BILL ANALYSIS Ó
AB 170
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Date of Hearing: March 17, 2015
ASSEMBLY COMMITTEE ON PRIVACY AND CONSUMER PROTECTION
Gatto, Chair
AB
170 (Gatto) - As Amended March 11, 2015 As Proposed to be Amended
SUBJECT: Newborn screening: genetic diseases: blood samples
collected
SUMMARY: Requires the Department of Public Health (DPH) to
prepare and provide informational materials about the California
Newborn Screening Program (CNSP) to a parent or guardian of a
newborn prior to a newborn screening test, and requires DPH to
obtain written informed consent from a parent or legal guardian
before storing, retaining and using a newborn's blood sample for
medical research. Specifically, this bill:
1)Requires DPH to:
a) Obtain the informed consent of the parent or guardian of
a newborn child before storing, retaining or using a
newborn child's blood sample for medical research and
defines "informed consent" for purposes of the CNSP as "a
written authorization signed and dated by a parent or legal
guardian of a newborn child";
b) Destroy, or not use for research purposes, the blood
sample of a minor, upon request of the minor's parent or
legal guardian;
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c) Destroy, or not use for research purposes, the blood
sample of an individual who is at least 18 years of age,
upon request of the individual;
d) Prepare and provide informational materials on the CNSP
that explain to parents and guardians of newborn children
the following:
i. The storage, retention and use of the blood
sample;
ii. The parent or guardian's right to request
that a blood sample be destroyed or not used for
research purposes; and
iii. The right of an individual at least 18 years
of age to request that his or her blood sample be
destroyed or not used for research purposes.
e) Prepare and provide a standard informed consent form for
the CNSP that sets forth clearly and in detail the
following:
i. The purpose of the newborn child screening
test and retention of newborn blood samples;
ii. The benefits of the screening and the research
undertaken regarding heritable and congenital
disorders;
iii. A space for the parent or legal guardian to
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acknowledge receipt of informational materials about
the newborn child screening test;
iv. A space for the parent or legal guardian to
indicate his or her consent to the storage, retention,
and use of the newborn's blood sample for medical
research;
v. A space for the parent to legal guardian to
indicate his or her request for information about the
right to refuse a newborn child screening test on the
ground that the test conflicts with his or her
religious beliefs or practices; and
vi. A space for the parent or legal guardian to
sign and date the form.
2)Requires that a parent or guardian of a newborn child must
receive the CNSP informational materials and informed consent
form prior to the newborn screening test.
3)Requires every birth attendant engaged in perinatal care to
provide the DPH informational materials and standard informed
consent form to a pregnant woman.
4)Requires every perinatal licensed health facility to provide
the DPH informational materials and standard informed consent
form to each pregnant woman admitted for delivery prior to the
collection of the blood sample, if the consent form was not
already provided during perinatal care.
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5)Requires every local registrar of births to provide the DPH
informational materials and standard informed consent form to
each person registering the birth of a newborn that occurred
outside of a perinatal licensed health facility when the
newborn was not admitted to a perinatal licensed health
facility within the first 30 days of age.
6)Requires a copy of the standard informed consent form to be
maintained with the newborn child's medical records.
7)Specifies that DPH may not store, retain, or use for medical
research a newborn child's blood sample collected and used for
the newborn screening test, unless the parent or guardian of
the newborn child indicates his or her consent on a completed
informed consent form.
8)Makes other clarifying or nonsubstantive changes.
EXISTING LAW:
1)Requires DPH to establish a genetic disease unit to coordinate
all DPH programs in the area of genetic disease that promotes
a statewide program of information, testing, and counseling
services, designates tests and regulations to be used in
executing this program, and designates tests and regulations
used in executing the CNSP. (Health and Safety Code (HSC)
Section 124977 et seq.)
2)Requires DPH to fully inform a parent or guardian of a minor
of the purposes of testing for hereditary disorders prior to
performing any genetic testing. (HSC 124980)
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3)Specifies that no test may be performed on any minor over the
objection of the minor's parent or guardian and requires DPH
to give a parent or guardian of a minor a reasonable
opportunity to object. (HSC 124980)
4)Gives the parent or guardian of the newborn child a specific
option to object to the newborn screening test on the ground
that the test conflicts with his or her religious beliefs or
practices. (HSC 125000)
5)Requires DPH to provide genetic screening and follow-up
services, allows DPH to provide laboratory testing facilities
or work with qualified outside labs to conduct testing,
requires DPH to charge a fee for newborn screening and
follow-up services, and requires the amount of the fee to be
periodically adjusted in order to meet the costs of CNSP.
(HSC 124977 and 125000)
6)Prohibits, under the State Confidentiality of Medical
Information Act (CMIA), providers of health care, health care
service plans, or contractors, as defined, from sharing
medical information without the patient's written
authorization, subject to exceptions, including among others,
certain research. (Civil (Civ.) Code Section 56 et seq.)
7)Protects, under the federal Health Insurance Portability and
Accountability Act (HIPAA), the privacy of patients' health
information and generally provides that a covered entity, as
defined (health plan, health care provider, and health care
clearing house), may not use or disclose "protected," i.e.,
individually identifiable, health information except as
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specified or as authorized by the patient in writing. (45
Code of Federal Regulations Section 160 et seq.)
8)Prohibits, under the Unruh Civil Rights Act and the Fair
Employment and Housing Act (FEHA), discrimination on the basis
of genetic information. (Civ. Code 51 and Government Code
Section 12920 et seq.)
9)Prohibits, under the federal Genetic Information and
Nondiscrimination Act (GINA), discrimination in group health
plan coverage and employment based on genetic information.
(Public Law 110-233)
10) Requires separate written consent for the release of certain
types of sensitive medical information, including: HIV status
and test results, the donation of human egg cells for research
purposes, and genetic test results for life or disability
insurance applications. (HSC 120975-121125; HSC 125350 et
seq.; and Insurance Code (IC) Section 10140.1)
11) Establishes various penalties concerning the disclosure of
genetic test results, when the genetic test is requested by an
insurer for purposes of life or disability insurance. (IC
10149.1)
FISCAL EFFECT: Unknown
COMMENTS:
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1)Purpose of this bill . This bill is intended to ensure that
parents receive information about the CNSP and protect
children's genetic privacy by requiring DPH to obtain written
informed consent from parents and guardians before keeping and
using children's genetic data for medical research. This
measure will be heard as proposed to be amended, based upon
mocked-up amendments provided by the author. This measure is
author-sponsored.
2)Author's statement . According to the author's office, "AB 170
is necessary because, regardless of current regulations, the
majority of parents are not aware that their child's newborn
blood sample is being retained by the state and may
potentially be used in research. A report from the Council
for Responsible Genetics cites numerous studies that indicate
the vast majority of surveyed parents would prefer an informed
consent process instead of the current opt-out afforded to
them. Most interestingly, a study by Beth Tarini found that
"[i]f parental permission was obtained, most parents reported
that they would either be 'very willing'(38%) or 'somewhat
willing' (37.4%) to permit use of their children's newborn
screening samples for future research studies . . . If
parental permission was not obtained, substantially fewer
parents reported that they would either be 'very willing'
(11.3%) or 'somewhat willing' (16.9%) to permit use of the
[CNSP] sample for research. Moreover, over half of parents
(55.7%) would be 'very unwilling' to permit the use of their
child's newborn screening sample for research purposes."
3)CNSP . According to DPH, the CNSP is recognized nationally as
an essential preventive health program. All states in the
nation and the District of Columbia have established newborn
screening programs. In California, the test is administered
to virtually every newborn before the baby leaves the hospital
by taking a few drops of blood from the baby's heel and
placing the blood spots on a special filter paper that is then
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sent to a state-approved laboratory for testing.
If identified early, many genetic disorders can be treated
before they cause serious health problems. According to DPH,
approximately 500,000 newborns are screened each year for over
80 genetic and congenital disorders, and about 875 children
are identified with a genetic disorder each year in
California. Parents can get the test results from the baby's
doctor or clinic, which takes about two weeks. If the baby
needs more tests, parents will get a letter or a phone call a
few days after discharge from the hospital. Positive test
results are immediately telephoned to a follow-up coordinator
at one of the Newborn Screening Area Service Centers
throughout the state. The coordinator contacts the newborn's
physician to arrange for repeat testing. If repeat testing
determines that the baby has a disorder, the coordinator will
supply the latest clinical information on diagnosis and
treatment and assist with referrals to special care clinics.
Medi-Cal, health plans, and most private insurance providers
pay for the test.
4)The California Biobank . According to DPH, blood samples
collected from newborns under the CNSP are maintained in the
California Biobank which contains the combined biospecimen and
data resources of two DPH screening and monitoring programs,
the California Genetic Disease Screening Program (GDSP) and
the California Birth Defects Monitoring Program. GDSP
administers the CNSP and the Prenatal Screening Program. The
California Biobank is required to makes specimens and related
data available to researchers for the following approved
purposes:
a) Identify risk factors for children's and women's
diseases;
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b) Develop and evaluate screening tests;
c) Develop and evaluate screening strategies; and,
d) Develop and evaluate treatments.
The California Biobank houses more than 16 million newborn
blood samples. According to DPH, since the CNSP began in
1980, the GDSP has banked leftover blood spots from screened
newborns in freezer storage, but only those banked since 1982
are readily available. The specimens are physically labeled
with a unique number and stored without any identifying
information. Researchers may receive both specimens and the
data related to specimens. GDSP's 16 million newborn
specimens represent "an entire generation of Californians"
according to DPH.
5)Current privacy and consumer protections for genetic data .
Currently, federal and state laws offer various protections
for genetic information. For example, HIPAA and CMIA
generally require a patient's written consent before
disclosure of medical information. In 2008, the federal
government enacted GINA to prohibit discrimination in group
health plan coverage and employment based on genetic
information. In California, the Unruh Civil Rights Act and
FEHA prohibit discrimination on the basis of genetic
information.
Current law governing the CNSP requires DPH to fully inform a
parent or guardian of the purposes of the newborn screening
test and offer a reasonable opportunity to opt-out of the test
for religious reasons.
This bill would expand the current privacy protections in
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place for CNSP by creating an opt-in consent requirement - not
for the test itself - but for the future storage, retention
and use of a newborn's blood sample for medical research. In
addition to requiring opt-in consent for medical research
uses, the bill also strengthens current privacy law by
specifically requiring informational materials about the CNSP
program to be provided prior to newborn testing, and by
requiring DPH to create and use a standard informed consent
form that contains spaces for a parent or guardian to:
a) Acknowledge receipt of informational materials;
b) Opt in to medical research uses of the blood sample
taken; and,
c) Request more information about opting out of the newborn
screening test itself.
6)Privacy and genetic data . As noted by the United States
Department of Health and Human Services (DHHS) in a 2009
progress report, genetic information raises unique ethical and
legal issues that other types of medical information may not.
According to that report: "A particular concern is that
whole-genome scans will provide a unique DNA identifier that
could potentially be linked with data obtained or stored in
other contexts, which has implications for consent and
privacy." (A Progress Report and Future Directions of the
Secretary's Advisory Committee on Genetics, Health, and
Society, The Integration of Genetic Technologies Into Health
Care and Public Health, January 2009, p. 8.)
While the benefits of having large databanks of genetic data
for medical research are undisputed, the author contends that
the unknown potential future uses of genetic data create the
need for revisiting current law privacy protections for
genetic data. In fact, in October 2012, the Presidential
Commission for the Study of Bioethical Issues, an advisory
panel of the nation's leaders in medicine, science, ethics,
religion, law, and engineering, released a report that
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recommends adopting new policies to help ensure privacy and
security as the field of genomics advances and urged federal
and state governments to ensure a consistent floor of privacy
protections covering whole genome sequencing data regardless
of how that genetic information was obtained. (Privacy and
Progress in Whole Genome Sequencing, Presidential Commission
for the Study of Bioethical Issues, Oct. 11, 2012)
By way of precedent, California law already requires a
separate written consent for other types of sensitive medical
information, including:
a) Genetic test results for a life or disability insurance
application;
b) HIV status and test results, except for diagnosis, care,
and treatment; and,
c) Donation of human egg cells for research purposes.
1)Arguments in support . The American Federation of State,
County and Municipal Employees (AFSCME) states in support of
the bill, "AFSCME supports AB 170 because we believe that a
person must have the right to decide how their blood samples
are being used."
2)Arguments in opposition . According to the California Hospital
Association, "This bill changes the current system of testing
newborns for preventable heritable and congenital disorders
which has worked very well in California for over 30 years.
Currently, hospitals provide new mothers with written
information developed by the California Department of Public
Health about newborn testing. Mothers then have the ability
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to decline the testing if they wish. Very few mothers decline
testing their babies for these disorders. The net result of
this bill would be to decrease the number of newborns tested
for these devastating disorders which can be prevented or
ameliorated if detected."
3)Prior Legislation . AB 1559 (Pan), Chapter 565, Statutes of
2014, expanded DPH statewide screening of newborns to include
screening for adrenoleukodystrophy (ALD) as soon the federal
Recommended Uniform Screening Panel approved the addition of
ALD.
SB 222 (Padilla) of 2014 would have enacted the Genetic
Information Privacy Act, which would have required an
individual's written authorization prior to the collection of
genetic information for testing, analysis, retention or
disclosure. SB 222 was held in the Senate Appropriations
Committee.
SB 1267 (Padilla) of 2012 would have required an individual's
written authorization prior to the collection of genetic
information for testing, analysis, retention or disclosure.
The bill would have required destruction of the genetic
information upon completion of the purpose authorization was
obtained. SB 1267 was held in the Senate Appropriations
Committee.
SB 1731 (Block), Chapter 336, Statutes of 2012, established
the Newborn Critical Congenital Heart Disease (CCHD) Screening
Program and required hospitals, beginning July 1, 2013, to
offer a pulse oximetry test for the identification of CCHD to
parents of newborns prior to discharge.
AB 395 (Pan), Chapter 461, Statutes of 2011, expanded
statewide screening of newborns to include screening for
severe combined immunodeficiency.
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SB 1103 (Committee on Budget and Fiscal Review), Chapter 228,
Statutes of 2004, expanded statewide screening of newborns to
include tandem mass spectrometry screening for fatty acid
oxidation, amino acid, organic acid disorders, and congenital
adrenal hyperplasia.
AB 442 (Committee on Budget), Chapter 1161, Statutes of 2002,
required hospitals to collect fees associated with any tests
conducted under CNSP.
SB 537 (Greene), Chapter 1011, Statutes of 1998, required DPH
to establish a program to provide extended newborn genetic
screening services for persons who elect to have, and pay for,
the additional screening.
4)Double-referral . This bill has been double-referred to the
Assembly Health Committee, where it will be heard if passed by
this Committee.
REGISTERED SUPPORT / OPPOSITION:
Support
American Federation of State, County and Municipal Employees
(AFSCME)
Opposition (Prior Version)
California Hospital Association (CHA)
Analysis Prepared
by: Jennie Bretschneider/P. & C.P./(916) 319-2200
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