BILL ANALYSIS
AB 1487
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 1487 (Hill)
As Amended August 10, 2010
2/3 vote. Urgency
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|ASSEMBLY: | |(May 18, 2009) |SENATE: |31-0 |(August 12, |
| | | | | |2010) |
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(vote not relevant)
Original Committee Reference: PUB. S.
SUMMARY : Extends, to January 1, 2014, the date by which the
Department of Public Health (DPH) is required to adopt
regulations prescribing sperm processing facilities' handling
and storage of sperm from donors who are carriers of human
immunodeficiency virus (HIV) and human T lymphotrophic virus
(HTLV), and requires a physician providing insemination and
advanced reproductive technologies (ART) to make specified
disclosures to a recipient of sperm from a HIV or HTLV reactive
spouse, partner, or designated donor.
The Senate amendments delete the Assembly version of this bill,
and instead:
1)Require the testing of transplant donor tissue for infection
with HTLV only in tissues that are rich in viable leukocytes.
2)Require a physician providing ART to notify the recipient of
sperm from a HIV or HTLV reactive spouse, partner, or
designated donor of all of the following:
a) Sperm processing may not eliminate all of the risks of
HIV or HTLV transmission;
b) The sperm may be tested to determine whether or not it
is reactive for HIV or HTLV;
c) The recipient must document prior to treatment that she
has a physician to provide ongoing care during and after
her fertility services; and,
d) Information about recommendations published by the
American Society of Reproductive Medicine (ASRM) regarding
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follow-up testing for HIV and HTLV, and a requirement that
the recommendations regarding follow-up testing will be
documented in the recipient's medical record.
3)Clarify that a physician providing ART is not responsible for
prophylactic testing, monitoring, and follow-up of the
recipient. Require the physician to recommend follow-up
testing for HIV or HTLV, according to ASRM's published
guidelines, to the physician who will be providing the
recipient's ongoing care, as specified.
4)Require, in the event the recipient becomes HIV or HTLV
positive, the physician assuming ongoing care of the recipient
to treat or provide information regarding referral to a
physician who can provide ongoing treatment for HIV or HTLV.
5)Extend the date by which DPH is required to adopt regulations
prescribing sperm processing facilities' handling and storage
of sperm from donors who are carriers of HIV, HTLV, or any
other virus DPH deems appropriate from January 1, 2010, to
January 1, 2014.
6)Permit DPH to propose to adopt, as initial regulations,
specified recommendations published by the ASRM using a
specified process.
7)Exempt adoption of regulations for sperm processing facilities
from requirements for written responses to public comments and
the Administrative Procedure Act.
8)Make other minor technical clarifying changes and add an
urgency clause to make the provisions of this bill take effect
immediately upon enactment.
EXISTING LAW :
1)Requires DPH to adopt, by January 1, 2010, regulations to
prescribe sperm processing facilities' handling and storage of
sperm from donors who are carriers of HIV, HTLV-1, or any
other virus DPH deems appropriate. Requires sperm processing
facilities to follow facility and sperm processing guidelines
published by the ASRM until DPH adopts regulations.
2)Prohibits the transplantation of tissue into the body of
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another, unless the donor of the tissue has been screened and
found to be free from infection with HIV, hepatitis B virus
(HBV), hepatitis C virus (HCV), HTLV-1, and syphilis, except
under specified conditions.
3)Allows a recipient of sperm to consent to therapeutic
insemination of sperm or use of sperm in other ART even if the
sperm donor is found reactive for hepatitis B virus, hepatitis
C virus, HIV, HTLV-I, or syphilis if the sperm donor is the
spouse of, partner of, or designated donor for the recipient.
4)Requires the physician providing insemination or ART services
to advise the donor and recipient of the potential medical
risks associated with receiving sperm from a reactive donor.
Requires the donor and recipient to sign a document affirming
their consent and comprehension of the medical repercussions.
5)Allows the use of sperm from a donor who has tested reactive
for syphilis for insemination or ART after the donor has been
treated for syphilis. Allows the use of sperm from a donor
who has tested reactive for HBV for insemination or ART after
the recipient has been vaccinated against HBV.
6)Allows the use of sperm from a donor who has tested reactive
for HIV or HTLV-1 for insemination or ART after the sperm has
been processed to minimize the risk of infection for that
specific donation and where informed and mutual consent has
occurred. Requires the physician to inform the recipient that
processing may not remove all risks of HIV or HTLV-1
transmission, that the sperm may be tested to determine
whether it is free of HIV or HTLV-1, and the harmful effects
that testing may have on the sperm.
7)Requires the physician to verify that a donor who has tested
reactive for HIV or HTLV-1 is under the care of a physician
managing the HIV or HTLV-1 infection, in order to minimize the
risk of transmission. Requires the physician to provide
appropriate prophylactic treatment to the recipient to
minimize the risk of infection.
AS PASSED BY THE ASSEMBLY , this bill increased from $3 to $6 the
fee charged for each inmate-initiated medical visit by an inmate
confined in a county or city jail.
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FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS : According to the author, HIV is now considered a
chronic disease, and many HIV-infected adults have near normal
life expectancy with typical life goals such as starting a
family. The author states that due to advances in reproductive
technologies, sperm washing can separate healthy sperm from the
other components in semen that may contain HIV, removing 99.9%
of HIV particles, so HIV- and HTLV-infected sperm can be used in
ART with virtually no risk of transmission to mother and baby.
Over 4,500 assisted reproduction procedures are documented in
the literature with no reports of HIV transmission when using
standardized sperm washing methods with either intrauterine
insemination or in-vitro fertilization. SB 443 (Migden),
Chapter 207, Statutes of 2007, was intended to ensure access to
reproductive treatment for HIV-discordant couples (HIV-positive
male and HIV-negative female). However, the author states SB
443 was unclear about which medical professionals were
responsible for the care of the infected sperm donor and for
follow-up of the recipient, and included some medical
terminology that was inaccurate or insufficiently inclusive.
Also, sperm infected with different types of HTLV, not just
HTLV-I, can be safely used once processed, so this bill uses the
broader language. The author argues this bill is needed to fix
those problems.
The processing of sperm from a donor testing reactive for HIV or
HTLV is commonly referred to as sperm washing. Numerous studies
have confirmed that HIV is primarily found in white blood cells
and plasma in semen, not generally within the sperm itself. The
sperm washing process involves centrifuging the semen in order
to separate it from the sperm. This process can also involve a
"swim-up" technique that removes inactive sperm. The remaining
active sperm can then be used for insemination or ART. Numerous
studies report that the sperm-washing process reduces HIV levels
in sperm, and the technology and procedures continue to improve.
This bill was substantially amended in the Senate and the
Assembly-approved version of this bill was deleted. This bill,
as amended in the Senate, is inconsistent with Assembly actions.
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Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097
FN: 0005880