Prenatal screening program.

Existing law requires the State Department of Public Health to administer a statewide program for prenatal testing for genetic disorders and birth defects, including, but not limited to, ultrasound, amniocentesis, chorionic villus sampling, and blood testing. Existing law requires the department to expand prenatal screening to include all tests that meet or exceed the current standard of care as recommended by nationally recognized medical or genetic organizations. Existing law requires a clinical laboratory performing laboratory tests or examinations classified as moderate or high complexity under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) to obtain a clinical laboratory license from the department. Existing law generally exempts specified clinical laboratories from rules and regulations of the department, including clinical laboratories owned and operated by the United States and certified under CLIA. Under existing regulations, a certificate of accreditation issued by the United States Department of Health and Human Services is considered a state license or registration issued by the department, as specified. Existing law requires a city or county public health laboratory, as specified, to be approved by the department and to comply with the requirements of CLIA. This bill would prohibit the department, by way of rule, regulation, contract, or any other manner, from preventing a laboratory with both a CLIA certificate of accreditation and a current state clinical or public health laboratory license from offering noninvasive prenatal tests to pregnant persons who have an order from a prenatal care provider, as defined, and have opted out of the California Prenatal Screening Program or have chosen to have testing done in addition to the genetic tests offered as part of the California Prenatal Screening Program. The bill would also prohibit the department from limiting the number of noninvasive prenatal tests that the laboratory may provide.