Honestly, if you look at a map of the United States healthcare infrastructure, you might expect to see a slow, steady climb in the number of medical labs. More people, more tests, more labs—right? Well, it’s not quite that linear. The number of CLIA-certified labs in the US over time tells a much more chaotic story of regulatory shifts, pandemic panics, and a massive migration toward "waived" testing that has fundamentally changed how we get diagnosed.
Back in 1993, shortly after the Clinical Laboratory Improvement Amendments (CLIA) regulations really took hold, the landscape was dominated by traditional, high-complexity facilities. But fast forward to early 2026, and the data from the Centers for Medicare & Medicaid Services (CMS) shows we are living in a completely different world. We’ve gone from roughly 150,000 labs in the early 90s to over 330,000 today.
That’s a huge jump. But it’s not because we have double the number of massive hospital labs.
The "Waiver" Explosion: Why Simple Tests Won the Race
If you want to understand why the total count of labs has skyrocketed, you have to look at the Certificate of Waiver (CoW).
Basically, a "waived" lab is one that only performs simple tests with a low risk of an incorrect result—think pregnancy tests, rapid strep, or those COVID-19 antigen kits we all have in our junk drawers. In 2000, there were about 85,000 waived labs. By 2024, that number hit nearly 245,000.
Why? Because technology got better.
Tests that used to require a PhD and a room full of expensive machinery can now be done on a plastic cartridge at a CVS MinuteClinic or a local elementary school nurse's office. This shift has democratized testing, but it’s also inflated the "total number of labs" statistic in a way that’s sorta misleading if you're looking for clinical depth.
The Pandemic Peak and the 2023 Correction
You can't talk about lab numbers without mentioning the COVID-19 "gold rush." Between 2020 and 2022, thousands of new CLIA numbers were issued as pop-up testing sites, pharmacies, and even warehouses tried to get in on the testing action.
But then 2023 happened.
Industry experts noticed a sharp "correction" during this period. According to proprietary data shared by LabProspects, 2023 saw one of the highest rates of lab closures in nearly 30 years. The "fly-by-night" operations that existed solely for PCR testing folded. What we’re left with in 2026 is a leaner, though still historically large, collection of facilities.
Breaking Down the Current 2026 Landscape
As of the latest CMS quarterly updates for 2026, the distribution of labs is heavily weighted toward the small players. Here is a rough look at how the different certificate types currently stack up:
- Certificate of Waiver: The undisputed king, making up over 75% of all registrations.
- Certificate of Compliance: Around 16,000–17,000 labs. These are the ones inspected directly by the state or CMS.
- Certificate of Accreditation: Roughly 15,000–16,000 labs. These guys choose to be "accredited" by private organizations like the College of American Pathologists (CAP) or COLA.
- Provider-Performed Microscopy (PPM): About 25,000 labs. Think of your doctor looking at a slide during your physical.
It’s interesting to note that while the number of labs is high, the type of labs is concentrating. Physician Office Labs (POLs) account for a massive chunk of the total—over 110,000—but their test volumes are tiny compared to the "Big Two" (Quest and LabCorp) and large hospital systems.
The 2026 "Paperless" Transition: A New Hurdle
If you're running a lab right now, you've probably heard the March 1, 2026 deadline mentioned in every industry newsletter. CMS is officially going paperless.
Historically, the number of CLIA-certified labs in the US over time has stayed relatively stable in terms of administrative renewals because, well, the bill came in the mail and you paid it. Now, if a lab doesn't switch to electronic notifications and update their email with their State Agency, they might miss their renewal coupon entirely.
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Could this lead to a dip in the "active" lab count later this year? Honestly, probably. Small offices are notoriously bad at checking "official" emails that look like spam.
The "Exempt State" Nuance
Most people don't realize that New York and Washington are special. They have "CLIA-exempt" status.
In these states, the state's own laboratory oversight is considered equal to or more stringent than the federal CLIA rules. So, while they are still counted in the grand totals, they operate under a different set of inspectors. New York, specifically, is famous in the industry for being the "Final Boss" of lab regulations. If your lab can pass New York's requirements, you can pass anything.
What Does This Mean for the Future?
We are moving toward a world where the "lab" is no longer a destination. It’s a feature of other businesses. We see pharmacies, grocery stores, and even workplaces maintaining CLIA certificates.
The number of high-complexity labs—the ones doing DNA sequencing and complex pathology—is actually quite stable. It’s the "Point of Care" (POC) sector that is driving the trend lines upward.
Actionable Steps for Lab Stakeholders
If you're trying to make sense of these numbers for business or health reasons, here is what you actually need to do:
- Check the CMS QIES Database: If you're looking for a partner lab, don't just take their word for it. You can pull the "CLIA Statistical Tables" directly from CMS.gov to see if a specific region is oversaturated.
- Verify the Certificate Type: A "CLIA Certified" lab sounds great, but a Certificate of Waiver lab cannot legally perform a COVID-19 PCR test or a complex blood panel. Always ask: "What is your level of complexity?"
- Update Your Email (For Lab Owners): If you haven't switched to the CMS electronic system by March 1, 2026, your certification is at risk. Contact your State Agency immediately to ensure your "Go Paperless" status is active.
- Monitor the CLFS Updates: The Clinical Laboratory Fee Schedule (CLFS) for 2026 has already introduced new codes and pricing changes. Staying certified is only half the battle; getting paid is the other.
The growth of the number of CLIA-certified labs in the US over time is a testament to our obsession with data. We want more health data, faster, and closer to home. As long as that's true, the number of "waived" labs will likely keep pushing the total count toward new records, even as the "traditional" lab market consolidates.