Amended in Senate April 18, 2016

Amended in Senate April 4, 2016

Senate BillNo. 1408


Introduced by Senator Allen

February 19, 2016


An act to amend Section 1644.5 of the Health and Safety Code, relating to public health.

LEGISLATIVE COUNSEL’S DIGEST

SB 1408, as amended, Allen. Tissue donation.

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Existing

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begin insert(1)end insertbegin insertend insertbegin insertExistingend insert 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 lymphotropic 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.

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(2) Under existing law, it is a felony for a person to donate blood, body organs or other tissue, or semen to a medical center or semen bank who knows that he or she has acquired immunodeficiency syndrome (AIDS) except if the person is a sperm donor who has been screened and found nonreactive under the above provisions. Under existing law, a person afflicted with any contagious, infectious, or communicable disease who willfully exposes himself or herself to another person, and any person who willfully exposes another person afflicted with the disease to someone else, is guilty of a misdemeanor, except as provided.

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This bill would exempt those sperm donors and tissue donors from those criminal 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:

P2    1

SECTION 1.  

Section 1644.5 of the Health and Safety Code is
2amended to read:

3

1644.5.  

(a) Except as provided in subdivision (c) or (d), no
4tissues shall be transferred into the body of another person by
5means of transplantation, unless the donor of the tissues has been
6screened and found nonreactive by laboratory tests for evidence
7of infection with human immunodeficiency virus (HIV), agents
8of viral hepatitis (HBV and HCV), and syphilis. For tissues that
9are rich in viable leukocytes, the tissue shall be tested for evidence
10of infection with human T lymphotropic virus (HTLV) and found
11nonreactive. The department may adopt regulations requiring
12additional screening tests of donors of tissues when, in the opinion
13of the department, the action is necessary for the protection of the
14public, donors, or recipients.

15(b) Notwithstanding subdivision (a), infectious disease screening
16of blood and blood products shall be carried out solely in
17accordance with Article 2 (commencing with Section 1602.5) of
18Chapter 4.

19(c) All donors of sperm shall be screened and found nonreactive
20as required under subdivision (a), except in the following instances:

21(1) A recipient of sperm, from a sperm donor known to the
22recipient, may waive a second or other repeat testing of that donor
23if the recipient is informed of the requirements for testing donors
24under this section and signs a written waiver.

25(2) A recipient of sperm may consent to therapeutic insemination
26of sperm or use of sperm in other assisted reproductive technologies
27even if the sperm donor is found reactive for hepatitis B, hepatitis
28C, syphilis, HIV, or HTLV if the sperm donor is the spouse of,
29partner of, or designated donor for that recipient. The physician
P3    1providing insemination or assisted reproductive technology services
2shall advise the donor and recipient of the potential medical risks
3associated with receiving sperm from a reactive donor. The donor
4and the recipient shall sign a document affirming that each
5comprehends the potential medical risks of using sperm from a
6reactive donor for the proposed procedure and that each consents
7to it. Copies of the document shall be placed in the medical records
8of the donor and the recipient.

9(3) (A) Sperm whose donor has tested reactive for syphilis may
10be used for the purposes of insemination or assisted reproductive
11technology only after the donor has been treated for syphilis. Sperm
12whose donor has tested reactive for hepatitis B may be used for
13the purposes of insemination or assisted reproductive technology
14only after the recipient has been vaccinated against hepatitis B.

15(B) (i) Sperm whose donor has tested reactive for HIV or HTLV
16may be used for the purposes of insemination or assisted
17reproductive technology for a recipient testing negative for HIV
18or HTLV only after the donor’s sperm has been effectively
19processed to minimize the infectiousness of the sperm for that
20specific donation and where informed and mutual consent has
21occurred.

22(ii) The department shall adopt regulations regulating facilities
23that perform sperm processing, pursuant to this subparagraph, that
24prescribe standards for the handling and storage of sperm samples
25of carriers of HIV, HTLV, or any other virus as deemed appropriate
26by the department. The department may propose to adopt, as initial
27regulations, the recommendations made within the “Guidelines
28for Reducing Risk of Viral Transmission During Fertility
29Treatment” as published by the American Society for Reproductive
30Medicine. Notice of the department’s proposed adoption of the
31regulations shall be posted on the department’s Internet Web site
32for at least 45 days. Public comment shall be accepted by the
33department for at least 30 days after the conclusion of the 45-day
34posting period. If a member of the public requests a public hearing
35during the 30-day comment period, the hearing shall be held prior
36to the adoption of the regulations. If no member of the public
37requests a public hearing, the regulations shall be deemed adopted
38at the conclusion of the 30-day comment period. Comments
39received shall be considered prior to the adoption of the final initial
40regulations. The department may modify any guidance published
P4    1by the American Society for Reproductive Medicine. Adoption of
2initial regulations by the department pursuant to this subdivision
3shall not be subject to the rulemaking requirements of Chapter 3.5
4(commencing with Section 11340) of Part 1 of Division 3 of Title
52 of the Government Code and written responses to public
6comments shall not be required. Updates to the regulations shall
7be adopted pursuant to the same process. Until the department
8adopts these regulations, facilities that perform sperm processing
9pursuant to this section shall follow facility and sperm processing
10guidelines for the reduction of viral transmission developed by the
11 American Society for Reproductive Medicine. Nothing in this
12section shall prevent the department from monitoring and
13inspecting facilities that process sperm to ensure adherence to the
14regulations, or, until regulations are adopted, to the guidelines set
15forth by the American Society for Reproductive Medicine.

16(iii) Prior to insemination or other assisted reproductive
17technology services, the physician providing the services shall
18inform the recipient of sperm from a spouse, partner, or designated
19donor who has tested reactive for HIV or HTLV of all of the
20following:

21(I) That sperm processing may not eliminate all of the risks of
22HIV or HTLV transmission.

23(II) That the sperm may be tested to determine whether or not
24it is reactive for HIV or HTLV.

25(III) That the recipient must provide documentation to the
26physician providing insemination or assisted reproductive
27technology services prior to treatment that she has established an
28ongoing relationship with another physician to provide for her
29medical care during and after completion of fertility services.

30(IV) The recommendations made within the “Guidelines for
31Reducing the Risk of Viral Transmission During Fertility
32Treatment” published by the American Society for Reproductive
33Medicine regarding followup testing for HIV and HTLV after use
34of sperm from an HIV or HTLV reactive donor and have the
35recommendations regarding followup testing be documented in
36the recipient’s medical record.

37(iv) The physician providing insemination or assisted
38reproductive technology services shall also verify, and document
39in the recipient’s medical record, that the donor of sperm who tests
P5    1reactive for HIV or HTLV is under the care of a physician
2managing the HIV or HTLV.

3(v) The physician providing insemination or assisted
4reproductive technology services shall recommend to the physician
5who will be providing ongoing care to the recipient recommended
6followup testing for HIV and HTLV according to the “Guidelines
7for Reducing the Risk of Viral Transmission During Fertility
8Treatment” published by the American Society for Reproductive
9Medicine, which shall be documented in the recipient’s medical
10record.

11(vi) If the recipient becomes HIV or HTLV positive, the
12physician assuming ongoing care of the recipient shall treat or
13provide information regarding referral to a physician who can
14provide ongoing treatment of the HIV or HTLV.

15(4) A recipient of sperm donated by a sexually intimate partner
16of the recipient for reproductive use may waive a second or repeat
17testing of that donor if the recipient is informed of the donor testing
18requirements of this section and signs a written waiver. For
19purposes of this paragraph, “sexually intimate partner of the
20recipient” includes a known or designated donor to whose sperm
21the recipient has previously been exposed in a nonmedical setting
22in an attempt to conceive.

23(d) Subdivision (a) shall not apply to the transplantation of tissue
24from a donor who has not been tested or, with the exception of
25HTLV, has been found reactive for the infectious diseases listed
26in subdivision (a) or for which the department has, by regulation,
27required additional screening tests, if both of the following
28conditions are satisfied:

29(1) The physician and surgeon performing the transplantation
30has determined any one or more of the following:

31(A) Without the transplantation the intended recipient will most
32likely die during the period of time necessary to obtain other tissue
33or to conduct the required tests.

34(B) The intended recipient already is diagnosed with the
35infectious disease for which the donor has tested positive.

36(C) The symptoms from the infectious disease for which the
37donor has tested positive will most likely not appear during the
38intended recipient’s likely lifespan after transplantation with the
39tissue or may be treated prophylactically if they do appear.

P6    1(2) Consent for the use of the tissue has been obtained from the
2recipient, if possible, or if not possible, from a member of the
3recipient’s family, or the recipient’s legal guardian. For purposes
4of this section, “family” shall mean spouse, adult son or daughter,
5either parent, adult brother or sister, or grandparent.

6(e) The penalties ofbegin delete Sectionend deletebegin insert prescribed in Sectionsend insert 1621.5begin delete shallend delete
7begin insert and 120290 doend insert not apply to a sperm donor covered under
8subdivisionbegin delete (c).end deletebegin insert (c) or a tissue donor covered under subdivision
9(d).end insert

10(f) Human breast milk from donors who test reactive for agents
11of viral hepatitis (HBV and HCV), HTLV, HIV, or syphilis shall
12not be used for deposit into a milk bank for human ingestion in
13California.



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