Bill Text: CA AB995 | 2009-2010 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Tissue bank licensing.

Sponsorship: Partisan Bill (Democrat 1)

Status: (Passed) 2009-10-11 - Chaptered by Secretary of State - Chapter 497, Statutes of 2009. [AB995 Detail]

Download: California-2009-AB995-Amended.html

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BILL NUMBER: AB 995	AMENDED
	BILL TEXT

	AMENDED IN SENATE  JUNE 30, 2009
	AMENDED IN ASSEMBLY  MAY 11, 2009
	AMENDED IN ASSEMBLY  MAY 5, 2009
	AMENDED IN ASSEMBLY  APRIL 13, 2009

INTRODUCED BY   Assembly Member Block

                        FEBRUARY 27, 2009

   An act to amend Section  1639.01 of, and to add Section
1643.3 to,   1635.1 of  the Health and Safety Code,
relating to tissue banks.



	LEGISLATIVE COUNSEL'S DIGEST


   AB 995, as amended, Block. Tissue bank licensing. 
   Existing law requires all tissue banks, with certain specified
exceptions, to be licensed by the State Department of Public health.
 
   This bill would add to the list of licensure exceptions the
storage of federal Food and Drug Administration (FDA)-regulated
tissue-engineered products by a person licensed to provide health
care services, acting within the scope of their license and
practicing in a lawful practice setting, provided that the federal
FDA-regulated tissue-engineered product has been obtained from a
licensed tissue bank and is stored in strict accordance with federal
FDA regulations and guidelines and is used for the express purpose of
implantation into or application on a patient and is not intended
for further distribution.  
   Existing law requires the State Department of Public Health to
establish regulations, as specified, governing the operation and
maintenance of tissue banks licensed in California. Existing law
allows for the revocation or suspension of a tissue bank's license
for specified reasons. Violation of these provisions is a
misdemeanor.  
   This bill would require the collection, processing, storage, or
distribution of human tissue by licensed tissue banks and tissue for
use in California to comply with the 12th edition of Standards for
Tissue Banking as published by the American Association of Tissue
Banks, and would require future amendments of these standards to be
evaluated and considered for adoption by the department pursuant to a
specified process. This bill would also allow the department to
impose on licensed tissue banks, as an alternative to suspension or
revocation of a tissue bank's license, a civil administrative penalty
of $100 per day of noncompliance per violation not to exceed an
aggregate of $3,000 per day.  
   Because the bill would make changes to the definition of a crime,
it constitutes a state-mandated local program.  
   The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.  
   This bill would provide that no reimbursement is required by this
act for a specified reason. 
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program:  yes   no  .



THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

   SECTION 1.    Section 1635.1 of the   Health
and Safety Code   is amended to read: 
   1635.1.  (a) Except as provided in subdivision (b), every tissue
bank operating in California on or after July 1, 1992, shall have a
current and valid tissue bank license issued or renewed by the
department pursuant to Section 1639.2 or 1639.3.
   (b) This chapter shall not apply to any of the following:
   (1) The collection, processing, storage, or distribution of human
whole blood or its derivatives by blood banks licensed pursuant to
Chapter 4 (commencing with Section 1600) or  any 
 a  person exempt from licensure under that chapter.
   (2) The collection, processing, storage, or distribution of tissue
for autopsy, biopsy, training, education, or for other medical or
scientific research or investigation, where transplantation of the
tissue is not intended or reasonably foreseeable.
   (3) The collection of tissue by an individual physician and
surgeon from his or her patient or the implantation of tissue by an
individual physician and surgeon into his or her patient. This
exemption shall not be interpreted to apply to any processing or
storage of the tissue, except for the processing and storage of semen
by an individual physician and surgeon when the semen was collected
by that physician and surgeon from a semen donor or obtained by that
physician and surgeon from a tissue bank licensed under this chapter.

   (4) The collection, processing, storage, or distribution of fetal
tissue or tissue derived from a human embryo or fetus.
   (5) The collection, processing, storage, or distribution by an
organ procurement organization (OPO), as defined in Section 485.302
of Title 42 of the Code of Federal Regulations, if the OPO, at the
time of collection, processing, storage, and distribution of the
organ, has been designated by the Secretary of Health and Human
Services as an OPO, pursuant to Section 485.305 of Title 42 of the
Code of Federal Regulations, and meets the requirements of Sections
485.304 and 485.306 of Title 42 of the Code of Federal Regulations,
as applicable.
   (6) The storage of prepackaged, freeze-dried bone by a general
acute care hospital.
   (7) The storage of freeze-dried bone and dermis by  any
  a  licensed dentist practicing in a lawful
practice setting, 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. 
   (8) The storage of federal Food and Drug Administration
(FDA)-regulated tissue-engineered products by a person licensed to
provide health care services, acting within the scope of their
license and practicing in a lawful practice setting, provided that
the federal FDA-regulated tissue-engineered product has been obtained
from a licensed tissue bank and is stored in strict accordance with
federal FDA regulations and guidelines and is used for the express
purpose of implantation into or application on a patient and is not
intended for further distribution.  
  SECTION 1.    Section 1639.01 of the Health and
Safety Code is amended to read:
   1639.01.  (a) Notwithstanding Section 1639, 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 and in effect on May 1, 2008. These shall
be the standards for all licensed tissue banks operating in
California or providing tissue to be used in California.
   (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. 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
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 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.
 
  SEC. 2.    Section 1643.3 is added to the Health
and Safety Code, to read:
   1643.3.  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 except that the aggregate penalty per day shall
not exceed three thousand dollars ($3,000). This penalty may be
imposed only after notice and an opportunity to respond in accordance
with Section 100171.  
  SEC. 3.    No reimbursement is required by this
act pursuant to Section 6 of Article XIII B of the California
Constitution because the only costs that may be incurred by a local
agency or school district will be incurred because this act creates a
new crime or infraction, eliminates a crime or infraction, or
changes the penalty for a crime or infraction, within the meaning of
Section 17556 of the Government Code, or changes the definition of a
crime within the meaning of Section 6 of Article XIII B of the
California Constitution.