Abstract
Newborn screening is the largest genetic testing effort in the United States and is considered one of the ten great public health achievements during the first 10 years of the 21st century. For over 35 years, the Newborn Screening Quality Assurance Program (NSQAP) at the US Centers for Disease Control and Prevention has helped NBS laboratories ensure that their testing does not delay diagnosis, minimizes false-positive reports, and sustains high-quality testing performance. It is a multi-component program that provides comprehensive quality assurance services for dried blood spot testing. The NSQAP, the Biochemical Mass Spectrometry Laboratory (BMSL), the Molecular Quality Improvement Program (MQIP) and the Newborn Screening Translation Research Initiative (NSTRI), aid screening laboratories achieve technical proficiency and maintain confidence in their performance while processing large volumes of specimens daily. The accuracy of screening tests could be the difference between life and death for many babies; in other instances, identifying newborns with a disorder means that they can be treated and thus avoid life-long disability or severe cognitive impairment. Thousands of newborns and their families have benefited from reliable and accurate testing that has been accomplished by a network of screening laboratories and the NSQAP, BMSL, MQIP and NSTRI.
Highlights
Newborn screening (NBS) is the largest genetic testing effort in the United States and is considered one of the ten great public health achievements during the first 10 years of the 21st century [1]
In 2011, Molecular Quality Improvement Program (MQIP), in collaboration with the Association of Public Health Laboratories (APHL), launched a laboratory site visit program to assess the molecular components of the newborn screening laboratory
Newborn Screening Quality Assurance Program (NSQAP), Biochemical Mass Spectrometry Laboratory (BMSL), MQIP and Newborn Screening Translation Research Initiative (NSTRI) provide proficiency testing (PT) testing, quality control (QC) materials, filter paper evaluations, special consultations, and technical assistance to public health and private laboratories engaged in NBS
Summary
Newborn screening (NBS) is the largest genetic testing effort in the United States and is considered one of the ten great public health achievements during the first 10 years of the 21st century [1]. The Centers for Disease Control and Prevention’s Newborn Screening Quality Assurance Program (NSQAP) helps NBS laboratories ensure that testing accurately detects these disorders, does not delay diagnosis, minimizes false-positive reports, and sustains high-quality testing performance [3]. All NBS laboratories in the United States must meet strict quality assurance (QA) criteria in order to perform testing on human specimens through the Clinical Laboratory Improvement Amendments (CLIA) [4]. They must participate in proficiency testing (PT) programs designed to evaluate the quality of laboratory performance on a periodic basis using specimens in the dried blood matrix.
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