Newborn Screening Quality Assurance Program

Overview

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 670 newborn screening laboratories around the world, including all newborn screening laboratories in the U.S., laboratories in more than 86 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. NSQAP services to participating laboratories include:

• Providing reference materials
• Providing proficiency testing and quality control reports
• Offering training and consultation

Reference materials

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. The 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 1 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. NSQAP provides summary reports of all results to help participating laboratories maintain accurate and reliable testing practices.

Reference materials are critical for:

1. Proficiency testing – evaluating a laboratory's performance on specific tests or measurements.
2. Quality control – monitoring the quality of the analytical testing processes to assure the accuracy and precision of test results over time.
3. 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 troubleshoots any problems. NSQAP then publishes data summary proficiency testing reports after each event.

Quality control materials are sent twice a year for periodic use and proficiency testing materials three times a 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 cosponsors a number of events that help labs detect newborn disorders. These include:

• Conferences
• Web casts
• Hands-on laboratory workshops on the latest technologies and screening methods

Receive additional information about upcoming training opportunities by contacting:

Newborn Screening Quality Assurance Program

Mail Stop F-19
4770 Buford Highway, NE
Atlanta, GA 30341-3724

Phone: 770-488-4582

Email: NSQAPDMT@cdc.gov

Participation

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 visit the NSQAP Participant Portal. Products and shipping are free for participating laboratories. Laboratories are responsible for the cost of the following:

• Required documentation
• Import fees
• Taxes
• Other costs

Participants must report data for each product requested online.