42 U.S.C. § 300b–12 — Laboratory quality and surveillance
submitted 82 years ago by Pub. L. 110-204 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 197 words · no verdicts yet
The CDC Director must ensure quality control for labs that screen newborns for heritable disorders. This covers test accuracy, speed, and technical support. The CDC may also coordinate data-sharing between newborn screening and state birth-defects tracking programs.
(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.
The Secretary*, acting through the Director* of the Centers for Disease Control and Prevention and taking into consideration the expertise of the Advisory Committee* on Heritable Disorders in Newborns and Children established under section 300b–10 of this title, shall provide for—
quality assurance for laboratories involved in screening newborns and children for heritable disorders, including quality assurance for newborn-screening tests, timeliness for processing such tests, performance evaluation services, and technical assistance and technology transfer to newborn screening laboratories to ensure analytic validity and utility of screening tests; and
appropriate quality control and other performance test materials to evaluate the performance of new screening tools.
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children established under section 300b–10 of this title, may provide, as appropriate, for the coordination of surveillance activities, including—
through standardized data collection and reporting, as well as the use of electronic health records; and
by promoting data sharing regarding newborn screening with State*-based birth defects and developmental disabilities monitoring programs.
Source credit: (July 1, 1944, ch. 373, title XI, § 1113, as added Pub. L. 110–204, § 6, Apr. 24, 2008, 122 Stat. 710; amended Pub. L. 110–237, § 1(a)(5), May 27, 2008, 122 Stat. 1557; Pub. L. 113–240, § 6, Dec. 18, 2014, 128 Stat. 2854.)
- 1944Enacted · Pub. L. 110-204 · 122 Stat. 710
- 2008Amended · Pub. L. 110-237 · 122 Stat. 1557
- 2014Amended · Pub. L. 113-240 · 128 Stat. 2854
A history note hasn’t been published yet. The record shows enactment by Pub. L. 110-204 on 1944-07-01.
all 0 arguments · sorted by: best
no arguments yet — make the first case