Section 120. Scope and content of Virginia Newborn Screening Program

A. The mission of Virginia Newborn Screening Program is to prevent intellectual disability, permanent disability, or death through early identification and treatment of infants who are affected by those heritable disorders and genetic diseases listed in 12VAC5-71-30 D.

B. The scope of the newborn screening program shall include the following:

1. Ensure that infants born in the Commonwealth receive newborn dried-blood-spot screening, confirmatory testing, and follow-up services for selected heritable disorders or genetic diseases;

2. Locate and track infants with screened-abnormal results or unsatisfactory results, a short-term process of ensuring that the identified healthcare provider is informed of results, in a timely matter, by at least six months of age, to determine if the infant has a selected heritable disorder or genetic disease;

3. Ensure that the department receives all diagnostic test results, both normal and screened-abnormal results, from healthcare providers;

4. Ensure that appropriate diagnostic data are collected, stored, and organized in a secure data management information system that allows for efficient extraction of appropriate data from the testing laboratory to newborn screening services in accordance with federal and state laws and regulations;

5. Assess and evaluate the newborn screening program follow-up activities by collecting and reporting data required annually for Title V national performance measures that address how well the system functions;

6. Educate healthcare providers, parents, and the general public by electronic or written materials and educational sessions, as deemed necessary by the department;

7. Facilitate the entry of infants with screened-abnormal results into medical and dietary management services as needed upon receiving notification from the contracted lab of such results;

8. Ensure that residents of the Commonwealth who are diagnosed with selected heritable disorders or genetic diseases identified through the newborn screening program are referred to the Care Connection for Children network for care coordination services; and

9. Provide information to residents of the Commonwealth who are diagnosed with selected heritable disorders or genetic diseases identified through the newborn screening program regarding available assistance for obtaining metabolic formula, low protein modified foods, and metabolic supplements that are medically necessary to manage their diagnosed heritable disorder or genetic disease listed in 12VAC5-71-30 D.

C. To ensure full implementation of the newborn screening program, the department may establish contracts with, but not be limited to, the following entities, and the established contracts shall comply with all federal assurances:

1. A designated testing laboratory;

2. Medical facilities to provide metabolic treatment and genetic services; and

3. Other entities as needed.

D. The Title V national performance measures, as required by the federal Government Performance and Results Act (GPRA; Public Law 103-62), shall be used to establish the newborn screening program goals. The following goals shall change as needed to be consistent with applicable Title V national performance measures:

1. All infants who are born in the Commonwealth and who are residents of Virginia will receive appropriate newborn dried-blood-spot screening, confirmatory testing, and follow-up services.

2. All infants who are born in the Commonwealth and who are not residents of Virginia will receive appropriate newborn dried-blood-spot screening and be referred to their state of residence for confirmatory testing and follow-up services.

Historical Notes

Derived from Volume 23, Issue 13, eff. April 4, 2007; amended, Virginia Register Volume 30, Issue 07, eff. January 24, 2014.

Statutory Authority

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