Amended in Assembly May 26, 2016

Amended in Assembly May 23, 2016

Amended in Senate May 4, 2016

Amended in Senate April 18, 2016

Amended in Senate April 4, 2016

Senate Bill No. 1408

Introduced by Senator Allen

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(Coauthors: Assembly Members Achadjian, Baker, Chang, Chiu, Jones, Mayes, and Wood)

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February 19, 2016

An act to amend Section 2221.1 of the Business and Professions Code, and to amend Sections 1621.5, 1635, 1635.1, 1644.5, and 120290 of the Health and Safety Code, relating to public begin delete health. end delete begin insert health, and declaring the urgency thereof, to take effect immediately. end insert

LEGISLATIVE COUNSEL’S DIGEST

SB 1408, as amended, Allen. Tissue donation.

(1) 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 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. The bill would require a physician and surgeon performing the transplantation of an organ from an HIV-reactive donor to ensure that the recipient is also HIV reactive and complying with federal law, as specified.

(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.

This bill would exempt those sperm donors and organ donors from those criminal provisions.

(3) Existing law authorizes the Medical Board of California and the California Board of Podiatric Medicine to take disciplinary action against a physician, surgeon, and other licensed or regulated individual who knowingly fails to protect patients by failing to follow infection control guidelines and risks transmission of blood-borne infectious diseases, as specified.

This bill would exempt the performance of an organ transplant, as authorized by this bill, from disciplinary action.

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This bill would declare that it is to take effect immediately as an urgency statute.

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Vote:  begin delete majority end delete begin insert ²⁄₃ end insert . Appropriation: no. Fiscal committee: no. State-mandated local program: no.

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

SECTION 1.  

Section 2221.1 of the Business and Professions
Code is amended to read:

2221.1.  

(a) The board and the California Board of Podiatric
Medicine shall investigate and may take disciplinary action,
including, but not limited to, revocation or suspension of licenses,
against physicians and surgeons and all others licensed or regulated
by the board, or by the California Board of Podiatric Medicine,
whichever is applicable, who, except for good cause, knowingly
fail to protect patients by failing to follow infection control
guidelines of the applicable board, thereby risking transmission
of blood-borne infectious diseases from the physician and surgeon
or other health care provider licensed or regulated by the applicable
board to patients, from patients, and from patient to physician and
surgeon or other health care provider regulated by the applicable
board. In so doing, the boards shall consider referencing the
standards, regulations, and guidelines of the State Department of
Health Services developed pursuant to Section 1250.11 of the
Health and Safety Code and the standards, guidelines, and
regulations pursuant to the California Occupational Safety and
Health Act of 1973 (Part 1 (commencing with Section 6300),
Division 5, Labor Code) for preventing the transmission of HIV,
hepatitis B, and other blood-borne pathogens in health care settings.
As necessary, the board and the California Board of Podiatric
Medicine shall consult with the Board of Dental Examiners, the
Board of Registered Nursing, and the Board of Vocational Nursing
and Psychiatric Technicians, to encourage appropriate consistency
in the implementation of this section.

(b) Subdivision (a) shall not apply to an organ transplant
performed begin insert within the standard of care and end insert in compliance with
subdivision (d) of Section 1644.5 of the Health and Safety Code.

(c) The board shall seek to ensure that licentiates and others
regulated by the board are informed of the responsibility of
licentiates to follow infection control guidelines and of the most
recent scientifically recognized safeguards for minimizing the
transmission of blood-borne infectious diseases.

SEC. 2.  

Section 1621.5 of the Health and Safety Code is
amended to read:

1621.5.  

(a)  It is a felony punishable by imprisonment pursuant
to subdivision (h) of Section 1170 of the Penal Code for two, four,
or six years, for any person to donate blood or tissue, semen to
any medical center or semen bank that receives semen for purposes
of artificial insemination, or breast milk to any medical center or
breast milk bank that receives breast milk for purposes of
distribution, whether he or she is a paid or a volunteer donor, who
knows that he or she has acquired immunodeficiency syndrome
(AIDS), as diagnosed by a physician and surgeon, or who knows
that he or she has tested reactive to HIV. This section shall not
apply to any person who is mentally incompetent or who self-defers
his or her blood at a blood bank or plasma center pursuant to
subdivision (b) of Section 1603.3 or who donates his or her blood
for purposes of an autologous donation.

(b)  In a criminal investigation for a violation of this section,
no person shall disclose the results of a blood test to detect the
etiologic agent of AIDS or antibodies to that agent to any officer,
employee, or agent of a state or local agency or department unless
the test results are disclosed as otherwise required by law pursuant
to any one of the following:

(1)  A search warrant issued pursuant to Section 1524 of the
Penal Code.

(2)  A judicial subpoena or subpoena duces tecum issued and
served in compliance with Chapter 2 (commencing with Section
1985) of Title 3 of Part 4 of the Code of Civil Procedure.

(3)  An order of a court.

(c)  For purposes of this section, “blood” means “human whole
blood” and “human whole blood derivatives,” as defined for
purposes of this chapter and includes “blood components,” as
defined in subdivision (k) of Section 1603.1.

(d) For purposes of this section, “tissue” shall have the same
meaning as defined in paragraph (1) of subdivision (c) of Section
1635.

SEC. 3.  

Section 1635 of the Health and Safety Code is amended
to read:

1635.  

(a) “Donor” means an individual, living or deceased,
from whom tissue is removed.

(b) “Person” means an individual, corporation, business trust,
estate trust, partnership, association, state or local government, or
subdivision or agency thereof, or any other legal entity.

(c) (1) “Tissue” means a human cell, group of cells, including
the cornea, sclera, or vitreous humor and other segments of, or the
whole eye, bones, skin, arteries, sperm, blood, other fluids, and
any other portion of a human body, but shall not include an organ
when recovered for transplantation or research purposes.

(2) For purposes of paragraph (1), “organ” means a human
kidney, liver, heart, lung, pancreas, intestine (including the
esophagus, stomach, small or large intestine, or any portion of the
gastrointestinal tract), or vascularized composite allograft, and
associated blood vessels recovered from an organ donor during
the recovery of the organ.

(d) “Tissue bank” means a place, establishment, or institution
that collects, processes, stores, or distributes tissue for
transplantation into human beings.

(e) “Transplantation” means the act or process of transferring
tissue, including by ingestion, from a donor to the body of the
donor or another human being.

(f) “Department” means the State Department of Public Health.

SEC. 4.  

Section 1635.1 of the Health and Safety Code is
amended to read:

1635.1.  

(a) Except as provided in subdivision (b), every tissue
bank operating in California on or after July 1, 1992, shall have a
current and valid tissue bank license issued or renewed by the
department pursuant to Section 1639.2 or 1639.3.

(b) This chapter does not apply to any of the following:

(1) The collection, processing, storage, or distribution of human
whole blood or its derivatives by blood banks licensed pursuant
to Chapter 4 (commencing with Section 1600) or any person
exempt from licensure under that chapter.

(2) The collection, processing, storage, or distribution of tissue
for autopsy, biopsy, training, education, or for other medical or
scientific research or investigation, when transplantation of the
tissue is not intended or reasonably foreseeable.

(3) The collection of tissue by an individual physician and
surgeon from his or her patient or the implantation of tissue by an
individual physician and surgeon into his or her patient. This
exemption shall not be interpreted to apply to any processing or
storage of the tissue, except for the processing and storage of semen
by an individual physician and surgeon when the semen was
collected by that physician and surgeon from a semen donor or
obtained by that physician and surgeon from a tissue bank licensed
under this chapter.

(4) The collection, processing, storage, or distribution of fetal
tissue or tissue derived from a human embryo or fetus.

(5) The collection, processing, storage, or distribution by an
organ procurement organization (OPO), as defined in Section
485.302 of Title 42 of the Code of Federal Regulations, if the OPO,
at the time of collection, processing, storage, and distribution of
the tissue, has been designated by the Secretary of Health and
Human Services as an OPO, pursuant to Section 485.305 of Title
42 of the Code of Federal Regulations, and meets the requirements
of Sections 485.304 and 485.306 of Title 42 of the Code of Federal
Regulations, as applicable.

(6) The storage of prepackaged, freeze-dried bone by a general
acute care hospital.

(7) The storage of freeze-dried bone and dermis by any licensed
dentist practicing in a lawful practice setting, if the freeze-dried
bone and dermis has been obtained from a licensed tissue bank, is
stored in strict accordance with a kit’s package insert and any other
manufacturer instructions and guidelines, and is used for the
express purpose of implantation into a patient.

(8) The storage of a human cell, tissue, or cellular- or
tissue-based product, as defined by the federal Food and Drug
Administration, that is either a medical device approved pursuant
to Section 510 or 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. Secs. 360 and 360e) or that is a biologic product
approved under Section 351 of the federal Public Health Service
Act (42 U.S.C. Sec. 262) by a licensed physician or podiatrist
acting within the scope and authority of his or her license and
practicing in a lawful practice setting. The medical device or
biologic product must have been obtained from a California
licensed tissue bank, been stored in strict accordance with the
device’s or product’s package insert and any other manufacturer
instructions, and used solely for the express purpose of direct
implantation into or application on the practitioner’s own patient.
In order to be eligible for the exemption in this paragraph, the
entity or organization where the physician or podiatrist who is
eligible for the exemption is practicing shall notify the department,
in writing, that the practitioner is licensed and meets the
requirements of this paragraph. The notification shall include all
of the following:

(A) A list of all practitioners to whom the notice applies.

(B) Acknowledgment that each listed practitioner uses the
medical device or biologic product in the scope and authority of
his or her license and practice for the purposes of direct patient
care as described in this paragraph.

(C) A statement that each listed practitioner agrees to strictly
abide by the directions for storage in the device’s or product’s
package insert and any other manufacturer instructions and
guidelines.

(D) Acknowledgment by each practitioner that the medical
device or biologic product shall not be resold or distributed.

(9) The collection, processing, storage, or distribution of any
organ, as defined in paragraph (2) of subdivision (c) of Section
1635, within a single general acute care hospital, as defined in
subdivision (a) of Section 1250, operating a Medicare-approved
transplant program.

SEC. 5.  

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 lymphotropic 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) 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) 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
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 all 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) The physician and surgeon performing the transplantation
has ensured that an organ from an individual who has been found
reactive for HIV may be transplanted only into an individual who
satisfies both of the following:

(A) The individual has been found reactive for HIV before
receiving the organ.

(B) The individual is either participating in clinical research
approved by an institutional review board under the criteria,
standards, and regulations described in subsections (a) and (b) of
Section 274f-5 of Title 42 of the United States Code, or, if the
United States Secretary of Health and Human Services determines
under subsection (c) of Section 274f-5 of Title 42 of the United
States Code that participation in this clinical research is no longer
warranted as a requirement for transplants, the individual is
receiving the transplant under the standards and regulations under
subsection (c) of Section 274f-5 of Title 42 of the United States
Code.

(3) 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 prescribed in Sections 1621.5 and 120290 do
not apply to a sperm donor covered under subdivision (c) or an
organ donor who donates an organ for transplantation or research
purposes.

(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.

SEC. 6.  

Section 120290 of the Health and Safety Code is
amended to read:

120290.  

(a) Except as provided in Section 120291 or in the
case of the removal of an afflicted person in a manner the least
dangerous to the public health, any 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.

(b) This section shall not apply to a person who donates an organ
for transplantation or research purposes.

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begin insert SEC. 7. end insert   

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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:

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In order to provide for organ donations and transplants to occur
at the earliest opportunity, it is necessary that this act take effect
immediately.

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