Someone was talking to me about a lab having "CLIA Registration but not a License."
I asked Chat GPT what that means.
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AI CORNER
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In CLIA language, “registered but not licensed” is a very specific (and slightly confusing) distinction. Here’s the clean way to understand it:
1. CLIA “Registration” = You have applied, but are not yet certified
When a lab applies for a CLIA certificate (often a Certificate of Compliance or Certificate of Accreditation), CMS immediately assigns a CLIA number and the lab becomes “registered.”
During this registration period:
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The lab may not perform moderate- or high-complexity testing
(unless it already holds a valid certificate) -
The lab is essentially in pre-certification status
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CMS is reviewing paperwork, proficiency testing enrollment, director qualifications, fees, etc.
This is analogous to:
“We received your application; you’re in the system.”
2. CLIA “License / Certificate” = The actual approval to perform testing
A CLIA certificate (what states often call a “license”) is the document that allows the lab to operate legally.
There are several types:
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Certificate of Waiver
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Certificate for Provider-Performed Microscopy
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Certificate of Compliance
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Certificate of Accreditation
A CLIA certificate has:
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Issue date
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Expiration date
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Authorized specialties/subspecialties
Without the certificate, you cannot run patient testing (beyond waived/PPT if applicable).
3. Why the distinction matters
When someone says a lab has:
“CLIA registration but not a license”
They mean:
The lab has a CLIA number and is in the CMS database,
but has not yet been granted an operational certificate (the license) that legally allows them to perform non-waived testing.
This period often lasts weeks to months.
In business terms, it is like:
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Having an EIN but not yet having a business permit
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Being pending approval, not yet authorized to operate
4. Two common scenarios where this phrase appears
(A) New labs awaiting initial inspection
CMS issues a registration number so a lab can:
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Enroll in proficiency testing
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Order instruments
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Hire staff
But actual patient testing must wait until:
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The state agency performs an inspection
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CMS issues the certificate
(B) Labs temporarily between certificates
For example:
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A certificate expired due to late renewal
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CMS hasn’t issued the new certificate yet
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The lab is still “registered” but technically unlicensed
This is a regulatory limbo zone, and performing testing here is a CLIA violation.
5. Bonus: States that complicate the language
A few states (CA, NY, WA, MD) have state laboratory licenses in addition to federal CLIA certificates.
Sometimes people conflate:
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Federal CLIA certificate
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State lab license
But even in those states, the federal term “registration” still means “pre-certificate” status.
Short version (for your slide deck or client memo)
A lab with “CLIA registration but no license” has applied for CLIA, has a CLIA number, and appears in the CMS database, but does not yet have an active CLIA certificate authorizing patient testing. They are pending inspection/approval and cannot legally perform moderate- or high-complexity testing.
If you want, I can also create a one-slide summary, a diagram, or formulate this in a regulatory memo tone suitable for a client.