Amended in Senate April 4, 2016

Senate Bill No. 1408

Introduced by Senator Allen

February 19, 2016

An act to amend Section begin delete 125285.5 end delete begin insert 1644.5 end insert of the Health and Safety Code, relating to begin delete mental end delete begin insert public end insert health.

LEGISLATIVE COUNSEL’S DIGEST

SB 1408, as amended, Allen. begin delete Alzheimer’s disease: updated guidelines. end delete begin insert Tissue donation. end insert

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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.

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This bill would delete the exception of HIV from this provision.

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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.

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This bill would make technical, nonsubstantive changes to these provisions.

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Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.

The people of the State of California do enact as follows:

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begin insert SECTION 1. end insert   

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begin insert Section 1644.5 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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)  begin delete Not later than January 1, 2014, the end delete begin insert The end insert 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)  begin delete In the event that end delete begin insert If end insert 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
begin delete HIV and end delete 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.

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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.

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