CHAPTER 717
An Act to amend and reenact §§ 32.1-65 through 32.1-67.1 of the Code of Virginia and to repeal the second enactment of Chapter 440 of the Acts of Assembly of 2002, relating to newborn screening services.
Approved March 25, 2005
Be it enacted by the General Assembly of Virginia:
1. That §§ 32.1-65 through 32.1-67.1 of the Code of Virginia are amended and reenacted as follows:
Article 7.
Detection and Control of Phenylketonuria and Other Inborn
Errors of Metabolism Newborn Screening.
§ 32.1-65. Certain newborn screening required.
In order to prevent mental retardation, and
permanent disability or death, every infant who is born in this the Commonwealth
shall be subjected to a screening test for biotinidase deficiency,
phenylketonuria, hypothyroidism, homocystinuria, galactosemia, congenital
adrenal hyperplasia, medium-chain acyl-CoA dehydrogenase (MCAD or MCADH) deficiency,
and Maple Syrup Urine Disease, and each infant determined at risk shall be
subject to a screening test for sickle cell diseases tests for various
disorders consistent with, but not necessarily identical to, the uniform
condition panel recommended by the American College of Medical Genetics in its
report, Newborn Screening: Toward a Uniform Screening Panel and System, that
was produced for the U.S. Department of Health and Human Services. Further,
upon the issuance of guidance for states' newborn screening programs by the
federal Department of Health and Human Services, every infant who is born in
the Commonwealth shall be screened for a panel of disorders consistent with,
but not necessarily identical to, the federal guidance document.
Any infant whose parent or guardian objects thereto on the
grounds that such test conflicts tests conflict with his
religious practices or tenets shall not be required to receive a such
screening test tests.
The physician or certified nurse midwife in charge of the infant's
care after delivery shall cause such test 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 this service.
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.) of this chapter.
§ 32.1-66. Commissioner to notify physicians; reports to Commissioner.
Whenever a newborn screening test result indicates
suspicion of biotinidase deficiency, phenylketonuria, hypothyroidism,
homocystinuria, galactosemia, Maple Syrup Urine Disease or any sickle cell
disease any condition pursuant to § 32.1-65, the Commissioner shall
notify forthwith the attending physician and shall perform or provide for
any additional testing required to confirm or disprove the diagnosis of
biotinidase deficiency, phenylketonuria, hypothyroidism, homocystinuria,
galactosemia, Maple Syrup Urine Disease or the sickle cell disease. All
physicians, certified nurse midwives, public health nurses, or any
nurse receiving such test result, and administrators of hospitals in this
the Commonwealth, shall report the discovery of all cases of
biotinidase deficiency, phenylketonuria, hypothyroidism, homocystinuria,
galactosemia, Maple Syrup Urine Disease any condition for which newborn
screening is conducted pursuant to § 32.1-65 to the Commissioner, as
well as sickle cell diseases in infants less than one year of age for
infants and children up to two years of age.
§ 32.1-67. Duty of Board for follow-up and referral protocols; regulations.
Infants identified with any condition for which newborn
screening is conducted pursuant to § 32.1-65 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, but
not be limited to, a list of newborn screening tests conducted pursuant to §
32.1-65, 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. The Board shall
recommend procedures for the treatment of biotinidase deficiency,
phenylketonuria, hypothyroidism, homocystinuria, galactosemia, Maple Syrup
Urine Disease and sickle cell diseases, and shall provide such treatment for
infants in medically indigent families. The Board shall create procedures to
provide to (i) the parents or guardian of any child or (ii) any pregnant woman,
who is a legal resident of the Commonwealth and who is diagnosed as requiring
treatment for phenylketonuria, the special food products required in the
management of phenylketonuria out of such funds as may be appropriated for this
purpose. The special food products shall include medical formulas which are
designed specifically for the treatment of phenylketonuria and low protein
modified foods (not foods naturally low in protein) which are designed
specifically for use in the treatment for inborn errors of metabolism. The
parents or guardian of any such child, or the pregnant woman, shall, in the
discretion of the Department, reimburse to the local health department the cost
of such special medical formulas in an amount not to exceed two percent of
their gross income. The parents or guardian of any such child, or the pregnant
woman, shall, with such funds as are appropriated, receive reimbursement from
the Department for the cost of such special low protein modified foods in an
amount not to exceed $2,000 per diagnosed person per year. The reimbursement
required by this section shall be payable quarterly by the first day of
January, April, July, and October.
§ 32.1-67.1. Confidentiality of records; prohibition of discrimination.
The results of the newborn screening programs
services conducted pursuant to this article may be used for research and
collective statistical purposes. No publication of information, biomedical
research, or medical data shall be made which that identifies
any infant having a genetic disease heritable or genetic disorder.
All medical records maintained as part of newborn screening services
the screening programs shall be confidential and shall be accessible only
to the Board, the Commissioner, or his agents.
2. That the second enactment of Chapter 440 of the 2002 Acts of Assembly is repealed.
3. That the provisions of this act shall become effective on March 1, 2006.
4. That, notwithstanding the provisions of the third enactment clause, the Board of Health shall promulgate regulations to implement the provisions of this act to be effective within 280 days of its enactment.