BILL ANALYSIS �
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THIRD READING
Bill No: AB 1822
Author: Bonta (D), et al.
Amended: 5/28/14 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 8-0, 6/25/14
AYES: Hernandez, Morrell, Beall, De Le�n, DeSaulnier, Evans,
Monning, Nielsen
NO VOTE RECORDED: Wolk
SENATE APPROPRIATIONS COMMITTEE : 7-0, 8/4/14
AYES: De Le�n, Walters, Gaines, Hill, Lara, Padilla, Steinberg
SENATE FLOOR : 32-0, 8/14/14
AYES: Anderson, Beall, Berryhill, Block, Cannella, Corbett,
Correa, De Le�n, Evans, Fuller, Gaines, Galgiani, Hernandez,
Hill, Hueso, Huff, Knight, Lara, Leno, Lieu, Liu, Monning,
Morrell, Nielsen, Padilla, Pavley, Roth, Steinberg, Torres,
Vidak, Wolk, Wyland
NO VOTE RECORDED: Calderon, DeSaulnier, Hancock, Jackson,
Mitchell, Walters, Wright, Yee
NOTE: This bill passed the Senate on 8/14/14, but a motion
for reconsideration was granted.
ASSEMBLY FLOOR : 73-0, 5/8/14 (Consent) - See last page for vote
SUBJECT : Tissue banks
SOURCE : American Association of Tissue Banks
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DIGEST : This bill exempts from tissue bank licensure the
storage of tissue by a person licensed to provide health care
services who is acting within the scope of the license and
practicing in a lawful practice setting.
ANALYSIS : Existing law:
1.Defines "tissue" as a human cell, group of cells, including
the cornea, sclera, or vitreous humor and other segments of,
or the whole eye, bones, skin, arteries, sperm, blood, other
fluids, and any other portion of a human body.
2.Establishes rules and regulations adopted by the Department of
Public Health (DPH) governing tissue banks engaged in the
collection of human musculoskeletal tissue, skin, and veins
for transplantation in humans, requires the regulations to be
substantially based upon criteria used by tissue bank trade
associations, and requires the regulations to include minimum
standards for storing and using tissue. Requires DPH to
report to the appropriate policy and fiscal committees of the
Legislature regarding the status of the proposed regulations.
3.Requires every tissue bank operating in California to have a
current and valid tissue bank license issued or renewed by DPH
with specified exceptions.
This bill exempts from tissue bank licensure the storage of
tissue by a person licensed to provide health care services who
is acting within the scope of the license and practicing in a
lawful practice setting if all of the following apply:
1.The tissue has been obtained from a licensed tissue bank;
2.The tissue has been stored in accordance with the Food and
Drug Administration (FDA) regulations and guidelines; and,
3.The tissue is used for the express purpose of implantation
into or application on a patient, and is not intended for
further distribution.
Background
The Center for Biologics Evaluation and Research within the FDA
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regulates biological products for human use under applicable
federal laws, including the Public Health Service Act and the
Food, Drug, and Cosmetic Act. Human cells or tissue intended
for implantation, transplantation, infusion, or transfer into a
human recipient are regulated as human cell, tissue, and
cellular- and tissue-based product. Examples of such tissue are
bone, skin, corneas, ligaments, tendons, heart valves, oocytes,
and semen. The Center for Biologics Evaluation and Research
does not regulate the transplantation of vascularized human
organs, such as the kidney, liver, heart, lung, or pancreas.
Federal regulations require tissue banks to screen and test
donors, to prepare and follow written procedures for the
prevention of the spread of communicable disease, and to
maintain records.
DPH regulations. Current law requires DPH to develop
regulations regarding tissue banks engaged in the collection of
human tissue, skin, and veins for transplantation into humans.
However, according to DPH, regulations were drafted but not
successfully promulgated because a subcommittee of the Clinical
Laboratory Technology Advisory Committee stated that it would
take several years to develop a regulatory package of this
complexity. The subcommittee stated that technical and
administrative changes were advancing at such a rate that the
regulations would be out-of-date before being promulgated.
Instead, it was recommended that, by reference, the American
Association of Tissue Bank Standards and the annual updates be
adopted into law. To date, regulations have yet to be
promulgated. DPH instead has developed a frequently asked
questions (FAQ) document to provide guidance to entities as to
whether or not they need to apply for a tissue bank license.
The FAQ states that entities will need to apply for a tissue
bank license if they perform any or all of four functions:
collection, processing, storage, or distribution of human tissue
for purposes of transplantation. The FAQ further states that a
facility needs a tissue bank license whenever the facility
stores any material without using it or does not return unused
tissue on the same calendar day.
Comments
According to the author, under current law, certain entities
must apply for a state license if an entity stores tissue for
purposes of transplantation into human beings. According to
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DPH, an entity will need to apply for a tissue bank license if
it performs any or all of four functions: collection,
processing, storage, or distribution of human tissue for
purposes of transplantation. While not defined in regulations,
DPH guidance requires that an entity that simply stores tissue
without implantation or without returning the unused tissue on
the same calendar day of receipt be licensed as a tissue bank,
regardless of whether the other three functions were performed.
Due to the burdens of licensure, many hospitals and ambulatory
surgery centers located in California are simply opting not to
obtain a tissue bank license from the state. Rather, they enter
into agreements with tissue bank suppliers to deliver tissues
via costly courier services at the beginning of the calendar day
and then obtain a courier to return any unused tissue at the end
of the day. Such courier fees have been known to cost one
California-licensed tissue supplier more than $150,000 in one
year. These fees are generally included in the overall cost of
providing tissue, thus further increasing the cost of health
care in California.
Prior legislation
AB 995 (Block, Chapter 497, Statutes of 2009), provides an
exemption from tissue bank licensure for medical devices
approved, as specified, or that is a biologic product approved
by a licensed physician or podiatrist acting within the scope
and authority of his/her license and practicing in a lawful
practice setting.
AB 1060 (Laird, Chapter 427, Statutes of 2008) establishes an
exemption from existing tissue bank licensure requirements for
licensed dentists who store freeze-dried bone and dermis, under
specified conditions.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee, anticipated
annual reduction in licensing workload and fee revenues of about
$260,000 per year to DPH (Licensing and Certification Fund).
DPH anticipates that about 270 facilities are currently licensed
as tissue banks but would be exempt under this bill. Senate
Appropriations Committee staff notes that it is not likely that
DPH will reduce staff expenditures immediately under the bill,
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therefore DPH 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.
SUPPORT : (Verified 8/6/14)
American Association of Tissue Banks (source)
AFSCME
California Healthcare Institute
Donate Life California
OPPOSITION : (Verified 8/6/14)
Department of Public Health
ARGUMENTS IN SUPPORT : A group of supporters write that
physicians use tissue allografts to save and improve the lives
of more than one million Americans each year. They argue that
this bill fixes a current problem by allowing hospitals and
ambulatory surgery centers to retain and store unused tissue
allografts in accordance with FDA guidelines. They cite that
currently, in the event that a patient's transplant is
rescheduled, health care facilities must return the unused
tissues to the tissue bank, which they argue comes at a great
cost.
ARGUMENTS IN OPPOSITION : DPH opposes this bill because they
believe the new exemptions this bill creates does not provide
adequate protection to ensure the safety of tissue stored by
facilities. DPH states that the storage requirements, in
accordance with FDA regulations, are not enforceable against
hospitals and clinical facilities as they only apply to
manufacturers that supply tissue to hospitals and clinical
facilities. DPH states that this bill provides no oversight for
the storage of tissue released to exempt hospitals and clinical
facilities as these entities are exempt from California tissue
bank storage requirements and dilutes DPH's objective to
maintain safe storage of tissue prior to use.
ASSEMBLY FLOOR : 73-0, 5/8/14
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Bigelow, Bloom,
Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian
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Calderon, Campos, Chau, Ch�vez, Chesbro, Conway, Cooley,
Dababneh, Dahle, Daly, Dickinson, Donnelly, Fong, Fox,
Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon,
Grove, Hagman, Harkey, Roger Hern�ndez, Holden, Jones,
Jones-Sawyer, Levine, Linder, Logue, Lowenthal, Maienschein,
Medina, Melendez, Mullin, Muratsuchi, Nazarian, Nestande,
Olsen, Pan, Patterson, Perea, Quirk, Quirk-Silva, Rendon,
Ridley-Thomas, Rodriguez, Salas, Skinner, Stone, Ting, Wagner,
Waldron, Weber, Wieckowski, Wilk, Williams, Yamada, John A.
P�rez
NO VOTE RECORDED: Eggman, Gorell, Gray, Hall, Mansoor, V. Manuel
P�rez, Vacancy
JL:nl 8/15/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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