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Virginia Administrative Code
Title 12. Health
Agency 5. Department of Health
Chapter 71. Regulations Governing Virginia Newborn Screening Services
11/23/2024

12VAC5-71-100. Responsibilities of the testing laboratory providing newborn dried-blood-spot screening tests.

A. Newborn dried-blood-spot screening tests shall be performed by the Division of Consolidated Laboratory Services or other laboratory the department has contracted with to provide this service in accordance § 32.1-65 of the Code of Virginia.

B. The testing laboratory shall maintain accreditation under the federal Clinical Laboratory Improvement Amendments regulations as defined in 42 CFR Part 493.

C. The testing laboratory shall perform required initial and secondary tests using validated analytical test methods and establish normal ranges and notification protocols as defined in the contract with the department. The testing laboratory may seek the advice of the Newborn Screening Subcommittee of the Virginia Genetics Advisory Committee.

D. On completion of newborn dried-blood-spot screening tests for the infant, the testing laboratory shall provide the completed test results to the submitting facility and to the infant's healthcare provider, as indicated on the newborn screening sample.

E. The testing laboratory shall provide the department's newborn screening program with the newborn dried-blood-spot screening test data that are necessary to carry out follow-up services.

F. The testing laboratory shall manage the distribution of newborn dried-blood-spot screening specimen collection kits.

G. The testing laboratory is authorized to set the fee charged to birthing hospitals and physicians for purchase of newborn dried-blood-spot screening specimen collection kits in consultation with the department and in accordance with applicable state statutes and regulations.

H. The testing laboratory shall maintain an information management system capable of electronic data exchange between the laboratory and the department's newborn screening program.

Statutory Authority

§§ 32.1-12 and 32.1-67 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 23, Issue 13, eff. April 4, 2007; amended, Virginia Register Volume 30, Issue 7, eff. January 24, 2014.

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