Timeliness Toolkit for Expanding Newborn Screening Services

Section 2: Policy Guide

This resource is part of the Timeliness Toolkit for Expanding Newborn Screening Services. Explore the full Timeliness Toolkit for Expanding Newborn Screening Services.

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Summary

Each state or territory, by law, operates its own newborn screening (NBS) program. Therefore, although all states have laws that require screening, changing those laws and policies governing NBS can vary by state.  This Policy Guide, developed in partnership with the March of Dimes, is designed for advocates who may be new to NBS  and provides a "how to" on the options and general steps needed to secure a policy or regulation change to address NBS timeliness goals.

What is Newborn Screening (NBS)?

Each year, 12,000 babies with serious, but treatable conditions are identified by state newborn screening programs. Newborn screening is a vital public health program that tests newborns for critical disorders that may not show clinical symptoms at birth but can cause permanent disability or death if not detected and treated in the early days, weeks or months of life. Newborn screening is a multi-step system that involves families, birthing facilities, laboratories, follow-up programs and healthcare providers where any delay in the newborn screening process may jeopardize the health and survival of affected babies.

All newborns should be screened between 24 and48 hours after birth. For most tests, a small blood sample is taken from the newborn’s heel and placed on a newborn screening card. This card is then sent to the to the state public health laboratory for analysis. If an unusual result is detected, the baby’s health provider is notified, who then works with the family to receive confirmatory testing and other necessary services.

Why is Timeliness Important?

In November 2013, the Milwaukee Journal Sentinel article series, Deadly Delays, reported on serious delays in testing and follow-up among newborn screening programs across the country. Key factors in these delays included laboratories being closed on weekends and holidays, slow transport of samples, and insufficient tracking of hospitals that sent late samples. Since then, state and federal officials and stakeholders have been working to improve programs.

In 2015, the U.S. Department of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) recommended timeliness goals for newborn screening and encouraged benchmark progress of achieving 95% of each goal by 2017. The overall goal is to communicate all presumptive results for time-critical conditions within five days of the baby’s life. All other conditions should be communicated no later than seven days of life. To achieve this and reduce delays,  initial specimens should be collected no later than 48 hours of life and should be received at the laboratory within one or two days for testing.

Barriers and Solutions

Newborn screening is a state-specific public health activity, and therefore hospital protocols and lab requirements vary from state to state. Newborn screening is a multi-step process that involves individual health care providers, hospital administrators, couriers to transport samples, and state health department laboratory and follow-up staff. As a result, there are multiple junctures where barriers to timely screening can occur. These include a lack of understanding and awareness of the importance of timely screening, inconsistent hospital protocols across municipalities and states, transporting samples in batches that contain multiple days of bloodspots, insufficient lab hours and workforce to process samples.

As of May 2018, 34 newborn screening programs operate at six or seven days a week (see the NewSTEPs map for up-to-date information). States that have expanded their courier services and specimen processing schedules to include Saturdays and holidays have reduced the time between receiving samples and reporting results.

Step 1: Determine the Status and Needs of the NBS Program
  • Research the state’s law or regulations that guide the newborn screening program’s policies impacting timeliness goals such as transit time, courier services and laboratory operating hours.
  • Confirm with newborn screening officials if the state is meeting the timeliness goals. View your state’s timeliness quality indicators here.
  • Identify barriers and determine if a policy solution including funding is required to address them.
Step 2: Identify Stakeholders and Partners who would Support a Policy Change

State Health Officials

Newborn screening and state health officials, including state health officers and maternal and child health directors, are critical partners in providing advocates with information and technical assistance about the newborn screening program. Key staff includes lab directors and program and follow-up staff such as genetic counselors, nurses and social workers. Advocates should solicit their support, but recognize how state government employees are permitted to interact with advocates. For example, officials may be able to respond to requests for information and provide briefings to elected officials and advocates, but they are not allowed to contact legislators. It is important for advocates to involve state officials throughout the process to help develop a policy that will support and/or improve the newborn screening program and allow officials to interact appropriately in the process.

Partners

Organizations that may be interested in this issue include those that represent parents and caregivers, maternal and child health advocates, healthcare providers, and hospitals. Health care providers include both primary care and specialty physicians, midwives, nurses, social workers and genetic counselors. Newborn screening covers a broad array of conditions and the issue is of interest to advocates from the rare disease clinical and research communities. Among interested groups is the March of Dimes, American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP), American Congress of Obstetrics and Gynecologists (ACOG), state hospital associations and Baby's First Test of the Genetic Alliance.

For more information on how newborn screening programs can effectively collaborate with family advocates, watch Working with Family Advocates in Newborn Screening, hosted by Baby’s First Test on September 21, 2017.

State Policy Makers

Successful policymaking involves establishing and maintaining ongoing relationships with key elected officials including the governor and state legislators and their staff. Cultivate bi-partisan relationships with the legislative leadership and members of key committees who have jurisdiction over the newborn screening program and its budget, which is usually part of the health department. Elected officials (or their staff) who have had an experience with the issue can be a powerful ally by either sponsoring or promoting legislation Legislatures inclined to be supportive could include one who has a personal experience with a newborn screening condition or has a professional connection (i.e. health care provider, genetics background).

Key policymakers include:

  • Governor
  • Lt. Governor
  • State Health Officer (Secretary of Health, Health Commissioner, Director of Health)
  • Senate President
  • Speaker of the House/Assembly
  • Minority leaders (both chambers)
  • Chairs of the Health, Finance, Appropriations, Budget Committees (both chambers)
Step 3: Determine the Appropriate Strategy to Secure the Policy Change

Changes in state health policy may require several strategies with some strategies requiring more activities and resources than others. The options include approval by an advisory committee, the health department and/or board of health; adoption of a regulation (rulemaking); passage of an appropriation bill (state budget funding); or passage of an authorization bill (legislation). Policymakers are often interested in knowing the following about a policy change:

  • What is its short-or long-term public health impact?
  • What is the cost and cost-effectiveness of making the change?
  • What has been the experience in other states that have made changes to transit times, courier services and/or laboratory operating hours? (See the case narratives from 10 participating NBS programs detailing their experiences, challenges, and lessons learned when expanding to weekend and holiday operations)

State Health Authority

Newborn screening programs are located within the state health department, which may have the authority to change newborn screening policy through one or more of the agency’s functions: the Newborn Screening Advisory Committee, the Title V (MCH) Coordinator, the State Health Commissioner, Secretary or Director of the Health, and/or the Board of Health.

Regulation (rulemaking)

A regulation or rule is issued by the agency which has authority over the program and carries the force of law. Each state’s administrative procedure act (or equivalent law) prescribes the guidelines for issuing regulations and allowing public comment. A regulation may be required following enactment of legislation or may be sufficient to change the policy on its own. Consider the following in developing a regulatory strategy:

  • Is a regulation required in order to change the policy?
  • If a regulation is needed, when can it be issued and what are the steps and timeline in the process?
  • Are public comments allowed, and if so, at what point in the process?

For more information about rulemaking, see Know the Rules: An Overview of State Agency Rulemaking by ChangeLab Solutions.

Appropriations (funding)

An appropriation is a directive from the state legislature to the state treasury to obligate or spend funds for a specific purpose. A program can be funded through an appropriation without an authorization for the program. Newborn screening programs develop a budget or fiscal note for the state health department and/or other budget authority depending upon the state budgeting process.'

State fiscal years vary by state, but the majority begin July 1. Exceptions are Alabama, Michigan and the District of Columbia beginning October 1, New York on June 1, and Texas on September 1. Planning for legislative budget initiatives takes place months in advance. According to the National Association of State Budget Officers (NASBO), 30 states operate on an annual operating budget cycle providing appropriations for one fiscal year. Twenty states have biennial budgets providing funding for a two-year fiscal cycle. 

Authorization (legislation)

An authorization bill provides direction to the state health department on how to change the policy. Authorizing legislation can be considered the last option for changing the law as it requires more activities and resources, and can also put the law at risk of unwanted changes. Consider the following in developing a legislative strategy to authorize a change in the law or to appropriate funds to support it:

  • Is there support from the state health officer and the governor?
  • Who should be the principal sponsors of the legislation?
  • Which other policymakers would be willing to support the legislation?
  • Do the sponsors sit on committees with jurisdiction over the program or are they in a leadership position?
  • Does the issue have bipartisan support?
  • Do you need separate strategies for the House and Senate?
Step 4: Develop an Action Plan

Successful changes in policy to improve newborn screening program timeliness goals depends on developing and implementing a comprehensive action plan. Listed below are actions that can be taken to support each strategy. Note that advisory committee and regulatory strategies do not usually require the same level of activity as legislative advocacy, but some of these actions may apply.

Agency/Board/Regulation

Activities could include public comments and meetings with state health authorities.

  • Develop an issue brief, fact sheet, and talking points (see Section 5)
  • Identify families who can share their stories
  • Identify providers who can share their expertise
  • Present verbal and/or written testimony to the NBS advisory committee or at regulatory hearings (include family stories and provider expertise)
  • Secure support from the State Health Officer and/or Board of Health

Legislation/Appropriation

Activities could include securing legislative champions or sponsors, providing legislative language, testifying and/or providing letters of support, holding an advocacy day at the state capitol and holding other meetings with legislators, utilizing action alerts and social media messages and press activities.

  • Secure legislative sponsors to champion the issue
  • Develop an issue brief, fact sheet, and talking points (see Section 5)
  • Identify families who can share their stories
  • Identify providers who can share their expertise
  • Hold an educational briefing for policymakers
  • Present verbal and/or written testimony to legislative committee hearings include family stories and provider expertise
  • Conduct an advocacy day at the state capitol to meet with legislators
  • Implement a media strategy that includes press events, family stories, letters to the editor (targeted papers or statewide)
  • Launch a grassroots campaign including legislative alerts and social media
  • Use key contacts (individuals who know elected officials) to gain access to policymakers

See "Developing an Advocacy Strategy" (Chapter 3) in UNICEF's Advocacy Toolkit for additional information.