BILL ANALYSIS �
AB 1822
Page 1
Date of Hearing: April 8, 2014
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 1822 (Bonta) - As Introduced: February 18, 2014
SUBJECT : Tissue banks.
SUMMARY : Allows certain healthcare providers to store unused
tissue without being licensed as a tissue bank, provided they
maintain the tissue in accordance with federal Food and Drug
Administration (FDA) laws and guidelines, and do not further
distribute the tissue. Specifically, this bill :
1)Allows a person licensed to provide health care services,
acting within the scope of his or her license and practicing
in a lawful practice to store unused tissue if all of the
following apply:
a) The tissue has been obtained from a licensed tissue
bank;
b) The tissue has been stored in accordance with FDA
regulations and guidelines; and,
c) The tissue is used for the express purpose of
implantation into or application on a patient, and is not
intended for further distribution.
EXISTING LAW :
1)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.
2)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
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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
manufacturers' instructions and is used for the express
purpose of implantation into a patient.
h) The storage of a human cell, tissue, or cellular- or
tissue-based product that is either a medical device
approved by the 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.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . 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
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the calendar day, and then use a courier to return any unused
tissue grafts at the end of the day. The author further
states that courier fees have been known to cost one
California licensed tissue supplier over $150,000 in one year.
The author notes these fees are generally included in the
overall cost of providing tissue grafts in California, further
increasing the cost of health care.
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 Federal 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 tissues 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.
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 these 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 because technical and administrative changes were
advancing at such a rate that the regulations would be
out-of-date before promulgated. Instead it was recommended
that DPH adopt into law of the American Association of Tissue
Bank (AATB) Standards and the annual updates. AB 995 (Block)
of 2009, attempted to do this, but was later amended to deal
with a different subject matter. To date, regulations have
yet to be promulgated.
DPH has developed a "frequently asked question" or "FAQ"
document to provide guidance to entities as to whether or not
they need to apply for a tissue bank license which states,
"you will need to apply for a tissue bank license if you
perform any or all of the four functions, namely collection,
processing, storage, or distribution of human tissue for
purposes of transplantation." The FAQ further states that a
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facility needs a tissue bank license whenever the facility
stores any material without using it or returning it on the
same calendar day.
3)SUPPORT . The AATB is the sponsor of this bill and writes in
support that under current law, certain entities must apply
for a state license if the entity simply stores tissue for
purposes of transplantation into human beings. They note DPH
guidance in the FAQ has suggested that any storage without
implantation or return of the tissue on the same calendar day
of receipt, would require a tissue bank license. AATB further
states that allowing hospitals and ambulatory surgery centers
to retain and store unused tissue, provided they maintain the
tissue in strict accordance with FDA requirements will reduce
unnecessary costs. Donate Life California supports this bill,
stating that they endorse efforts to ensure the safe and
efficient handling of all donated tissue, and that these
donated gifts of life improve and heal the lives of thousands
each year.
4)PREVIOUS LEGISLATION .
a) 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.
b) SB 1135 (Polanco and Murray), Chapter 929, Statutes of
2002, requires DPH (then Department of Health Services), on
or before July 1, 2003, 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.
5)POLICY COMMENT . To date, the Legislature has granted eight
separate exemptions to tissue bank licensing requirements.
DPH is authorized to develop regulations but as yet has not
done so. According to health care practitioners and
facilities, the lack of regulation creates uncertainty and a
greater potential for committing a violation. DPH has
attempted to address their concern by publishing the FAQ
document. However, to the extent that the FAQs provide
regulatory guidance, it could constitute underground
regulations and should be subject to the provisions of the
Administrative Procedures Act, including public review and
comment.
AB 1822
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REGISTERED SUPPORT / OPPOSITION :
Support
American Association of Tissue Banks (sponsor)
American Federation of State, County and Municipal Employees,
AFL-CIO
California Healthcare Institute
Donate Life California
Opposition
None on file.
Analysis Prepared by : Lara Flynn / HEALTH / (916) 319-2097