NewSTEPs Data Request Policies and Procedures

 

What is the NewSTEPs Data Repository?

The Newborn Screening Technical assistance and Evaluation Program (NewSTEPs), a program of the Association of Public Health Laboratories (APHL) which offers technical assistance and quality improvement initiatives to state newborn screening (NBS) programs. The NewSTEPs Data Repository collects data from each participating NBS program in the United States including 50 states and three territories (Puerto Rico, Guam, and Washington D.C.).

 

Description of NewSTEPs Data 

Submission of data by NBS programs is voluntary and certain data require each NBS program to enter into a Memorandum of Understanding (MOU) with APHL. The MOU includes information regarding the following aspects of data sharing within the NewSTEPs Data Repository: data ownership; data reporting and data security. 

In no event will APHL share state-level quality indicator data or case data with partners. Any data sharing request from a third party of information that is not publicly available will be channeled through APHL's governance structure and each data sharing request from a third party will be directed to the Data Review Workgroup. 

Data collected in the NewSTEPs Data Repository is classified into four categories described below. The Department of Health and Human Services (HHS) Office of Human Research and Protection (OHRP) and the Colorado Multiple Institutional Review Board (COMIRB) have classified NewSTEPs as not engaged in in human subject research and all data collected in the NewSTEPs Data Repository is exempt from Institutional Review Board (IRB) review.  For a descriptive summary and outline of all data collected in the NewSTEPs Data Repository, please refer to the NewSTEPs Data Repository Data Elements document. 

  1. State Profiles - NBS program descriptive data that includes information on program policies and structure, disorders screening status, NBS fees, Health Information Technology (HIT) capabilities, and more. Data classified in this category are collected as annual snapshots beginning with the year 2015, are public facing, and do not require a ratified MOU for submission. NBS programs are encouraged to update this information for the current year by September 1 of the current year. 
  2. Annual Quality Indicators –NBS program annual summary process data collected as eight quality indicators developed by representatives from NBS programs and external NBS stakeholders. Process measures include timeliness of NBS activities, number of total screened, number of screened positives, number of true cases, percentage of eligible newborns without a NBS screen, and more, and allow for longitudinal comparisons within and between NBS programs. For a comprehensive description of all quality indicator measures and their subparts, please refer to the Quality Indicator Source Document. NBS programs are encouraged to provide annual quality indicator data for the current year-1 by April 15 of the current year. For example, 2015 quality indicators are to be entered by April 15, 2016. 
  3. Monthly Timeliness Quality Indicators – Aggregate process data measuring the timeliness of NBS activities for 28 NBS programs participating in an initiative called NewSTEPs 360 with purpose of improving the timeliness of NBS in participating states and territories. These data are composed of three of the eight quality indicators collected under the Annual Quality Indicators classification specific to measuring aspects of timeliness. Data collected between January 2016 through August 2018 (anticipated end date of initiative), classified in this category, are not public facing, submitted only by the 28 participating NBS programs, and require a ratified MOU for submission. For a comprehensive description of these measures and their subparts, please refer to Quality Indicators 1, 2, and 5 in the Quality Indicator Source Document.
  4. Cases – De-identified infant level case data that meet the very specific criteria of a case as defined for public health surveillance (in contrast to what a clinician might define as a case that requires clinical monitoring) provide a standardized characterization of the frequency of NBS disorders in the U.S. and can be linked to date related to the timing of screening and diagnostic activities. Cases entered by NBS programs must have a confirmed diagnosis of a disorder and once entered, the data will be harmonized by NewSTEPs algorithms utilizing public health surveillance case definitions for national monitoring of children’s health outcomes, thereby allowing for comparison of state to state data. Data classified in this category are collected annually beginning with the year 2012, are absent of all information that could potentially identify an infant, are not public facing, and require a ratified MOU for submission. For a comprehensive description of case definitions and case data fields, please refer to the Case Information Worksheet. NBS programs provide time critical case data for the current year - 2 by March 15 of the current year and non-time critical case data for current year - 2 by June 15, 2017. 

Note There are limitations to drawing conclusions about the birth incidences of newborn screening conditions in the US; not all NBS programs are providing cases and not all cases within a state may be reported.

 

Data Request Review 

The NewSTEPs Data Review Subcommittee is charged with providing expertise to make recommendations to NewSTEPs staff and the NewSTEPs Steering Committee on any requests made for data collected within the NewSTEPs Data Repository. Please submit your request with this timeline in mind.  The NewSTEPs Data Review Subcommittee will adhere to the following data request review procedure:

  • There will be an acknowledgement of each request. A log of each request will be kept and made available– date of request, date of decision, name of requestor. Requests for quality assurance projects from NBS programs that are contributing data, take top priority. In general the subcommittee will respect the order in which a request has come in and prioritization will be at the subcommittee’s discretion.
  • Allow at least eight weeks for requests of annual quality indicator data, monthly timeliness quality indicator data, and case data. Requests that are more complex may take additional time.
  • Allow at least three weeks for requests of State Profile data, or other requests deemed expedited by the Data Review Subcommittee.
  • Requesters will be notified if their data request has been reviewed and any clarifications on the data request will be sought. 
  • If the request is granted, the data review workgroup will provide a timeline of when the data will be provided. 
  • If the request is denied, the data review workgroup will provide the reason(s).

 

Third Party Data Request 

Requests for data for projects originating from an entity outside of a data contributor will be considered third party requests. Third party requests for public facing State Profile data, non-identifiable Annual Quality Indicator data, non-identifiable Monthly Timeliness Quality Indicator data, or non-identifiable Case data must obtain approval from the NewSTEPs Data Review Workgroup and NewSTEPs Steering Committee, which reserve the right to grant in their sole and absolute discretion.  

Third party requests for identifiable Annual Quality Indicator data, Monthly Timeliness Quality Indicator data or Case data must obtain approval from the NBS programs directly by the requestor. In the event that a NBS Program does not grant permission to release its identifiable data, the NewSTEPs Data Review Workgroup and NewSTEPs Steering Committee will not grant the third party’s request to access that data. The NewSTEPs Data Review Workgroup and NewSTEPs Steering Committee will only approve of a third party request for identifiable data if a NBS program grants permission to release its identifiable data. 

Additionally, request approval for all NewSTEPs Repository data is contingent upon the terms and conditions agreed to between each NBS program and APHL within their ratified MOU.

Examples of Third parties that may request data include but are not limited to the following:

  1. NBS programs requesting data from NBS programs other than their own; 
  2. Federal agencies; 
  3. Third party affiliates including but not limited to the Genetic Alliance, the Association of State and Territorial Health Officials (ASTHO), March of Dimes (MOD), and others; 
  4. Corporate partners providing services to NBS programs; 
  5. Media 
  6. Advocacy groups, and 
  7. Academic Researches 

 

Data Request Submission 

Upon submission of a data request, you automatically agree to the following provisions: 

  1. Protecting the confidentiality of the States. The release of surveillance data containing state identifying information is strictly prohibited, unless the State 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 in certain circumstances (that would be outlined prior to 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) under grant # U22MC24078 for $1,500,000 Heritable Disorders $850,000. 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 endorsements 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 (NewSTEPs) should not be construed as an endorsement of any analyses, interpretation, or conclusions 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 the reporting system. 
  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. Attempt to do so from public data is a violation of the Federal Privacy Act, 5U.S.C. and the HIPAA Rule.