BILL ANALYSIS Ó
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2015 - 2016 Regular Session
AB 2750 (Gomez) - Tissue banks
-----------------------------------------------------------------
| |
| |
| |
-----------------------------------------------------------------
|--------------------------------+--------------------------------|
| | |
|Version: June 13, 2016 |Policy Vote: HEALTH 7 - 0 |
| | |
|--------------------------------+--------------------------------|
| | |
|Urgency: No |Mandate: No |
| | |
|--------------------------------+--------------------------------|
| | |
|Hearing Date: June 27, 2016 |Consultant: Brendan McCarthy |
| | |
-----------------------------------------------------------------
This bill does not meet the criteria for referral to the
Suspense File.
Bill
Summary: AB 2750 would provide an exemption from the requirement that
tissue banks be licensed by the state for persons providing
health care services, under specified conditions
Fiscal
Impact: 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
AB 2750 (Gomez) Page 1 of
?
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.
Background: Under current law, entities acting as tissue banks must be
licensed by the Department of Public Health and must meet
specified regulatory requirements. Tissue banks collect, store,
and provide musculoskeletal tissue, skin, and veins for
transplantation. Current law exempts a number of activities from
the licensing requirement, such as the collection and storage of
human blood and its derivatives.
Under current law, the Department is required to develop and
adopt regulations governing tissue banks. However, the
Department has not yet adopted regulations. In guidance provided
to potential licensees, the Department has indicated that any
facility that stores any tissue or does not return unused tissue
to a licensed tissue bank within the same day as receiving the
tissue must be licensed as a tissue bank.
In many cases, a tissue bank will send tissue for
transplantation for a specific patient to a hospital or
ambulatory surgical center but the transplantation cannot occur
on that day. In such cases, a hospital or surgery center may
store the tissue overnight for transplantation the next day.
According the Department, such a hospital or surgery center
would need to be licensed as a tissue bank in that case. In
fact, according to the Department, 191 hospitals and 77
ambulatory surgery centers are licensed as tissue banks,
presumably due to this requirement.
Proposed Law:
AB 1822 would provide an exemption for persons providing
health care services, under specified conditions from the
requirement that tissue banks be licensed by the state.
Specifically, the bill would exempt a hospital or ambulatory
surgical center from licensure as a tissue bank if certain
record keeping requirements are met, certain storage and
handling requirements are met, and the allograft tissue is
AB 2750 (Gomez) Page 2 of
?
registered with the federal Food and Drug Administration and
designated to be maintained at ambient room temperature.
Related
Legislation: AB 1822 (Bonta, 2014) was substantially similar to
this bill. That bill was vetoed by Governor Brown.
Staff
Comments: Staff notes that it is not likely that the Department
would reduce staff expenditures immediately under the bill,
therefore the Department is likely to support current staff with
other licensing fees for some period of time before staff are
fully redirected to other licensing activities or positions are
eliminated.
-- END --