Advocacy - Comment Letter
Dear Secretary Kennedy:
The Association for Diagnostics & Laboratory Medicine (ADLM) supports the Administration’s efforts to improve children’s health. As the leading laboratory association in pediatric medicine, we believe it is essential that the health problems plaguing our youngest population receive the attention they deserve. Access to accurate laboratory testing is critical to ensuring the well-being of our youth and making them healthy again.
Following our review of the Make Our Children Healthy Again: Assessment released by the Make America Healthy Again Commission on September 9, 2025, ADLM would like to bring to your attention a serious problem involving pediatric laboratory testing and offer a solution for resolving the issue.
Healthcare professionals order laboratory tests to diagnose whether a child has a medical condition. If the results are outside of the normal range of values for a healthy child, the care giver may order a medical intervention to treat the illness. Therefore, it is imperative that the range of normal values (also called the reference interval) used to interpret the result be as accurate as possible.
Inaccurate reference intervals can lead to unnecessary and expensive follow-up testing, as well as misdiagnosing the child – a medical error that could result in unnecessary, and potentially harmful interventions. While excellent reference intervals are widely available for adults, reference intervals for children are often of poor quality.
Unfortunately, laboratories do not have the resources needed to obtain the samples needed from large numbers of healthy children to develop reference intervals for a variety of medical conditions. Quite often, laboratories are forced to rely upon reference ranges that are based on specimens from sick children, which can lead to medical errors.
Alternatively, some laboratories may use adult reference intervals, but these also can lead to less optimal medical decisions. A national effort is needed to deal with this children’s health issue. As your recent assessment points out children are often subjected to overmedicalization and unnecessary treatment. Ensuring children have accurate test results will reduce the incidence of overmedicalization in our pediatric population.
Since 2020, Congress has recognized the importance of this issue on four occasions through report language. Unfortunately, no funds have been allocated for this vital, highly cost-effective initiative. The Centers for Disease Control and Prevention (CDC) have the infrastructure in place to generate these pediatric reference intervals (PRIs) from a nationwide cohort of healthy children in every corner of our nation. The cost for this effort is estimated at $10 million annually.
There is also wide support for improving pediatric reference intervals within the healthcare community. In addition to ADLM, the Children’s Hospital Association, the American Academy of Pediatrics, the National Rural Health Association, and many healthcare entities have endorsed this initiative.
ADLM strongly encourages the Administration to include improving the quality of PRIs in its overall plan to promote children’s health. We look forward to collaborating with you on this most important issue – one we believe is at the heart of advancing our children’s health. If you
have any questions, please email Vince Stine, PhD, ADLM’s Senior Director of Government and Global Affairs, at [email protected], or Evan Fortman, MPA, ADLM’s Manager of Government Affairs at [email protected].
Sincerely,
Paul J. Jannetto, Ph.D., DABCC, FAACC President, ADLM