BILL ANALYSIS Ó
AB 170
Page 1
Date of Hearing: May 13, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
AB
170 (Gatto) - As Amended April 30, 2015
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|Policy |Privacy and Consumer |Vote:|9 - 2 |
|Committee: |Protection | | |
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| |Health | |17 - 0 |
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Urgency: No State Mandated Local Program: YesReimbursable:
Yes
SUMMARY:
This bill changes requirements related to the state's newborn
screening program to provide additional information about the
storage and use of newborn screening blood samples for research.
AB 170
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Specifically, this bill:
1)Requires the California Department of Public Health (CDPH) to
provide information about the newborn screening tests, and to
obtain a signed informational acknowledgment form for the
receipt of specified 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)Modifies provisions related to the newborn screening program
fee, to allow the fee to be adjusted to meet the reasonable
costs of the program.
3)Allows people to request their blood samples, or those of
their children, be destroyed or not used for research, and
requires CDPH to comply with those requests.
4)Requires CDPH to prepare, provide, and distribute a single
page of specified informational materials, and a standard
informational acceptance form.
5)Requires every birth attendant and every perinatal licensed
health facility to provide each pregnant woman a copy of the
informational materials and a copy of the standard
informational acceptance form, and requires the local
registrar of births to provide this information for births
outside licensed facilities.
6)Requires a copy of the standard informational acceptance form
to be maintained with the medical records of the mother of the
newborn child.
AB 170
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FISCAL EFFECT:
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.
COMMENTS:
1)Purpose. 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 research is conducted using the samples. The
author states that most parents are poorly informed, if at
all, about the storage and medical research of these samples.
2)Genetic Disease Screening Program. In 1966, California began
its newborn screening program with the testing of
phenylketonuria. Since its creation, the program 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.
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Current regulations permit a parent to decline the screening
test. A parent must then sign a 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)California BioBank. DPH maintains a large and diverse
biobank, the California Biobank Program, which houses over
17.5 million prenatal serum samples and newborn leftover blood
spots. These samples were collected for testing by the
prenatal and newborn screening programs. The program is an
internationally recognized public health asset because of its
large size and culturally, geographically and genetically
diverse population. Current CDPH regulations allow parents to
request their child's specimen be destroyed or not used for
research; however, the option to opt out does not appear to be
particularly well-publicized
4)Support. The American Federation of State, County and
Municipal Employees and the Council for Responsible Genetics
support this bill.
5)Opposition. There was significant opposition to prior
versions of this bill that had more impact on the newborn
screening program. The bill has been significantly amended to
address only increased information related to the storage of
blood spots and their use in research. According to the
author, all opposition except for the California Hospital
Association has submitted letters that they are neutral on the
current version.
6)Staff Comments. This bill includes duplicative requirements
related to the production and distribution of information and
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forms. Numerous provisions could be streamlined and
clarified. Additionally, staff notes there is a significant
administrative burden to obtain signed informational
acknowledgement forms related to approximately 500,000 births
annually. It is unclear whether the collection of forms is
unclear whether these additional administrative costs will
result in a tangible benefit.
Analysis Prepared by:Lisa Murawski / APPR. / (916)
319-2081