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Title 42, The Public Health and WelfareRelease 119-73not60

§300b–12 Laboratory Quality and Surveillance

Title 42 › Chapter 6A— PUBLIC HEALTH SERVICE › Subchapter IX— GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT DEATH SYNDROME › Part A— Genetic Diseases › § 300b–12

Last updated Apr 5, 2026|Official source

Summary

The Secretary, through the CDC Director and with advice from the Advisory Committee on Heritable Disorders in Newborns and Children, must make sure labs that screen newborns and children for inherited disorders meet quality standards. That includes making sure tests are accurate and useful, are processed quickly, giving labs performance checks, and helping them with technical support and new technology. The Secretary must also provide quality control materials to test new screening tools. The Secretary may help coordinate tracking and reporting of screening results. That can include using common data rules, using electronic health records, and encouraging sharing of newborn screening data with state birth defects and developmental disabilities monitoring programs.

Full Legal Text

Title 42, §300b–12

The Public Health and Welfare, Source: USLM XML via OLRC

(a)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—
(1)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
(2)appropriate quality control and other performance test materials to evaluate the performance of new screening tools.
(b)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—
(1)through standardized data collection and reporting, as well as the use of electronic health records; and
(2)by promoting data sharing regarding newborn screening with State-based birth defects and developmental disabilities monitoring programs.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

2014—Pub. L. 113–240, § 6(1), inserted “and surveillance” after “quality” in section catchline. Subsec. (a). Pub. L. 113–240, § 6(2)(A), substituted “and taking into consideration the expertise of the Advisory Committee” for “and in consultation with the Advisory Committee” in introductory provisions. Subsec. (a)(1). Pub. L. 113–240, § 6(2)(B), inserted “timeliness for processing such tests,” after “newborn-screening tests,”. Subsec. (b). Pub. L. 113–240, § 6(3), added subsec. (b) and struck out former subsec. (b). Prior to amendment, text read as follows: “For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2009, $5,062,500 for fiscal year 2010, $5,125,000 for fiscal year 2011, $5,187,500 for fiscal year 2012, and $5,250,000 for fiscal year 2013.” 2008—Subsec. (b). Pub. L. 110–237 substituted “2009, $5,062,500 for fiscal year 2010, $5,125,000 for fiscal year 2011, $5,187,500 for fiscal year 2012, and $5,250,000 for fiscal year 2013.” for “2008, $5,062,500 for fiscal year 2009, $5,125,000 for fiscal year 2010, $5,187,500 for fiscal year 2011, and $5,250,000 for fiscal year 2012.”

Reference

Citations & Metadata

Citation

42 U.S.C. § 300b–12

Title 42, The Public Health and Welfare

Last Updated

Apr 5, 2026

Release point: 119-73not60