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Article 2. Newborn Screening of California Health And Safety Code >> Division 106. >> Part 5. >> Chapter 1. >> Article 2.
(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.
(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.
(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, 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 expand statewide screening of newborns to include screening for severe combined immunodeficiency (SCID) as soon as possible. In implementing the SCID screening test, the department shall also screen for other T-cell lymphopenias that are detectable as a result of screening for SCID, insofar as it does not require additional costs or equipment beyond that needed to test for SCID.
(d) The department shall expand statewide screening of newborns to include screening for adrenoleukodystrophy (ALD) as soon as ALD is adopted by the federal Recommended Uniform Screening Panel (RUSP).
(b) The department shall expand statewide screening of newborns to include tandem mass spectrometry screening for fatty acid oxidation, amino acid, 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 expand statewide screening of newborns to include screening for severe combined immunodeficiency (SCID) as soon as possible. In implementing the SCID screening test, the department shall also screen for other T-cell lymphopenias that are detectable as a result of screening for SCID, insofar as it does not require additional costs or equipment beyond that needed to test for SCID.
(d) The department shall expand statewide screening of newborns to include screening for adrenoleukodystrophy (ALD) as soon as ALD is adopted by the federal Recommended Uniform Screening Panel (RUSP).
(a) In order to align closely related programs and in order
to facilitate research into the causes of, and treatment for, birth
defects, the Birth Defects Monitoring Program provided for pursuant
to Chapter 1 (commencing with Section 103825) of Part 2 of Division
102 shall become part of the Maternal, Child, and Adolescent Health
program provided for in Article 1 (commencing with Section 123225) of
Chapter 1 of Part 2 of Division 106.
(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:
(1) Research to identify risk factors for children's and women's diseases.
(2) Research to develop and evaluate screening tests.
(3) Research to develop and evaluate prevention strategies.
(4) Research to develop and evaluate treatments.
(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:
(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the department's approved researchers.
(2) Protocol review for scientific merit by the department or another entity authorized by the department.
(3) Protocol review by the State Committee for the Protection of Human Subjects.
(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.
(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.
(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:
(1) The research project was approved by the State Committee for the Protection of Human Subjects.
(2) The research project's protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.
(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.
(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.
(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.
(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:
(1) Research to identify risk factors for children's and women's diseases.
(2) Research to develop and evaluate screening tests.
(3) Research to develop and evaluate prevention strategies.
(4) Research to develop and evaluate treatments.
(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:
(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the department's approved researchers.
(2) Protocol review for scientific merit by the department or another entity authorized by the department.
(3) Protocol review by the State Committee for the Protection of Human Subjects.
(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.
(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.
(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:
(1) The research project was approved by the State Committee for the Protection of Human Subjects.
(2) The research project's protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.
(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.
(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.
(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.
