BILL NUMBER: AB 995	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Block

                        FEBRUARY 27, 2009

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


	LEGISLATIVE COUNSEL'S DIGEST


   AB 995, as introduced, Block. Tissue bank licensing.
   Existing law requires the Department of Health Care Services 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. This bill would also allow the department to impose on
licensed and unlicensed tissue banks, as an alternative to suspension
or revocation of a tissue bank's license, a civil administrative
penalty of up to $100 per infraction or immediate jeopardy, up to a
maximum amount of $3,050 per day of noncompliance.
   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.


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

  SECTION 1.  Section 1639.01 of the Health and Safety Code is
amended to read:
   1639.01.   (a)   
Notwithstanding Section 1639,  the state department shall
adopt, on or before July 1, 2004, rules and regulations governing
licensed tissue banks engaged in the collection of human
musculoskeletal tissue, skin, and veins for transplantation in
humans. The regulations shall be substantially based upon the
criteria used by tissue bank trade associations in their respective
accreditation processes including, but not limited to, those of the
Eye Bank Association of America and the American Association of
Tissue Banks, and the scientific and technical data submitted by
individual tissue banks   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)  Regulations adopted by the state department, pursuant to
subdivision (a), shall include minimum standards for all of the
following:  
   (1)  Safe preservation, transportation, storage, and handling of
tissue acquired or used for transplantation.  
   (2)  Testing of donors to determine compatibility when
appropriate.  
   (3)  Testing or assessment of donors to prevent the spread of
disease through transplantation.  
   (4)  Equipment.  
   (5)  Methods.  
   (6)  Personnel qualifications.  
   (7)  Any other area concerning the operation or maintenance of a
tissue bank, not inconsistent with this chapter, as may be necessary
to carry out this chapter.  
   (c)  On or before July 1, 2003, the department shall report to the
appropriate policy and fiscal committees of the Legislature
regarding the status of the proposed regulations. 
  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 up to one hundred dollars
($100) per infraction or immediate jeopardy, up to a maximum amount
of three thousand fifty dollars ($3,050) per day of noncompliance.
This penalty may be imposed only after notice and an opportunity to
respond in accordance with Section 100171 and may also be imposed
upon nonlicensed tissue banks.
  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.