BILL ANALYSIS
AB 995
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 995 (Block)
As Amended July 23, 2009
Majority vote
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|ASSEMBLY: | |(May 28, 2009) |SENATE: |38-0 |(August 27, |
| | | | | |2009) |
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(vote not relevant)
Original Committee Reference: HEALTH
SUMMARY : Exempts from tissue bank licensing requirements a
licensed physician or podiatrist storing a human cell, tissue,
or cellular- or tissue-based medical device or biologic product,
as specified.
The Senate amendments delete the Assembly version of this bill,
and instead:
1)Add to the list of exceptions from Department of Public Health
(DPH) tissue bank licensing requirements the storage of a
human cell, tissue, or cellular- or tissue-based medical
device or biologic product that is approved by the federal
government, as specified, by a licensed physician or
podiatrist acting within his or her scope of practice and in a
lawful setting, if the product was obtained from a California
licensed tissue bank and stored as directed by the
manufacturer, for use by the physician or podiatrist on his or
her own patient.
2)Require the entity or organization where the physician or
podiatrist practices to notify DPH of the following: the
practitioner is licensed and working within the scope and
authority of his or her license and practice for the purpose
of direct patient care; a list of practitioners to whom the
notification applies; agreement of each listed practitioner to
strictly abide by the manufacturer's directions for storage
and other instructions and guidelines; and, acknowledgement
that the product will not be resold or distributed.
EXISTING LAW defines a tissue bank as any place, establishment,
or institution that
collects, processes, stores, or distributes tissue for
AB 995
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transplantation into human beings, and requires tissue banks to
be licensed by DPH, except as specified.
AS PASSED BY THE ASSEMBLY , this bill deleted requirements that
DPH regulate tissue banks, and instead required tissue banks to
comply with the current standards of the American Association of
Tissue Banks, required DPH to evaluate and consider for adoption
future amendments to the AATB standards pursuant to a prescribed
process, and changed the civil administrative penalties DPH may
impose for noncompliance with the standards.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS : The author states DPH regulations require podiatrists
to register as tissue banks if they store tissues for more than
24 hours. According to the author, this additional licensing
requirement and fee for licensed practitioners who lawfully
obtain products from a California licensed tissue bank and use
and store them in accordance with existing federal laws and
manufacturer guidelines for direct patient care could jeopardize
access to advanced products, such as bioactive devices and
products. The author states that newly developed bioactive
devices and products deliver living, cell-based products to
stimulate the body's own healing process, and are approved by
the federal Food and Drug Administration to treat diabetic foot
ulcers and venous leg ulcers, which are painful, last many
years, and are the most frequently occurring chronic wounds
suffered by patients.
This bill was substantially amended in the Senate and the
Assembly-approved provisions of this bill were deleted. This
bill, as amended in the Senate, is inconsistent with Assembly
actions.
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097
FN: 0002570