CLIA Cease Testing Letter: What It Means and What to Do

A cease-testing letter means your lab must stop reporting patient results for the analyte, specialty or whole lab named in the letter, starting on the stated date. For CMS this usually means a limitation or suspension of your CLIA certificate (42 CFR 493.1806). Comply on time, refer specimens to a certified lab, review affected results, and follow the reinstatement steps.

Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice. Your letter's instructions and deadlines control.

Key facts and official sources

• Principal sanctions are suspension, limitation or revocation of any CLIA certificate. Alternative sanctions are a directed plan of correction, state onsite monitoring or a civil money penalty. Source: 42 CFR 493.1806

• Procedures for suspension, limitation and revocation: 42 CFR 493.1840

• Appeal rights: 42 CFR 493.1844

• Reinstatement after PT-related sanctions: 42 CFR 493.807

What is the difference between a limitation, a suspension and a revocation?

• Limitation: Removes approval for specific analytes, tests or specialties. You stop testing those and can continue the rest

• Suspension: Stops all testing under the certificate for a period

• Revocation: Ends the certificate. The owner or operator is barred from owning or operating a CLIA lab for 2 years (42 U.S.C. 263a(i)(3); §493.1840(a)(8))

Each of these is often paired with cancellation of the lab's approval to receive Medicare payment for the affected services.

Why do labs receive cease-testing letters?

The most common causes:

• Unsuccessful proficiency testing for an analyte or specialty (§493.803). See what to do after a failed PT event.

• Immediate jeopardy found on survey (§493.1812).

• Condition-level deficiencies that were not corrected (§493.1814).

• PT referral: sending PT samples to another lab (§493.1840(b)).

Accrediting organizations such as CAP and COLA have their own PT monitoring and cease-testing processes. If your letter comes from an accreditor, follow its instructions and deadlines as well as any CMS notice.

What should you do in the first 72 hours?

1. Read the letter closely. Note exactly which analytes or specialties are affected, the effective date, and the response deadline.

2. Stop testing on time. Remove the affected tests from your orderable menu, or block them in your LIS, as of the effective date.

3. Refer specimens. Send affected tests to a lab certified in that specialty, and update requisitions and client communications.

4. Look back. Review recent patient results for the affected tests and correct reports if needed.

5. Investigate the root cause. Use PT records, QC, calibration and competency records.

6. Decide on your response. Choose between an allegation of compliance, voluntary withdrawal of the analyte, or a hearing request, and act within the deadline in the notice.

7. Document everything. Surveyors will ask for evidence later.

Can you appeal?

Suspension, limitation and revocation are initial determinations that can be appealed to an administrative law judge (§493.1844). In general, CMS does not suspend or limit a certificate until a hearing decision upholds it. Exceptions include immediate jeopardy and refusal of an inspection or information request (§493.1840(d)). The appeal deadline is in your notice, so talk to counsel early.

How do you get reinstated?

For PT-related sanctions, the current rule requires two consecutive satisfactory PT events before CMS will consider reinstatement of the failed analyte, specialty or subspecialty. The sanction period is at least six months (§493.807). For other sanctions, CMS verifies compliance with all condition-level requirements, which may involve a revisit.