42 U.S.C. § 300b–12 — Laboratory quality and surveillance

(a) In general: Working through the CDC Director, and considering the Advisory Committee's expertise (section 300b–10), the Secretary must provide: (1) quality assurance for labs that screen newborns and children for heritable disorders — covering test accuracy, how fast tests are processed, performance evaluation, and technical help and technology transfer to make sure screening tests are valid and useful; and (2) quality-control materials and other test materials needed to evaluate new screening tools. (b) Surveillance activities: Working through the CDC Director, and considering the Advisory Committee's expertise, the Secretary may coordinate surveillance activities, including (1) standardized data collection and reporting, and use of electronic health records; and (2) sharing newborn screening data with state birth-defects and developmental-disabilities tracking programs.