BILL ANALYSIS Ó
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CONCURRENCE IN SENATE AMENDMENTS
AB
2750 (Gomez)
As Amended June 13, 2016
Majority vote
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|ASSEMBLY: |78-0 |(May 12, 2016) |SENATE: | 37-0 |(August 11, |
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Original Committee Reference: HEALTH
SUMMARY: Creates an additional exemption from tissue bank
licensing requirements.
The Senate amendments exempt the storage of allograft issue by a
person from tissue bank licensure requirements if all of the
following apply:
1)The person is a hospital or an outpatient setting regulated by
the Medical Board of California, including an ambulatory
surgical center;
2)The person maintains a log that includes the date on which the
allograft tissue was received, the expiration date of the
allograft tissue, the date on which each allograft tissue is
used for clinical purposes, and the disposition of any
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allograft tissue samples that remain unused at the time the
allograft tissue expires; and,
3)The allograft tissue meets all of the following:
a) Was obtained from a tissue bank licensed by the state;
b) Is individually boxed and labeled with a unique
identification number and expiration date so that opening
the shipping container will not disturb or otherwise alter
any of the allograft tissue that is not being utilized;
c) Is intended for the express purpose of implantation into
or application on a patient;
d) Is not intended for further distribution; and,
e) Is registered with the Food and Drug Administration and
designated to be maintained at ambient room temperature
requiring no refrigeration.
FISCAL EFFECT: According to the Senate Appropriations
Committee, ongoing reduction in licensing workload and fee
revenues, likely less than $100,000 per year (Tissue Bank
License Fund). Currently, there are about 270 hospitals and
ambulatory surgical centers that are licensed as tissue banks.
Under the bill, some portion of those facilities could surrender
their tissue bank license, to the extent that such entities have
a tissue bank license only due to their storage of allograft
tissue that meets the exemption requirement in the bill. The
share of hospitals or ambulatory surgical centers that only have
a tissue bank license due to their storage of such tissue is
unknown. Because the exemption provided for in this bill is
only for tissue that is designated for storage at ambient room
temperature, there are likely to be a significant number of
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hospitals and ambulatory surgical centers that will still need
to maintain their tissue bank license, in order to continue to
store other tissues. For example, if 40% of such facilities
surrendered their license, the reduction in licensing workload
and fee revenue would be about $100,000 per year.
COMMENTS: According to the author, due to the burdens of
licensure, many hospitals and ambulatory surgical centers
located in California are simply opting not to obtain a tissue
bank license from the state. Rather, they make daily deliveries
of the specified tissue grafts at the beginning of the calendar
day, and then use a courier to return any unused tissue grafts
at the end of the day. The author states that courier fees have
been known to cost one California licensed tissue supplier over
$150,000 in one year. These fees are generally included in the
overall cost of providing tissue grafts in California, further
increasing the cost of health care.
BACKGROUND: Allograft is a graft of tissue obtained from a
donor of the same species as, but with a different genetic
make-up from the recipient, used as a tissue transplant between
two humans. Also called homograft. Tissues commonly used for
allografts include cornea, cartilage, bone, artery, and cadaver
skin stored in a skin-tissue bank.
Analysis Prepared by:
Lara Flynn / HEALTH / (916) 319-2097 FN:
0003651
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