The Department of Health and Senior Services (Department) is proposing to amend N.J.A.C. 8:18 governing Newborn Biochemical Screening to implement P.L. 2004, c. 12 (“Act”), codified in part as N.J.S.A. 26:2-111.1, “Option of additional screening for disorders in infants required; cost.”

Existing N.J.A.C. 8:18, Newborn Biochemical Screening, establishes procedures and requirements for testing newborns for certain metabolic disorders, pursuant to P.L.1977, c.321 (N.J.S.A. 26:2-110 et seq.).  Early identification of these conditions is particularly crucial, as timely intervention can lead to a significant reduction of morbidity, mortality and associated disabilities in affected infants, such as mental retardation.  The existing screening panel that the Department mandates pursuant to N.J.A.C. 8:18-1.3 tests newborns for disorders that, if not treated very early in life, can cause severe disability or death.

The Act requires health care providers to “give an infant's parent or guardian the option of consenting to the performance of testing by qualified laboratories for disorders in infants for which testing is not required pursuant to P.L.1977, c.321 … on a form and in a manner prescribed by the Commissioner of Health and Senior Services.  The health care provider shall not be required to assume the cost of such testing.”  The Act further requires the Commissioner to “prepare and make available electronically, on the Internet website of the Department …, information that explains the availability of testing performed by qualified laboratories for disorders in infants for which testing is not required pursuant to P.L.1977, c.321” (N.J.S.A. 26:2-110 et seq.).  The Act requires health care providers to give an infant's parent or guardian a hard copy of this information and to provide the parent or guardian with a reasonable opportunity to read the information when giving the parent or guardian the option of consenting to the performance of testing.

The Act directs the Commissioner to adopt rules necessary to carry out the provisions of the Act.  The proposed amendments would implement the Commissioner’s obligations under the Act.

The proposal appears in the May 15, 2006 issue of the New Jersey Register.  The public has until July 14, 2006 to comment on the proposal.  Persons wishing to comment on the proposal must submit their comments in writing to Gloria M. Rodriguez, D.S.W., Director, Special Child Health and Early Intervention Services, Division of Family Health Services, Department of Health and Senior Services, P O Box 364, Trenton, NJ 08625-0364.  Written comments must be postmarked on or before July 14, 2006, which is the close of the 60-day public comment period.

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