[REVISED]
Someone was talking to me about a lab having "CLIA Registration but not a License."
The question is a source of immediate confusion because the CLIA agency does not seem to use the term "license" but rather has three types of registration status (CoR, CoC, CoA as further below). While I've seen AMA PLA instructions that use the term [CLIA License].
Here is a key passage from a CLIA agency government PDF:
Here's what I came up with after several emails with colleagues and after reading more CLIA documents like the link above.
https://www.cms.gov/files/document/laboratory-quick-start-guide-cms-clia-certification-november-2024.pdf
But if you look at AMA CPT PLA instructions, they do use the term "CLIA license."
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AI CORNER [REVISED]
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What “CLIA Registration” Really Means — Untangling a Common Point of Confusion
In CLIA discussions, few phrases create more misunderstanding than “registered but not licensed.” The confusion stems from the fact that “registration” has both an informal meaning in everyday conversation and a formal meaning within the CLIA regulatory framework.
The formal term: Certificate of Registration (CoR)
Under CLIA, a Certificate of Registration (CoR) is not just a placeholder or a pre-approval. It is a valid CLIA certificate issued to new laboratories applying for either a Certificate of Compliance (CoC, from CLIA itself) or a Certificate of Accreditation (CoA, i.e. accreditation by CAP).
The Certificate of Registration is issued when the application has passed a paperwork review, but not yet a physical inspection.
The CoR is temporary—valid for up to two years—but during this period it fully authorizes the laboratory to perform moderate- and high-complexity testing, as well as waived testing. (See the quotation that opened this essay).
The purpose of the CoR is to allow a new laboratory to begin operating while awaiting its first full inspection. After that inspection, the CoR is replaced by a CoC or CoA. Until that transition occurs, the CoR serves as the operative license, and no additional CLIA certification is required for the lab to run non-waived tests.
The informal usage: “We’re registered with CLIA”
Outside of regulatory documents, companies often use “registered with CLIA” loosely to mean that they have submitted an application, received a CLIA number, and appear in CMS’s database.
This status—essentially a pending application that has been filed but not reviewed—does not authorize any moderate- or high-complexity patient testing. A CLIA number alone is not a certificate.
Thus, the informal phrase “registered but not licensed” probably refers to this pre-certificate stage, not to a laboratory holding an actual Certificate of Registration.
Why the distinction matters
The formal CoR and the informal “registration” reflect two entirely different regulatory statuses:
| Status | Formal CLIA Term? | Does it authorize moderate/high-complexity testing? |
|---|---|---|
| Application submitted, CLIA number assigned | No | No |
| Certificate of Registration (CoR) issued | Yes | Yes |
| Certificate of Compliance (CoC) [CLIA] | Yes | Yes |
| Certificate of Accreditation (CoA) [CAP] | Yes | Yes |
Understanding these distinctions prevents the common error of assuming that a “registered” laboratory cannot legally perform testing. In CLIA’s vocabulary, a Certificate of Registration is itself the legal authority to operate until inspection.
The bottom line
A CLIA Certificate of Registration is a genuine, valid CLIA certificate that authorizes all levels of testing for up to two years while a new laboratory awaits inspection. The lab's paperwork has been reviewed, and passed, but the inspection is still in the future. Confusion only arises when “registration” is used informally to describe the pre-certificate stage. Clarifying this difference ensures accurate communication, particularly in regulatory, operational, and consulting contexts where the precise meaning of CLIA terms has real consequences.
You said:
ChatGPT said:
Here is a concise, concrete example you can drop into your blog:
Example: ABC Lab and the Difference Between “Registration” and a Certificate of Registration
Imagine ABC Lab, a brand-new molecular diagnostics lab.
January 5, 2026
- ABC Lab submits its CLIA application. CMS assigns a CLIA number the same week.
- At this point, ABC Lab is informally “registered” in the database—but it cannot perform any moderate- or high-complexity patient testing.
February 1, 2026
- CMS issues ABC Lab a Certificate of Registration (CoR).
- This is a real CLIA certificate, valid for up to two years, and it immediately authorizes ABC Lab to begin performing moderate- and high-complexity testing while awaiting its initial inspection.
It means the applicatoin has passed an initial review - for example, that high-complexity staff have appropriate training per the application on January 5.
September 2026
The state agency performs ABC Lab’s first full CLIA inspection.
October 2026
After passing inspection, ABC Lab’s CoR is replaced with a Certificate of Compliance, which becomes the long-term certificate for the lab.
This example shows the key distinction:
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A CLIA number alone (January) does not authorize testing.
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A Certificate of Registration (February) does authorize testing until inspection.
I can also format this as a shaded call-out box, sidebar, or timeline graphic if you want it to visually stand out in your blog.
You said:
ChatGPT said:
Between January 5 (application submitted) and February 1 (Certificate of Registration issued), it looks like “nothing is happening”—but in reality CMS and the state CLIA agency are doing several non-trivial administrative checks behind the scenes. None of it is glamorous, but none of it is simply “reading the name and address,” either.
Here is what actually occurs during that gap.
What Happens Between Application and Issuance of the Certificate of Registration
1. CMS validates the application data (CLIA-116)
They review that ABC Lab has provided:
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Correct lab type (e.g., independent, hospital-based, physician office, etc.)
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Accurate address and contact information
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Appropriate test menu (claimed complexity)
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Proposed clinical specialties/subspecialties
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Correct payment category (fees vary by complexity and test volume)
This includes checking for mismatches—e.g., a lab claiming high-complexity molecular testing but listing personnel who only qualify for moderate complexity.
2. Verification of the Laboratory Director’s credentials
This is the most time-consuming part.
CMS/state reviewers confirm that the proposed director:
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Meets CLIA high-complexity director requirements (PhD + board certification, pathology MD, etc.)
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Has appropriate documentation (licenses, ABMGG/ABMM/ABP certification, or equivalent)
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Has no gaps, mismatches, or missing credentialing documents
If anything is incomplete, CMS requests additional materials—this alone can stretch the timeline.
3. Personnel review for key positions
For moderate- or high-complexity labs, CMS may also check:
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Technical supervisor qualifications
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Clinical consultant qualifications
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General supervisor qualifications
For some states, this must be manually approved.
4. Fee processing and confirmation
CLIA will not issue a certificate until:
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The invoice is generated
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The lab pays the fee
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The payment is confirmed by the accounting contractor
This can add 1–2 weeks depending on timing.
5. Enrollment in Proficiency Testing (PT)
CMS verifies that the lab has:
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Selected an approved PT provider (e.g., CAP, API, AAB)
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Enrolled in applicable PT programs for the tests they plan to run
A lab cannot claim certain specialties on its CoR without demonstrating PT enrollment.
6. Assignment to the state survey agency or accreditation body
CMS flags the new lab for:
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State inspection (if pursuing a Certificate of Compliance), or
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Accreditation review (if applying under CAP, COLA, etc.)
This step places the lab in the queue for its upcoming inspection, and the CoR cannot be issued until this routing is configured.
So is it trivial paperwork?
Not really.
It’s bureaucratic and unexciting, but it is real work that must be manually verified.
Most delays occur because of:
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Missing director credential documents
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Incomplete PT enrollment
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Fee processing delays
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Manual review by state agency staff
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Seasonal backlogs (e.g., January is notoriously slow)
Once all these pieces are checked and validated, CMS issues the Certificate of Registration (CoR), which allows the lab to begin moderate- and high-complexity testing.
