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Condition Nomination Process

Nominate a Condition

The Michigan Newborn Screening (NBS) Program has established a multistep process for adding conditions to the state NBS panel. The process begins with submission of a comprehensive nomination package by a Michigan stakeholder or group of stakeholders with knowledge and expertise in the condition being considered. Nominated conditions will follow the systematic process outlined in the infographic below showing the steps from nomination package submission through addition to the NBS panel. This comprehensive approach with reviews at multiple levels ensures that only suitable conditions ready for statewide screening are added. If at any point in the process the condition is not moved forward, the nominator(s) will be notified of the decision.

Instructions

Michigan stakeholders interested in nominating a condition for the state screening panel must submit the four-part nomination package outlined below.  Please note that the four parts need to be submitted together to the NBS Program for the request to be considered.

  1. Cover letter – The cover letter should introduce the condition and nominators and provide an explanation of why the condition should be considered for addition to the Michigan NBS panel.
  2. Nomination form – The nomination form is the most critical component of the nomination package. Please use the form provided to complete this requirement. Michigan Department of Health and Human Services (MDHHS) and advisory partners will use the data and evidence reported to consider whether to proceed with an in-state expert review of the condition using the Michigan NBS Condition Readiness Tool (CRT).
  3. Letters of support – A minimum of two letters supporting the nomination are required from subject experts (e.g. clinical, research, laboratory). Input from Michigan specialists with direct knowledge and experience regarding the condition is strongly encouraged.
  4. Conflict of interest form – All members of the nomination team must complete the conflict-of-interest form to disclose any potential conflicts of interest, including financial ones.

Completed nomination packages should be submitted by email to NewbornScreening@Michigan.gov. Upon receipt, the NBS team will review the package for completeness and provide a response within 30 days with requests for additional information or a projected timeline for condition consideration.

Steps for adding a condition to the MI NBS Panel

Michigan stakeholder submits a nomination package to Newborn Screening (NBS) Program.

NBS program staff reviews nomination package for completeness and essential NBS information.

Condition presented to TAC to determine if minimum criteria is met to move to expert-based review.

TAC - Technical Advisory Committee

Minimum criteria not met: Condition does not move forward, and response letter sent to nominators.

Disease-specific advisory committee completes evidence-based review using CRT to assess readiness.

CRT - Condition Readiness Tool

Readiness level ready or developmental: CRT findings sent to TAC.

Readiness level unprepared: Condition does not move forward, and response letter sent to nominators.

TAC reviews CRT findings and votes if condition should be further reviewed by QAAC.

QAAC - Quality Assurance Advisory Committee

QAAC reviews the condition for potential NBS panel inclusion and votes on a recommendation to add.

Not recommended: Condition is not added to Michigan screening panel. A response is sent to nominators outlining committee findings.

QAAC recommendation sent to the Director of MDHHS for approval.

Recommendation sent to Legislative Health Policy Committees for final approval.

Condition Nomination FAQ

  • Who can submit nomination packages for newborn screening panel consideration?

    Any Michigan stakeholder(s) can submit a nomination package provided they have sufficient information to complete the nomination form. Michigan stakeholders include but are not limited to advocacy groups, clinicians, researchers, institutions, laboratories, and individuals who reside in or are affiliated with organizations in Michigan.

  • Why does Michigan have a formal nomination and review process to consider new NBS conditions?

    The nomination and review process helps ensure that only conditions with strong scientific evidence of benefit from early detection and treatment are added to Michigan’s NBS panel. It incorporates input from clinical, laboratory, and NBS experts from within the state to assess the appropriateness and feasibility of universal screening and follow-up for a new disorder.

  • What are the roles of Michigan’s NBS Advisory Committees?

    The NBS Advisory Committees provide expertise and guidance to the Michigan Department of Health and Human Services (MDHHS) regarding NBS. Membership varies based on each committee’s role but often includes representatives from NBS coordinating centers, pediatric specialties, Children’s Special Health Care Services, allied health professions, health care organizations, and parents. Meetings are held on a regular basis to review screening performance metrics, policies, recommendations, and strategies to improve NBS in Michigan. The different types of advisory committees include Disease Specific Advisory Committees, Technical Advisory Committee (TAC), and Quality Assurance Advisory Committee (QAAC).

  • What is the Condition Readiness Tool?

    The Condition Readiness Tool (CRT) is a document developed by the Michigan NBS Program to help assess whether a disorder is appropriate for inclusion on the NBS panel and the state’s readiness to implement screening. It consists of a series of required and supporting criteria related to the disorder, newborn screen, diagnostic test(s), treatment, follow-up, and NBS costs. The criteria are evaluated to determine which are met or unmet to inform next steps.

  • How long does it take to add a new condition to Michigan's NBS panel?

    Adding a new condition to the screening panel is a complex, lengthy process that typically takes a few years from nomination to screening implementation. Once a nomination package advances for formal consideration, it requires successive reviews and recommendations by the Disease Specific, Technical, and Quality Assurance Advisory Committees that meet only one to two times per year.  QAAC recommendations are then forwarded to the Michigan Director of Health and Human Services and Legislative Health Policy Committees for final approval.  Screening can only begin after laboratory and follow-up systems are in place.  Additional time is generally needed for procurement of new lab equipment/materials, validation studies, laboratory information management system (LIMS) integration, and development of follow-up protocols with clinical partners.

  • What conditions are currently included on Michigan’s NBS panel?

    Michigan currently screens for 59 conditions.  The full list can be found on the Michigan Newborn Screening List of Disorders and Fact Sheets webpage.

  • Who should I contact if I have any questions?

    Questions regarding the nomination and review process can be sent to newbornscreening@Michigan.gov. 

Revised 8.2026

 

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