Association for Diagnostics & Laboratory Medicine (formerly AACC) honors Representatives John Joyce, MD, and Cathy McMorris Rodgers for their commitment to ensuring that patients have access to high quality clinical tests

WASHINGTON – The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) is pleased to announce that Representatives John Joyce, MD (R-Pa.), and Cathy McMorris Rodgers (R-Wash.) are the recipients of ADLM’s Outstanding Legislator Awards for the 118^th Congress. These awards respectively recognize Rep. Joyce for his tireless efforts to improve pediatric care through better pediatric reference intervals and Rep. McMorris Rodgers for her dedication to safeguarding patient access to essential laboratory developed tests.

When making diagnoses, healthcare professionals interpret laboratory test results within the context of reference intervals — i.e., the range of expected values for healthy children. If a test result falls outside of this expected range, that’s usually what prompts a clinician to initiate a medical intervention for a health condition. Unfortunately, the pediatric reference intervals in use today are highly inconsistent for a broad range of common clinical laboratory tests, a problem that puts children at risk for inappropriate or even harmful medical care. ADLM has worked for years to improve pediatric reference ranges, and the association’s efforts recently led to Congress directing the Centers for Disease Control and Prevention to develop a plan to fix this problem.

Rep. Joyce played an integral role in this initiative by participating in ADLM’s 2023 congressional briefing with the Children’s Hospital Association to increase awareness of the need for better pediatric reference intervals. With Rep. Joyce’s help, ADLM was able to increase the number of organizations supporting the pediatric reference interval initiative to more than 40. Rep. Joyce has also led on this critical issue by submitting a request for pediatric reference interval funding as one of his priorities to the House Appropriations Committee.

Laboratory developed tests are tests that are developed, validated, and used within a single clinical laboratory in response to a specific patient care need. In particular, they play a critical role in testing for newborns, young children, individuals with rare disorders, and patients requiring specialized care. These tests are subject to rigorous oversight under the Centers for Medicare & Medicaid Services (CMS) via the Clinical Laboratory Improvement Amendments (CLIA). However, in spite of the fact that these tests are already regulated, the Food and Drug Administration (FDA) recently issued a final rule that will place these tests under dual FDA-CMS oversight and that could force many labs to stop performing these essential tests.

ADLM has long asserted that any reforms to laboratory developed test regulation should be made by updating the existing CLIA standards, not by subjecting these tests to duplicative FDA oversight. Rep. McMorris Rodgers has given our advocacy efforts in this area her critical support. Throughout this most recent session of Congress, she voiced legitimate concerns about the harmful impact of the FDA’s proposed and now final rule. Similarly, her involvement has been vital to ensuring that Congress closely examines this issue and prevents the FDA from circumventing the legislative process through unilateral rulemaking.

“ADLM extends our most sincere gratitude to Reps. Joyce and McMorris Rodgers for their unflagging support of these vital issues,” said ADLM President Dr. Octavia Peck Palmer. “Improving pediatric reference intervals and preserving patient access to laboratory developed tests are both critical to ensuring that the country’s most vulnerable patient populations get accurate diagnoses and high-quality care. When Rep. McMorris Rodgers departs Congress this year, we hope it is with a sense of pride in the work she has done to stop FDA regulation of laboratory developed tests. We also greatly look forward to continuing to work with Rep. Joyce to obtain funding for the establishment of accurate pediatric reference intervals.”

About the Association for Diagnostics & Laboratory Medicine (ADLM)

Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.