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July 8, 2025
A Letter to Secretary of Health and Human Services Robert F. Kennedy Jr. on Reinstating CLIAC
Dear Secretary Kennedy,
On behalf of the undersigned organizations representing the nation’s clinical and public health laboratories, we urge you to reinstate the Clinical Laboratory Improvement Advisory Committee (CLIAC) and schedule a November 2025 meeting. CLIAC provides recommendations to the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) on relevant updates to the Clinical Laboratory Improvement Amendments (CLIA) regulations to assure accuracy and reliability of laboratory test results that inform patient care and treatment.
Dear Secretary Kennedy,
On behalf of the undersigned organizations representing the nation’s clinical and public health laboratories, we urge you to reinstate the Clinical Laboratory Improvement Advisory Committee (CLIAC) and schedule a November 2025 meeting. CLIAC provides recommendations to the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) on relevant updates to the Clinical Laboratory Improvement Amendments (CLIA) regulations to assure accuracy and reliability of laboratory test results that inform patient care and treatment.
The Public Health Services act authorizes the HHS Secretary to establish standards that “ensure consistent, accurate, and reliable test results” and CLIAC is the most effective and efficient way to achieve that goal. Laboratory science has moved forward by leaps and bounds since the implementation of CLIA. CLIAC fills a huge gap between the federal agencies and the frontline of laboratory testing. Without CLIAC, there are no opportunities to discuss the improvements needed to laboratory testing services and practice. Without a forum to discuss the needed changes, CLIA regulations will become outdated and disconnected from current laboratory practice. Ultimately, it is the patient who suffers from lower quality testing services and the entire health care system is eroded.
Through the years, CLIAC has been proven to be an irreplaceable forum for the three federal agencies to hear directly from frontline experts who represent various sectors of clinical laboratory communities and advise on needed revisions to federal regulations governing clinical laboratory science. CLIAC should be reinstated, and the November 2025 meeting should be scheduled so subject matter experts can continue communicating about issues affecting laboratory science with the federal agencies that govern CLIA to protect patients’ safety. This will ensure that healthcare providers will continue to receive accurate and reliable test results that guide their patients’ treatment.
The work of CLIAC can greatly support your efforts to make Americans healthy again. The undersigned organizations strongly urge you to restore CLIAC and support its work to make sure clinical laboratory regulations remain adequate to protect patient safety and make life-saving improvements to current clinical laboratory practice, supporting diagnoses of medical conditions from acute infections to chronic diseases.
Sincerely,
American Association of Pathologists’ Assistants
American College of Medical Genetics and Genomics
American Medical Technologists
American Society for Clinical Laboratory Science
American Society for Clinical Pathology
American Society for Clinical Pathology Board of Certification
American Society for Histocompatibility and Immunogenetics
American Society for Microbiology
American Society of Cytopathology
American Society of Hematology
Association for Academic Pathology
Association for Diagnostics & Laboratory Medicine
Association for Pathology Informatics
Association of Public Health Laboratories
Big Cities Health Coalition
Clinical and Laboratory Standards Institute
Commission on Laboratory Accreditation, Inc.
College of American Pathologists
Infectious Diseases Society of America
National Accrediting Agency for Clinical Laboratory Sciences
National Association of Medical Examiners
National Society for Histotechnology
National Society of Genetic Counselors
Philippine Association of Medical Technologists-USA, Inc.
Project Santa Fe Foundation - Lab 2.0
Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) Collaborative Community