The Department of Health and Senior Services is proposing to readopt the rules at N.J.A.C. 8:19 governing Newborn Screening.

 N.J.A.C. 8:19-1 governs mandatory newborn hearing screening.  N.J.A.C. 8:19-2 governs newborn biochemical screening.  The Department is proposing technical amendments throughout the chapter.  In addition, the Department is proposing to recodify with amendments existing N.J.A.C. 8:19-2, Newborn Biochemical Screening, as a separate chapter at new N.J.A.C. 8:18-1.

Newborn Hearing Screening

The rules at N.J.A.C. 8:19-1 implement a statutory mandate that the facility of birth conduct hearing screening on all newborns prior to discharge. The Department is proposing to readopt these rules with only technical amendments. 

In a proposal published in the New Jersey Register at 36 N.J.R. 5058(a) on November 15, 2004, the Department proposed to repeal the existing rules and adopt new rules in their stead.  The comment period for that proposal has closed and the program is reviewing public responses to the proposal.

At least until the Department is prepared to adopt the November 15, 2004 proposal, the proposed readoption of the existing rules would prevent the chapter’s expiration and allow the rules to continue in operation.

Newborn Biochemical Screening

The Department is proposing to readopt the Newborn Biochemical Screening rules at N.J.A.C. 8:19-2, with substantive amendments, and to recodify it as the new N.J.A.C. 8:18-1.

The Newborn Biochemical Screening rules implement a statutory mandate that all newborns be screened within hours of birth for biochemical disorders that can cause mental retardation or other permanent disabilities if not promptly treated, and that all newborns testing positive for such disorders be treated.  The facility of birth is required to collect a heel-stick blood specimen from all newborns and transmit the specimen to the Department’s Inborn Errors of Metabolism Laboratory for analysis.

The subchapter specifies the responsibilities of hospital administrators, physicians, birth attendants, local health officials, the Department’s Inborn Errors of Metabolism Laboratory, and the Department’s Newborn Screening and Genetic Services follow-up program, in ensuring newborns and their families receive appropriate screening, notification, treatment, follow up, and access to appropriate services when a newborn’s specimen tests positive for one of the metabolic disorders listed in the subchapter.

Proposed substantive amendments would add definitions for “Follow-up Program,” to mean Newborn Screening and Genetic Services of Special Child Health and Early Intervention Services of the Department; “Health care professional,” to mean a health care professional licensed pursuant to Title 45 of the Revised Statutes that provides health care services to newborn infants; and “newborn,” to mean an infant up to 28 days old.  A proposed amendment would revise the existing definition of “Responsible physician” to mean the physician providing care at the time of specimen collection whose name is placed on the Inborn Errors of Metabolism (IEM) specimen collection form by the hospital of birth or birth attendant.

A proposed substantive amendment would add six more metabolic disorders to the list of disorders for which the Department conducts screening and would revise the requirements for 24 hours of protein feeding in healthy infants and infants requiring prolonged hospitalization.

A proposed substantive amendment would articulate that reports the Department collects pursuant to the subchapter are “information relating to medical history, diagnosis, treatment or evaluation” within the meaning of Executive Order 26, § 4b1 (McGreevey, August 13, 2002), http://www.nj.gov/infobank/circular/eom26.shtml, and not “government records” subject to public access or inspection within the meaning of N.J.S.A. 47:1A-1 et seq., particularly 1A-1.1.

Submitting Public Comments

The proposal appears in the May 16, 2005 issue of the New Jersey Register.  The public has until July 15, 2005 to comment on the proposal.

Comments must be submitted 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 15, 2005, which is the close of the 60-day public comment period.

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