Most Recent Program Reports
Summary Report Inborn Errors of Metabolism (January 2004)
Summary Report Tandem Mass Spectrometry (February 2004)
Midyear QC Report (July 2004)
Annual Summary and Midyear QC Reports (2003, 2002)
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One Page Summary of Program
Tandem Mass Spectrometry QC/QA for Newborn Screening Web Conference - Jan/Feb 2004
NEWBORN SCREENING
Background
Newborn Screening Quality Assurance Program
Applications of Bloodspot Technology
Newborn Screening and Bloodspot
Technology Services Available
Important Links to Learn More About Newborn Screening and Related Topics
Newborn Screening Request Participation Form
Background
Newborn screening is one of the largest
disease prevention programs in the United States, reaching approximately 4 million babies born each year. States test blood spots
collected from newborns for metabolic and genetic diseases such
as phenylketonuria (PKU), hypothyroidism, galactosemia, and sickle cell disease. In
addition, a few states and private laboratories have more comprehensive
programs that screen for more than 30 disorders. Affected newborns are identified
quickly and treated to prevent mental retardation, severe
illness, and premature death.
Accurate screening for newborn diseases
is of critical importance to ensure that affected newborns are identified
quickly, to avoid missing any cases, and to minimize "false
positive" results that can cause parental anxiety. The irreversible
nature of the outcomes of missed cases requires testing to be of the
highest quality.
Newborn Screening Quality Assurance
Program
The
Newborn Screening Branch,
Division of Laboratory Sciences, operates the Newborn Screening Quality
Assurance Program (NSQAP). NSQAP is a voluntary, non-regulatory program to
help state health departments and their laboratories maintain and enhance
the quality of test results. The program is operated in partnership with
the Association of Public Health
Laboratories. The program provides services
to more than 73 domestic newborn screening
laboratories, 28 manufacturers of diagnostic products, and laboratories in
53 countries. NSQAP has been the only comprehensive source of essential quality assurance
services for dried-blood-spot testing for over 26 years.
Services provided by
NSQAP to
participating laboratories include: (1) training, (2) guidelines, (3)
consultation, (4) proficiency testing, and (5) reference materials. The
proficiency testing services provide coded specimens to participating
laboratories to see if they arrive at the expected answer. If a
participating laboratory does not get the correct answer, NSQAP immediately
works with the laboratory to identify and solve the problem. NSQAP publishes
quarterly reports on the performance of participating laboratories.
Each year approximately 3,000 babies
with severe disorders are identified in the United States using newborn
screening programs. The field of newborn screening is rapidly expanding
because of new technologies and genetic discoveries. As states adopt new tests
for additional diseases, the NSQAP will need to extend its services to
ensure the quality of test results.
If you are interested in participating
in this program, please click here to see an overview
of the quality assurance program.
Applications of Bloodspot Technology
A large
number and variety of substances have
been measured using dried-blood spots. Click here to see a list
obtained from literature citations for an indication of applications for
this versatile matrix.
NSQAP has conducted research and provided
technical assistance in using dried-blood spots to measure autoantibodies
related to type 1 diabetes. NSQAP has conducted two workshops on this
topic and recently obtained funding from the National Institutes of Health
to develop a pilot program for population-based screening for type 1
diabetes using newborn bloodspots.
NSQAP also applies its bloodspot
technology to detect HIV-1 antibodies. NSQAP has
provided quality assurance services for surveys of HIV infection and
consultation services for other applications of bloodspot technology.
Newborn Screening and Bloodspot
Technology Services Available
NSQAP has the following
materials and services available
for use by public health laboratories upon request: (1) amino acid and TSH reference
materials for calibration; (2)
other special bloodspot materials; and (3) consultation on applications of
bloodspot technology, e.g., for measurement of measles antibodies, risk factors for
cerebral palsy, and a variety of other conditions.
Important Links to
Learn More About Newborn Screening and Related Topics
Federal
agencies
HRSA
NIH/Human Genome
State
newborn screening programs
(selected programs)
Colorado
Georgia
New England
Michigan
Missouri
New Mexico
New York
North Carolina
Oregon
Texas
Washington
Wisconsin
Private Organizations
American Sickle Cell Anemia Association
Association of Public Health Laboratories
Fatty Oxidation Disorder Family Support Group
Genetic Alliance
Institute of Metabolic Disease, Baylor University
International Society for
Neonatal Screening
March of Dimes
National Coalition for PKU and Allied Disorders
National Committee for Clinical Laboratory Standards
(NCCLS)
National Newborn Screening & Genetics Resource Center
National Urea Cycle Disorders Foundation
Pediatrix Screening
Save Babies Through Screening
Safe Workplace
Guidelines for Prevention of Transmission of HIV and Hepatitus B Virus to Health-Care Workers
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