BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: AB 995
A
AUTHOR: Block
B
AMENDED: June 30, 2009
HEARING DATE: July15, 2009
9
CONSULTANT:
9
Hansel/cjt
5
SUBJECT
Tissue bank licensing
SUMMARY
Exempts from tissue bank licensing requirements the storage
of federal Food and Drug Administration (FDA) regulated
tissue-engineered products by a person who is licensed to
provide health care services and who is acting within the
scope of their license, provided the tissue-engineered
product has been obtained from a licensed tissue bank and
is stored in strict accordance with federal Food and Drug
Administration regulations and guidelines, and is used for
the purpose of implantation into, or application on, a
patient and is not intended for further distribution.
CHANGES TO EXISTING LAW
Existing federal regulations:
Require firms to register and list their human cells,
tissues, or tissue products with FDA and establishes good
tissue practices for human cell and tissue products.
Existing state law:
Requires DPH to license and regulate tissue banks and gives
DPH the authority to revoke or suspend the license of any
Continued---
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tissue bank that violates licensing standards pertaining to
tissue banks.
Defines "tissue" as any human cell, group of cells, tissue
or organ 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.
Requires DPH to adopt, on or before July 1, 2004,
regulations governing licensed tissue banks engaged in the
collection of human musculoskeletal tissue, skin, and veins
for transplantation in humans. Requires the regulations to
be substantially based on accreditation standards issued by
tissue bank trade associations, as specified.
Requires regulations for tissue banks to include minimum
standards related to preservation, storage, and handling of
tissue; equipment, methods, and personnel qualifications of
tissue banks; and testing of donors, as specified.
Exempts several activities and entities from tissue bank
licensing requirements, including the collection of tissue
by a physician or surgeon from his or her patient or the
implantation of tissue, defined to not include the
processing or storage of the tissue; and the storage of
prepackaged, freeze-dried bone by a general acute care
hospital or the storage of freeze-dried bone and dermis by
a licensed dentist, as specified.
This bill:
Also exempts from tissue bank licensing requirements the
storage of FDA regulated tissue-engineered products by a
person who is licensed to provide health care services and
who is acting within the scope of their license, provided
the tissue-engineered product has been obtained from a
licensed tissue bank, is stored in strict accordance with
FDA regulations and guidelines, and is used for the purpose
of implantation into, or application on, a patient and is
not intended for further distribution.
FISCAL IMPACT
This bill in its current amended form has not been analyzed
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by a fiscal committee.
BACKGROUND AND DISCUSSION
According to the author, recent actions by DPH would
require podiatrists to possess a tissue bank license in
order to hold tissue products overnight for the purpose of
treating diabetic ulcers. The author argues an exemption
similar to that granted to dentists with the passage of AB
1060 (Laird) of 2008 is warranted for medical practitioners
generally who obtain the tissue products from a California
licensed tissue bank and store the tissue in accordance
with the directions of the manufacturer. The author notes
that end-users of tissue products must follow FDA
requirements governing the use and storage of FDA-approved
tissue products, and there is little value in requiring
these entities to obtain an expensive license. The end
users are also subject to oversight and licensing by other
entities such as the Medical Board, and also face
malpractice liability for misuse of tissue products. The
original intent of the tissue bank licensing law was to
address front-end potential for bacterial contamination and
disease transmission at the donor level, and was not meant
to license health care practitioners, who handle and use
the tissue products.
DPH tissue bank regulations
DPH has been responsible for oversight of tissue banks
since 1991. The original legislation giving DPH this
responsibility authorized DPH to set licensing standards
via regulations. SB 1135 of 2002, by contrast, required
the Department of Health Services (now DPH) to adopt
regulations by July 1, 2004.
According to DPH, 539 tissue banks currently hold
California licenses; of these, 422 are in California and
117 are out of state. 50 are accredited by the AATB. The
state's goal is to inspect licensed tissue banks every two
to three years.
FDA standards
According to the FDA, as derivatives of the human body, all
human cell, tissue and cellular, and tissue-based products
(HCT/Ps) pose some risk of carrying pathogens that could
potentially infect recipients or handlers. The FDA has
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issued three rules related to HCT/Ps. The first requires
domestic and foreign establishments that recover, process,
store, label, package, or distribute HCT/Ps, or that
perform screening or testing of cells or tissue donors to
register and list their HCT/Ps with the FDA. The second
rule requires HCT/Ps to screen and test donors of tissues
for communicable diseases and agents. The third rule
requires HCT/P establishments to follow a set of good
tissue practices, which include product tracking
requirements, reporting adverse events, including specific
information on the HCT/P label or package insert, and
standard operating procedures, including for facility
cleaning, sanitizing, calibrating equipment, records
management, and documentation of complaints.
The FDA defines HCT/Ps as articles containing or consisting
of human cells or tissues that are intended for
implantation, transplantation, infusion, or transfer into a
human recipient, including skin, musculoskeletal tissue
(notably, bone and ligaments), ocular tissue (especially
corneas), heart valve allografts, dura mater, hematopoietic
stem and progenitor cells derived from peripheral and cord
blood, reproductive tissue, cellular therapies, and
combination products consisting of tissue with a device
and/or drug.
Under the rules, FDA approvals are needed for the
manufacturing, distribution, storage, shipping containers,
and expiration dates, as well as the approved conditions
and instructions for using HCT/Ps, and any restrictions on
their use. The FDA inspects HCT/P manufacturing,
distribution, and storage centers at least once every two
years, and may schedule additional inspections at any
point.
Earlier this year, the FDA issued additional guidance
regarding its good tissue practices.
AATB standards
The American Association of Tissue Banks (AATB) has
operated an accreditation program since 1986. In 1988, the
Association began a certification program for individuals
working in tissue banking. The AATB sets standards for
collecting, processing, storing, and distributing tissues
used for human transplants, as well as for donor selection,
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which are updated annually by experts in the field. Tissue
banks seeking accreditation undergo an independent review
of their operating procedures and on-site inspections of
their facilities and operations, which examine their
standards and policies for recordkeeping, quality control,
quality assurance, donor screening, testing and suitability
determinations.
The 12th Edition of the Standards of Tissue Banking, which
was published in February 2008, establishes performance
requirements for donor selection as well as for the
processing, storage, packaging, labeling, and distribution
of transplantable human musculoskeletal, skin,
reproductive, cardiac, and vascular tissue. The Standards
are also updated regularly with replacement sections. The
13th Edition is due in 2010. According to DPH, AATB
standards are updated every one to two years. The AATB
additionally provides certification for tissue bank
personnel.
Arguments in support
Advanced BioHealing, Inc., a co-sponsor of AB 995, states
that exempting medical practitioners who store a limited
type of FDA approved tissue products from the requirement
to be licensed as a tissue bank, is consistent with the
original intent of the tissue banking statute, which was
never intended to regulate medical practitioners, as the
end-users of tissues, who are not otherwise involved in the
manufacturing or distribution of these products. Advanced
BioHealing states that podiatrists and other clinicians who
treat diabetic foot ulcers with tissue products are
threatened with the extensive paperwork and expense of
registering as tissue banks in the absence of the bill,
even though they obtain tissues from California licensed
tissue banks and use the products in strict accordance with
FDA approved manufacturers' instructions. This threat
exists despite the absence of any evidence that any problem
exists or that doing so would provide any further patient
protections.
The California Podiatric Medical Association (CPMA) states
that as a result of DPH reinterpreting its tissue bank
regulations, podiatrists and other health care providers
who were never intended to covered by the original tissue
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bank law are now facing the requirement to be licensed as
tissue banks. CPMA states that diabetic ulcers and other
chronic wounds can result in significant pain, diminished
qualify of life, impaired mobility, reduced productivity
and, in some cases, amputations and loss of life. In some
cases bioengineered tissue products can be used to assist
the body's natural healing process. Exempting podiatrists
from being licensed as tissue banks will ensure continued
access to care for these patients.
Concerns
The AATB states several concerns regarding the June 25,
2009 version of AB 995: (1) It exempts an overly broad
array of persons and entities from tissue bank licensing
requirements; (2) The bill lacks any oversight or
enforcement mechanism to ensure compliance with precise
storage requirements that accompany many tissue products;
(3) The bill does not provide a limit on the amount of
tissue that could be stored, or that it be exclusively for
the provider's treatment of his or her own patients; and,
(4) The bill lacks a mechanism to ensure that patients who
receive tissue products that are subsequently recalled can
be identified and notified, as tissue banks must do.
Prior legislation
AB 1060 (Laird), Chapter 427, Statutes of 2008, exempts the
storage of freeze-dried
bone and dermis by any licensed dentist practicing in a
lawful practice setting from tissue bank licensing
requirements, providing that the freeze-dried bone and
dermis has
been obtained from a licensed tissue bank and is stored in
strict accordance with a kit's package insert and any other
manufacturer instructions and guidelines and is used for
the express purpose of implantation into a patient.
SB 1135 (Polanco), Chapter 929, Statutes of 2002, requires
the Department of Health Services (DHS) to adopt
regulations by July 1, 2004 governing licensed tissue banks
and requires the regulations to be substantially based on
the criteria used by tissue bank
trade associations in their accreditation processes, as
well as scientific and technical data submitted by
individual tissue banks.
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AB 2209 (Speier), Chapter 801, Statutes of 1991, requires
tissue banks to be licensed by the Department of Health
Services (now DPH) with certain exceptions.
SB 968 (Watson), Chapter 800, Statutes of 1991, requires
persons who engage in the production of human blood or
human whole blood derivatives to collect, prepare, label,
and store blood in accordance with Standards for Blood
Banks and Transfusion Services as published by the American
Association of Blood Banks. Allows DPH to, by regulation,
require compliance with additional requirements as the
department deems appropriate to ensure the safety of human
blood or human whole blood derivatives.
PRIOR ACTIONS
Not applicable.
COMMENTS
1. Bill broadens current exemptions from tissue bank
licensing.
Current exemptions from tissue banking requirements for
medical practitioners are fairly limited. Current
exemptions include storage of prepackaged, freeze-dried
bone by a hospital, and storage of freeze-dried bone and
dermis by a dentist, where the tissue is obtained from a
licensed tissue bank, is stored in strict accordance with
the package insert and manufacturers' instructions, and
is used for implantation into a patient. This bill would
create a broad exemption for medical practitioners
generally who acquire tissue from licensed tissue banks,
store it according to FDA requirements, and use it for
treating patients.
2. Oversight and monitoring of tissue handling practices
under bill is unclear.
This bill raises a difficult public health issue; namely,
who should provide oversight and monitoring of tissue
handling practices of medical practitioners who acquire
tissues from licensed tissue banks and use them to treat
patients, and what level of oversight is warranted?
While the bill references FDA approved tissue products
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and storage in accordance with FDA regulations and
guidelines, FDA oversight is focused for the most part on
manufacturers and distributors of tissue products. A
recommended amendment would be to require medical
practitioners to register with DPH to qualify for the
exemption. This would allow DPH to monitor and inspect
practitioners in response to complaints and to require
practitioners who deviate from the scope of the exemption
to be licensed as tissue banks.
3. Author's amendments.
The author will offer additional amendments to clarify
several provisions of the bill,
including providing a more specific definition of the
tissue products to which the
exemption would apply, clarifying that the exemption
does not impact a similar
exemption currently in place for dentists, and
limiting the exemption to tissues that
are acquired from a California licensed tissue bank.
POSITIONS
(On the June 30, 2009 version of the bill)
Support: Advanced BioHealing, Inc. (co-sponsor)
California Podiatric Medical Association
(CPMA)
Organogenesis, Inc.
Oppose: None received
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