NewSTEPs Data Request Policies and Procedures

The NewSTEPs Data Repository

The Newborn Screening Technical assistance and Evaluation Program (NewSTEPs), a program of the Association of Public Health Laboratories (APHL) offers technical assistance and quality improvement initiatives to newborn screening (NBS) programs. The NewSTEPs Repository collects data from participating NBS programs in the United States (US), including the 50 states, Washington D.C., and five territories (i.e., American Samoa, Commonwealth of Nothern Mariana Islands, Guam, Puerto Rico, and US Virgin Islands). 

NewSTEPs staff makes efforts to validate all data; however, due to the self-reporting, voluntary nature of data collection, the data could be subject to errors or inaccuracies. 

 

NewSTEPs Data

  1. NBS Program Profiles - provide programmatic information that is specific to the newborn screening program, such as disorders screened, policies, fees, and program structure. This information is available to the public. NewSTEPs requests that programs update their profile data when changes occur and review their profiles for completion every August for the current year.
  2. Quality Indicators - monitor the performance across the NBS system on a monthly and annual basis. See the Quality Indicator Source Document for complete definitions. Quality indicators are due each April for the previous calendar year (e.g., 2021 quality indicator data is due by April 2022).
  3. Cases - provide confirmed case counts for each newborn screening disorder, stratified by birth year. Confirmed cases are entered as a two-year delay and only for disorders that were part of the NBS program's routine screening panel during the year of birth. All confirmed cases entered in the NewSTEPs Repository are self-reported; although NewSTEPs does its best to validate this data, variations may exist depending on the criteria utilized within the program and the clinical criteria applied when entering data. Additionally, some programs may face challenges classifying certain diseases, especially those with milder or later onset phenotypes. As a result, case counts may change over time.
    • Individual case data - are infant-level cases that provide demographic, screening information (e.g., time to medical intervention, time to diagnosis), and details related to the final diagnosis. See the NewSTEPs Case Worksheets for more information on the infant-level metrics collected.
    • Aggregate case data - reflect the total number of confirmed case counts per disorder, stratified by year. Each state/territory is requested to enter aggregate cases for Core RUSP conditions and the option to enter aggregate cases for Secondary RUSP conditions.
      • Note: Although the individual case collection provides more information at the infant-level, this is often incomplete given the time and resources it takes to enter this level of information. Therefore, aggregate case counts serve as a more complete condition count. 

Data Sharing and Privacy

APHL will not share state/territory-level quality indicator or case data with investigators unless permission is provided by the NBS program. Sharing aggregate, unpublished data with investigators must be approved by the NewSTEPs Steering Committee. For case data, NewSTEPs will follow the "Rule of 5," which prevents data sharing if there are five newborns or fewer for a given category in a given year. 

 

Data Request Process

NewSTEPs encourages data requests for research and quality improvement purposes. NewSTEPs will not share state/territorial-level quality indicator or case data unless explicit permission has been granted by the NBS program. Investigators can submit a data request for quality indicator or case data via the web form. Each data request will first be directed to the NewSTEPs Data Manager, who will review the request and follow up with any additional questions or caveats to keep in mind. Depending on the nature of the request, the NewSTEPs Steering Committee will also provide recommendations regarding sharing data collected with the repository. Please submit your request with this timeline in mind. 

Overall, NewSTEPs will adhere to the following data request review procedure:

  1. There will be an acknowledgment of each request, and the request will be entered into our log. In general, NewSTEPs will respect the order in which a request was received, and prioritization will be at NewSTEPs' discretion.
  2. Investigators will be notified if their data request has been reviewed, and any clarification on the data request will be sought. Depending on the nature of the request, the NewSTEPs Data Manager may schedule a call with the investigator to discuss the request and any data limitations.
  3. Depending on the nature of the request, the NewSTEPs Steering Committee will review and provide feedback. If the request is granted, a timeline will be provided for data availability. 

Allow at least three weeks for requests for NBS Profile data, and national-level quality indicator and case data. Requests that are more complex may take additional time. If the request is for state-level quality indicator and case data, we will need to get permission from the NBS Programs; this can take about eight weeks. 

 

Data Request Submission

Upon submission of a data request, investigators automatically agree to the following provisions.

  1. Protecting the confidentially of the NBS programs. The release of surveillance data containing state/territory identifying information is strictly prohibited unless the state/territory has provided explicit permission to do so. All results of a study shall be restricted to aggregate data and shall not identify any individual, institution, or firm.
  2. NewSTEPs reserves the right to suppress data to maintain case confidentiality. Case data tables will not contain potentially identifying information, small cell values less than five, or information on small subgroups.
  3. All publications using the data provided must acknowledge the NewSTEPs program, and certain circumstances (that will be outlined before the release of data) may need to acknowledge specific state programs. The following is a suggested citation for NewSTEPs: This project is/was supported by the Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services (HHS) under grant # U22MC24078 for $2,300,000. This Information or content and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsement be inferred by HRSA, HHS or the US Government.
  4. The dissemination of any interpretation or findings based upon the data provided must be accompanied by the following disclaimer: The authorized release of <data category> newborn screening data by the Newborn Screening Technical assistance and Evaluation Program (NewSTPEs) should not be construed as an endorsement of any analyses, interpretation, or conclusion reached by the author(s).
  5. The data provided will be used only for the purposes stated in the data request form.
  6. The data are provisional. Newborn screening programs can modify or delete past data at any time, even months or years after they are initially entered, due to the dynamic nature of reporting systems.
  7. Data should not be released to a third party who is not listed on the request form. The third party should be referred directly to the Newborn Screening Technical assistance and Evaluation Program (NewSTEPs).
  8. Requesters agree not to use de-identified data to determine the identity of individual infants or state newborn screening programs. Attempting to do so from public data is a violation of the Federal Privacy Act, 5U.S.C. and the HIPAA Rule.