NSQAP FAQs

At a glance

See below for our most Frequently Asked Questions.

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Enrollment information

What are criteria for participation in NSQAP?

The laboratory must use the dried blood spot (DBS) matrix, and the laboratory’s analyte reference ranges must represent the newborn period of life.

How do I request participation in the Newborn Screening Quality Assurance Program?

NEW PARTICIPANTS must complete the Participation Request Form.

NOTE: When completing the request form, you must provide a business street address. We cannot ship to a residential address or a Post Office Box. Tax ID and broker information may be required for laboratories located outside the United States.

What are my laboratory’s responsibilities when participating in NSQAP?

  • You are responsible for any documents, import permits, fees, taxes, or other costs required by your country for release of your package from customs.
  • You must report results at least one time each year for all PT and/or QC programs you receive. Failure to report results will result in inactivation for the program(s).

I tried to enroll in NSQAP but was told the laboratory limit for my country has been reached. Can an exception be made for my laboratory?

NSQAP can support up to 50 laboratories per country. We cannot make an exception to the country limit.

We are a manufacturer of newborn screening analysis kits. Can we enroll in NSQAP?

A manufacturer must have at least three NSQAP participants using your product to enroll in our program. We will verify this criterion when we receive your registration request.

Is there a cost for materials or shipping?

There is no cost for DBS materials or shipping for regularly scheduled shipments. You are responsible for any documents, import permits, fees, taxes, or other costs required by your country for release of your package from customs. While there is no monetary cost for materials or shipping, results must be reported for all PT and/or QC programs you receive. You must report results at least one time each year to stay active in NSQAP and to continue to receive materials in the following year. Failure to report results will result in inactivation from the program(s).

When will I begin receiving PT and/or QC DBS materials?

All participation requests must be received by October 31 to begin receiving materials in January of the following year. Refer to the shipping schedule in the calendar section on the home page of the NSQAP Participant Portal.

Example: Enroll by October 31, 2024 for participation starting in January of 2025. Participation requests received after October 31 are processed for the following year.

Shipping

Can a carrier besides FedEx be used to ship our materials?

No, FedEx is the designated carrier for CDC. NSQAP must send materials using FedEx.

Common questions

I am already enrolled in NSQAP. How do I request additional programs?

Log into the NSQAP Participant Portal:

• Click on HELP on black bar
• Click on HELP on the drop-down
• Click “OPEN NEW REQUEST”
• On next screen, click on “Modify (Add/Delete) Program” under the Help Category
• Type the program(s) to add or delete. (refer to the list of programs at the end of these FAQs)
• Click Submit

NOTE: You can verify enrolled programs by viewing your laboratory details in the LAB INFORMATION section.

When are proficiency testing and quality control materials shipped?

The NSQAP event schedule is located on the NSQAP Participant Portal CALENDAR: KEY DATES AND EVENTS.

Where do I enter my proficiency testing and/or quality control results?

Participating laboratories are given access to the NSQAP Participant Portal where all results are reported.

Proficiency testing programs

Three events per year.

Program

Analyte(s) Included

Acylcarnitines (ACPT)

C0(L), C2(L), C3, C3DC, C3DC+C4OH, C4, C4OH, C5, C5:1, C5DC, C5OH, C6, C8, C10, C10:1, C10:2, C14, C14:1, C16, C16OH, C18, C18:1, C18OH

Adrenoleukodystrophy (ALDPT)

24:0-Lysophosphatidylcholine, 26:0-Lysophosphatidylcholine

Amino Acids and SUAC (AAPT)

Arginine, Citrulline, Creatine, Guanidinoacetic Acid, GAMT Ratio, Leucine, Methionine, Phenylalanine, Succinylacetone, Tyrosine, Valine

Biotinidase Deficiency (BIOTPT)

Biotinidase

Cystic Fibrosis DNA Variant Detection (CFDNA)

Cystic Fibrosis DNA Variants

Galactose-1-phosphate Uridyltransferase Deficiency (GALTPT)

Galactose-1-phosphate Uridyltransferase

Glucose-6-phosphate Dehydrogenase Deficiency (G6PDPT)

Glucose-6-phosphate Dehydrogenase

anti-HIV-1 Antibodies (HIVPT)

anti-HIV-1 Antibodies

Hormone + Total Galactose (HORMPT)

Thyroxine, Thyroid Stimulating Hormone, 17 α-Hydroxyprogesterone, and Total Galactose

Immunoreactive Trypsinogen (IRTPT)

Immunoreactive Trypsinogen

Lysosomal Storage Disorders (LSDPT)

Galactoceramidase, Acid α-Glucosidase, α-L-Iduronidase

Second-tier Congenital Adrenal Hyperplasia (CAHPT) by LC-MS/MS

17 α-hydroxyprogesterone, 4-androstenedione, cortisol, 11-deoxycortisol, 21-deoxycortisol

Sickle Cell Disease and Other Hemoglobinopathies (HbPT)

Enrollment currently closed. Sickle Cell Disease and Other Hemoglobinopathies

Spinal Muscular Atrophy (SMAPT)

Survival Motor Neuron 1 (SMN1) Exon 7

T-cell Receptor Excision Circle (TRECPT)

T-cell Receptor Excision Circle

anti-Toxoplasma Antibodies (TOXOPT)

Toxoplasma gondii IgM Antibodies

Quality control programs

Two events per year.

Program

Analyte(s) Included

17 α-Hydroxyprogesterone + Total Galactose (17OHPQC and TGalQC)

17 α-Hydroxyprogesterone, and Total Galactose

Cystic Fibrosis DNA Variant Detection (CFDNAQC)

QC specimens collectively contain the original 23 CFTR pathogenic variants recommended by the American College of Medical Genetics and Genomics.

Galactose-1-phosphate Uridyltransferase (GALTQC)

Galactose-1-phosphate Uridyltransferase

anti-HIV-1 Antibodies (HIVQC)

anti-HIV-1 Antibodies

Immunoreactive Trypsinogen (IRTQC)

Immunoreactive Trypsinogen

Lysosomal Storage Disorders (LSDQC)

Galactoceramidase, Acid α-Glucosidase, α-L-Iduronidase α-Galactosidase, β-Glucocerebrosidase, Acid Sphingomyelinase, Iduronate-2-Sulfatase

Tandem MS 1 (MSMS1QC)

Arginine, Alanine, Citrulline, Creatine, Creatinine, Guanidinoacetic Acid, Glycine, Leucine, Methionine, Ornithine, Phenylalanine, Succinylacetone, Tyrosine, Valine, C0, C2, C3, C3DC, C3DC+C4OH, C4, C4OH, C5, C5:1, C5DC, C5OH, C6, C8, C10, C12, C14, C14:1, C16, C16OH, C18, C18OH, C20-LPC, C22-LPC, C24-LPC, C26-LPC, Adenosine, Deoxyadenosine

Thyroxine (T4QC)

Thyroxine

Thyroid-Stimulating Hormone (TSHQC)

Thyroid Stimulating Hormone

Second-tier quality control programs

Two events per year.

Program

Analyte(s) Included

Second-tier Congenital Adrenal Hyperplasia by LC-MS/MS (CAHQC)

17 α-Hydroxyprogesterone, 4-Androstenedione, Cortisol, 11-Deoxycortisol, 21- Deoxycortisol

Second-tier Maple Syrup Urine Disease and Phenylketonuria by LC-MS/MS (MSUD-PKUQC)

Alloisoleucine, Isoleucine, Leucine, Phenylalanine, Tyrosine, Valine

Second-tier Methylmalonic/Propionic Acidemia and Homocystinuria by LC-MS/MS (MMA- HCYQC

Malonic Acid, Methylmalonic Acid, Ethylmalonic Acid, 2-Methylcitric Acid, Total Homocysteine