BILL NUMBER: AB 1487	CHAPTERED
	BILL TEXT

	CHAPTER  444
	FILED WITH SECRETARY OF STATE  SEPTEMBER 29, 2010
	APPROVED BY GOVERNOR  SEPTEMBER 29, 2010
	PASSED THE SENATE  AUGUST 12, 2010
	PASSED THE ASSEMBLY  AUGUST 26, 2010
	AMENDED IN SENATE  AUGUST 10, 2010
	AMENDED IN SENATE  JUNE 14, 2010
	AMENDED IN SENATE  MARCH 2, 2010
	AMENDED IN SENATE  JUNE 22, 2009
	AMENDED IN ASSEMBLY  APRIL 2, 2009

INTRODUCED BY   Assembly Member Hill
   (Coauthor: Senator Leno)

                        FEBRUARY 27, 2009

   An act to amend Sections 1635, 1644, and 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 1487, 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.
   This bill would require testing for evidence of infection with
HTLV only in tissues that are rich in viable leukocytes.
   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.
   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 extend until January 1, 2014, the date for
adopting regulations and would allow the department to adopt initial
regulations based on the "Guidelines for Reducing Risk of Viral
Transmission During Fertility Treatment" using a specified process.
The bill would also require the physician to inform the recipient
that she must provide documentation to the physician providing
insemination or advanced reproductive technology services prior to
treatment that she has established an ongoing physician relationship
with another physician to provide for her medical care during and
after completion of fertility services and about the medical
guidelines for testing after use of sperm from an HIV or HTLV
reactive spouse, partner, or designated 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.


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

  SECTION 1.  Section 1635 of the Health and Safety Code is amended
to read:
   1635.  (a) "Donor" means an individual, living or deceased, from
whom tissue is removed.
   (b) "Person" means an individual, corporation, business trust,
estate trust, partnership, association, state or local government, or
subdivision or agency thereof, or any other legal entity.
   (c) "Tissue" means a human cell, group of cells, including the
cornea, sclera, or vitreous humor and other segments of, or the whole
eye, bones, skin, arteries, sperm, blood, other fluids, and any
other portion of a human body.
   (d) "Tissue bank" means a place, establishment, or institution
that collects, processes, stores, or distributes tissue for
transplantation into human beings.
   (e) "Transplantation" means the act or process of transferring
tissue, including by ingestion, from a donor to the body of the donor
or another human being.
   (f) "Department" means the State Department of Public Health.
  SEC. 2.  Section 1644 of the Health and Safety Code is amended to
read:
   1644.  (a) For purposes of this chapter, "donor," "person,"
"tissue," "transplantation," and "department" shall have the meaning
as defined for those terms in Section 1635.
   (b) For purposes of this chapter, "HIV" shall mean human
immunodeficiency virus.
  SEC. 3.  Section 1644.5 of the Health and Safety Code is amended to
read:
   1644.5.  (a) Except as provided in subdivision (c) or (d), 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 human immunodeficiency virus (HIV), agents of viral
hepatitis (HBV and HCV), and syphilis. For tissues that are rich in
viable leukocytes, the tissue shall be tested for evidence of
infection with human T lymphotrophic virus (HTLV) and found
nonreactive. 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 1602.5) 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) Not later than January 1, 2014, the department 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. The
department may propose to adopt, as initial regulations, the
recommendations made within the "Guidelines for Reducing Risk of
Viral Transmission During Fertility Treatment" as published 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 the
conclusion of the 45-day posting period. 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. If no
member of the public requests a public hearing, the regulations
shall be deemed adopted at the conclusion of the 30-day comment
period. 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.
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 spouse, partner, or designated
donor who has tested reactive for HIV or HTLV 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 must provide documentation to the
physician providing insemination or advanced reproductive technology
services prior to treatment that she has established an ongoing
relationship with another physician to provide for her medical care
during and after completion of fertility services.
   (IV) The recommendations made within the "Guidelines for Reducing
the Risk of Viral Transmission During Fertility Treatment" published
by 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 have the recommendations regarding followup
testing 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
for HIV and HTLV according to the "Guidelines for Reducing the Risk
of Viral Transmission During Fertility Treatment" published by the
American Society for Reproductive Medicine, which shall be documented
in the recipient's medical record.
   (vi) In the event that the recipient becomes HIV or HTLV positive,
the physician assuming ongoing care of the recipient shall treat or
provide information regarding referral to a physician who can provide
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. 4.  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.