BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 2750|
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THIRD READING
Bill No: AB 2750
Author: Gomez (D)
Amended: 6/13/16 in Senate
Vote: 21
SENATE HEALTH COMMITTEE: 7-0, 6/8/16
AYES: Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan, Roth
NO VOTE RECORDED: Hall, Wolk
SENATE APPROPRIATIONS COMMITTEE: 6-0, 6/27/16
AYES: Bates, Beall, Hill, McGuire, Mendoza, Nielsen
NO VOTE RECORDED: Lara
ASSEMBLY FLOOR: 78-0, 5/12/16 (Consent) - See last page for
vote
SUBJECT: Tissue banks
SOURCE: Author
DIGEST: This bill exempts from tissue bank licensure the
storage of allograft tissue by a person, as defined, if
specified criteria are met.
ANALYSIS:
Existing law:
1)Requires every tissue bank operating in California to have a
current and valid tissue bank license issued or renewed by the
Department of Public Health (DPH) with the following
exceptions:
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a) Licensed blood banks;
b) Entities collecting, processing, storing or distributing
tissue for autopsy, biopsy, training, education, or for
other medical or scientific research or investigation where
transplantation of the tissue is not intended;
c) A licensed physician and surgeon collecting tissue from
his or her patient, or the implantation of tissue into his
or her patient. This exemption does not apply to any
processing or storage of the tissue, except for the
processing and storage of semen collected from a semen
donor or obtained from a licensed tissue bank;
d) The collection, processing, storage, or distribution of
fetal tissue or tissue derived from a human embryo or
fetus;
e) The collection, processing, storage, or distribution by
an organ procurement organization;
f) The storage of prepackaged, freeze-dried bone by a
general acute care hospital;
g) The storage of freeze-dried bone and dermis by a
licensed dentist, provided that it has been obtained from a
licensed tissue bank and stored in accordance to the
manufacturer's instructions and is used for the express
purpose of implantation into a patient; and,
h) The storage of a human cell, tissue, or cellular- or
tissue-based product that is either a medical device
approved by the federal Food and Drug Administration (FDA),
or that is a biologic product approved under the federal
Public Health Service Act by a licensed physician or
podiatrist. The medical device or biologic product must
have been obtained from a licensed tissue bank, been stored
in accordance with the device's or product's package insert
and any other manufacturer instruction, and be used solely
for the use of direct implantation into or application on
the practitioner's own patient.
2)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, but does not
include an organ when recovered for transplantation or
research purposes.
3)Defines "person" as an individual, corporation, business
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trust, estate trust, partnership, association, state or local
government, or subdivision or agency thereof, or any other
legal entity.
4)Requires the DPH to adopt rules and regulations, on or before
July 1, 2004, 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, on or
before July 1, 2003, to report to the appropriate policy and
fiscal committees of the Legislature regarding the status of
the proposed regulations.
This bill exempts from tissue bank licensure the storage of
allograft tissue by a person, as defined in 3) of existing law
above, 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
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 FDA and designated to be
maintained at ambient room temperature requiring no
refrigeration.
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Background
The Center for Biologics Evaluation and Research (CBER) within
the FDA 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. CBER 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. In California,
tissue banks are licensed by DPH for an annual license fee of
$975.
Comments
1)Author's statement. 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. 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. AB 2750 is intended to
help mitigate courier costs by enabling hospitals and
ambulatory surgery centers to store certain tissue products
under certain protocols, without having a tissue bank license.
2)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. According to DPH, regulations were drafted in 1998 but
were not successfully promulgated because a subcommittee of
the Clinical Laboratory Technology Advisory Committee (CLTAC)
stated that it would take several years to develop a
regulatory package of this complexity. CLTAC stated that
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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 (AATB) 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.
AB 1822 (Bonta, of 2014), which was substantially similar to
this bill, was vetoed by Governor Brown. Subsequently, DPH
issued a document, "Important Notice Regarding Storage of
Allograft Tissue," in which it announced that the FAQ was
updated to state that a facility does not need a tissue bank
license if it orders a frozen or cryopreserved allograft for a
specific patient and holds it in the unopened, validated,
temperature-controlled shipping container for no longer than
the validation expiration date and time specified by the
shipper before implanting, returning, or discarding the
tissue. The updated FAQ does not allow for the temporary
storage of room temperature allografts that do not require
refrigeration. The FAQ also states that DPH's Tissue Bank
Program of Laboratory Field Services is in the process of
formulating regulations to interpret and clarify tissue bank
statutes. However, no expected date for when the regulations
would be promulgated is provided.
Related/Prior Legislation
AB 1822 (Bonta, 2014) was substantially similar to this bill.
AB 1822 was vetoed by Governor Brown who stated, in part, "While
I support eliminating overly burdensome regulation, I'm not
convinced that the bill strikes the right balance between safety
and economy. I will direct DPH to continue working with
interested parties to develop an approach that balances
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appropriate oversight with cost savings for suppliers."
AB 995 (Block, Chapter 497, Statutes of 2009) provided an
exemption from tissue bank licensure for medical devices
approved pursuant to Section 510 or 515 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. Sec. 360, 360e) or that is a
biologic product approved under Section 351 of the federal
Public Health Service Act (42 U.S.C. Sec. 262) by a licensed
physician or podiatrist acting within the scope and authority of
his or her license and practicing in a lawful practice setting.
AB 1060 (Laird, Chapter 427, Statutes of 2008) established an
exemption from existing tissue bank licensure requirements for
licensed dentists who store freeze-dried bone and dermis, under
specified conditions.
SB 1135 (Polanco, Chapter 929, Statutes of 2002) required DPH,
on or before July 1, 2004, to adopt rules and regulations
governing tissue banks, and requires the rules and regulations
to be substantially the same as the standards set forth in the
most recent publication of the AATB Standards for Tissue
Banking. Required DPH, on or before July 1, 2003, to report to
the appropriate policy and fiscal committees of the Legislature
regarding the status of the proposed regulations.
AB 2209 (Speier, Chapter 801, Statutes of 1991) required tissue
banks to be licensed by the Department of Health Services (now
DPH) with certain exceptions.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
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
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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 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.
SUPPORT: (Verified6/28/16)
MiMedx
OPPOSITION: (Verified 6/28/16)
None received
ARGUMENTS IN SUPPORT: MiMedx states that Governor Brown, when
vetoing AB 1822, directed DPH to work with tissue providers on
new guidance to strike a balance between appropriate oversight
and cost savings for suppliers. MiMedx states that DPH's FAQ
still requires that each tissue sample be shipped individually,
which is wasteful and unnecessary, especially when one considers
that many of the products are approved to be stored at ambient
temperatures for extended periods of time. MiMedx argues that
this bill mitigates the need for additional oversight and
reduces costs, and, as a result, will make more tissue readily
available to hospitals and ambulatory surgery centers, and
ultimately patients.
ASSEMBLY FLOOR: 78-0, 5/12/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,
Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Calderon,
Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper,
Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines,
Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson,
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Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger
Hernández, Holden, Irwin, Jones, Kim, Lackey, Levine, Linder,
Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina,
Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen,
Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago,
Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber,
Wilk, Williams, Wood, Rendon
NO VOTE RECORDED: Burke, Jones-Sawyer
Prepared by:Reyes Diaz / HEALTH / (916) 651-4111
6/30/16 9:04:15
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