2005 California Health and Safety Code Sections 125000-125001 Article 2. Newborn Screening

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 mental
retardation 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 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 any
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.
125001.  (a) The department shall establish a program for the
development, provision, and evaluation of genetic disease testing,
and may provide laboratory testing facilities or make grants to,
contract with, or make payments to, any laboratory that it deems
qualified and cost-effective to conduct testing or with any metabolic
specialty clinic to provide necessary treatment with qualified
specialists. The program shall provide genetic screening and followup
services for persons who have the screening.
   (b) The department shall expand statewide screening of newborns to
include tandem mass spectrometry screening for fatty acid oxidation,
amino acid, and organic acid disorders and congenital adrenal
hyperplasia as soon as possible.  The department shall provide
information with respect to these disorders and available testing
resources to all women receiving prenatal care and to all women
admitted to a hospital for delivery. If the department is unable to
provide this statewide screening by August 1, 2005, the department
shall temporarily obtain these testing services through a competitive
bid process from one or more public or private laboratories that
meet the department's requirements for testing, quality assurance,
and reporting. If the department determines that contracting for
these services is more cost-effective, and meets the other
requirements of this chapter, than purchasing the tandem mass
spectrometry equipment themselves, the department shall contract with
one or more public or private laboratories.
   (c) The department shall report to the Legislature regarding the
progress of the program on or before July 1, 2006. The report shall
include the costs for screening, followup, and treatment as compared
to costs and morbidity averted for each condition tested for in the
program.