BILL NUMBER: AB 170 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY MARCH 11, 2015
INTRODUCED BY Assembly Member Gatto
JANUARY 22, 2015
An act to amend Section 125000 of, and to add Section
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 and storing, retaining, or using a blood
sample collected unless the parent or guardian has given fully
informed consent , as specified. The bill
authorize a parent or guardian of a minor child and the newborn
child, once he or she is legally an adult, at
least 18 years of age, to request that the department
destroy, destroy or not use for research
purposes, or both, the blood sample, and the department would be
required to do so. The bill would also require the department to
prepare and provide informational materials, to be distributed as
specified, regarding the newborn child blood sample collected
pursuant to the program that includes, but is not limited to,
information on storage, retention, and use of the blood sample, and
the right of specified persons to request that the blood sample be
destroyed, destroyed or not used for
research purposes, or both. The bill would require the
department to prepare and provide a standard informed consent form,
to be distributed as specified, that sets forth clearly and in detail
specified information.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
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) 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.
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.
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 if the fully informed consent
of the parent or guardian of a newborn child is obtained and
once the department has established 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 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) This section shall not apply if a parent or guardian of the
newborn child objects to a test on the ground that the test conflicts
with his or her religious beliefs or practices.
(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 unless the parent or guardian is fully
informed of the benefits of research regarding preventing heritable
and congenital disorders and is given a reasonable opportunity to
object to the storage, retention, and use of the newborn child blood
sample collected.
(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) 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 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 the plan
pays that portion of a fee established under this section that is
directly attributable to the department's cost of administering the
testing or counseling service and 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 receive no 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, destroy or not
use for research purposes, or both, the blood sample of the minor
collected as a newborn, and the department shall do so.
(j) An individual who is at least 18 years of age may request the
department to destroy, destroy or not
use for research purposes, or both, his or her blood sample that was
collected, and the department shall do so.
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,
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,
destroyed or not used for research purposes, or both, and
the information necessary to make that request.
(b) The department shall provide to a parent or legal guardian the
standard informed consent form provided in Section 125004 regarding
the options for newborn child screening and retention of newborn
child blood samples collected pursuant to this article.
(b)
( c) The informational materials and
the standard informed consent 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 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 form
provided by the department, prior to collection of the blood
sample, if that information or standard info rmed
consent 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 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.
(c)
( 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 form setting forth clearly and in detail 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) That the parent or legal guardian of the newborn child may
consent to the newborn child screening test.
(4) That the parent or legal guardian of the newborn child has the
right to refuse a newborn child screening test on the ground that
the test conflicts with his or her religious beliefs or practices.
(5) That if the parent or legal guardian of the newborn child
refuses to have the newborn child screening test done, he or she
accepts all responsibility and liability for the possible
consequences.
(6) A description of the health risks associated with foregoing
the newborn child screening test.
(7) That the parent or legal guardian of the newborn child may
consent to the storage, retention, and use of the blood sample.
(8) That the parent or legal guardian of the newborn child may
request the department to destroy or not use for research purposes,
or both, the blood sample collected and screened.
(b) A copy of the standard informed consent form shall be
maintained with the newborn child's medical records.