BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 170
---------------------------------------------------------------
|AUTHOR: |Gatto |
|---------------+-----------------------------------------------|
|VERSION: |July 8, 2015 |
---------------------------------------------------------------
---------------------------------------------------------------
|HEARING DATE: |July 15, 2015 | | |
---------------------------------------------------------------
---------------------------------------------------------------
|CONSULTANT: |Reyes Diaz |
---------------------------------------------------------------
SUBJECT : Newborn screening: genetic diseases: blood samples
collected.
SUMMARY : Requires the Department of Public Health to provide
information about genetic testing and to obtain a signed form,
as specified, from a parent or guardian of a newborn child
regarding the collection of blood samples, as specified. Allows
parents and guardians, and individuals at least 18 years of age,
to request, as specified, that blood samples not be used for
medical research, or to be destroyed, or both, as specified.
Existing law:
1)Requires the Department of Public Health (DPH) to establish a
genetic disease unit to coordinate all DPH programs in the
area of genetic disease that will promote a statewide program
of information, testing, and counseling services and to have
the responsibility of designating tests and regulations to be
used in executing this program and to have the responsibility
of designating tests and regulations to be used in executing
the California Newborn Screening Program (CNSP).
2)Requires DPH to provide genetic screening and follow-up
services. Allows DPH to provide laboratory (lab) testing
facilities or work with qualified outside labs to conduct
testing.
3)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 the CNSP.
4)Requires DPH to evaluate and prepare recommendations on the
implementation of tests for the detection of hereditary and
congenital diseases, including, but not limited to,
AB 170 (Gatto) Page 2 of ?
biotinidase deficiency and cystic fibrosis. Requires DPH to
also evaluate and prepare recommendations on the availability
and effectiveness of preventative follow-up interventions,
including the use of specialized medically necessary dietary
products.
5)Requires statewide screening of newborns to include tandem
mass spectrometry screening for fatty acid oxidation, amino
acid, and organic acid disorders and congenital adrenal
hyperplasia, and to include screening for severe combined
immunodeficiency, as soon as possible.
6)Requires specified entities to provide parents and guardians
information about the genetic screening program and blood spot
collection, including one's right to opt out, prior to the
estimated date of delivery or at the pregnancy clinic prior to
birth and collection of the blood sample.
7)Allows for parents and guardians to decline genetic testing
and to request a child's blood spot not be used for research
purposes or to be destroyed by the lab if the request it
submitted in writing, as specified.
This bill:
1)Requires DPH to provide information about genetic disease
tests and to obtain a signed informational acknowledgement
form for the receipt of information by the parent or guardian
of a newborn child regarding the storage, retention, and use
of the newborn child's blood sample for medical research.
2)Requires DPH to prepare informational material, confined to a
single page, that provides information regarding the newborn
blood sample collection to include, but not be limited to:
a) A brief, plain language explanation of, and
the purpose for, the newborn child screening test and
the storage, retention, and use of newborn child blood
samples;
b) A description of the benefits of both early
newborn child screening and the associated research
undertaken regarding preventable heritable or
congenital disorders;
c) A description of the California Biobank
Program (CBP), specifically pertaining to the Genetic
AB 170 (Gatto) Page 3 of ?
Disease Screening Program (GDSP), and subsequent
storage, retention, and use of the blood sample for
medical research; and,
d) An explanation of the parent's or legal
guardian's right, and a statement of an individual at
least 18 years of age having the right, to request
that the blood sample be destroyed or not used for
research purposes, or both, and the information
necessary to make that request.
3)Requires DPH to prepare a standard informational acceptance
form, confined to a single page and presented on a separate
document from the informational material required in 2) above,
that includes the following:
a) A brief, plan language explanation of, and the
purpose for, the newborn child screening test and
retention of blood samples collected;
b) An explanation of the parent's or legal
guardian's right to request that a child's blood
sample be destroyed or not used for research purposes,
or both, and the information necessary to make that
request;
c) A space for the parent or legal guardian to
acknowledge receipt of informational materials
regarding the storage, retention, and use of the blood
sample for medical research; and,
d) A space for the parent or legal guardian to
sign and date the form.
4)Requires DPH to distribute to a parent or legal guardian the
two separate informational materials, each confined to one
page, as follows:
a) A birth attendant engaged in providing
prenatal care is required to provide a pregnant woman,
prior to the estimated delivery date, with a copy of
both required materials;
b) If not provided as required in a) above, a
perinatal licensed health facility is required to
provide each pregnant woman admitted for delivery with
both required materials; and,
c) The local registrar of births and deaths is
required to provide both required materials to each
person registering the birth of a newborn that
AB 170 (Gatto) Page 4 of ?
occurred outside of a perinatal licensed health
facility when the newborn was not admitted to a
perinatal licensed facility within the first 30 days
of age. Requires the local registrar to notify the
local health officer and DPH of each of these types of
registrations.
5)Requires the acceptance form to be maintained in the medical
record of the mother of the newborn child.
6)Specifies that if there is no signed standard informational
acceptance form in the mother's medical record, the newborn
child will be administered the genetic screening test and the
blood sample will be stored and retained for medical research.
7)Allows a parent or legal guardian of a minor, or an individual
who is at least 18 years of age, to request that DPH destroy
the blood sample of the minor or of the individual collected
as a newborn, or not use it for research purposes, or both.
Requires DPH to comply with the requests.
8)Requires, if a parent or legal guardian or individual at least
18 years of age provides his or her email address, DPH to send
an email acknowledging receipt of the request.
FISCAL
EFFECT : According to the Assembly Appropriations Committee:
1)One-time costs of $120,000 to promulgate regulations (Genetic
Disease Testing Fund).
2)Annual costs of $550,000 (Genetic Disease Testing Fund) for
printing, storage, and distribution of forms, and staff to
provide technical support and enforce collection and submittal
of forms. If an increased number of requests to destroy
specimens is received, minor potential increased laboratory
staff costs would be incurred.
PRIOR
VOTES :
-----------------------------------------------------------------
|Assembly Floor: |66 - 11 |
|------------------------------------+----------------------------|
|Assembly Appropriations Committee: |17 - 0 |
AB 170 (Gatto) Page 5 of ?
|------------------------------------+----------------------------|
|Assembly Health Committee: |17 - 0 |
|Assembly Privacy and Consumer | |
|Protection Committee: |9 - 2 |
| | |
-----------------------------------------------------------------
COMMENTS :
1)Author's statement. According to the author, newborn screening
is one of the great public health success stories in this
country, but what happens to the samples after the screening
process is completed raises serious and troubling questions of
consent and privacy. In the case of California and a handful
of other states, these samples are indefinitely stored in
state repositories and made available to researchers for a
fee. Most parents are poorly informed, if at all, about the
storage and medical research of these samples. Nevertheless,
parents are assumed to have consented to long-term storage and
third-party use of their child's biological sample unless they
explicitly refuse in writing. California must revise its
approach to long-term storage and use of newborn DNA samples,
and include parents in the decision-making process. It is
imperative for both the health of this program and
Californians' continued trust in their government that parents
be fully informed of the CBP and the intended future use of
their child's DNA. AB 170 will ensure that parents have the
right to protect their children's genetic privacy. Parents,
understandably, want to be actively involved in
decision-making regarding their children's personal health
information. That choice is currently being denied.
2)CNSP. In 1966, California began its CNSP with the testing of
phenylketonuria. Since its creation, the CNSP has been
expanded several times as new discoveries are made and tests
developed, and now screens for more than 70 disorders.
Diseases have been continually added through regulation and
legislation.
Prior to leaving the hospital, a few drops of blood from a
newborn's heel are collected on filter paper. The newborn
screening test should be done when the baby is at least 12
hours of age but before six days of age. The ideal time to do
the test is when the baby is between 24 and 48 hours of age.
AB 170 (Gatto) Page 6 of ?
Blood collected before 12 hours of age is not always reliable
for some metabolic diseases. The sample is sent to one of
eight regional labs that contract with DPH for testing. The
results are sent to DPH for data collection and quality
control. Parents obtain the test results from the baby's
doctor or clinic. It takes about two weeks for the doctor to
receive the written results. If the baby needs more tests,
parents 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. In 2009-10,
approximately 520,000 newborns were screened for 75 genetic
disorders. Approximately 9,200, or under 2%, were classified
as positive or questionable and were referred for follow-up
testing or services.
Current regulations permit a parent to decline the test. A
parent must then sign a special form that states that not
having the test done can result in serious illness or
permanent damage to their child. It also states that the
parent must accept responsibility should this occur.
3)CBP. The CBP, a large and diverse biobank maintained by DPH,
houses over 17.5 million prenatal serum samples and newborn
leftover blood spots. These samples were collected for testing
by the Prenatal and Screening Program and CNSP, which are
linked to GDSP data and California Birth Defects Monitoring
Program (CBDMP) registry data. The samples and data are also
linked to the State Registrar of Vital Statistics databases
that include fetal death, live birth, and death data.
According to DPH, information is currently given to pregnant
women in DPH's booklet, Important Information for Parents
about the Newborn Screening Test, which is available in
English, Spanish, Armenian, Cambodian, Chinese, Farsi, Hmong,
Korean, Laotian, Russian, Tagalog, and Vietnamese. The booklet
is required to be provided to women, free of charge, prior to
the estimated date of delivery or at the maternal hospital
where she is going to give birth. The booklet, which is about
15 pages long, provides an address for parents to request that
AB 170 (Gatto) Page 7 of ?
GDSP not use a child's blood spot for research purposes and/or
to be destroyed by the lab.
4)Prior legislation. AB 1559 (Pan, Chapter 565, Statutes of
2014), expands DPH statewide screening of newborns to include
screening for adrenoleukodystrophy (ALD) as soon the federal
Recommended Uniform Screening Panel approve 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. 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.
AB 395 (Pan, Chapter 461, Statutes of 201), expands statewide
screening of newborns to include screening for severe combined
immunodeficiency.
SB 1103 (Committee on Budget and Fiscal Review, Chapter 228,
Statutes of 2004), expands statewide screening of newborns to
include tandem mass spectrometry screening for fatty acid
oxidation, amino acid, organic acid disorders, and congenital
adrenal hyperplasia.
AB 170 (Gatto) Page 8 of ?
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.
5)Support. Supporters of this bill argue that parents should
have a truly informed choice about whether the state should
permanently retain and use their child's personal genetic
information. Supporters state that newborn screening itself is
an important public health program but that there are
troubling consent and privacy issues raised by the storage and
use of samples long after the screening process has concluded.
Supporters further argue that studies have shown that parents
want to be actively involved in the decision making regarding
their child's personal health information and whether the
state should maintain a sample after screening is complete.
6)Opposition. The California Hospital Association (CHA) argues
that this bill requires obstetricians and hospitals to give
pregnant women four handouts related to genetic screening and
blood spot collection instead of the currently required two
handouts. CHA states that revising the process for genetic
screening this year is premature as the federal government is
currently developing new requirements regarding consent for
blood spot research. CHA argues that it is inevitable that
some health personnel and some parents will confuse the
"opt-out" process of the GDSP with DPH's current process to
opt-out of screening the baby for genetic diseases, which
could result in more seriously and permanently disabled
babies, and deaths.
7)Policy comment. DPH requires specified entities to provide
parents and guardians information about the GDSP and blood
spot collection (including one's right to have a child's blood
spot not used for medical research or to have it destroyed)
prior to the estimated date of delivery or at the pregnancy
clinic prior to birth and collection of the blood sample. The
author has stated that the intent of this bill is to provide
AB 170 (Gatto) Page 9 of ?
clearer information to women during a hectic time. However,
nothing in this bill ensures that providing an additional two
forms to women, in addition to other required forms, would
actually more effectively inform them about the GDSP and blood
spot collection. In the opinion of staff, the need for this
bill is unclear.
SUPPORT AND OPPOSITION :
Support: American Federation of State, County and Municipal
Employees, AFL-CIO
Council for Responsible Genetics
Oppose: California Hospital Association
-- END -