The proposed bill would amend current Arizona statutes regarding the newborn screening program by adding an exemption to the requirement that new congenital disorders be added to the state's screening panel within two years of their inclusion in the federal Recommended Uniform Screening Panel (RUSP). Specifically, the bill introduces a new subsection (E) that states the two-year timeframe does not apply if there is no commercially available test approved by the FDA and if a laboratory-developed test is used that requires FDA premarket review and approval or authorization.

Additionally, the bill makes technical and conforming changes to the existing language, including the deletion of outdated provisions and the insertion of new definitions and requirements. The current statute mandates that the newborn screening program include all congenital disorders listed on the RUSP, and the bill clarifies that the director of the Department of Health Services must ensure effective testing and reporting while allowing for the designation of other laboratory testing facilities under certain conditions. Overall, these updates aim to enhance the flexibility and efficiency of the newborn screening process in Arizona.

Statutes affected:
Introduced Version: 36-694
Senate Engrossed Version: 36-694
Chaptered Version: 36-694