	AMENDED IN ASSEMBLY  JULY 17, 2001
	AMENDED IN ASSEMBLY  JULY 5, 2001
	AMENDED IN SENATE  JUNE 4, 2001
	AMENDED IN SENATE  MAY 25, 2001
	AMENDED IN SENATE  APRIL 18, 2001

INTRODUCED BY   Senators Polanco and Murray

                        FEBRUARY 23, 2001

   An act to add Section 1639.01 to the Health and Safety Code,
relating to tissue banks.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1135, Polanco.  Tissue banks.
   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 and permits
regulations adopted by the department to include minimum standards
for various aspects related to tissue banks.
   This bill would require, rather than authorize, the department to
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, and would require that the regulations be substantially based
upon the criteria used by tissue bank trade associations in their
respective accreditation processes.  It would require, rather than
permit, regulations adopted by the department, pursuant to the bill,
to include minimum standards for various aspects related to tissue
banks, and would also require the department, on or before July 1,
2003, to report to the appropriate policy and fiscal committees of
the Legislature regarding the status of the proposed regulations.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  Section 1639.01 is added to the Health and Safety Code,
to read.
   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.