BILL NUMBER: SB 1408 AMENDED
BILL TEXT
AMENDED IN SENATE APRIL 4, 2016
INTRODUCED BY Senator Allen
FEBRUARY 19, 2016
An act to amend Section 125285.5 1644.5
of the Health and Safety Code, relating to mental
public health.
LEGISLATIVE COUNSEL'S DIGEST
SB 1408, as amended, Allen. Alzheimer's disease: updated
guidelines. 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
(HTLV), 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. Existing law authorizes the
transplantation of tissue from a donor who has not been tested for
specified infectious diseases or, with the exception of HIV and HTLV,
has been found reactive, if specified conditions are satisfied.
This bill would delete the exception of HIV from this provision.
Existing law, until January 1, 2018, requires the State Department
of Public Health to convene a workgroup to update the 2008
Guidelines for Alzheimer's Disease Management in California to
address changes in the health care system. Existing law requires the
department to submit a report of the updates and recommendations from
the working group to the Legislature on or before March 1, 2017.
This bill would make technical, nonsubstantive changes to these
provisions.
Vote: majority. Appropriation: no. Fiscal committee: no.
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) 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 assisted 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 assisted 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 assisted 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 assisted 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 assisted 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
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 assisted 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 assisted 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 assisted 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 assisted 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 If 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) A recipient of sperm donated by a sexually intimate partner of
the recipient for reproductive use may waive a second or repeat
testing of that donor if the recipient is informed of the donor
testing requirements of this section and signs a written waiver. For
purposes of this paragraph, "sexually intimate partner of the
recipient" includes a known or designated donor to whose sperm the
recipient has previously been exposed in a nonmedical setting in an
attempt to conceive.
(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) The penalties of Section 1621.5 shall not apply to a sperm
donor covered under subdivision (c).
(f) 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.
SECTION 1. Section 125285.5 of the Health and
Safety Code is amended to read:
125285.5. (a) The Legislature finds and declares all of the
following:
(1) It is estimated that there are between 60,000 and 85,000
people with dementia in California's Coordinated Care Initiative.
(2) Average per person Medicaid spending for seniors who are
dually eligible for Medicare and who have Alzheimer's disease and
other dementias is 19 times higher than average per person Medicaid
spending for all other seniors.
(3) The triple aim of the federal Patient Protection and
Affordable Care Act (Public Law 111-148) and Medicaid expansion is
improved population health, better experience of care, and lower per
capita health care costs.
(4) Dementia care management has been proven, through
peer-reviewed, evidence-based research, to achieve all three aims.
(b) The State Department of Public Health shall convene a
workgroup to update the 2008 Guidelines for Alzheimer's Disease
Management in California to address changes in the health care
system, including, but not limited to, changes in the federal Patient
Protection and Affordable Care Act (Public Law 111-148), Medicaid,
and Medicare. In updating the guidelines, the workgroup may draw on
evidence-based, peer-reviewed research and lessons learned from
demonstration and pilot projects.
(c) The workgroup shall consist of members determined by the
department. It may include multidisciplinary experts in Alzheimer's
disease detection, diagnosis, treatment, and support.
(d) The department shall submit a report of the updates and
recommendations from the working group to the Legislature on or
before March 1, 2017. This report shall be submitted in compliance
with Section 9795 of the Government Code.
(e) This section shall remain in effect only until January 1,
2018, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2018, deletes or extends
that date.