#United States #Washington #Children's Health #newborn screening #Lab Testing

Access to Quality Laboratory Testing for Children

Laboratory tests play a crucial role in diagnosing and treating children, from their earliest days to adulthood. A recent briefing by the Association for Diagnostics & Laboratory Medicine (ADLM) highlighted significant challenges in pediatric testing that demand urgent attention.

Importance of Newborn Screening

Newborn screening is recognized as one of the most successful public health initiatives in the U.S., serving nearly four million infants each year. This program has been instrumental in saving thousands of lives and providing infants with the best chance for a healthy future. However, the termination of the Advisory Committee on Heritable Disorders in Newborns and Children by the U.S. Department of Health and Human Services in April 2025 raises concerns. The committee had been pivotal in informing the use of newborn screening tests and developing vital guidelines and standards.

Without expert guidance, there are fears that newborn screening could lose its effectiveness and lead to missed diagnoses of serious conditions.

The Need for Improved Pediatric Reference Ranges

Another critical issue is the quality of pediatric reference ranges. These reference intervals help healthcare providers interpret lab test results, but many are either poorly defined or entirely absent. This absence can lead to misdiagnoses and inappropriate treatment, jeopardizing children's health.

As a result, many healthcare providers face challenges in determining what constitutes a 'normal' test result for children, consequently affecting the quality of care provided. The development of standardized pediatric reference intervals is therefore essential in enhancing the accuracy of diagnoses.

Role of Laboratory Developed Tests

Furthermore, because many childhood disorders are rare, few manufacturers create tests specifically tailored for children. Consequently, laboratories often rely on laboratory-developed tests to fill this void. These tests are critical for diagnosing pediatric conditions for which standardized commercial tests do not exist. Recent federal regulatory efforts, which threaten to impose duplicative regulations, could limit access to these essential tests.

The implications are significant: without these tests, many children could miss out on necessary diagnoses and treatments. On a broader scale, the challenges in accessing quality laboratory testing can have lasting impacts on pediatric healthcare

Call to Action for Congress

The briefing also highlighted that these issues fall under congressional jurisdiction. Lawmakers have the power to drive improvements in newborn screening programs, establish better pediatric reference ranges, and reform regulations for laboratory-developed tests, ensuring that children continue to have access to necessary health interventions.

Details of the Briefing

The ADLM briefing aims to illustrate these pressing issues to congressional leaders while engaging experts and advocates in pediatric health. Specific provisions will be discussed on how lawmakers can uphold the integrity and accessibility of pediatric testing in the U.S.

When: February 4, 2026, from 12 – 1 p.m.
Where: Room 198, Senate Russell Building
Speakers:

• - Dr. Dennis J. Dietzen, Phoenix Children’s Hospital
• - Dr. Danyel Tacker, West Virginia University Hospitals
• - Dr. Stanley F. Lo, Medical College of Wisconsin
• - Dr. Hubert Vesper, Centers for Disease Control and Prevention

The ADLM is committed to ensuring that quality laboratory testing remains accessible to all children, as it is fundamental to improving health outcomes. Join the movement to advocate for the necessary changes in pediatric laboratory testing today.

For further details and to RSVP, please contact Christine DeLong, ADLM Director, Editorial and Media Relations.