ARIZONA HOUSE OF REPRESENTATIVES Fifty-seventh Legislature First Regular Session
	Senate: HHS DP 7-0-0-0 | 3rd Read 29-0-1-0 House: HHS DP 12-0-0-0

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SB 1344: newborn screening program

Sponsor: Senator Shope, LD 16

Caucus & COW

Overview

Provides an exemption to the two-year timeframe requirement to add congenital disorders to the Arizona Newborn Screening Panel.

History

The Director of the Department of Health Services (DHS) is required to establish a newborn screening program to ensure that the testing for congenital disorders and the reporting of hearing test results are conducted in an effective and efficient manner. The newborn screening program must include all congenital disorders that are included on the recommended uniform screening panel (RUSP) adopted by the Secretary of the U.S. Health & Human Services (HHS) for both core and secondary conditions (A.R.S. § 36-694).

Congenital disorders that are added to the core and secondary conditions list of the RUSP must be added to the state's newborn screening panel within two years after their addition to the RUSP. The newborn screening program must include an education program for the general public, the medical community, parents and professional groups. The DHS Director must designate the State Laboratory as the only testing facility for the program, except that the DHS Director may designate other laboratory testing facilities for conditions or tests added to the newborn screening program on or after July 24, 2014 (A.R.S. § 36-694).

The State Laboratory screens every newborn in Arizona twice, once at 24-36 hours of age and again at 5-10 days old, for 35 different conditions, including but not limited to sickle cell anemia, cystic fibrosis, hearing differences and congenital heart defects (DHS).

Provisions

1. Excludes the two-year timeframe requirement to add congenital disorders to the Arizona Newborn Screening Panel if:

a) there is no commercially available test method approved by the U.S. Food and Drug Administration (U.S. FDA); and

b) a laboratory-developed test method is used to identify the disorder and requires premarket review and approval or authorization by the U.S. FDA. (Sec. 1)

2. Makes technical and conforming changes. (Sec. 1)

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6.                   SB 1344

7. Initials AG/AB    Page 0 Caucus & COW

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