---
kind: "section"
citation: "42 U.S.C. § 300b–12"
title: "42"
title_heading: "The Public Health and Welfare"
number: "300b–12"
heading: "Laboratory quality and surveillance"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/300b-12"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter IX — Genetic Diseases, Hemophilia Programs, and Sudden Infant Death Syndrome"
  - "Part A — Genetic Diseases"
---

# §300b–12. Laboratory quality and surveillance

- (a) **In general—** The [Secretary](/usc/42/201.md?p=c), acting through the [Director](/usc/42/11851.md?p=5) of the Centers for Disease Control and Prevention and taking into consideration the expertise of the [Advisory Committee](/usc/42/17061.md?p=2) on Heritable Disorders in Newborns and Children established under [section 300b–10 of this title](/usc/42/300b–10.md), 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](/usc/42/201.md?p=a), 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) **Surveillance activities—** The [Secretary](/usc/42/201.md?p=c), acting through the [Director](/usc/42/11851.md?p=5) of the Centers for Disease Control and Prevention, and taking into consideration the expertise of the [Advisory Committee](/usc/42/17061.md?p=2) on Heritable Disorders in Newborns and Children established under [section 300b–10 of this title](/usc/42/300b–10.md), 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](/usc/42/201.md?p=f)-based birth defects and developmental disabilities monitoring [programs](/usc/42/274l–1.md?p=4).

## 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.)

## Notes

### 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.”