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Newborn Screening: Nominate a Condition for the Newborn Screening Panel

Wisconsin health care providers can nominate a condition to add to the Wisconsin newborn screening panel. The panel is part of the Wisconsin Newborn Screening program. This page includes helpful details about this process and other requirements.

Newborn screening panel nomination information

Expand a section to learn more.

Wisconsin Stat. § 253.13 (1) mandates that newborns in Wisconsin be tested for congenital or metabolic disorders. The Wisconsin Department of Health Services (DHS) Secretary may add, by rule, congenital disorders to be tested for during the newborn screening process. The Secretary has established a process by which individuals or groups can nominate a condition. The condition will be considered based on the following criteria:

  • Criterion 1—Mandated testing should be limited to conditions that cause serious health risks in childhood that are unlikely to be detected and prevented in the absence of newborn screening.
  • Criterion 2—For each condition, there should be information about the incidence, morbidity and mortality, and natural history of the disorder.
  • Criterion 3—Conditions identified by newborn screening should be linked with interventions that have been shown in well-designed studies to be safe and effective in preventing serious health consequences.
  • Criterion 4—The interventions should be reasonably available to affected newborns.
  • Criterion 5—Appropriate follow-up should be available for newborns that have a false positive newborn screen.
  • Criterion 6—The characteristics of mandated tests in the newborn population should be known, including specificity, sensitivity, and predictive value.
  • Criterion 7—If a new sample collection system is needed to add a disorder, reliability and timeliness of sample collection must be demonstrated.
  • Criterion 8—Before a test is added to the panel, the details of reporting, follow-up, and management must be completely delineated, including development of standard instructions, identification of consultants, and identification of appropriate referral centers throughout the state/region.
  • Criterion 9—Recommendations and decisions should include consideration of the costs of the screening test, confirmatory testing, accompanying treatment, counseling, and the consequences of false positives. The mechanism of funding those costs should be identified. Expertise in economic factors should be available to those responsible for recommendations and decisions.

The current process for nominating a condition to add to the newborn screening panel started in 2014. These conditions have been nominated and/or considered. Select a link to learn more.

See the Conditions Newborns Are Screened for in Wisconsin.

The nomination process for adding a condition to the newborn screening panel follows these basic steps:

A nominator (resident of Wisconsin) submits a nomination packet for a specific condition. The nomination packet must include the nomination form, conflict of interest form(s), and key references. When nominating a new disorder to be added to the Wisconsin mandatory newborn screening panel, the nominator or nomination team must include at least one individual as lead or co-sponsor with in-depth knowledge of Wisconsin’s newborn screening infrastructure, capabilities, and processes, as well as resources to manage newborn screen-positive infants identified with the nominated condition. The nomination must include a detailed plan for implementation of both the screening test and management of affected individuals.

In addition, the nomination must address the management and treatments available specifically in Wisconsin. If treatment is not currently available in Wisconsin, details on how an infant with a positive screen would be managed must be addressed, including a plan for addressing payment for costs of out-of-state treatment, including transportation.

When the Division of Public Health (DPH) receives the nomination packet, DPH staff will check for completeness. If the packet is complete, it is reviewed by a Newborn Screening Subcommittee (if applicable for the specific condition) and the NBS Umbrella Committee. Both committees provide comments to the Secretary's Advisory Committee on Newborn Screening (SACNBS). There will also be opportunities for public input to the SACNBS through email or in person. The NBS Committees are explained on the Newborn Screening Program Committee Structure page.

The nomination is then reviewed by the SACNBS, which then makes a recommendation, by written report, to the Wisconsin DHS Secretary.

  • If the SACNBS recommends not approving a nomination, this recommendation is reported to the DHS Secretary for final decision.
  • If the SACNBS recommends approving a nomination, the recommendation is reported to the DHS Secretary for final decision. If the recommendation is accepted by the Secretary, the NBS Program begins the months-long process of rule-making to add the condition to the NBS panel. If the addition of a condition will increase the cost of screening, a fee increase will also be requested.
  • If the SACNBS recommends that a nomination be tabled, this recommendation is reported to the Secretary. If the Secretary accepts the recommendation, the nominator(s) may then begin a process of gathering additional information. Once the required information is gathered and presented to the committee, the nomination can be taken up again by the relevant Subcommittee, Umbrella Committee and SACNBS.

Nominations that are tabled may be re-nominated when the questions and concerns of the relevant committee have been addressed, and nominations that are declined may be re-nominated when new information that would lead to significant updates on the nomination form becomes available (e.g., new screening test modality, new treatment, etc.). A re-nomination must proceed through the same three-tier committee process that was used to review the original nomination.

In all instances in which the SACNBS makes a recommendation about addition or deletion from the Wisconsin Newborn Screening Panel of Conditions, the Wisconsin DHS Secretary makes a final decision and responds to the SACNBS recommendation as to whether the nominated condition will be added to the NBS panel. The nominator is also informed of the decision.

The nomination packet includes:

Learn about the Newborn Screening Program Committee Structure.

Contact us

Send in your nomination packet by email, or mail it to:

Division of Public Health
Newborn Screening Program
1 W. Wilson St., Room 233
Madison, WI 53703

For help with the nomination process—Email

For help completing the nomination packet—Talk with your health care team or parent group/association.

Last revised October 2, 2023