BILL ANALYSIS
AB 995
Page 1
ASSEMBLY THIRD READING
AB 995 (Block)
As Amended May 11, 2009
Majority vote
HEALTH 18-0 APPROPRIATIONS 14-0
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|Ayes:|Jones, Fletcher, Adams, |Ayes:|De Leon, Nielsen, |
| |Ammiano, Block, Carter, | |Ammiano, Charles |
| |Conway, De La Torre, De | |Calderon, Davis, Duvall, |
| |Leon, Emmerson, Hall, | |Fuentes, Hall, John A. |
| |Hayashi, Hernandez, | |Perez, Price, Skinner, |
| |Bonnie Lowenthal, Nava, | |Solorio, Audra |
| |V. Manuel Perez, Salas, | |Strickland, Torlakson |
| |Audra Strickland | | |
| | | | |
|-----+--------------------------+-----+--------------------------|
| | | | |
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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.
3)Requires DPH to evaluate updates to the AATB standards and do
the following prior to adopting them as regulations: a) post
the updates on the DPH Web site at least 45 days; b) accept
public comment for at least 30 days after posting the updates;
and, c) consider public comments before posting final changes.
Exempts adoption of the AATB standards from the requirements
of the Administrative Procedure Act.
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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.
EXISTING LAW establishes requirements for the licensing of
tissue banks and for licensing fees, and requires every tissue
bank to have a current and valid tissue bank license issued or
renewed by DPH, except as specified.
FISCAL EFFECT : According to the Assembly Appropriations
Committee analysis, minor absorbable workload costs.
COMMENTS : According to the author, DPH has been unable to
develop licensing standards for tissue banks because DPH
Laboratory Field Services (LFS) staff lacks internal expertise
and because tissue banking technology changes so rapidly that
draft standards were outdated before DPH legal staff could
review them. The author states numerous cases of tissue
contamination might have been avoided if DPH 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
tissue bank had adhered to AATB standards for storage of excised
tissue. 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.
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 and 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
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trauma, tumors, or other conditions. According to the AATB,
AATB-accredited tissue banks in the U.S. distribute more than
two million bone and tissue allografts from 30,000 donors each
year. The Joint Commission on Accreditation of Healthcare
Organizations stated in 2005 that tissue transplants had tripled
since 1990.
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:
1)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 DPH.
2)Inspect, photograph, or copy any records, reports, test
results, test specimens, or other information relevant to
determining compliance with state laws and regulations.
3)Secure any sample, photograph, or other evidence from any
building or premise for the purpose of enforcing state laws
and regulations.
4)Require licensed tissue banks to demonstrate satisfactory
performance in a proficiency testing program in laboratory
procedures which the tissue bank performs.
The CDC describes AATB as a voluntary accreditation organization
that sets standards for tissue banking. AATB states its mission
is to: 1) 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; 2) foster education and
research; and, 3) 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 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,
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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.
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 the federal Food and
Drug Administration (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.
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 (except organs, which the U.S. Health Resources
and Services Administration regulate). FDA began regulating
human tissue for transplantation in 1993, when it issued
requirements for donor screening and testing. In 2005, FDA
finalized and implemented a revised approach which: 1) requires
firms to register and list their tissue products with FDA; 2)
requires tissue establishments to screen and test donors to
reduce the transmission of infectious diseases; and, 3)
establishes current good practices for tissues intended for
transplantation.
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
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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 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.
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097
FN: 0000864