NSQAP's purpose is to improve interlaboratory comparability and to work toward interlaboratory harmonization of newborn screening tests that use DBSs. Current participants include newborn screening laboratories, confirmatory testing laboratories, diet monitoring laboratories, and manufacturers.
The QA program consists of two DBS distribution components: QC materials for periodic use and quarterly PT. Laboratories can participate in either or both parts. Results from participating laboratories are identified by laboratory code numbers to ensure confidentiality. For the QC part, NSQAP distributes DBS materials at 6-month intervals. Participants return quantitative results from five different analytical runs of the QC materials. For each 6-month period, NSQAP compiles and distributes the reported results. NSQAP offers QC programs for thyroxine (T4), thyroid-stimulating hormone (TSH), phenylalanine (Phe), total galactose (Gal), 17 alpha-hydroxyprogesterone (17-OHP), leucine (Leu), methionine (Met), tyrosine (Tyr), valine (Val), and citrulline (Cit). We recently began offering QC materials for acylcarnitines (CO, C2, C3, C4, C5, C5DC, C6, C8, C10, C14, C16 and C18).
For the PT part of the program, NSQAP distributes quarterly panels of DBS specimens that participants analyze once. They return their analytical results and qualitative (clinical) assessments for performance grading of the PT specimens. NSQAP prepares PT quarterly reports that show the distributions of analytical values and qualitative assessments reported by participants. NSQAP offers PT programs for T4, TSH, 17-OHP, Total Gal, biotinidase, galactose-1-phosphate uridyltransferase, amino acids (Phe, Leu, Met, Tyr, Val, Cit), acylcarnitines (C3, C4, C5, C5DC, C6, C8, C10, C14, C16), sickle cell disease (SCD) and other hemoglobinopathies. (Currently, the PT panels for SCDs and other hemoglobinopathies are limited to specimens containing hemoglobins related to SCDs, alpha-thalassemia, hemoglobin E-related disorders, and hemoglobins representative of beta-thalassemia in combination with a structural variant.)
At the end of each year, we prepare and distribute to all participants a summary of all PT and QC data reported for that year. There is no fee for participation in the NSQAP. Distributions of PT panels occur in January, April, July, and October. QC materials are distributed in January and July. Packages are shipped by FedEx. There is no cost to the participant for products or shipping. To request products, please download the Request Participation Form (PDF 16KB) and fax it to NSQAP at (770) 488-4255. If you have questions about the QA program, please contact:
Newborn Screening Quality Assurance Program
Centers for Disease Control and Prevention (CDC)
4770 Buford Highway N.E., Mailstop F-43
Atlanta, GA 30341-3724 USA
Voice Phone: (770) 488-4582
FAX Number: (770) 488-4255
E-Mail: CBell@cdc.gov
