BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1822
AUTHOR: Bonta
AMENDED: May 28, 2014
HEARING DATE: June 25, 2014
CONSULTANT: Diaz
SUBJECT : Tissue banks.
SUMMARY : 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.
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.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.
3.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
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AB 1822 | Page 2
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; 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.
This bill:
1. 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:
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.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, a potential decrease of about 40 percent in workload,
and a commensurate $250,000 reduction in annual fee revenue to
AB 1822 | Page
3
the DPH Tissue Bank licensing program. Remaining fee revenues
and the fund balance in the Tissue Bank Licensing Fund appear to
be adequate to support remaining workload.
PRIOR VOTES :
Assembly Health: 19- 0
Assembly Appropriations:17- 0
Assembly Floor: 73- 0
COMMENTS :
1.Author's statement. 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 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.
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
AB 1822 | Page 4
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.
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
but 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 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.
4.Prior legislation. 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
(then Department of Health Services), on or before July 1,
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5
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. 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.
SUPPORT AND OPPOSITION :
Support: American Association of Tissue Banks (sponsor)
American Federation of State, County and Municipal
Employees
California Healthcare Institute
Donate Life California
Oppose: None received.
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