BILL ANALYSIS �
Senate Appropriations Committee Fiscal Summary
Senator Kevin de Le�n, Chair
AB 1822 (Bonta) - Tissue banks.
Amended: May 28, 2014 Policy Vote: Health 8-0
Urgency: No Mandate: No
Hearing Date: August 4, 2014
Consultant: Brendan McCarthy
This bill does not meet the criteria for referral to the
Suspense File.
Bill Summary: AB 1822 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:
Anticipated annual reduction in licensing workload and fee
revenues of about $260,000 per year to the Department of
Public Health (Licensing and Certification Fund). The
Department anticipates that about 270 facilities are
currently licensed as tissue banks but would be exempt under
this bill. 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.
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. Typically, a tissue bank will provide specific
tissues to a hospital or surgery center for transplantation to a
specific patient. 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.
AB 1822 (Bonta)
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Current law exempts a number of activities from the licensing
requirement, such as the collection and storage of human blood
and its derivatives.
In many cases, a tissue bank may send tissue for transplantation
to a specific patient 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 from licensure as a tissue
bank an person who is licensed to provide health care services,
practicing within the scope of his or her license, provided that
the tissue is received from a licensed tissue bank, the tissue
is stored in accordance with federal regulations, and the tissue
is intended for use on a patient and not for further
distribution.
In practice, the bill will exempt hospitals and ambulatory
surgery centers that must be licensed as tissue banks under
current law, but do not provide tissue bank services to other
entities.