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      Newborn screening timeliness quality improvement initiative: Impact of national recommendations and data repository

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          Abstract

          Background

          Newborn screening (NBS) aims to achieve early identification and treatment of affected infants prior to onset of symptoms. The timely completion of each step (i.e., specimen collection, transport, testing, result reporting), is critical for early diagnosis. Goals developed by the Secretary of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) for NBS timeliness were adopted (time-critical results reported by five days of life, and non-time-critical results reported by day seven), and implemented into a multi-year quality improvement initiative (NewSTEPS 360) aimed to decrease the time to result reporting and intervention.

          Methods

          The NBS system from specimen collection through reporting of results was assessed (bloodspot specimen collection, specimen shipping, sample testing, and result reporting). Annual data from 25 participating NBS programs were analyzed; the medians (and interquartile range, IQR) of state-specific percent of specimens that met the goal are presented.

          Results

          The percent of specimens collected before 48 hours of life increased from 95% (88–97%) in 2016 to 97% (IQR 92–98%) in 2018 for the 25 states, with 20 (80%) of programs collecting more than 90% of the specimens within 48 hours of birth. Approximately 41% (IQR 29–57%) of specimens were transported within one day of collection. Time-critical result reporting in the first five days of life improved from 49% (IQR 26–74%) in 2016 to 64% (42%-71%) in 2018, and for non-time critical results from 64% (IQR 58%-78%) in 2016 to 81% (IQR 68–91%) in 2018. Laboratories open seven days a week in 2018 reported 95% of time-critical results within five days, compared to those open six days (62%), and five days (45%).

          Conclusion

          NBS programs that participated in NewSTEPs 360 made great strides in improving timeliness; however, ongoing quality improvement efforts are needed in order to ensure all infants receive a timely diagnosis.

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          Most cited references3

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          Tandem mass spectrometry: a new method for acylcarnitine profiling with potential for neonatal screening for inborn errors of metabolism.

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            NewSTEPs: The Establishment of a National Newborn Screening Technical Assistance Resource Center

            As newborn screening (NBS) programs in the US implement expanded screening panels, utilize emerging technologies and identify areas for improvement, the need to establish and maintain a community engagement based national technical assistance center becomes apparent. The Newborn Screening Technical assistance and Evaluation Program (NewSTEPs)—a program of the Association of Public Health Laboratories (APHL) in partnership with the Colorado School of Public Health (ColoradoSPH), offers expertise in newborn screening program development, member connection, data analysis, and program evaluation. NewSTEPs provides a secure online data repository designed to collect comprehensive data on newborn screening programs in three strata: state profiles (description of each state program including program hours, fees, and disorders screened), quality indicators (metrics of program performance encompassing screening accuracy and timeliness) and NBS public health surveillance case definitions. NewSTEPs was created in 2012 under a cooperative agreement with the United States Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (MCHB). Successful activities of NewSTEPs have resulted in the establishment of a technical assistance resource center and the organization of a network of newborn screening experts. In addition, NewSTEPs coordinates efforts with other federally funded programs in order to maximize resources and to ensure a unified approach to data collection and information sharing.
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              Delays at hospitals across the country undermine newborn screening programs, putting babies at risk of disability and death

              E. Gabler (2013)
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: VisualizationRole: Writing – original draft
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Funding acquisitionRole: ResourcesRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: ResourcesRole: Writing – review & editing
                Role: ResourcesRole: Writing – review & editing
                Role: ResourcesRole: Writing – review & editing
                Role: ResourcesRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: Project administrationRole: ResourcesRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: Writing – original draft
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                2 April 2020
                2020
                : 15
                : 4
                : e0231050
                Affiliations
                [1 ] Center for Public Health Innovation, CI International, Littleton, Colorado, United States of America
                [2 ] Department of Epidemiology, Colorado School of Public Health, University of Colorado Denver, Aurora, Colorado, United States of America
                [3 ] Association of Public Health Laboratories, Silver Spring, Maryland, United States of America
                [4 ] Maternal and Child Health Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services Rockville, Rockville, Maryland, United States of America
                [5 ] Department of Pediatrics, Willis-Knighton Health System, Tulane University School of Medicine, Shreveport, Louisiana, United States of America
                [6 ] Department of Community and Behavioral Health, Colorado School of Public Health, University of Colorado Denver, Aurora, Colorado, United States of America
                TNO, NETHERLANDS
                Author notes

                Competing Interests: The authors have read the journal's policy and have the following competing interests: MKS, JIM, and YKG are paid employees of CI International. The Cystic Fibrosis Foundation provided support for this study under Grant Number SONTAG16Q10 [MKS]. This does not alter our adherence to PLOS ONE policies on sharing data and materials. There are no patents, products in development or marketed products to declare.

                Author information
                http://orcid.org/0000-0003-2501-652X
                http://orcid.org/0000-0002-7665-3791
                http://orcid.org/0000-0003-4145-6453
                http://orcid.org/0000-0002-2532-1084
                http://orcid.org/0000-0002-7786-3301
                http://orcid.org/0000-0003-1753-7173
                Article
                PONE-D-19-27133
                10.1371/journal.pone.0231050
                7117765
                32240266
                509cf10b-da89-4bd0-9ca5-202b9d7fc4eb

                This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.

                History
                : 27 September 2019
                : 15 March 2020
                Page count
                Figures: 5, Tables: 7, Pages: 17
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100007305, Maternal and Child Health Bureau;
                Award ID: UG8MC28554
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000897, Cystic Fibrosis Foundation;
                Award ID: SONTAG16Q10
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100007305, Maternal and Child Health Bureau;
                Award ID: U22MC24078
                Award Recipient :
                The project described in this article was funded by the Department of Health and Human Services, Health Resources and Services Administration under Cooperative Agreements #UG8MC28554 [MKS] and #U22MC24078 [JO] and the Cystic Fibrosis Foundation under Grant Number SONTAG16Q10 [MKS]. The HRSA provided support in the form of salaries for authors [MKS, JIM, SM, CY, RS, SE, SS, JO, YKG], but did not have any additional role in the study design, or data collection and analysis. CI international provided support in the form of salaries for some of the authors [MKS, JIM, YKG]. The specific roles of these authors are articulated in the ‘author contributions’ section. The HSRA did however participate in the decision to publish as well as in the preparation of the manuscript. The CFF and CI International did not have any role in the study design, or data collection and analysis, the decision to publish, or preparation of the manuscript.
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                Custom metadata
                Data cannot be shared publicly because of signed memoranda of understanding between state newborn screening programs and the Association of Public Health Laboratories. Data requests are reviewed by the NewSTEPs Data Review Workgroup (contact via careema.yusuf@ 123456aphl.org ) for individuals who meet the criteria for access to state-level data.

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