Nominate a Condition for Addition to the Wisconsin Newborn Screening Panel

Wisconsin Stat. § 253.13 (1) mandates that newborns in Wisconsin be tested for congenital or metabolic disorders. The Secretary of the Wisconsin Department of Health Services 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 the 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.

What is the process for nominating a condition to the Wisconsin newborn screening panel?

  • 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 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 Advisory 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.
  • 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.

What are the forms I need to nominate a condition (Nomination Packet)?

If you would like to nominate a condition to be considered for addition to the Wisconsin NBS panel of conditions and you are a resident of the state of Wisconsin, you must complete two forms and submit them with key references.

  1. Nomination form: F-00986 (PDF) Please carefully follow the instructions to complete the form. Be sure to include your contact information and any co-sponsoring organizations' information.
  2. Conflict of Interest form: F-00986A (PDF) Please carefully follow the instructions to complete the form.
  3. Key references: Include all key references to support each criterion listed on the nomination form. Attach key references as PDF(s) or mail hard copies to the address below.

If you need help completing the Nomination Packet, please talk with your health care team or a parent group or association.

What conditions have been nominated or have been considered?

The current process for nominating a condition to be considered for addition to the newborn screening panel began in 2014 and will be applied to conditions nominated after the process was implemented. Conditions previously added to the newborn screening panel underwent a separate review process. Below are conditions that have been nominated and/or considered for addition to the newborn screening panel. Click the name of the condition to view the nomination forms.

Critical Congenital Heart Disease (CCHD)

Krabbe Disease

Carnitine Palmitoyltransferase 1A (CPT 1A)

Spinal Muscular Atrophy (SMA)

Pompe

 

Email nominations to:

The Division of Public Health

Or mail to:
Division of Public Health
Newborn Screening Program
1 West Wilson St., Room 233
Madison, WI 53703

For questions on the nomination process, please email Tami Horzewski, State Newborn Screening Program Coordinator.

For more information on the conditions currently being screened through Newborn Blood Screening, please go the Newborn Blood Screening page.

For more information on the Wisconsin Newborn Screening Program, please go to the Newborn Screening home page.

Last Revised: July 20, 2020