CLN - Federal Insider
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) has requested that Robert Kennedy Jr., secretary of the Department of Health and Human Services (HHS), reinstate the Clinical Laboratory Improvement Advisory Committee (CLIAC), which advised HHS on issues involving the Clinical Laboratory Improvement Amendments (CLIA) regulations. These standards regulate more than 300,000 clinical laboratories performing 14 billion patient tests annually.
Chartered by HHS in 1992, CLIAC has identified, debated, and provided input on a broad spectrum of issues affecting the quality of testing, personnel requirements, the precision and frequency of proficiency testing, and other aspects of the patient testing process, ADLM said in a letter to Kennedy. These suggestions were incorporated in CLIA final rules published by the Centers for Medicare & Medicaid Services (CMS). Similarly, CMS has included many CLIAC recommendations in the State Operations Manual used by inspectors to ensure the standards are up-to-date and that testing is performed in a safe and effective manner.
A spokesperson with the Centers for Disease Control and Prevention confirmed CLIAC was terminated on March 31 after being deemed “unnecessary.” The decision to eliminate the advisory panel came about under the aegis of a Trump administration executive order targeting the reduction of federal bureaucracy, the spokesperson said.
The CLIA program is funded by $80 million in user fees collected from the laboratory community, ADLM noted. This money is spent on educating clinical laboratories about best practices, managing quality assurance and accreditation programs, conducting inspections, and funding CLIAC. Given the vital role that CLIAC has played in improving laboratory testing and patient care, ADLM urged Secretary Kennedy to reinstate the committee.
The Food and Drug Administration (FDA) this month launched Elsa, a generative artificial intelligence (AI) tool designed to help its employees — from scientific reviewers to investigators — work more efficiently. The agency is already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets.
Elsa is a large language model-powered AI tool designed to assist with reading, writing, and summarizing. It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications, and more.
The FDA said that Elsa was built within a high-security GovCloud environment, offering a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff.
The introduction of Elsa is the initial step in the FDA’s overall AI journey, the agency said. As the tool matures, the agency has plans to integrate more AI in different processes, such as data processing and generative AI functions to further support the FDA’s mission.
The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) joined numerous organizations to write to the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies chair Shelley Moore Capito (R-W. Va.) and ranking member Tammy Baldwin (D-Wis.) and House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies chair Robert Aderholt (R-Ala.) and ranking member Rosa DeLauro (D-Conn.) to request $340 million annually for public health data modernization at the Centers for Disease Control and Prevention (CDC).
Additionally, ADLM and the co-signed organizations asked for $55 million for the CDC’s Center for Forecasting and Outbreak Analytics.
CDC’s public health data modernization efforts represent a long-term commitment to building and maintaining world-class data systems and a workforce that meets the nation’s ongoing need to safeguard health, ADLM said in the letter. Public health data is not only needed during an emergency response; it is also necessary for people and communities to thrive by rapidly identifying, tracking, and responding to daily public health threats of all types — acute, chronic, and emerging.
ADLM noted that data modernization plays a critical role in ensuring that public health workers and agencies receive data from the healthcare system that is essential to the disease detection and outbreak response efforts that keep communities safe and our nation secure.
Unfortunately, data modernization efforts across the country have been interrupted or completely halted by recent, abrupt CDC funding terminations, stalling progress on work that is needed to protect us from current and emerging public health threats. In light of these interruptions and the ongoing need to continue our modernization efforts, providing sustained yearly funding for public health data is key to ensuring the continuous improvement of our public health infrastructure, ADLM said.