Bill Text: CA AB170 | 2015-2016 | Regular Session | Amended
Bill Title: Newborn screening: genetic diseases: blood samples collected.
Sponsorship: Partisan Bill (Democrat 1)
Status: (Failed) 2016-11-30 - From Senate committee without further action. [AB170 Detail]
Download: California-2015-AB170-Amended.html
BILL NUMBER: AB 170 AMENDED
BILL TEXT
AMENDED IN SENATE JULY 8, 2015
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
INTRODUCED BY Assembly Member Gatto
JANUARY 22, 2015
An act to amend Section 125000 of, and to add Sections 125003,
125004, and 125005 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 require the department, if the individual making a request to
destroy the blood sample or to not use it for research purposes
provides his or her e-mail address, to send an e-mail to the
individual acknowledging that the department received 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 to 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. If the
parent or legal guardian making the request provides his or her
e-mail address, the department shall send an e-mail
acknowledging that the department received the 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,
and the department shall comply with that request. If the
individual making the request provides his or her e-mail address, the
department shall send an e-mail acknowledging that the department
received the 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) 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.
(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) 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.
(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.
(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.
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.
(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.
(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.
(4) A space for the parent or legal guardian of the newborn child
to sign and date the form.
(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.
(c) A copy of the standard informational acceptance form shall be
maintained in the medical record of the mother of the newborn child.
(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.
(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.
SEC. 4. Section 125005 is added to the Health and Safety Code, to
read:
125005. (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.
SEC. 5. 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.
