Quality Indicators

Quality Indicator 5: Timeliness of Newborn Screening Activities

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Purpose: To identify time components of the newborn screening system that may be shortened in order to shorten the time to identification of infants at risk for newborn screening disorders, thereby decreasing the risk of potential harm to infants who may be identified with a disorder on the newborn screening panel.

Proportion of specimens/ screens that were obtained during the following process intervals:

  • a) Time from birth to specimen collection/ point-of-care testing
  • b) Time from specimen collection to receipt at your state's newborn screening laboratory.1
  • c) Time from specimen receipt at your state's newborn screening laboratory to reporting out specimen results.
  • d) Time from birth to reporting out specimen results.
  • e) Time from reporting out-of-range results to medical intervention by an appropriate medical professional for infants with a confirmed clinical diagnosis.
  • f) Time from birth to confirmation of clinical diagnosis by an appropriate medical professional.
  • g) For infants with an out-of-range newborn screen result requiring a clinical diagnostic workup by an appropriate medical professional, time from birth to determining if a result was a false positive.

Screening Data for Denominators:

  • a) The denominators for 5a.i-5a.v are calculated as the summation of values entered for each of the specified time categories in units of hours from birth to specimen collection/ point-of-care testing:
    • i. Total number of first dried blood spot specimens collected.
    • ii. Total number of reported complete critical congenital heart disease (CCHD) screens.
    • iii. Total number of reported complete early detection and intervention (EHDI) screens.
    • iv. For two screen states, total number of first dried blood spot specimens collected for the second screen.
    • v. Total number of subsequent dried blood spot specimens collected.
  • b) The denominators for 5b.i and 5b.ii are calculated as the summation of values entered for the specified time categories in units of days from specimen collection to receipt at your state's newborn screening laboratory:
    • i. Total number of first dried blood spot specimens received at your state's newborn screening laboratory.
    • ii. Total number of subsequent dried blood spot specimens received at your state's newborn screening laboratory.
  • c) The denominators for 5c.i-5c.v are calculated as the summation of values entered for each of the specified time categories in units of days from specimen receipt at yoru state's newborn screening laboratory to reporting out results:
    • i. Total number of dried blood spot specimens with out-of-range results requiring clinical diagnositc workup by an appropriate medical professional for time critical disorders.2
    • ii. Total number of dried blood spot specimens with out-of range results requiring clinical diagnostic workup by an appropriate medical professional for non-time critical disorders.
    • iii. Total number of first dried blood spot specimens with a normal or out-of-range result for any disorder.
    • iv. Total number of subsequent dried blood spot specimens with a normal or out-of-range result for any disorder.
    • v. Total number of second screen dried blood spot specimens in two screen states with a normal or out-of-range result for any disorder.
  • d) The denominators for 5d.i-5d.ii are calculated as the summation of values entered for each of the speicifed time categories in units of days from birth to reporting out results:
    • i. Total number of dried blood spot specimens with out-of-range results requiring clinical diagnostic workup by an appropriate medical professional for time critical disorders.2
    • ii. Total number of dried blood spot specimens with out-of-range results requiring clinical diagnostic workup by an appropriate medical professional for non-time critical disorders.
    • iii. Total number of first dried blood spot specimens with a normal or out-of-range result for any disorder.
    • iv. Total number of subseqeuent dried blood spot specimens with a normal or out-of-range result for any disorder.
    • v. Total number of second screen dried blood spot specimens in two screen states with a normal or out-of-range result for any disorder.
  • e) No denominator is required. Data are pulled from cases entered into the NewSTEPs Repository and descriptive statistics are generated and displayed by disorder category.
  • f) No denominator is required. Data are pulled from cases entered into the NewSTEPs Repository and descriptive statistics are generated and displayed by disorder category.
  • g) Number of infants that had an out-of-range result requiring clinical diagnostic workup by an appropriate medical professional for:
    • i. A dried blood spot screen.
    • ii. A critical congenital heart disease (CCHD) point-of-care screen.
    • iii. An early hearing detection and intervention (EHDI) point-of-care screen.

Quick Tips 

  • Time from birth to collection (QI5a) is the only measure collected in the unit of hours. All other measures (QI 5b-d) are collected in the unit of days (i.e. will be an integer in units of whole days). 
  • Each quality indicator has a designated measure for first, subsequent and routine second screens. Please ensure that you separate out these screens and enter them in the appropriate fields. 
  • For time critical disorders (QI5c.i, QI5d.i) and non-time critical disorders (QI5c.ii and QI5d.ii), NewSTEPs does not specify whether these measures should include first specimens, subsequent specimens, or both. The purpose of this quality indicator is to capture the time it takes to interpret the results or act on that result. For this measure, time intervals should be calculated using the report-out times for the earliest specimen tested that detected the borderline or out-of-range result that led to an infant seeking diagnostic work-up by a medical professional. Please note that this is different than the ACHDNC guidelines, which only asks for initial specimens.
    • Calculate time to report out using the first specimen if: 
      • An out-of-range result was detected on the first specimen 
      • An out-of range result was detected on the first specimen and confirmed on the subsequent specimen
      • A borderline result was detected on the first specimen and an out-of-range result was detected on the subsequent specimen during repeat testing 
      • A first specimen was unsatisfactory, tested, and detected the out-of-range result (i.e. unsatisfactory first specimen detected an out-of-range result). 
    • Calculate the time to report out using the subsequent specimen if the first specimen was unsatisfactory, not tested, and the resulting subsequent specimen detected an out-of-range result during repeat testing
    • For two-screen states, calculate the time to report out sing the specimen from which the out-of-range was detected.

Footnotes:

  1. In the NewSTEPs Repository, state profiles will gather information on how newborn screening programs define receipt at laboratory and how this is recorded: Definition of receipt by lab: a) courier drop off; b) logged in by lab staff (electronic or manual); c) when testing is initiated; or d) Other, please describe. Recording of Specimen receipt by lab: a) Date and time stamp (Gold Standard); b) Date stamp; c) Other, please describe.
  2. Time Critical Disorders: Please see the table from the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children's (ACHDNC) recommendations on timeliness in newborn screening that was created based on the Societey for Inherited Metaoblic Disorders (SIMD) position statement and expert opinion from metabolic geneticists, hematologists, endocrinologists and pulmonologists.  
  3. A definition of medical intervention can be found in Appendix A: Glossary of Terms of the QI Source Document.
  4. Individual cases of early hearing detection and intervention (EHDI) are not collected in the NewSTEPs Repository at this time.
  5. A list of disorder categories can be found in Appendix A: Glossary of Terms of the QI Source Document.