Bill Text: CA SB1408 | 2015-2016 | Regular Session | Chaptered
Bill Title: Tissue donation.
Spectrum: Bipartisan Bill
Status: (Passed) 2016-05-27 - Chaptered by Secretary of State. Chapter 18, Statutes of 2016. [SB1408 Detail]
Download: California-2015-SB1408-Chaptered.html
BILL NUMBER: SB 1408 CHAPTERED
BILL TEXT
CHAPTER 18
FILED WITH SECRETARY OF STATE MAY 27, 2016
APPROVED BY GOVERNOR MAY 27, 2016
PASSED THE SENATE MAY 27, 2016
PASSED THE ASSEMBLY MAY 27, 2016
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
INTRODUCED BY Senator Allen
(Coauthors: Assembly Members Achadjian, Baker, Chang, Chiu, Jones,
Mayes, and Wood)
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 health, and
declaring the urgency thereof, to take effect immediately.
LEGISLATIVE COUNSEL'S DIGEST
SB 1408, 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.
This bill would declare that it is to take effect immediately as
an urgency statute.
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 within the standard of care and 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.
SEC. 7. 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:
In order to provide for organ donations and transplants to occur
at the earliest opportunity, it is necessary that this act take
effect immediately.
