Amended in Assembly March 25, 2015

Amended in Assembly March 11, 2015

California Legislature—2015–16 Regular Session

Assembly Bill No. 170

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 begin insert unless the parent or guardian is full end insert begin insert y informed, as specified, end insert and begin insert from end insert storing, retaining, or using begin insert for medical research end insert a blood sample collected unless the parent or guardian begin delete has given fully end delete begin insert provides end insert informed consent, as specified. The bill begin insert would end insert 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 begin delete sets forth clearly and in detail specified information. end delete begin insert 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. end insert

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)  begin insert (1) end insert begin insert   end insert 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.

begin delete

The

end delete

begin insert (2) end insert begin insert   end insert begin insert The end insert 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.

begin delete

The

end delete

begin insert (3) end insert begin insert   end insert begin insert The end insert information, tests, and counseling for children shall be
in accordance with accepted medical practices and shall be
administered to each child born in begin delete California if the fully end delete begin insert California.
The department shall provide information about the tests and shall
obtain the end insert informed consent of the parent or guardian of a newborn
child begin delete is obtained and once the department has established end delete begin insert for the
storage, retention, and use of the newborn child’s blood sample
for medical research. The department shall establish end insert 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 begin insert for medical research end insert unless the parent
or guardian is fully informed of the benefits of research regarding
preventing heritable and congenital disorders and begin delete is given a
reasonable opportunity to object end delete begin insert provides informed consent end insert 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 begin delete setting forth clearly and in detail end delete begin insert that includes end insert 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)  begin delete That end delete begin insert A space for end insert the parent or legal guardian of the newborn
child begin delete may consent end delete to begin insert acknowledge receipt of informational
materials regarding end insert the newborn child screening test.

begin insert

(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.

end insert begin delete

(4)

end delete

begin insert (5) end insert   begin delete That end delete begin insert A space for end insert the parent or legal guardian of the newborn
child begin delete has end delete begin insert to indicate his or her request for information about end insert the
right to refuse a newborn child screening test on the ground that
the test conflicts with his or her religious beliefs or practices.

begin delete

(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.

end delete begin insert

(6) A space for the parent or legal guardian of the newborn
child to sign and date the form.

end insert begin insert

(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.

end insert begin delete

(b)

end delete

begin insert (c) end insert  A copy of the standard informed consent form shall be
maintained with the newborn child’s medical records.

begin insert

(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.

end insert