If this bill were to become law, it would amend current statutes regarding the Arizona newborn screening program by adding an exemption to the requirement that new congenital disorders be added to the 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. This change aims to provide flexibility in the implementation of new screening requirements when testing methods are not yet available.

Additionally, the bill makes technical and conforming changes to the existing language in section 36-694 of the Arizona Revised Statutes. It clarifies that the director of the Department of Health Services is responsible for establishing the newborn screening program, which must include all congenital disorders on the RUSP, while also maintaining an education program for the public and medical community. The bill also updates the designation of the state laboratory as the primary testing facility, allowing for the possibility of other facilities to be designated for newer conditions or tests added after July 24, 2014.

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