Bill Text: CA AB1397 | 2009-2010 | Regular Session | Amended

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

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Bill Title: Tissue donation.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Vetoed) 2010-01-14 - Consideration of Governor's veto stricken from file. [AB1397 Detail]

Download: California-2009-AB1397-Amended.html

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BILL NUMBER: AB 1397	AMENDED
	BILL TEXT

	AMENDED IN SENATE  JULY 13, 2009
	AMENDED IN SENATE  JUNE 16, 2009

INTRODUCED BY   Assembly Member Hill
   (Principal coauthor: Senator Leno)

                        FEBRUARY 27, 2009

   An act to amend Section 1644.5 of the Health and Safety Code,
relating to tissue donation, and declaring the urgency thereof, to
take effect immediately.



	LEGISLATIVE COUNSEL'S DIGEST


   AB 1397, as amended, Hill. Tissue donation.
   Existing law prohibits the transfer of any tissues, as defined,
into the body of another person by means of transplantation, unless
the donor of the tissues has been screened and found nonreactive for
evidence of infection with human immunodeficiency virus (HIV), agents
of viral hepatitis (HBV and HCV), human T lymphotrophic virus-1
(HTLV-1), and syphilis, except as provided.
   Existing law requires that all donors of sperm be screened and
found nonreactive under the above provisions, except as provided.
Under existing law, a sperm donor who has tested reactive for HIV or
HTLV-1 may be used for insemination or advanced reproductive
technology for a recipient who has tested negative only after
processing to minimize the infectiousness of the sperm. The State
Department of Public Health is required to adopt regulations by
January 1, 2010, regulating facilities that perform this processing.

   This bill would, instead, make the adoption of the above
regulations voluntary. 
   Existing law further requires the physician providing insemination
or advanced reproductive technologies to, among other things, inform
the recipient that the processing may not eliminate the risk of
infection, that the sperm may be tested to ensure that it is free
from HIV or HTLV-1, and about the potential adverse effects of
testing on the sperm.
    This bill would remove the requirement that the recipient
be informed of the availability and consequences of further testing.
 This bill would require the physician to inform the
recipient  that she should establish an ongoing physician
relation   ship and  about the  medical 
guidelines for testing after use of sperm from an HIV or HTLV
reactive donor.
   Under existing law, the physician performing insemination or
advanced reproductive technology is required to provide prophylactic
treatments, followup testing, and monitoring, as specified, to the
recipient to minimize the risk of infection.
   This bill would remove those requirements but would require the
physician to recommend followup testing of the recipient for HIV and
HTLV, as specified.
   Existing law allows the use of sperm from a donor who has tested
reactive for HIV or HTLV-1 if the recipient has also previously been
documented with HIV or HTLV-1 and where mutual consent has been
obtained.
   This bill would remove this provision. The bill would also make
all of the provisions above applicable to donors who have tested
reactive for any of the human T lymphotrophic viruses.
   This bill would declare that it is to take effect immediately as
an urgency statute.
   Vote: 2/3. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.


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

  SECTION 1.  Section 1644.5 of the Health and Safety Code is amended
to read:
   1644.5.  (a) No tissues shall be transferred into the body of
another person by means of transplantation, unless the donor of the
tissues has been screened and found nonreactive by laboratory tests
for evidence of infection with HIV, agents of viral hepatitis (HBV
and HCV), human T lymphotrophic virus (HTLV), and syphilis, except as
provided in subdivision (c). The department may adopt regulations
requiring additional screening tests of donors of tissues when, in
the opinion of the department, the action is necessary for the
protection of the public, donors, or recipients.
   (b) Notwithstanding subdivision (a), infectious disease screening
of blood and blood products shall be carried out solely in accordance
with Article 2 (commencing with Section 1601) of Chapter 4.
   (c) All donors of sperm shall be screened and found nonreactive as
required under subdivision (a), except in the following instances:
   (1) A recipient of sperm, from a sperm donor known to the
recipient, may waive a second or other repeat testing of that donor
if the recipient is informed of the requirements for testing donors
under this section and signs a written waiver.
   (2) A recipient of sperm may consent to therapeutic insemination
of sperm or use of sperm in other advanced reproductive technologies
even if the sperm donor is found reactive for hepatitis B, hepatitis
C, syphilis, HIV or HTLV if the sperm donor is the spouse of, partner
of, or designated donor for that recipient. The physician providing
insemination or advanced reproductive technology services shall
advise the donor and recipient of the potential medical risks
associated with receiving sperm from a reactive donor. The donor and
the recipient shall sign a document affirming that each comprehends
the potential medical risks of using sperm from a reactive donor for
the proposed procedure and that each consents to it. Copies of the
document shall be placed in the medical records of the donor and the
recipient.
   (3) (A) Sperm whose donor has tested reactive for syphilis may be
used for the purposes of insemination or advanced reproductive
technology only after the donor has been treated for syphilis. Sperm
whose donor has tested reactive for hepatitis B may be used for the
purposes of insemination or advanced reproductive technology only
after the recipient has been vaccinated against hepatitis B.
   (B) (i) Sperm whose donor has tested reactive for HIV or HTLV may
be used for the purposes of insemination or advanced reproductive
technology for a recipient testing negative for HIV or HTLV only
after the donor's sperm has been effectively processed to minimize
the infectiousness of the sperm for that specific donation and where
informed and mutual consent has occurred.
   (ii)  The   Not later than January 1, 2010,
the  department  may   shall  adopt
regulations regulating facilities that perform sperm processing,
pursuant to this subparagraph, that prescribe standards for the
handling and storage of sperm samples of carriers of HIV, HTLV, or
any other virus as deemed appropriate by the department.  In
the absence of   The department may propose to adopt, as
initial regulations, guidelines made by the American Society for
Reproductive Medicine. Notice of the department's proposed adoption
of the regulations shall be posted on the department's Internet Web
site for at least 45 days. Public comment shall be accepted by the
department for at least 30 days after posting of the notice. If a
member of the public requests a public hearing during the 30-day
comment period, the hearing shall be held prior to the adoption of
the regulations. Comments received shall be considered prior to the
adoption of the final initial regulations. The department may modify
any   guidance published by the American Society for
Reproductive Medicine based on the comments received. Adoption of
initial regulations 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. Updates to the regulations shall be adopted pursuant
to the same process. Until the department adopts these 
regulations, facilities that perform sperm processing pursuant to
this section shall follow facility and sperm processing guidelines
for the reduction of viral transmission developed by the American
Society for Reproductive Medicine.  Nothing in this section shall
prevent the department from monitoring and inspecting facilities
that process sperm to ensure adherence to the regulations, or, until
  regulations are adopted, to the guidelines set forth by
the American Society for Reproductive Medicine. 
   (iii) Prior to insemination or other advanced reproductive
technology services, the physician  providing the services 
shall inform the recipient of sperm from a donor who has tested
reactive for HIV or HTLV  that sperm processing may not
eliminate all risks of HIV or HTLV transmission. The physician shall
also notify the recipient of the American Society for Reproductive
Medicine's medical guidelines for HIV and HTLV testing after use of
sperm from an HIV or HTLV reactive donor.   of all of
the following:  
   (I) That sperm processing may not eliminate all of the risks of
HIV or HTLV transmission.  
   (II) That the sperm may be tested to determine whether or not it
is reactive for HIV or HTLV.  
   (III) That the recipient should establish an ongoing physician
relationship, which the physician providing services shall document.
 
   (IV) The medical guidelines of the American Society for
Reproductive Medicine regarding followup testing for HIV and HTLV
after use of sperm from an HIV or HTLV reactive donor and that the
followup testing will be documented in the recipient's medical
record. 
   (iv) The physician providing insemination or advanced reproductive
technology services shall also verify, and document in the recipient'
s medical record, that the donor of sperm who tests reactive for HIV
or HTLV is under the care of a physician managing the HIV or HTLV.
   (v) The physician providing insemination or advanced reproductive
technology services shall recommend  to the physician who will be
providing ongoing care to the recipient recommended  followup
testing  of the recipient  for HIV and HTLV
according to the medical guidelines of the American Society for
Reproductive Medicine  ,   which shall be documented in
the recipient's medical record  .  If the recipient's
care is transferred, the transferring physician shall inform the
physician who will be providing the ongoing care of any testing
recommended by the American Society for Reproductive Medicine to
diagnose potential infection with HIV or HTLV. 
   (vi) In the event that the recipient becomes HIV or HTLV positive,
the physician assuming ongoing  management  
care  of the recipient shall inform the recipient of
treatments or procedures that may reduce the risk of transmission to
the offspring,   treat  or provide information
regarding referral to a physician who can provide that information
and ongoing treatment of the HIV or HTLV.
   (4) The penalties of Section 1621.5 shall not apply to a sperm
donor covered under this subdivision.
   (d) Subdivision (a) shall not apply to the transplantation of
tissue from a donor who has not been tested or, with the exception of
HIV and HTLV, has been found reactive for the infectious diseases
listed in subdivision (a) or for which the department has, by
regulation, required additional screening tests, if both of the
following conditions are satisfied:
   (1) The physician and surgeon performing the transplantation has
determined any one or more of the following:
   (A) Without the transplantation the intended recipient will most
likely die during the period of time necessary to obtain other tissue
or to conduct the required tests.
   (B) The intended recipient already is diagnosed with the
infectious disease for which the donor has tested positive.
   (C) The symptoms from the infectious disease for which the donor
has tested positive will most likely not appear during the intended
recipient's likely lifespan after transplantation with the tissue or
may be treated prophylactically if they do appear.
   (2) Consent for the use of the tissue has been obtained from the
recipient, if possible, or if not possible, from a member of the
recipient's family, or the recipient's legal guardian. For purposes
of this section, "family" shall mean spouse, adult son or daughter,
either parent, adult brother or sister, or grandparent.
   (e) Human breast milk from donors who test reactive for agents of
viral hepatitis (HBV and HCV), HTLV, HIV, or syphilis shall not be
used for deposit into a milk bank for human ingestion in California.
  SEC. 2.  This act is an urgency statute necessary for the immediate
preservation of the public peace, health, or safety within the
meaning of Article IV of the Constitution and shall go into immediate
effect. The facts constituting the necessity are:
   To help prevent the spread of HIV, at the earliest possible time,
it is necessary that this legislation take immediate effect.