About the Program
CDC's Newborn Screening Quality Assurance Program (NSQAP) provides unique products devoted to assuring the accuracy of newborn screening test results. The program provides quality assurance services to more than 650 newborn screening laboratories around the world, including all newborn screening laboratories in the U.S., laboratories in more than 75 countries, and 32 newborn screening test manufacturers. NSQAP helps participating newborn screening laboratories ensure that testing accurately detects disorders, does not delay diagnosis, minimizes false positive reports, and sustains high-quality performance. These services ultimately promote delivery of accurate newborn screening results to doctors and families.
Services offered by NSQAP to participating laboratories include:
- Providing reference materials
- Providing proficiency testing and quality control reports
- Offering training and consultation
NSQAP provides newborn screening laboratories with dried blood spot reference materials that mimic newborn specimens. Reference materials are blood samples with chemicals added to make them appear positive for a specific disorder detectable through newborn screening. These reference materials help laboratories assess their ability to produce accurate results for specific disorders.
NSQAP is the only comprehensive source of dried blood spot reference materials in the U.S. Nearly one million dried blood spot reference materials are sent to participating laboratories each year.
NSQAP creates and distributes two types of certified laboratory dried blood spot materials in support of regulatory compliance and accreditation for testing: quality control materials and proficiency testing materials. Laboratory performance is evaluated using these materials and NSQAP provides summary reports of all results to help participating laboratories maintain accurate and reliable testing practices.
Reference materials are critical for:
- Proficiency testing – evaluating a laboratory's performance on specific tests or measurements.
- Quality control – monitoring the quality of the analytical testing processes to assure the accuracy and precision of test results over time.
- Validating new screening tests - making sure new tests produce accurate results before they are put into use.
Proficiency testing and quality control reports
NSQAP helps laboratories maintain high standards of proficiency by assessing their ability to accurately detect markers of newborn screening disorders. Proficiency testing is required for laboratory certification and accreditation.
NSQAP distributes proficiency testing specimens to participating laboratories. After testing the specimens, each laboratory sends its results to NSQAP for review. NSQAP evaluates the results then provides each laboratory with an individualized report, and works to trouble-shoot any problems. NSQAP then publishes data summary proficiency testing reports after each event.
Quality control materials are sent twice per year for periodic use and proficiency testing materials three times per year. NSQAP publishes annual and midyear reports that summarize quality control results for all reported methods used for testing.
Training and consultation
CDC provides laboratories with valuable technical assistance and training. NSQAP co-sponsors conferences, web casts, and hands-on laboratory workshops on the latest technologies and screening methods to detect newborn disorders.
For information about upcoming training opportunities, contact:
Newborn Screening Quality Assurance Program
Mail Stop F-19
4770 Buford Highway, NE
Atlanta, GA 30341-3724
Fax: (770) 488-4255
Participation in the Newborn Screening Quality Assurance Program
Participants include newborn screening laboratories, confirmatory testing laboratories, specialty laboratories, and manufacturers of newborn screening testing materials.
If you are interested in participating in this program, please complete the Participant Request Form [PDF - 325 KB]. There is no cost to participating laboratories for products or shipping, but the laboratory is responsible for required documentation, import fees, taxes, or other costs.
Participants must report data for each product requested online.