Amended in Assembly May 28, 2015

Amended in Assembly April 30, 2015

Amended in Assembly April 21, 2015

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 begin delete 125003 and 125004 end delete begin insert 125003, 125004, and 125005 end insert 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 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, and the newborn child, once he or she is at least 18 years of age, to request that the department destroy the blood sample, not use it for research purposes, or both, and the bill would require the department to comply with the request. The bill would also require the department to prepare and provide informational materials regarding the same information about the newborn child’s blood sample collected pursuant to the 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 in a separate, single-page format. The bill would also require the department to prepare and provide a standard informational acceptance form, that includes, among other things, 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 would 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: 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 a signed
informational acknowledgment form for the receipt of information
by the parent or guardian of a newborn child 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) This section shall not apply if a parent or guardian of a
newborn child objects to a test on the ground that the test conflicts
with his or her religious beliefs or practices.

(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.

(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, 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 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 destroy the blood sample of the minor collected as a
newborn, or not use it for research purposes, or both, and the
department shall comply with that request.

(j) An individual who is at least 18 years of age may request
the department destroy his or her blood sample that was collected
as a newborn, or not use it for research purposes, or both, and the
department shall 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:

begin delete

(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.

(c) The department shall provide to a parent or legal guardian
the standard informational acceptance form provided in Section
125004 regarding the retention of newborn child blood samples
collected pursuant to this article.

(d) The informational materials and the standard 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 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 informational
acceptance form provided by the department, prior to collection
of the blood sample, if that information or standard 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 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.

(e) 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.

end delete begin insert

(1) 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 this
article.

end insert begin insert

(2) A description of the benefits of both early newborn child
screening and the associated research undertaken regarding
preventable heritable or congenital disorders.

end insert begin insert

(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.

end insert begin insert

(4) 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.

end insert begin insert

(5) 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.

end insert begin insert

(b) These informational materials shall be confined to a single
page and presented in a separate document from the standard
informational acceptance form required in Section 125004.

end insert

SEC. 3.  

Section 125004 is added to the Health and Safety Code,
to read:

125004.  

(a) The department shall prepare a standard
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.

begin delete

(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.

(4) A space for the parent or legal guardian of the newborn child
to acknowledge receipt of informational materials regarding the
storage, retention, and use of the newborn child’s blood sample
for medical research.

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

(b) A copy of the standard informational acceptance form shall
be maintained with the medical records of the mother of the
newborn child.

(c) As used in this article, “informational acceptance form”
means a written acknowledgment of received informational
materials, signed and dated by a parent or legal guardian of a
newborn child.

(d) If there is no signed standard informational acceptance form
retained in the mother’s medical record, the newborn child shall
still be administered the genetic screening test and the newborn
child blood sample shall be stored and retained for medical research
pursuant to Section 125000.

end delete begin insert

(2) 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.

end insert begin insert

(3) A space for the parent or legal guardian of the newborn
child to acknowledge receipt of informational materials regarding
the storage, retention, and use of the newborn child’s blood sample
for medical research.

end insert begin insert

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

end insert begin insert

(b) The standard informational acceptance form shall be
confined to a single page and presented in a separate document
from the informational materials required in Section 125003.

end insert begin insert

(c) A copy of the standard informational acceptance form shall
be maintained in the medical record of the mother of the newborn
child.

end insert begin insert

(d) As used in this article, “informational acceptance form”
means a written acknowledgment of received informational
materials, signed and dated by a parent or legal guardian of a
newborn child.

end insert begin insert

(e) In the event that there is no signed standard informational
acceptance form retained in the mother’s medical record, the
newborn child shall be administered the genetic screening test and
the newborn child blood sample shall be stored and retained for
medical research pursuant to Section 125000.

end insert

begin insert

begin insert SEC. 4. end insert   

end insert

begin insert Section 125005 is added to the end insert begin insert Health and Safety Code end insert begin insert ,
to read: end insert

begin insert

begin insert 125005. end insert   

(a) The department shall provide a parent or legal
guardian with the informational materials described in Section
125003 and the standard informational acceptance form described
in Section 125004 regarding the retention of newborn child blood
samples collected pursuant to this article.

(b) The informational materials and standard informational
acceptance form described in Section 125004 shall be distributed
as follows:

(1) A 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 informational acceptance form provided by the
department.

(2) If the informational materials or standard informational
acceptance form has not been provided pursuant to paragraph
(1), a 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 informational acceptance
form provided by the department.

(3) 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 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 registrar of births and deaths shall notify
the local health officer and the department of each of these
registrations.

(c) 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.

end insert

begin delete SEC. 4. end delete
begin insert SEC. 5. end insert   

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.