BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 2750
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|AUTHOR: |Gomez |
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|VERSION: |May 23, 2016 |
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|HEARING DATE: |June 8, 2016 | | |
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|CONSULTANT: |Reyes Diaz |
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SUBJECT : Tissue banks
SUMMARY : Exempts from tissue bank licensure the storage of allograft
tissue by a person, as defined, if specified criteria are met.
Existing law:
1)Requires every tissue bank operating in California to have a
current and valid tissue bank license issued or renewed by DPH
with the following exceptions:
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
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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.
3)Defines "person" as an individual, corporation, business
trust, estate trust, partnership, association, state or local
government, or subdivision or agency thereof, or any other
legal entity.
4)Requires the Department of Public Health (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:
1)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:
a) The person is a hospital or an outpatient setting
regulated by the Medical Board of California, including
an ambulatory surgical center;
b) The person maintains a log that includes the date on
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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,
c) The allograft tissue meets all of the following:
i. Was obtained from a tissue bank licensed
by the state;
ii. 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;
iii. Is intended for the express purpose of
implantation into or application on a patient;
iv. Is not intended for further distribution;
and,
v. Is registered with the FDA and designated
to be maintained at ambient room temperature
requiring no refrigeration.
FISCAL
EFFECT : According to the Assembly Appropriations Committee, this
bill will potentially result in a decrease of about 40% in
workload and a commensurate $260,000 reduction in annual fee
revenue to DPH's tissue bank licensing program. Remaining fee
revenues and the fund balance in the Tissue Bank Licensing Fund
appear to be adequate to support the remaining workload.
PRIOR
VOTES :
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|Assembly Floor: |78 - 0 |
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|Assembly Appropriations Committee: |20 - 0 |
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|Assembly Health Committee: |16 - 0 |
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COMMENTS :
1)Author's statement. According to the author, due to the
burdens of licensure, many hospitals and ambulatory surgical
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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)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.
3)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
after the passage of SB 1135 (Polanco, Chapter 929, Statutes
of 2002), which required DPH to adopt tissue bank rules and
regulations by July 1, 2004, 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 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
AB 2750 (Gomez) Page 5 of ?
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.
4)Prior legislation. AB 1822 (Bonta, of 2014), was substantially
similar to this bill. AB 1822 was vetoed by the Governor 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 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
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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.
5)Support. MiMedx states that the Governor, 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.
SUPPORT AND OPPOSITION :
Support: MiMedx Group (sponsor)
Oppose: None received
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