BILL ANALYSIS Ó
AB 2750
Page 1
Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2750
Gomez - As Amended April 7, 2016
SUBJECT: Tissue banks.
SUMMARY: Creates an additional exemption from tissue bank
licensing requirements for the storage of human cell, tissue or
cellular- or tissue-based product (HCT/P). Specifically, this
bill:
1)Allows a person licensed to provide health care services,
acting within the scope of his or her license and practicing
in a lawful practice to store HCT/P if all of the following
apply:
a) The person, as defined, is a hospital, or an outpatient
setting regulated by the Medical Board of California,
including an ambulatory surgical center; and,
b) The HCT/P being stored meets all of the following
requirements:
i) Was obtained from a tissue bank licensed by the
state;
ii) Is stored in the original unopened enclosure for one
finished unit of transplantable tissue and is stored in
strict accordance with the package insert and any other
AB 2750
Page 2
manufacturer instruction and guidelines;
iii) Is intended for the express purpose of implantation
into or application on a patient;
iv) Is not intended for further distribution; and,
v) Is regulated by the federal Food and Drug
Administration (FDA), as specified.
EXISTING LAW:
1)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.
2)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 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;
AB 2750
Page 3
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.
h) The storage of a HCT/P that is either a medical device
approved by the 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.
3)Establishes the Medical Board of California to regulate the
practice of medicine and approve accrediting agencies that
accredit outpatient settings in California.
FISCAL EFFECT: This bill has not been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, 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 to be licensed as a tissue bank.
The author states that this does not take into account
advancements in technology or other FDA and American
AB 2750
Page 4
Association of Tissue Bank (AATB) standards. The author
states this bill addresses this by providing an exemption when
products are obtained from a licensed tissue bank, are stored
in accordance with FDA regulations and guidance, and intended
for implantation, not for distribution. The author concludes
this will reduce costs and make more tissue readily available
to hospitals and ambulatory surgery centers, and ultimately
patients.
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 Federal Food, Drug and Cosmetic Act.
Human cells or tissue intended for implantation,
transplantation, infusion, or transfer into a human recipient
are regulated as HCT/P. Examples of such tissues 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 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.
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 these regulations were drafted but not successfully
promulgated because a subcommittee of the Clinical Laboratory
Technology Advisory Committee (Committee) stated that it would
take several years to develop a regulatory package of this
complexity because technical and administrative changes were
advancing at such a fast rate that the regulations would be
out-of-date before promulgation. Instead the Committee
recommended that DPH adopt into law the AATB standards and the
annual updates. AB 995 (Block) of 2009, attempted to do this,
but was later amended to deal with a different subject matter.
To date, regulations have yet to be promulgated.
AB 2750
Page 5
3)SUPPORT. MiMedx supports this bill stating, 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. MiMedx notes, 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. MiMedx concludes such courier fees have been known to
cost one California licensed tissue supplier more than
$150,000 in one year and these fees are generally included in
the overall cost of providing tissue, further increasing the
cost of health care in California.
4)PREVIOUS LEGISLATION.
a) AB 1822 (Bonta) of 2014 was substantially similar to
this bill. AB 1822 was vetoed by the Governor who stated,
in part, "While I support eliminating overly burdensome
regulation, I'm not convinced that the bill strikes the
right balance between safety and economy. I will direct
the Department of Public Health to continue working with
interested parties to develop an approach that balances
appropriate oversight with cost savings for suppliers."
b) 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.
c) SB 1135 (Polanco and Murray), Chapter 929, Statutes of
2002, requires DPH (then Department of Health Services), 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
AB 2750
Page 6
Standards for Tissue Banking.
5)POLICY COMMENTS.
a) Underground regulations. To date, the Legislature has
granted eight separate exemptions to tissue bank licensing
requirements. DPH is required to develop regulations but
as yet has not done so, failing to fulfill its regulatory
obligation. According to health care practitioners and
facilities, the lack of regulations creates uncertainty and
a greater potential for committing a violation. DPH has
attempted to address their concern by publishing a
Frequently Asked Questions (FAQ) document. However, to the
extent that the FAQs provide regulatory guidance, it could
be construed as underground regulations and should be
subject to the provisions of the Administrative Procedures
Act, including public review and comment.
b) Veto. This bill is similar to AB 1822 which was vetoed
by the Governor. The Committee may wish to ask the author
how he will address the Governor's veto message.
REGISTERED SUPPORT / OPPOSITION:
Support
MiMedx
Opposition
AB 2750
Page 7
None on file.
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097