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

PLoS One. 2020 Apr 2;15(4):e0231050. doi: 10.1371/journal.pone.0231050. eCollection 2020.

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Advisory Committees / standards
  • Child
  • Humans
  • Infant, Newborn
  • Laboratories / standards
  • Neonatal Screening / standards*
  • Quality Improvement / standards*

Grants and funding

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.