12 Va. Admin. Code § 5-71-100 - 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.
Notes
Statutory Authority: §§ 32.1-12 and 32.1-67 of the Code of Virginia.
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