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.

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.