Virginia Law

Article 7. Newborn Screening.

A. For the purposes of this section, "RUSP" means the federal Recommended Uniform Screening Panel recommended by the Secretary of the U.S. Department of Health and Human Services.

B. In order to prevent intellectual disability and permanent disability or death, every infant who is born in the Commonwealth shall be subjected to screening tests for various disorders consistent with, but not necessarily identical to, the RUSP recommended by the U.S. Secretary of Health and Human Services and the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children.

C. The Department shall ensure that testing for any disorder that is included on the RUSP as of January 1, 2025, is included in the testing required under this section if determined appropriate by the Department. For any disorder included on the RUSP, the Department shall:

1. Conduct an evaluation to determine whether the disorder should be included on the Commonwealth's screening program, including an assessment of the estimated costs of including the disorder and a fiscal impact on the fee for the tests performed; and

2. If the Department determines the disorder should be included in the testing required under this section, commence the rulemaking process to add the disorder to the Commonwealth's screening program.

The Department shall conduct such evaluation and commence such rulemaking process, if applicable, within 12 months of the addition of any disorder added to the RUSP after January 1, 2025. If a condition is added to the Commonwealth's screening panel by rule, and there is an available test that meets all federal and state laboratory requirements for newborn screening programs, the Department shall implement screening for the condition in the Commonwealth's screening program within six months of completion of the rulemaking process. If there is not an available test that meets state and federal laboratory requirements for newborn screening programs, the program shall secure an appropriate test as soon as available.

D. For any disorder included on the RUSP that the Department determines in an initial evaluation should not be included under the Commonwealth's screening program, the Department shall determine whether reevaluation is necessary by (i) reviewing the medical literature published on the disorder since the initial evaluation and (ii) allowing for public input. The Department shall conduct such determination annually. If the Department determines reevaluation is necessary during such annual determination, the Department shall conduct an evaluation and commence the rulemaking process, if applicable, within 12 months pursuant to subsection C. The Department shall not include in the testing required under this section any disorder not included on the RUSP unless it has first conducted an evaluation and commenced the rulemaking process to add the disorder in the same manner as is required for any disorder included on the RUSP in accordance with subsection C.

E. The Department shall submit a status report to the General Assembly on the screening program annually. Such status report shall include:

1. The current disorders included under the Commonwealth's screening program;

2. Any new disorders currently under consideration or recommended for inclusion under the Commonwealth's screening program;

3. Any new disorders considered but not recommended for inclusion in the Commonwealth's screening program in the prior 12-month period and the reason for not recommending such disorders;

4. Any disorders for which the Department determined a reevaluation was unnecessary in the prior 12-month period and the reason that such reevaluation is not necessary at the time of such determination; and

5. Any delay in complying with the timeframes specified by this section for evaluation, inclusion, or reevaluation of a disorder and the reason for such delay.

F. Any infant whose parent or guardian objects thereto on the grounds that such tests conflict with his religious practices or tenets shall not be required to receive such screening tests.

G. The physician, licensed midwife, or certified nurse midwife in charge of the infant's care after delivery shall cause such tests to be performed. The screening tests shall be performed by the Division of Consolidated Laboratory Services or any other laboratory the Department of Health has contracted with to provide such service. Screening tests for time-critical disorders identified by the U.S. Department of Health and Human Services and the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children shall be performed seven days a week.

H. The program for screening infants for sickle cell diseases shall be conducted in addition to the programs provided for in Article 8 (§ 32.1-68 et seq.).

Code 1950, §§ 32-112.1, 32-112.9; 1966, c. 179; 1979, c. 711; 1983, c. 582; 1986, c. 172; 1988, c. 97; 1992, cc. 747, 873; 2001, c. 255; 2002, c. 440; 2004, c. 760; 2005, cc. 717, 721; 2012, cc. 147, 476, 507; 2018, c. 531; 2025, c. 483.

In order to prevent disability or death, the Board shall require every hospital in the Commonwealth having a newborn nursery to perform a critical congenital heart defect screening test using pulse oximetry or other Board-approved screening test that is based on standards set forth by the American Academy of Pediatrics on every newborn in its care when such infant is at least 24 hours old but no more than 48 hours old or, in cases in which the infant is discharged from the hospital prior to reaching 24 hours of age, prior to discharging the infant.

Any infant whose parent or guardian objects thereto on the grounds that such tests conflict with his religious practices or tenets shall not be required to receive such screening tests.

The physician or health care provider in charge of the infant's care after delivery shall cause such tests to be performed.

2014, cc. 4, 175.

Whenever a newborn screening test result indicates suspicion of any condition pursuant to § 32.1-65, the Commissioner shall notify forthwith the attending physician and shall perform or provide for additional testing required to confirm or disprove the diagnosis. All physicians, certified nurse midwives, public health nurses, or any nurse receiving such test result, and administrators of hospitals in the Commonwealth, shall report the discovery of all cases of any condition for which newborn screening is conducted pursuant to § 32.1-65 to the Commissioner for infants and children up to two years of age.

Code 1950, § 32-112.5; 1966, c. 179; 1979, c. 711; 1986, c. 172; 1988, c. 97; 2005, cc. 717, 721.

Infants identified with any condition for which newborn screening is conducted pursuant to § 32.1-65 or 32.1-65.1 shall be eligible for the services of the Children with Special Health Care Needs Program administered by the Department of Health. The Board of Health shall promulgate such regulations as may be necessary to implement Newborn Screening Services and the Children with Special Health Care Needs Program. The Board's regulations shall include a list of newborn screening tests conducted pursuant to §§ 32.1-65 and 32.1-65.1 and authorization to charge fees for such tests, notification processes conducted pursuant to § 32.1-66, follow-up procedures, appropriate referral processes, and services available for infants and children who have a heritable disorder or genetic disease identified through Newborn Screening Services.

Code 1950, § 32-112.6; 1966, c. 179; 1979, c. 711; 1980, c. 470; 1981, c. 164; 1986, c. 172; 1988, c. 97; 2000, c. 916; 2005, cc. 717, 721; 2012, c. 147; 2014, cc. 4, 175; 2025, c. 483.

The results of the newborn screening services conducted pursuant to this article may be used for research and collective statistical purposes. No publication of research or statistical data shall be made that identifies any infant having a heritable or genetic disorder.

The Commissioner may authorize linkages between secure electronic data systems maintained by the Department of Health containing newborn screening records and the Virginia Immunization Information System (VIIS) operated pursuant to § 32.1-46.01. The Commissioner may authorize health care providers authorized to view VIIS to view the newborn screening records of individuals to whom the providers are providing health care services. The records may be made available until the child reaches seven years of age, after which the records shall not be made available through a linkage to VIIS. Such linkages shall be subject to all applicable state and federal privacy laws and regulations.

1988, c. 97; 2005, cc. 717, 721; 2012, c. 147.