Assuring Laboratory Quality

Quality Assurance in Newborn Screening

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.

There is no margin for error in newborn screening. Precise analysis and assiduous follow-up are required to protect the health of potentially affected children. Any suspect test result must be confirmed immediately with follow-up diagnostic studies and treatment to prevent mental retardation and premature death.

Working in partnership with APHL, the Centers for Disease Control and Prevention operates a voluntary, non-regulatory program to maintain and enhance the quality of newborn test results at state public health laboratories. This Newborn Screening Quality Assurance Program provides services to more than 73 domestic newborn screening laboratories, 29 manufacturers of diagnostic products and laboratories in 58 countries. It has served as the reputable source for newborn screening quality assurance services for over 29 years.

The Newborn Screening Quality Assurance Program 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.

Quality Assurance/Quality Control Subcommittee

APHL’s Quality Assurance/Quality Control Subcommittee of the Newborn Screening and Genetics in Public Health Committee links the CDC with state newborn screening programs. It fosters collaboration and provides input to quality assurance and proficiency testing. The QA/QC subcommittee also:

• Serves as a liaison to organizations, programs, and activities that address issues concerning quality assurance of newborn screening systems.
• Provides guidance for the Newborn Screening Quality Assurance Program (NSQAP) on procedures, policies, and activities for the quality assurance of laboratory testing.
• Provides a communications conduit between NSQAP and newborn screening systems.
• Examines quality assurance concerns identified by the subcommittee and APHL members, newborn screening systems, NSQAP and other organizations.