BILL ANALYSIS
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|SENATE RULES COMMITTEE | AB 995|
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THIRD READING
Bill No: AB 995
Author: Block (D)
Amended: 7/13/09 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 10-0, 7/15/09
AYES: Alquist, Strickland, Aanestad, Cedillo, Cox,
DeSaulnier, Leno, Negrete McLeod, Pavley, Wolk
NO VOTE RECORDED: Maldonado
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : Not relevant
SUBJECT : Tissue bank licensing
SOURCE : Author
DIGEST : This bill adds to the list of licensure
exceptions relative to tissue banks, the storage of a human
cell, tissue, or cellular- or tissue- based product that is
either a medical device or a biologic product, as defined,
by licensed physician or podiatrist acting within the scope
of his/her license and practicing in a lawful practice
setting, as specified. The bill also requires, to be
eligible for this exemption, that the entity where the
physician or podiatrist practices notify the department of
specified information.
ANALYSIS :
CONTINUED
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Existing law:
1. Requires the Department of Public Health (DPH) to
license and regulate tissue banks and gives DPH the
authority to revoke or suspend the license of any tissue
bank that violates licensing standards pertaining to
tissue banks.
2. Defines "tissue" as any human cell, group of cells,
tissue or organ including the cornea, sclera, or
vitreous humor and other segments of, or the whole eye,
bones, skin, arteries, sperm, blood, other fluids, and
any other portion of a human body.
3. Requires DPH to adopt, on or before July 1, 2004,
regulations governing licensed tissue banks engaged in
the collection of human musculoskeletal tissue, skin,
and veins for transplantation in humans. Requires the
regulations to be substantially based on accreditation
standards issued by tissue bank trade associations, as
specified.
4. Requires regulations for tissue banks to include minimum
standards related to preservation, storage, and handling
of tissue; equipment, methods, and personnel
qualifications of tissue banks; and testing of donors,
as specified.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 8/19/09)
California Podiatric Medical Association
Advanced BioHealing, Inc.
Organogenesis, Inc.
ARGUMENTS IN SUPPORT : DPH, the sponsor of this bill,
states that due to rapid changes in tissue banking
technology, it has been unable to promulgate standards for
tissue banks. DPH argues that the AATB standards that
tissue banks would have to meet under this bill are updated
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on a routine basis, reflect the latest technological
advances, and are nationally recognized as accepted
standards for safety. DPH further argues that adopting the
AATB standards, combined with an expedited process for
adopting changes to the standards and new authority to levy
monetary penalties for licensing violations, will allow it
to take more effective enforcement action.
The AATB states that it publishes the only authoritative
industry standards for tissue banks, and that it has been
the driving force behind the development of standards for
human tissue by federal and state authorities. In
particular, AATB states that its standards are the most
detailed and comprehensive standards for tissue banking in
the world and have served as the template for FDAs
regulations, as well other state and international
standards. AATB argues that, although California tissue
banks are licensed by the state and registered with the
FDA, requiring the banks to additionally meet AATB
standards will provide an added measure of protection for
consumers.
CTW:DLW:do 8/19/09 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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