BILL NUMBER: AB 170 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 21, 2015
AMENDED IN ASSEMBLY MARCH 25, 2015
AMENDED IN ASSEMBLY MARCH 11, 2015
INTRODUCED BY Assembly Member Gatto
JANUARY 22, 2015
An act to amend Section 125000 of, and to add Sections 125003 and
125004 to, the Health and Safety Code, relating to newborn screening.
LEGISLATIVE COUNSEL'S DIGEST
AB 170, as amended, Gatto. Newborn screening: genetic diseases:
blood samples collected.
Existing law requires the State Department of Public Health to
establish a program for the development, provision, and evaluation of
genetic disease testing, and the program is required to provide
genetic screening and followup services for persons who have the
screening. The program includes statewide screening of newborn
children through the collection of blood samples, unless the parent
or guardian objects on the grounds of religious beliefs or practices.
This bill would instead prohibit the department from both
testing a newborn child unless the parent or guardian is fully
informed, as specified, and from storing, retaining, or using for
medical research a blood sample collected unless the parent or
guardian provides informed consent, as specified.
provide that the program for testing the blood sample of a newborn
child and the authority to store, retain, or use the sample for
medical research would not apply to a parent or guardian of the
newborn child who objects to the testing program. The bill would
require the department to provide information about the testing
program, and to obtain a form signed by the parent or guardian
acknowledging receiving information regarding the storage, retention,
and use of the newborn child's blood sample for medical research.
The bill would authorize a parent or guardian of a minor
child child, and the newborn child,
once he or she is at least 18 years of age, to request that the
department destroy or the blood sample,
not use it for research purposes, or both, the
blood sample, and the bill would require the
department would be required to do so to
comply with the request . The bill would also require the
department to prepare and provide informational materials ,
to be distributed as specified, regarding the same
information about the newborn child
child's blood sample collected pursuant to the program
that includes, but is not limited to, program,
information on storage, retention, and use of the blood sample
, for medical research, and the right
of specified persons to request that the blood sample be destroyed or
not used for research purposes , or both. in
a separate, single- page format. The bill would
also require the department to prepare and provide a standard
informed consent informational acceptance
form, to be distributed as specified, that
includes, among other things, an explanation of the newborn
child screening test and a space for the parent or legal guardian of
the newborn child to indicate his or her consent to the storage,
retention, and use of the blood sample for medical research.
a brief, plain language explanation of, and the
purpose for, the newborn child screening test and retention of
newborn child blood samples. The bill would require the informational
acceptance form to be provided to, and signed by, the parent or
guardian when either version of the informational materials is
provided. The bill would require specified persons to distribute the
informational material and the informational acceptance form,
including requiring the local registrar of births to provide a copy
of the informational material and a copy of the standard
informational acceptance form to each person registering the birth of
a newborn that occurred outside of a perinatal licensed health
facility, as specified. The bill w ould also require the
local registrar to notify the local health officer and the department
of each of these registrations by the local registrar. By imposing
additional duties on local registrars of births, this bill would
impose a state-mandated local program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that, if the Commission on State Mandates
determines that the bill contains costs mandated by the state,
reimbursement for those costs shall be made pursuant to these
statutory provisions.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no yes .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 125000 of the Health and Safety Code is amended
to read:
125000. (a) (1) It is the policy of the State of California to
make every effort to detect, as early as possible, phenylketonuria
and other preventable heritable or congenital disorders leading to
intellectual disability or physical defects.
(2) The department shall establish a genetic disease unit, that
shall coordinate all programs of the department in the area of
genetic disease. The unit shall promote a statewide program of
information, testing, and counseling services and shall have the
responsibility of designating tests and regulations to be used in
executing this program.
(3) The information, tests, and counseling for children shall be
in accordance with accepted medical practices and shall be
administered to each child born in California. The department shall
provide information about the tests and shall obtain the
informed consent of a signed informational
acknowledgment form for the receipt of information by the
parent or guardian of a newborn child for
regarding the storage, retention, and use of the newborn child'
s blood sample for medical research. The department shall establish
appropriate regulations and testing methods. The information, tests,
and counseling for pregnant women shall be in accordance with
accepted medical practices and shall be offered to each pregnant
woman in California once the department has established appropriate
regulations and testing methods. These regulations shall follow the
standards and principles specified in Section 124980. The department
may provide laboratory testing facilities or contract with any
laboratory that it deems qualified to conduct tests required under
this section. However, notwithstanding former Section 125005,
provision of laboratory testing facilities by the department shall be
contingent upon the provision of funding therefor by specific
appropriation to the Genetic Disease Testing Fund enacted by the
Legislature. If moneys appropriated for purposes of this section are
not authorized for expenditure to provide laboratory facilities, the
department may nevertheless contract to provide laboratory testing
services pursuant to this section and shall perform laboratory
services, including, but not limited to, quality control,
confirmatory, and emergency testing, necessary to ensure the
objectives of this program.
(b) The department shall charge a fee for any tests performed
pursuant to this section. The amount of the fee shall be established
and periodically adjusted by the director in order to meet the
reasonable costs of this section.
(c) The department shall inform all hospitals or physicians and
surgeons, or both, of required regulations and tests and may alter or
withdraw any of these requirements whenever sound medical practice
so indicates. To the extent practicable, the department shall provide
notice to hospitals and other payers in advance of an increase in
the fees charged for the program.
(d) (1) A test shall not be performed on any newborn child unless
the parent or guardian is fully informed of the purpose and benefits
of testing for preventable heritable and congenital disorders and is
given a reasonable opportunity to refuse a newborn child screening
test on the ground that the test conflicts with his or her religious
beliefs or practices.
(2) A newborn child blood sample shall not be stored, retained,
and used by the department for medical research unless the parent or
guardian is fully informed of the benefits of research regarding
preventing heritable and congenital disorders and provides informed
consent to the storage, retention, and use of the newborn child blood
sample collected.
(d) This section shall not apply to a parent or guardian of a
newborn child who objects to a test.
(e) The genetic disease unit is authorized to make grants or
contracts or payments to vendors approved by the department for all
of the following:
(1) Testing and counseling services.
(2) Demonstration projects to determine the desirability and
feasibility of additional tests or new genetic services.
(3) To initiate the development of genetic services in areas of
need.
(4) To purchase or provide genetic services from any sums as are
appropriated for this purpose.
(f) (1) The genetic disease unit shall
evaluate and prepare recommendations on the implementation of tests
for the detection of hereditary and congenital diseases, including,
but not limited to, biotinidase deficiency and cystic fibrosis. The
genetic disease unit shall also evaluate and prepare recommendations
on the availability and effectiveness of preventative followup
interventions, including the use of specialized medically necessary
dietary products.
It
(2) It is the intent of the
Legislature that funds for the support of the evaluations and
recommendations required pursuant to this subdivision, and for the
activities authorized pursuant to subdivision (e), shall be provided
in the annual Budget Act appropriation from the Genetic Disease
Testing Fund.
(g) Health care providers that contract with a prepaid group
practice health care service plan that annually has at least 20,000
births among its membership, may provide, without contracting with
the department, any or all of the testing and counseling services
required to be provided under this section or the regulations adopted
pursuant thereto, if the services meet the quality standards and
adhere to the regulations established by the department and
department, the plan pays that portion of a fee
established under this section that is directly attributable to the
department's reasonable cost of administering the testing
or counseling service and attributable to any required
testing or counseling services provided by the state for plan
members. The payment by the plan, as provided in this subdivision,
shall be deemed to fulfill any obligation the provider or the
provider's patient may have to the department to pay a fee in
connection with the testing or counseling service.
(h) The department may appoint experts in the area of genetic
screening, including, but not limited to, cytogenetics, molecular
biology, prenatal, specimen collection, and ultrasound ,
to provide expert advice and opinion on the interpretation and
enforcement of regulations adopted pursuant to this section. These
experts shall be designated agents of the state with respect to their
assignments. These experts shall not receive no
a salary, but shall be reimbursed for expenses
associated with the purposes of this section. All expenses of the
experts for the purposes of this section shall be paid from the
Genetic Disease Testing Fund.
(i) A parent or legal guardian of a minor may request the
department to destroy the blood sample of the
minor collected as a newborn, or not use it for
research purposes, or both, the blood sample of the minor
collected as a newborn, and the department shall
do so. comply with that request.
(j) An individual who is at least 18 years of age may request the
department to destroy his or her blood sample
that was collected as a newborn, or not use it for
research purposes, or both, his or her blood sample that was
collected, and the department shall do so.
comply with that request.
SEC. 2. Section 125003 is added to the Health and Safety Code, to
read:
125003. (a) The department shall prepare and provide
informational materials regarding newborn child blood samples
collected pursuant to this article that include, but are not limited
to, all of the following:
(1) Storage, retention, and use of the blood sample.
(2) The parent 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.
(3) The right of an individual who is at least 18 years of age 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.
(b) These informational materials shall be confined to a single
page and presented in a separate document from informational
materials pertaining to the newborn screening program.
(b)
(c) The department shall provide to a parent or legal
guardian the standard informed consent
informational acceptance form provided in Section 125004
regarding the options for newborn child screening and retention of
newborn child blood samples collected pursuant to this article.
(c)
(d) The informational materials and the standard
informed consent informational acceptance
form prepared and provided by the department shall be
distributed as follows:
(1) Every birth attendant engaged in providing perinatal care
shall provide a pregnant woman, prior to the estimated date of
delivery, with a copy of the informational materials and a copy of
the standard informed consent informational
acceptance form provided by the department.
(2) Every perinatal licensed health facility shall provide each
pregnant woman admitted for delivery with a copy of the informational
materials and a copy of the standard informed consent
informational acceptance form provided by the
department, prior to collection of the blood sample, if that
information or standard informed consent
informational acceptance form has not been provided pursuant to
paragraph (1).
(3) The local registrar of births shall provide a copy of the
informational material and a copy of the standard informed
consent informational acceptance form provided
by the department 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. The local health officer and the
department shall be notified of each of these registrations by the
local registrar.
(d) For the purposes of this section, the following terms shall
have the following meanings:
(1) "Birth attendant" means a person licensed or certified by the
state to provide maternity care and to deliver pregnant women or to
practice medicine.
(2) "Perinatal licensed health facility" means a health facility
licensed by the state and approved to provide perinatal, delivery,
newborn intensive care, newborn nursery, or pediatric services.
SEC. 3. Section 125004 is added to the Health and Safety Code, to
read:
125004. (a) The department shall prepare a standard
informed consent informational acceptance form
that includes all of the following:
(1) A brief, plain language explanation of, and the purpose for,
the newborn child screening test and retention of newborn child blood
samples collected pursuant to this article.
(2) A description of the benefits of both early newborn child
screening and the associated research undertaken regarding
preventable heritable or congenital disorders.
(3) A description of the California Biobank Program, specifically
as it pertains to the Genetic Disease Screening Program, and
subsequent storage, retention, and use of the newborn child's blood
sample for medical research.
(3)
(4) A space for the parent or legal guardian of the
newborn child to acknowledge receipt of informational materials
regarding the newborn child screening test , and the
storage, retention, and use of the newborn child's blood sample for
medical research .
(4) A space for the parent or legal guardian of the newborn child
to indicate his or her consent to the storage, retention, and use of
the blood sample for medical research.
(5) A space for the parent or legal guardian of the newborn child
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.
(6)
(5) (a) A space for the parent or
legal guardian of the newborn child to sign and date the form.
(b) The department shall 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 has first indicated his or her consent on the completed
standard informed consent form.
(c)
(b) A copy of the standard informed consent
informational acceptance form shall be
maintained with the newborn child's medical records.
(d)
(c) As used in this article, "informed consent"
"informational acceptance form"
means a written authorization acknowledgment
of received informational materials, signed and dated by a
parent or legal guardian of a newborn child.
SEC. 4. If the Commission on State Mandates
determines that this act contains costs mandated by the state,
reimbursement to local agencies and school districts for those costs
shall be made pursuant to Part 7 (commencing with Section 17500) of
Division 4 of Title 2 of the Government Code.