BILL ANALYSIS �
AB 1822
Page 1
Date of Hearing: April 30, 2014
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Mike Gatto, Chair
AB 1822 (Bonta) - As Introduced: February 18, 2014
Policy Committee: HealthVote:19-0
Urgency: No State Mandated Local Program:
No Reimbursable: No
SUMMARY
This bill exempts a licensed health care provider, as specified,
storing human cell, tissue, or cellular- or tissue-based product
(HCT/P) that is regulated by the federal Food and Drug
Administration (FDA) from state licensure as a tissue bank if
all of the following apply:
a)The tissue has been obtained from a licensed tissue bank.
b)The tissue has been stored in accordance with FDA regulations
and guidelines.
c)The tissue is used for the express purpose of implantation
into or application on a patient, and is not intended for
further distribution.
FISCAL EFFECT
A potential decrease of about 40% in workload, and a
commensurate $250,000 reduction in annual fee revenue to the
Department of Public Health (DPH) Tissue Bank licensing program.
Remaining fee revenues and the fund balance in the Tissue Bank
Licensing Fund appear to be adequate to support remaining
workload.
COMMENTS
1)Purpose . According to the author, due to the burdens of
licensure, many hospitals and ambulatory surgical centers
located in California opt not to obtain a tissue bank license
from the state, and instead make daily deliveries of the
specified tissue grafts at the beginning of the calendar day,
using couriers to return any unused tissue grafts at the end
of the day. The author states this is inefficient and costly.
AB 1822
Page 2
This bill is sponsored by the American Association of Tissue
Banks (AATB), a trade association that publishes guidance and
standards related to tissue banks, and performs accreditation
of tissue banks and certification of related personnel.
2)Background . A tissue bank is defined as an establishment that
collects, processes, stores, or distributes tissue (cells,
groups of cells, segments of eyes and other body parts, sperm,
blood, and other fluids) for transplantation into humans.
Current law requires the Department of Public Health to adopt
regulations on or before January 1, 2004, governing tissue
banks, and requires the regulations to be based on criteria
used by tissue bank trade associations in their accreditation
processes. The law references the AATB and one other trade
association specifically. Finally, it requires every tissue
bank to have a valid license.
DPH has not issued regulations as required by existing law.
DPH maintains that any facility collecting, processing,
storing, or distributing human tissue for purposes of
transplantation needs to be licensed as a tissue bank, as
specified in the law. Eight exemptions have been added over
the years; this bill would add a ninth exemption. The AATB
believes it is unnecessary for providers to be licensed as
tissue banks with the state when they are only storing tissue
for use in their own patients in accordance with FDA
regulations and oversight.
According to AATB, California is the only state in which
providers that are simply storing tissue are required to be
licensed as tissue banks.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081