BILL ANALYSIS Ó
AB 170
Page 1
ASSEMBLY THIRD READING
AB
170 (Gatto)
As Amended May 28, 2015
Majority vote
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|Committee |Votes |Ayes |Noes |
| | | | |
| | | | |
|----------------+------+--------------------+----------------------|
|Privacy |9-2 |Gatto, Wilk, |Baker, Chang |
| | |Calderon, Chau, | |
| | |Cooper, Dababneh, | |
| | |Dahle, Gordon, Low | |
| | | | |
|----------------+------+--------------------+----------------------|
|Health |17-0 |Bonta, Maienschein, | |
| | |Bonilla, Burke, | |
| | |Chávez, Chiu, | |
| | |Gomez, Gonzalez, | |
| | |Roger Hernández, | |
| | |Lackey, | |
| | | | |
| | | | |
| | |Ridley-Thomas, | |
| | |Rodriguez, | |
| | |Santiago, | |
| | |Steinorth, | |
| | |Thurmond, Waldron, | |
| | |Wood | |
| | | | |
AB 170
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|----------------+------+--------------------+----------------------|
|Appropriations |17-0 |Gomez, Bigelow, | |
| | |Bonta, Calderon, | |
| | |Chang, Daly, | |
| | |Eggman, Gallagher, | |
| | |Eduardo Garcia, | |
| | |Gordon, Holden, | |
| | |Jones, Quirk, | |
| | |Rendon, Wagner, | |
| | |Weber, Wood | |
| | | | |
| | | | |
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SUMMARY: Requires the Department of Public Health (DPH) to
provide information to the parent or guardian of a newborn child
about the California Newborn Screening Program (CNSP) and obtain a
signed acknowledgment form regarding the storage, retention, and
use of the newborn child's blood sample for medical research, and
also allows a parent or legal guardian of a minor or an individual
who is at least 18 years of age to request that the blood sample
be destroyed or not used for research purposes. Specifically,
this bill:
1)Requires DPH to provide information about the CNSP and obtain a
signed acknowledgment form from 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)Clarifies that the fee charged by DPH for any tests shall be
established and adjusted to meet the reasonable costs of the
program.
3)Authorizes 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 collected as a newborn, or
not use it for research purposes, or both, and requires DPH to
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comply with that request.
4)Requires DPH to provide informational materials regarding
newborn child blood samples that include, but are not limited
to, all of the following information:
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 collected
pursuant to the CNSP;
b) A description of the benefits of early newborn child
screening and the associated research undertaken regarding
preventable heritable or congenital disorders;
c) A description of the California Biobank Program,
specifically as it pertains to the Genetic Disease Screening
Program, and the subsequent storage, retention, and use of
the newborn child's blood sample for medical research; and,
d) An explanation of the parent's or legal guardian's right
to request that his or her minor child's blood samples be
destroyed or not used for research purposes, or both, and the
information necessary to make that request.
e) A statement that an individual who is at least 18 years of
age has the right to request that his or her blood sample be
destroyed or not used for research purposes, or both, and the
information necessary to make that request.
1)Requires these informational materials to be confined to a
single page and presented in a document separate from the
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standard informational acceptance form, as specified.
2)Requires DPH to prepare a standard informational acceptance form
that includes all of the following:
a) A brief, plain language explanation of the newborn child
screening test and retention of newborn child blood samples
collected pursuant to the CNSP.
b) An explanation of the parent's or legal guardian's right
to request that his or her minor 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 of the newborn
child to acknowledge receipt of informational materials; and,
d) A space for the parent or legal guardian of the newborn
child to sign and date the form
1)Requires the standard informational acceptance form to be
confined to a single page and presented in a separate document
from the informational materials.
2)Requires a copy of the standard informational acceptance form to
be maintained in the medical record of the mother of the newborn
child.
3)Requires, in the event that there is no signed standard
informational acceptance form retained in the mother's medical
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record, the newborn child to receive the genetic screening test
and the newborn child blood sample to be stored and retained for
medical research, as specified.
4)Requires DPH generally to provide a parent or legal guardian
with the informational materials and standard informational
acceptance form regarding the retention of newborn child blood
samples.
5) Requires the informational materials and standard informational
acceptance form to be distributed as follows:
a) A birth attendant who provides perinatal care to a
pregnant woman, prior to the estimated date of delivery,
shall provide a copy of the informational materials and a
copy of the standard informational acceptance form provided
by DPH.
b) If the informational material or standard informational
acceptance form has not yet been provided, a perinatal
licensed health facility shall provide a pregnant woman
admitted for delivery with a copy of the informational
materials and a copy of the standard informational acceptance
form provided by DPH.
c) The local registrar of births and deaths shall provide a
copy of the informational material and a copy of the standard
informational acceptance form provided by DPH 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; and shall notify the local health
officer and DPH of each of these registrations.
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1)Makes findings and declarations pertaining to legislative
intent.
2)Makes other clarifying or nonsubstantive changes.
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.
COMMENTS:
Purpose of this bill. This bill is intended to ensure the
informed consent of parents and protect the genetic privacy of
children born in this state by requiring DPH to provide parents
with informational materials and a written acknowledgment form
regarding the CNSP, its use of blood samples for subsequent
medical research, and the right to request that the blood sample
for one's child or oneself be destroyed or not used for research
purposes. This measure is author-sponsored.
Analysis Prepared by:
Jennie Bretschneider / P. & C.P. / (916) 319-2200
AB 170
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FN:
0000826