Bill Text: CA AB1397 | 2009-2010 | Regular Session | Enrolled
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-Enrolled.html
BILL NUMBER: AB 1397 ENROLLED
BILL TEXT
PASSED THE SENATE SEPTEMBER 1, 2009
PASSED THE ASSEMBLY SEPTEMBER 3, 2009
AMENDED IN SENATE AUGUST 17, 2009
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, 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.
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 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 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 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 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, 2010, 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, 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 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 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
recommendations regarding 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
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.
(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. 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.
