BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: AB 995
A
AUTHOR: Block
B
AMENDED: May 11, 2009
HEARING DATE: June 25, 2009
9
CONSULTANT:
9
Hansel/cjt
5
SUBJECT
Tissue bank licensing
SUMMARY
Repeals a current requirement that the Department of Public
Health (DPH) adopt regulations governing licensed tissue
banks and instead requires tissue banks to comply with
standards published by the American Association of Tissue
Banks (AATB). Adopts an expedited process for adoption of
changes to standards for tissue banks, in lieu of meeting
requirements of the Administrative Procedures Act, as
specified.
CHANGES TO EXISTING LAW
Existing law:
Requires DPH to license and regulate tissue banks and gives
DPH the authority to revoke or suspend the license of any
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
Continued---
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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.
This bill:
Repeals the requirement that DPH 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.
Instead, provides that no person shall engage in the
collection, processing, storage, or distribution of human
tissue unless the tissue is collected, prepared, labeled,
stored, and
distributed in accordance with the standards set forth in
the 12th edition of Standards for Tissue Banking as
published by the American Association of Tissue Banks
(AATB) and in effect on May 1, 2008.
Provides that these standards shall be the standards for
all licensed tissue banks operating in California or
providing tissue to be used in California.
Adopts an expedited process for adoption of changes to
standards for tissue banks, in lieu of meeting requirements
of the Administrative Procedures Act, as follows:
DPH would be required to evaluate updates to the AATB
standards, including later editions, and post changes to
the standards on the department's website at least 45
days prior to their adoption.
Public comment would be accepted by the department for at
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least 30 days after each posting.
If a member of the public requests a public hearing
during the 30-day posting period, the hearing would be
held prior to the adoption of the proposed changes.
Comments received would be considered prior to the
posting of final changes.
Provides DPH with the authority to impose, after notice and
an opportunity for the tissue bank to respond, an
administrative penalty of $100 per day of noncompliance per
licensing violation, including an immediate jeopardy
violation, except that the aggregate penalty per day shall
not exceed $3,000, as an alternative to revoking or
suspending the license of a tissue bank.
This penalty may be imposed only after notice and an
opportunity to respond in accordance with Section 100171.
FISCAL IMPACT
According to the Assembly Appropriations Committee analysis
of AB 995, minor absorbable workload to DPH to continue
oversight of tissue banks in California.
BACKGROUND AND DISCUSSION
DPH, the sponsor of AB 995, states that it has been unable
to develop licensing standards by regulation, as required
by SB 1135 (Polanco) of 2002, because it lacks internal
expertise in the area of tissue banks. DPH states that it
took several years in the mid-1990s for it to draft
regulations with input from experts and stakeholders, but
the standards became almost immediately outdated. Due to
rapid changes in tissue banking technology, DPH has found
the regulatory process to be too slow to adapt to changes,
and believes a process of accreditation, followed by an
expedited process for adopting changes to accreditation
standards, will be more protective of the public. DPH
argues that adopting AATB standards as standards of
licensure will allow DPH to more readily take enforcement
action to protect public health.
DPH states that there have been a number of high profile
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cases involving tissue contamination that may have been
avoided if DPH had been able to apply specific AATB
standards. The department cites a case involving an
out-of-state, but California-licensed tissue bank, which
provided knee blocks contaminated with Clostridium, which
resulted in injury and death to several patients. This
could have been avoided had the AATB standards for storage
of tissue been followed.
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.
AATB standards
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, 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
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standards are updated every one to two years.
AATB additionally provides certification for tissue bank
personnel and a specialty certification for reproductive
cryotechnology specialists.
FDA standards
Tissue banks must register with the FDA and adhere to all
FDA regulations governing
tissue banking, and are subject to inspection by the FDA.
The FDA has issued three rules related to tissue banking.
One requires firms to register and list their human cells,
tissues, or tissue products with FDA. A second rule
requires tissue establishments to evaluate donors, through
screening and testing, to reduce the transmission of
infectious diseases through tissue transplantation. The
third rule establishes current good tissue practices for
human cell and tissue products.
Arguments in support
DPH, the sponsor of AB 995, states that due to rapid
changes in tissue banking technology, it has been unable to
promulgate standards for tissue banks. DPH argues that the
AATB standards that tissue banks would have to meet under
this bill are updated on a routine basis, reflect the
latest technological advances, and are nationally
recognized as accepted standards for safety. DPH further
argues that adopting the AATB standards, combined with an
expedited process for adopting changes to the standards and
new authority to levy monetary penalties for licensing
violations, will allow it to take more effective
enforcement action.
The AATB states that it publishes the only authoritative
industry standards for tissue banks, and that it has been
the driving force behind the development of standards for
human tissue by federal and state authorities. In
particular, AATB states that its standards are the most
detailed and comprehensive standards for tissue banking in
the world and have served as the template for FDAs
regulations, as well other state and international
standards. AATB argues that, although California tissue
banks are licensed by the state and registered with the
FDA, requiring the banks to additionally meet AATB
standards will provide an added measure of protection for
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consumers.
Oppose unless amended
Taking an oppose unless amended position, the American
Society for Reproductive Medicine (ASRM) states its
standards on the issue of providing compensation, in
addition to reimbursement of expenses, to donors of sperm
and ooctyes (human egg) for fertility treatment, conflict
with AATBs standards. ASRM states that up to 15 percent of
IVF treatments use donor eggs, which is expected to
increase. The ASRM guidelines, in an attempt to strike a
balance between not inducing women to donate oocytes and
recognizing the time, inconvenience, risk, and pain endured
by women who donate, state that compensation within certain
limits is not inappropriate (the average compensation
amount is $4,300). By contrast, the AATB standards limit
compensation to tissue donors to reimbursement of costs
directly related to the donation (which, in the case of egg
donation involves taking hormones and medical monitoring
over several weeks, and surgical extraction of the eggs).
ASRM requests an amendment to either reference ASRM
guidelines on compensation for persons who donate
reproductive health tissues, such as women donating eggs
for fertility purposes, or a statement that nothing in the
bill is intended to prohibit compensation to donors of
reproductive health tissues.
Related bills
AB 1317 (Block) requires a specified warning in all
advertisements for human egg donations associated with the
delivery of fertility treatment and requires donors to
fertility treatment centers be provided with medically
accurate information regarding potential risks. Scheduled
to be heard in Senate Health Committee on June 24, 2009.
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
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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.
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
Assembly Floor 78-0
Assembly Appropriations:14-0
Assembly Health: 18-0
COMMENTS
1. Process for adoption of AATB standards for licensed
tissue banks.
As drafted, the bill would create process for adoption of
updates to the AATB standards, whereby DPH would evaluate
the updates and propose changes to the standards, and
provide an opportunity for public comment and public
hearing on the changes. By contrast, the bill would deem
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the latest edition of AATBs standards for tissue banks to
be the initial standards for tissue banks operating in,
or providing tissue to be used in, California, without a
similar review by DPH, or opportunity for public comment.
A suggested amendment would be to require DPH to adopt
the initial standards using a similar process to that
outlined in the bill for adoption of updates to the
standards.
2. Suggested technical amendments.
On page 2, lines 11 - 28, and page 3, lines 1 - 8, amend as
follows:
(b) Consistent with the purposes of this chapter, the
department shall evaluate updates to the standards made by
the American Association of Tissue Banks, including later
editions, to determine which changes to incorporate into
the regulations. Proposed changes to the standards shall
be posted on the department's Internet Web site at least 45
days prior to their adoption. Public comment shall be
accepted by the department for at
least 30 days after each posting. If a member of the public
requests a public hearing during the 30-day posting period,
the hearing shall be held prior to the adoption of the
proposed changes. Comments received shall be considered
prior to the posting of final changes. Adoption of changes
by the department pursuant to this subdivision section
shall not be subject to the rulemaking requirements of
Chapter 3.5 (commencing with Section 11340) of Part 1 of
Division 3 of Title 2 of the Government Code and written
responses to public comments shall not be required.
1643.3. (a) As an alternative to revocation or suspension
of a license issued under this chapter, the department may
impose an alternative civil administrative penalty of one
hundred dollars ($100) per day of noncompliance per
violation, including an immediate
jeopardy, violation jeopardy violation, except that the
aggregate penalty per day shall not exceed three thousand
dollars ($3,000). This penalty may be imposed only after
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notice and an opportunity to respond in accordance with
Section 100171.
(b) For purposes of this section, "immediate
jeopardy" means a situation in which the licensee's
noncompliance with one or more requirements of licensure
has caused, or is likely to cause, serious injury or death
to the patient.
POSITIONS
Support: American Federation of State, County and
Municipal Employees
American Association of Tissue Banks
Blood Centers of California
California Department of Public Health
Oppose: American Society for Reproductive Medicine (unless
amended)
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