APHL collaborates with CDC to assure the proficiency of newborn screening laboratories. Emergency coordination, policy guidance and exchange of information also serve to improve quality.
Working in partnership with APHL, the CDC's Newborn Screening Molecular Biology Branch (NSMBB) operates a voluntary, non-regulatory program to maintain and enhance the quality of newborn test results at state public health laboratories. The Newborn Screening Quality Assurance Program (NSQAP) provides services to more than 85 domestic newborn screening laboratories, 31 manufacturers of diagnostic products and laboratories in 67 countries. It has served as the reputable source for newborn screening quality assurance services for over 33 years.
The NSQAP sends coded specimens to participating laboratories to assess their testing proficiency. If a laboratory makes an error in identification, the program works with the institution to identify the error and improve laboratory practices. The program also publishes quarterly reports to allow laboratories to benchmark practices against their peers.
Feedback Requested: Newborn Screening Cutoffs using Dried Blood Spots
The APHL Newborn Screening Quality Assurance and Quality Control Subcommittee has developed a document, "Overview of Cutoff Determinations and Risk Assessment Methods used in Dried Blood Spot Newborn Screening." The purpose of this document is to provide an overview of general considerations and approaches laboratories have historically used to determine cutoffs to distinguish between normal and out-of-range screen results. Considerations for specific categories of newborn screening disorders are outlined along with information on the variety of approaches to determine cutoff values for various analytes.
APHL is requesting your feedback on this document. Please review the document and respond to the accompanying feedback survey (links below) by Friday, January 5, 2018.
Your feedback is extremely important and we thank you for your time. If you have any questions, please contact Laura Russell.
Newborn Screening Analyte Interference List
The Newborn Screening Analyte Interference List is a compilation of published and observed analyte interferences of newborn screening assays. The list serves as a central, one-stop resource for all known newborn screening assay interferences. Users can both review and add interferences to the list.
Quality Control/Quality Assurance Training Materials
2017 MPS I Webinar Series
Implementation Considerations Webinar Recording and Transcript
Clinical Aspects Webinar Recording and Transcript
Overview of Available Screening Methods Webinar Recording and Transcript
Other QA/QC Webinars
2016 APHL X-ALD 101- Clinical Aspects and Screening Methods Webinar Recording and Transcript
2014 APHL Pompe Disease 101 - Clinical Aspects and Screening Methods Webinar