BILL NUMBER: AB 170	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Gatto

                        JANUARY 22, 2015

   An act to amend Section 125000 of, and to add Section 125003 to,
the Health and Safety Code, relating to newborn screening.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 170, as introduced, 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 authorize a parent or guardian of a minor child
and the newborn child, once he or she is legally an adult, to request
that the department destroy, 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, not used for research
purposes, or both.
   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 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.
   (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, 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, 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, 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, not used for
research purposes, or both, and the information necessary to make
that request.
   (b) The informational materials 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 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 provided by the department, prior to collection of the
blood sample, if that information has not been provided pursuant to
paragraph (1).
   (3) The local registrar of births shall provide a copy of the
informational material 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) 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.