Newborn Screening - Use of NBS Blood Spots after Completion of Newborn Screening

 

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Dried blood spots remaining after newborn screening has been completed are an essential part of quality assurance and quality control (QA/QC). QA/QC ensures that newborn screening tests are consistently producing accurate, reliable and repeatable results. In addition, completion of QA/QC is a requirement for federal certification of the DSHS Laboratory.

These “residual” dried blood spots are also an invaluable resource in improving the health of current and future children in Texas and beyond. Research using these dried blood spots could help with the development of improved screening tests for disorders in newborns as well as better treatments or cures.
DSHS Policy Regarding Use of Residual Dried Blood Spots

Consistent with changes to Texas state law in 2011 ( Texas Health & Safety Code Sec. 33.018), DSHS has adopted a strict policy ( CD2010.01) regarding allowable uses of residual newborn screening blood spots and associated data.

Newborn Screening Blood Spot and Data Use Policy

The purpose of the policy is to:

  • Ensure requests for proposed uses of newborn screening (NBS) residual dried blood spots and/or associated data are processed under applicable law and reviewed as appropriate by DSHS management and/or the DSHS Institutional Review Board (IRB).
  • Provide specific guidelines for the review process of all requests for NBS dried blood spots and/or associated data for QA/QC and/or research.
Quality Assurance & Quality Control Uses of NBS Blood Spots

The DSHS newborn screening quality assurance process ensures that the entire testing process is working right. A continual supply of residual blood spots that represent the diverse nature of the Texas population is needed to make sure that the tests produce accurate results in any Texas baby.

Quality control—a specific part of the quality assurance process—consists of steps to make sure that each final test result is accurate. Steps include reviewing each specimen for acceptability, ensuring chemicals and instruments are working correctly and ensuring that the results being reported to the healthcare provider are accurate.

All proposed QA/QC uses are reviewed by DSHS Management and/or the DSHS IRB to determine if the uses are appropriate, scientifically sound, and allowable under the policy.

Types of Quality Assurance and Quality Control (QA/QC) Uses

QA/QC to Maintain Standards for Laboratory Testing Established by the Federal Government

[Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA)]

DSHS QA/QC for the Texas Newborn Screening Program

Studies to make sure new tests, chemicals, and equipment meet standards set by the manufacturer

Evaluations to make sure new test equipment or procedures are working correctly and are producing accurate test results

Ongoing monitoring to make sure test systems continue to be accurate and reliable over time

Evaluations to make sure all pieces of equipment used to run the same test give the same result

Studies to see if different equipment or tests produce more accurate, the same, or less accurate results

CLIA-required specimen exchange

De-identified* blood spots are sometimes sent to newborn screening laboratories in other states who are doing the same tests to make sure we are producing similar results

De-identified* blood spots are sometimes shared with newborn screening laboratories in other states to help them validate a new test.  For example, we could share samples from babies with severe combined immunodeficiency (SCID) with a state trying to add screening for SCID so they can make sure their test can accurately detect babies with SCID. (DSHS also receives de-identified blood spots from other state newborn screening laboratories when implementing new test methods.)

QA/QC to meet Food and Drug Administration (FDA) licensing requirements for manufacturing public health-related products

Newborn Screening test kits, chemicals, and equipment 

De-identified* blood spots may be used to test whether new chemicals, equipment, or supplies for newborn screening work correctly and produce accurate results. 

Chemicals and test kits for other medical conditions important to public health

De-identified* blood spots may be used in the FDA-licensing process and for general public health related QA/QC.

* De-identified, as defined by the Newborn Screening Blood Spot and Data Use Policy (CD2010.01): Specimens or data that neither identify nor provide a reasonable basis to identify the child or the parents of the child from which the specimen was collected.

Public Health Research Uses of Newborn Screening Blood Spots

All proposed research uses are reviewed by DSHS Commissioner designees and by the DSHS IRB. The IRB is tasked with ensuring the protection of the safety, rights, and welfare of human participants involved in the project. If a project is approved, the requester may only use the blood spots and/or data in the way specified in the final IRB-approved project description. 


Requests for Residual Newborn Screening Specimens or Associated Data


    List of research uses that have been allowed by DSHS
    Requestor Title of Study Purpose Description of blood spots and/or data requested and approved Date Approved 
     Center for Applied Genomics, the Children's Hospital of Philadelpia Testing DNA extraction protocol on external dried blood spot samples of neonates To evaluate the quality and quantity of the DNA extracted from various dried blood spot collections and to improve upon the ability to positively impact our understanding of pediatric health and disease through genomics by developing and validating an automated protocol to efficiently extract DNA in large batches from dried blood spot collections. 20 de-identified blood spots and associate non-identifying demographic data 3/2/2017
     PerkinElmer, Inc. Multi-Center Evaluation of NeoLSD MSMS Kit 3093-001U To demonstrate that the device performance is safe and effective when used for the stated intended use and that the use of this device will be beneficial for affected newborns by providing early identification of Lysosomal Storage Disorders (LSD).  De-identified analytical result data, date of specimen collection, birthweight, gender, and ethnicity for 55,000 specimens. 1/10/2017
     Texas Department of State Health Services andUniversity of New Mexico

    Feasibility of Estimating Prenatal Alcohol Exposure from Residual Newborn Screening Specimens

    		To ascertain the feasibility of assessing PEth biomarker, as a measure of prenatal alcohol exposure, in residual dried blood spot cards.  1,100 de-identified blood spots and associated non-identifying demographic data  11/20/2014
     PerkinElmer, Inc. Study to Establish Screening Performance for EnLite Neonatal TREC Test System To validate a new diagnostic method for newborn screening. The study results are needed to get permission to place the product on the market and made available for the newborn screening community in USA.  None - Request cancelled after approved. 3/28/2014
     Texas Department of State Health Services andARUP Laboratories Evaluation and Implementation of Second-Tier Testing for Disorders Identified by MS/MS in Newborn Blood Spots in the Mountain States RegionTo evaluate 1) the efficacy of performing second tier newborn screening tests for congenital adrenal hyperplasia and select metabolic disorders detected by tandem mass spectrometry and 2) the efficacy of establishing a regional laboratory to perform these second-tier tests.  342 De-identified blood spots 4/5/2010



    Contact Us

    If you have questions regarding the DSHS Newborn Screening Laboratory:
    Contact:

    Texas Department of State Health Services
    Newborn Screening Laboratory, MC 1947
    PO Box 149347
    Austin, TX  78714-9347

    (512) 458-7333
    (888) 963-7111, ext. 7333 toll free
    email Newborn Screening Laboratory


    Note: External links to other sites are intended to be informational and do not have the endorsement of the Texas Department of State Health Services. These sites may not be accessible to people with disabilities.


    Last updated October 26, 2018