BILL NUMBER: AB 170 AMENDED
BILL TEXT
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 full
y informed, as specified, and from storing,
retaining, or using for medical research a blood sample
collected unless the parent or guardian has given fully
provides informed consent, as specified. The
bill would authorize a parent or guardian of a minor child
and the newborn child, once he or she is at least 18 years of age,
to request that the department 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 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.
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.
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) (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.
The
(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.
The
(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 if the fully California. The department
shall provide information about the tests and shall obtain the
informed consent of the parent or guardian of a newborn child
is obtained and once the department has established
for 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 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
is given a reasonable opportunity to object provides
informed consent 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 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 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 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) 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.
(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 informed 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.
(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
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) That A space for the parent or
legal guardian of the newborn child may consent to
acknowledge receipt of informational materials regarding
the newborn child screening test.
(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.
(4)
(5) That A space for the
parent or legal guardian of the newborn child has
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.
(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.
(6) 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.
(b)
(c) A copy of the standard informed consent form shall
be maintained with the newborn child's medical records.
(d) As used in this article, "informed consent" means a written
authorization signed and dated by a parent or legal guardian of a
newborn child.