BILL ANALYSIS
AB 995
Page 1
Date of Hearing: April 21, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
AB 995 (Block) - As Amended: April 13, 2009
SUBJECT : Tissue bank licensing.
SUMMARY : Deletes requirements that the Department of Public
Health (DPH) regulate tissue banks, and instead requires tissue
banks to comply with the current standards of the American
Association of Tissue Banks (AATB), and changes the civil
administrative penalties DPH may impose for noncompliance with
the standards. Specifically, this bill :
1)Deletes a requirement that DPH adopt regulations governing
tissue banks engaged in the collection of human
musculoskeletal tissue, skin, and veins for transplantation in
humans.
2)Prohibits a person from collecting, processing, storing, or
distributing human tissue except in accordance with the 12th
edition of Standards for Tissue Banking as published by AATB
and in effect on May 1, 2009. Establishes the AATB standards
as the standards for all licensed tissue banks operating in
California or providing tissue to be used in California.
3)Requires DPH to, upon approval, adopt as regulations not later
than 90 days after publication by AATB, amendments to, or
later editions of, the AATB Standards for Tissue Banking.
Exempts adoption of the AATB standards from the requirements
of the Administrative Procedure Act.
4)Authorizes DPH to impose, as an alternative to revocation or
suspension of a tissue bank license, a civil administrative
penalty of up to $100 per day of noncompliance per violation,
and limits the aggregate penalty to $3,000 per day. Requires
the penalty to be imposed only after notice and an opportunity
to respond, in accordance with specified administrative
adjudication requirements.
EXISTING LAW :
1)Requires DPH to adopt, on or before July 1, 2004, rules and
regulations governing licensed tissue banks engaged in the
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collection of human musculoskeletal tissue, skin, and veins
for transplantation in humans, and specifies that the
regulations must be based on criteria used by tissue bank
trade associations, including AATB, among other requirements.
Requires DPH to report, on or before July 1, 2003, to the
Legislature regarding the status of the proposed regulations.
2)Defines tissue to include any human cell, group of cells,
tissue or organ, including parts of, or the whole eye, bones,
skin, arteries, sperm, blood, other fluids, and any other
portion of a human body. Defines a tissue bank as any place,
establishment, or institution that collects, processes,
stores, or distributes tissue for transplantation into human
beings.
3)Establishes requirements for the licensing of tissue banks and
for licensing fees. Requires every tissue bank to have a
current and valid tissue bank license issued or renewed by
DPH, except as specified. Provides that any person who
violates the body of law governing tissue banks is guilty of a
misdemeanor and upon conviction, must be punished by a fine
not to exceed $1,000 or by imprisonment in a county jail for a
period not to exceed 180 days, or by both fine and
imprisonment.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, DPH has been
unable to develop licensing standards for tissue banks for
several reasons. First, because DPH Laboratory Field Services
(LFS) staff lacks internal expertise, it must rely on experts
in the tissue bank field to advise on tissue processing
standards this bill. The author states it took several years
for LFS to draft initial regulations with input from experts
and stakeholders, and because of rapid changes in tissue
banking technology, the draft standards were outdated before
they could be reviewed by DPH legal staff. In short, the
process of developing regulations was too slow and
unresponsive.
The author states there have been numerous high profiles cases
of tissue contamination that might have been avoided if DPH
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had been able to apply specific AATB standards to tissue
banks. For example, one out-of-state, California-licensed
tissue bank provided knee blocks contaminated with
Clostridium, resulting in injury to California patients and
death to patients in other states. The author argues these
incidents could have been prevented if the AATB standards for
storage of excised tissue had been followed.
According to the author, tissue banks are not currently required
to comply with AATB standards, though many comply voluntarily.
The author argues this bill is needed to adopt the AATB
standards as a condition of tissue bank licensure so DPH can
take specific, standardized enforcement action as needed.
2)BACKGROUND . According to the United States (U.S.). Centers
for Disease Control and Prevention (CDC), the bones or tissues
that are transplanted from the body of one person to another
person are called allografts. Tissue allografts can include
bones, heart valves, blood vessels, skin, and tendons, and are
usually obtained from deceased donors. Tissue from one donor
can be processed into many forms and used to treat many
people. Bone and tissue allografts are used in a variety of
procedures that can save lives, replace skin after severe
burns, repair limbs, restore eyesight, relieve pain, help
people start a family, or otherwise enhance a patient's
quality of life. For example, tissue allografts can be used
to replace damaged heart valves and skin. Tissue allografts
are also frequently used in orthopedic surgery to replace
tendons or bones damaged by trauma, tumors, or other
conditions. According to the AATB, AATB-accredited tissue
banks in the U.S. distribute more than 2 million bone and
tissue allografts from 30,000 donors each year. The Joint
Commission on Accreditation of Healthcare Organizations stated
in a 2005 tissue transplant meeting organized by the federal
government that tissue transplants had tripled since 1990.
In 2007, over 2,000 human tissue banks were registered with the
U.S. Food and Drug Administration (FDA). Tissue banks perform
a variety of functions, including procuring ("recovery"),
processing, storing, and distributing human tissues.
According to a 2001 report by the U.S. Department of Health
and Human Services Office of the Inspector General (OIG),
among the 58 cadaveric tissue banks that were accredited by
AATB, 54 retrieved tissue, 34 processed tissue, and 56 stored
and distributed tissue. Some tissue banks limit their
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activities to specific tissues, such as semen or corneas. Of
the 58 cadaveric tissue banks in the OIG report, 51 retrieved
musculoskeletal tissues, 37 retrieved cardiovascular tissues,
and 20 retrieved skin.
As a condition of participation in federal programs, every
hospital in the U.S. is required to report all deaths to the
organ procurement organization in its region, such as the
California Transplant Donor Network (Transplant Network).
When a potential donor is identified, the Transplant Network
contacts the tissue bank that contracts with the hospital, and
the tissue bank assesses the patient's medical chart and
history to determine whether the deceased person is suitable
for tissue donation. If the deceased patient is deemed
suitable, the tissue bank contacts the next of kin, and a team
from the tissue bank comes to the hospital to remove the
tissues. Tissues are sent to tissue banks for processing and
distribution. Tissue banks subject tissues to one or more
disinfection processes that are designed to kill or remove any
bacteria, fungi, or viruses that might be present. According
to CDC, different companies use different methods to disinfect
the tissue, including rinsing with antimicrobial chemicals,
sometimes under pressure, as well as irradiation. In some
instances, multiple methods might be used. CDC states
individual tissues from eligible donors are tested for the
presence of bacteria, mold, and fungi when they are removed
from the donor, and this testing is repeated after the tissues
have been subjected to the procedures designed to remove
organisms.
1)TISSUE BANK LICENSING . According to DPH, 545 tissue banks
currently hold California licenses; of these, 421 are in
California and 125 are out-of-state. The license application
and renewal fees are each $975. DPH is authorized to do any
of the following:
a) Enter or inspect, with or without announcement, any
building, premise, equipment, materials, records, or
information to secure compliance with, or prevent a
violation of, tissue bank laws or regulations adopted by
DHS;
b) Inspect, photograph, or copy any records, reports, test
results, test specimens, or other information relevant to
determining compliance with state laws and regulations;
c) Secure any sample, photograph, or other evidence from
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any building or premise for the purpose of enforcing state
laws and regulations; and,
d) Require licensed tissue banks to demonstrate
satisfactory performance in a proficiency testing program
in laboratory procedures which the tissue bank performs.
DPH reports that it inspects tissue banks, and has a goal of
inspecting each tissue bank once every two years, but with
current staff is only able to inspect about 60 per year.
1)AATB . CDC describes AATB as a voluntary accreditation
organization that sets standards for tissue banking. AATB
traces its founding to 1949, when a group of physicians and
scientists founded the U.S. Navy tissue bank, the nation's
first tissue bank. AATB states its mission is to: a)
Establish and promulgate standards to provide tissue banks
with performance requirements for the purposes of preventing
disease transmission and assisting clinical performance of
tissue transplants; b) Foster education and research; and, c)
Promote quality and safety in tissue banking and
transplantation. AATB also states it is dedicated to ensuring
that human tissues intended for transplantation are of uniform
high quality, safe and free of infectious disease, and
available in quantities sufficient to meet national needs.
The AATB states it has accredited more than 100 tissue banks
and has 1,100 individual members.
The 12th Edition of the Standards of Tissue Banking was
published in February 2008 and 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 AATB Standards also
establish requirements related to organization; recordkeeping;
personnel qualifications; consent procedures for living and
deceased donors; screening donors; testing tissues for
infections; informing donors of test results; re-testing
donors; and, quality control measures, including proficiency
testing and investigation of errors. The Standards are also
updated regularly with replacement sections, and AATB also
publishes Guidance Documents. The 13th Edition is due in
2010. AATB also provides accreditation, which can take nine
months; 14 California tissue banks have received AATB
accreditation. Additionally, AATB provides certification for
tissue bank personnel and a specialty certification for
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reproductive cryotechnology specialists.
According to AATB, six states and the District of Columbia
require tissue banks to obtain AATB accreditation; several
other states require adherence to AATB standards for all or
specified tissue bank activities; and, two states incorporate
AATB standards by reference, for example, burn centers may
only obtain tissue from AATC-accredited tissue banks. AATB
also states its standards serve as a model for FDA
regulations, Health Canada's Draft Guidance for tissue safety,
New York Department of Health's tissue and cell standards,
European Union Directives, European Association of Tissue
Banks standards, the British Association of Tissue Banks
standards, and the developing standards for the Latin American
Association for Tissue Banks.
2)FEDERAL REGULATION OF TISSUE BANKS . Tissue banks must
register with FDA and adhere to all FDA regulations governing
tissue banking, and are subject to inspection by the FDA. The
FDA Center for Biologics Evaluation and Research regulates
human tissues intended for transplantation (although the U.S.
Health Resources and Services Administration regulates the
transplantation of organs such as kidneys, livers, and
hearts). According to a 2007 report of the FDA Human Tissue
Task Force, FDA did not begin regulating human tissue intended
for transplantation until 1993, when it issued requirements
for donor screening and testing. In 1997, FDA issued a
revised approach with three rules, which was finalized and
became effective in 2005. One rule requires firms to register
and list their tissue products with FDA. The 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 tissues
intended for transplantation.
3)SUPPORT . AATB writes in support that although California
tissue banks must be licensed by the State and registered with
FDA, adherence to AATB standards would provide additional
consumer safety and protection in every aspect of tissue
banking. AATB further states the standards contain the latest
expertise of tissue bank professionals and are developed with
input from tissue-specific councils and appropriate standing
or ad hoc committees as needed. The Blood Centers of
California (BCC) writes in support that it has functioned
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under standards published by the American Association of Blood
Banks, which serve as the state law governing all blood
centers in California, and that this has worked well. BCC
writes this bill will provide assurance that adherence to
standards provide governance in every aspect of tissue
banking. The American Federation of State, County, and
Municipal Employees, AFL-CIO writes it supports this bill to
encourage the regulation of tissue banks within California.
4)RELATED LEGISLATION .
a) AB 1397 (Hill), pending in the Assembly, deletes a
requirement that DPH adopt regulations related to
processing sperm to minimize infectiousness and removes
other requirements related to sperm donations in cases
where the donor tests positive for human T-lymphotrophic
virus-1.
b) AB 1132 (Jones), pending in the Assembly, requires the
Department of Motor Vehicles to include organ and tissue
donation information on the vehicle registration
application and renewal forms and allows drivers who
register or renew their vehicle to make a voluntary $2
contribution to benefit organ donation education and
awareness.
5)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
(DHS)), 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.
c) AB 2167 (Gallegos), Chapter 829, Statutes of 2000,
requires DPH (DHS) to submit a report to the Legislature no
later than January 1, 2003, that includes examining
administrative expenditures of tissue banks; use of
informed consent in tissue donation and recovery;
disclosure requirements by tissue banks to the donor or the
person authorized to make a donation on behalf of a
decedent of all potential uses of donated and recovered
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tissues; a system in which individuals for whom donated
tissues are medically necessary are given priority; the
feasibility of state subsidies to implement the system;
and, the process for tissue recovery and distribution.
6)POLICY QUESTION . This bill allows DPH to adopt regulations
without the public review process required under the
Administrative Procedure Act. The author may wish to consider
requiring DPH to provide the public an opportunity to review
new AATB standards and provide comment before DPH adopts them
as regulations.
REGISTERED SUPPORT / OPPOSITION :
Support
California Department of Public Health (sponsor)
American Association of Tissue Banks
American Federation of State, County, and Municipal Employees,
AFL-CIO
Blood Centers of California
Opposition
None on file.
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097