‘CLIAC Served as a Critical Venue’ for Lab Community, Says ADLM President

Observers of US clinical laboratory policy remain concerned about the sudden ending—for now, at least—of the Clinical Laboratory Improvement Advisory Committee (CLIAC).

G2 Intelligence, a partner publication to Today’s Clinical Lab, confirmed that the federal health officials pulled the plug the committee on March 31 to the surprise of some current and former members.

The Association for Diagnostics & Laboratory Medicine (ADLM) has called on the Department of Health and Human Services to reinstate CLIAC. 

In this interview, ADLM president Anthony Killeen, MD, BCh, PhD, DABCC, FADLM, discusses how CLIAC played an important role in discussions about changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the void that he sees being left now. Killeen is also professor and vice chair for clinical affairs in the Department of Laboratory Medicine and Pathology at the University of Minnesota.

Killeen’s answers have been lightly edited for clarity.

It seems like CLIAC was the epicenter of making updates to the CLIA regulations. Is that how you view CLIAC?

Yes, outside of CLIAC, there are really no other public mechanisms for assessing the regulations set forth by CLIA. There are deemed organizations that perform lab inspections or handle proficiency testing, but CLIAC was the one group that could assess CLIA in its totality. It served as a critical venue for working through current problems with the rule and also for expert input on how new technologies—such as next-generation sequencing, digital pathology, and artificial intelligence-assisted diagnostics—should be assessed and integrated under CLIA.

I also want to strongly emphasize that CLIAC was the only forum that brought together a cross-section of representatives of affected groups—including federal agencies, laboratories across a range of practice settings, academic medical centers, healthcare providers, manufacturers, and consumers—to evaluate and guide CLIA regulation holistically.

For an everyday clinical lab manager who may never think of CLIAC, what is the significance of CLIAC being disbanded?

CLIAC was the one public venue where any individual could inform the government about problems they had with CLIA that needed to be addressed. It wasn’t just federal agencies that could bring issues before the panel; all members of the laboratory medicine community, including lab managers, could do so as well. Since most sectors of the lab community were represented on CLIAC, the panel also enabled problems to be resolved in a collaborative, transparent manner that isn’t possible now.

The recent court ruling vacating the FDA’s final rule on LDTs increased the chances that future LDT regulation may be through CLIA modernization. Without CLIAC, where will those debates occur now?

The absence of CLIAC could significantly hinder efforts to modernize CLIA, especially concerning oversight of laboratory-developed tests (LDTs). CLIAC was the one entity that brought together most of the constituents involved in the LDT debate, and it was unique in convening experts from across the profession who understood both the technical and regulatory aspects of LDTs, their value, and how oversight could be improved within the current regulatory structure. 

Without CLIAC as a venue for informed and balanced dialogue, it will be more difficult to navigate future regulatory updates or consensus on LDT oversight within the existing CLIA framework. The federal agencies involved in the LDT debate could potentially initiate public forums, but those are typically organized and managed by the agencies and would likely not include the wide range of experts that comprised CLIAC’s established panel.