Academy of Diagnostics & Laboratory Medicine - Scientific Short
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One pillar of ADLM’s strategic plan is advocacy and influence — and it exists for a single reason: better patient care. Over the past decade, our advocacy has shifted from reactive to proactive, built on familiarity and frequency with the people who shape our world: members of Congress and the regulators who oversee laboratories like the FDA and CMS. In a town where inboxes overflow by mid-morning, being remembered requires regular, respectful contact. We are, unapologetically, the squeaky wheel.
We advocate because we understand the impact of laboratory medicine on the lives of our patients and make no mistake, nearly every patient is our patient. “Advocating for patients means ensuring their voices are heard even when they cannot speak for themselves.” This unattributed quote encapsulates why we focus on children’s health. Many of our core issues — laboratory-developed tests (LDTs), harmonization, reference intervals, access to testing, reimbursement, and newborn screening — fit naturally under this umbrella. And frankly, few want to be on the wrong side of children’s health.
This approach has delivered results. Against some steep odds, we prevented adoption of the VALID Act. Our most visible win against regulatory overreach was a court decision that halted — for now — the FDA’s latest attempt to regulate LDTs. Pediatric lab medicine relies disproportionately on LDTs: rare genetic disorders demand cutting-edge sequencing and informatics; inborn errors of metabolism require state-of-the-art mass spectrometry; and newborn screening succeeds only when painstakingly validated methods separate the affected from the unaffected so treatment can begin immediately. These victories were not due to luck — they were the product of hundreds of coalition letters, Hill visits, briefings, and direct engagement by our members.
Even as Congress has grown more chaotic over the past six months, the Policy and External Affairs Core Committee (PEACC) is pressing ahead to secure funding for pediatric reference intervals. ADLM has worked on this front for nearly two decades, because the best intervals are prospective and built from large numbers of diverse, healthy, consented participants — an especially hard lift in neonates and children. Despite earnest efforts, today’s intervals remain inconsistent and insufficient.1 Early nationwide momentum through the National Children’s Study faded when the study was defunded. Despite this, AACC sponsored one of the few analyses leveraging those data to characterize neonatal steroid and amino acid intervals.2 Now our focus is securing funds for a joint CDC/NHANES/ADLM initiative to produce the largest, best-annotated, most geographically and ethnically diverse pediatric reference intervals in the world.
Distractions abound but the doors are still open. Children’s health has never been more urgent. PEACC is not easily discouraged, and neither are the laboratory practitioners, patients, and families we serve. Regulatory and legislative advocacy is about connections, persistence, patience, and patients. A focus on child health including LDT’s, harmonization, newborn screening, and reference intervals remains at the core of ADLM’s message. The current political climate has made razor sharp messaging more difficult and that much more important. Rest assured, ADLM is still engaged on behalf of laboratorians, patients, and their families. If you would like to participate in ADLM’s ongoing grassroots campaign to get funding for the Centers for Disease Control and Prevention to improve pediatric reference intervals, please go to our website https://myadlm.org/advocacy-and-outreach/laboratory-voice and send an e-letter to your legislators in support of this effort.
