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PO Box 360
Trenton, NJ 08625-0360
|Poonam Alaigh, MD, MSHCPM, FACP|
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The Newborn Screening Laboratory of the Division of Public Health and Environmental Laboratories of the Department of Health and Senior Services (Department), and the Newborn Screening and Genetic Services of the Special Child Health and Early Intervention Services of the Division of Family Health Services of the Public Health Services Branch of the Department, jointly propose to readopt with amendments N.J.A.C. 8:18, the rules governing newborn biochemical screening. The notice of proposal appears in the November 1, 2010, issue of the New Jersey Register.
N.J.A.C. 8:18 establishes standards for the implementation of N.J.S.A. 26:2-110 and N.J.S.A. 26:2-111 (P.L. 1988, c.24), the statutory basis for New Jersey’s Newborn Screening Program. Newborn biochemical screening is a public health activity aimed at the early identification of infants who are affected by metabolic disorders, such as for hypothyroidism, galactosemia, phenylketonuria, and other preventable biochemical disorders. Early identification of these conditions is crucial, as timely intervention can lead to a significant reduction of morbidity, mortality and associated disabilities in affected infants. In addition, timely intervention results in the abatement or avoidance altogether of the costs of maintaining untreated children in institutions, special education programs, and sheltered care settings.
The Department’s Newborn Biochemical Screening Program is comprised of two units, the Newborn Screening Laboratory (formerly known as the Inborn Errors of Metabolism Laboratory), and the Newborn Biochemical Screening Follow-up Program. N.J.A.C. 8:18 identifies the responsibilities of all the involved health care providers. Newborn screening for inborn errors of metabolism is a system that includes primary medical practitioners, hospital staff, laboratory personnel, administrative and follow-up personnel, tertiary care centers, specialists, and parents.
The Newborn Biochemical Screening Program continues to be successful in the early identification of newborns affected with biochemical disorders. In fiscal year 2009, the Department received and assayed approximately 108,000 initial specimens and approximately 19,000 repeat specimens. This resulted in the Program, in partnership with healthcare providers statewide, confirming the presence of treatable disorders in more than 325 infants.
In consultation with experts in the field of newborn biochemical screening and interested members of the regulated community, the Department is in the process of developing rulemaking to make the chapter more user-friendly and to articulate more precisely some of the required specimen collection procedures. Pending the promulgation of that rulemaking, the Department proposes to readopt N.J.A.C. 8:18 without change to the specimen collection standards contained therein.
In addition, the Department proposes to amend N.J.A.C. 8:18 to reflect that in May 2009, the Department expanded the number of conditions for which the newborn screening laboratory tests samples collected from newborns to include 33 additional conditions. This brought the total number of disorders for which the Department screens newborns from 21 to 54. As a result of this expansion, New Jersey ranks among the top five states in terms of the number of disorders for which screening of newborns is mandated.
The public has until December 31, 2010, to comment on the proposal. Persons wishing to comment on the proposal must submit their comments in writing by regular mail to Ruth Charbonneau, Director, Office of Legal and Regulatory Affairs, Office of the Commissioner, NJ Department of Health and Senior Services, P O Box 360, Trenton, NJ 08625-0360. Written comments must be postmarked on or before December 31, 2010, which is the close of the 60-day public comment period. The Department will not accept telefacsimiles or electronic mail messages as official comments on the notice of proposal.
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Department of Health
P. O. Box 360, Trenton, NJ 08625-0360