Nora Hess, MBA, MT(ASCP), who owns Next Horizon Consulting, has been involved with diagnostic laboratories for more than 50 years. She started out as a medical technologist and eventually served as a lab administrator and director at two large health systems before becoming a consultant.
At the 2026 Lab Manager Leadership Summit, Today’s Clinical Lab sat down with Hess to discuss the current regulatory environment for labs and where CLIA regulations may need to head in the future. She argued that the recent legal battle about the oversight of laboratory-developed tests (LDTs) provides clues on why CLIA’s organizers should think strongly about modernizing its mandates.
When President Donald Trump returned to office in 2025, one of his administration’s big goals was to pull back on regulations. Has the anti-regulatory stance helped or hurt clinical labs?
Hess: I think it’s neutral right now. All politics is temporary. No one should get too comfortable with this political environment because it could change in a couple of years. Don’t forget, if your lab is inspected by an accrediting agency, they’re still doing their biannual inspections. They’re still holding labs accountable for meeting CLIA requirements. CMS is still going out and inspecting labs, mostly through state agencies, and still citing them. Where the administration’s anti-regulatory position is going to make a difference is in new requirements, like the LDT final rule that was defeated in court last year.
Before the court vacated the LDT final rule, the rule was going to bring LDT oversight under the FDA. How did you view that final rule?
Hess: Lab-developed tests have been around for a long time, but what we saw in COVID was an explosion of LDTs. Some companies came out with bogus tests that didn’t work and submitted them to the FDA for Emergency Use Authorization. Lab-developed tests fall under CMS as the enforcement agency for CLIA, but CMS has struggled with it because these tests take such different forms.
Nora Hess, MBA, MT(ASCP)
Courtesy of Nora Hess
On one end of the LDT spectrum, you have large academic institutions doing cutting-edge research and testing, and when they routinely do it right, it is super impressive. On the other end, you have some bad players who are out there trying to market a bad test with shortcuts and not following good laboratory practices the way they should be followed.
The rescinded LDT rule was going to add another regulatory layer to hospital labs and dedicated research labs. Those labs were going to have to hire another person to track the proposed FDA requirements for LDTs. The rule was penalizing those labs.
Do you see paths where the FDA could go if it doesn’t have this LDT final rule anymore, but it still wants to influence oversight of LDTs?
Hess: Right now, LDTs are outside the FDA’s wheelhouse. The FDA is in charge of looking at instrumentation and methods, giving approval, and assigning the test classification. Is a test waived? Is it moderately complex? Is it highly complex? That’s the FDA’s role. The regulatory side of LDTs is a CMS area, and I think clinical labs want it to stay that way.
Should LDT regulations be strengthened? Probably, but I think it’s a daunting task because there’s a wide variety of lab-developed tests that are out there. The problem, too, as I see it, is the CLIA regulations were first written in 1988 and were officially enacted in 1992. Well, the clinical lab industry has changed a lot since 1992. The CLIA regulations were written for an earlier time. And we saw some of that with COVID when pathologists started reading cases at home. There was a question of whether pathologists needed a CLIA certificate for their home. Do they have to report that they read a case at their home? There was no leeway in CLIA for things like that because the technology to do so didn’t exist back in 1988.
Do you foresee a situation where CLIA regulations overall will need to be modernized, or will this be a piecemeal effort based on technology advancements?
Hess: CLIA would require major changes. I think what regulators could do—I don’t know that they would ever do this—is look at independent quality standards. Outside the US, the rest of the world runs on quality standards, such as ISO standards, and other countries do just fine with them. I think CLIA could adopt that kind of approach. Some of the regulatory agencies offer ISO certification, including A2LA and the College of American Pathologists. I think that’s the way to go. If the rest of the world can modernize regulations under ISO standards, why can’t the US? The ISO standards are a little broader in some places and a little tighter in some others, but they have a good framework to work under. It’s something CLIA could adopt.
Editor’s note: After this interview was conducted, US Representative Neal Dunn filed the Enhancing CLIA Act in Congress, which aims to modernize aspects of CLIA and clarify LDT oversight.
