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2005 SESSION
051522136Be 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:
§ 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 [ 2004 ] 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.
[ 5. That the provisions of this act shall not become effective unless an appropriation of general funds effectuating the purposes of this act is included in the general appropriations act passed by the 2005 Session of the General Assembly, which becomes law. ]