WASHINGTON, June 27,
2024 /PRNewswire/ -- 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 118th 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.
Christine DeLong
ADLM
Associate Director, Communications & PR
(p) 202.835.8722
cdelong@myadlm.org
Molly Polen
ADLM
Senior Director, Communications & PR
(p) 202.420.7612
(c) 703.598.0472
mpolen@myadlm.org
View original content to download
multimedia:https://www.prnewswire.com/news-releases/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-302184949.html
SOURCE Association for Diagnostics & Laboratory Medicine
(ADLM)