How to Write a CLIA Plan of Correction

Key facts and official sources

• Under CMS State Operations Manual Chapter 6, a PoC, evidence of correction (EoC) or allegation of compliance (AoC) is due within 10 calendar days of receiving the Form CMS-2567. Always use the date in your own cover letter. Source: SOM Chapter 6

• Enforcement, sanctions and appeal rights are in 42 CFR 493 Subpart R. For notice of proposed sanctions, see §493.1810.

• D-tags and surveyor guidance: SOM Appendix C

Standard-level vs condition-level deficiencies

• Standard-level: one requirement within a condition is not met. The lab submits an acceptable PoC with completion dates, and the state agency verifies correction.

• Condition-level: the deficiencies are serious enough that a whole CLIA condition (for example, PT enrollment, QC systems or the laboratory director) is not met. CMS can propose principal or alternative sanctions under Subpart R. The lab responds with a credible allegation of compliance and evidence that the problem is corrected, not just planned.

• Immediate jeopardy follows faster timelines set out in Chapter 6. Act the same day.

What makes an allegation of compliance credible?

Under 42 CFR 493.2, a credible allegation is made by a lab representative with a history of compliance and of taking corrective action. It must be realistic, meaning the correction could be done between the exit conference and the date of the allegation, and it must show that the problems are resolved. In practice it states that each deficiency is corrected, explains how, and is backed by evidence such as records, training sign-offs, revised SOPs and QC or PT data.

Plan of correction template (per deficiency tag)

1. Tag and citation: the D-tag and the regulation as written on the 2567.

2. Corrective action: what was fixed, with the date.

3. Look-back: how you identified other patients, results or tests affected, and what you did about them (for example, corrected reports or physician notification).

4. Systemic change: the SOP, training, staffing or system change that prevents recurrence.

5. Monitoring: who checks the fix (by title), how often, what they review, and where it is documented.

6. Completion date: a realistic date for each item.

7. Evidence attached: an index of the documents you are submitting.

8. Signature: the laboratory director or an authorized official, with the date.

Checklist before you submit

• Every tag on the 2567 has a response

• No response just says "staff were retrained" without a monitoring step

• Look-back done and documented

• Dates are realistic and no later than the agency's requirement

• Evidence attached and labeled by tag

• Director signature

• Copy kept, along with the agency's acceptance letter

How SLC helps

SLC helps labs draft Plans of Correction (POC) and allegations of compliance after survey citations. We review each tag, build the evidence and set up monitoring. We work with labs inspected by CMS state agencies, CAP, COLA and The Joint Commission. Related: Statement of deficiencies and CMS-2567, Allegation of compliance, Evidence of correction, Condition-level sanctions, Inspection deficiencies.

FAQs

How long do I have to submit a CLIA plan of correction? SOM Chapter 6 lists 10 calendar days from receiving the CMS-2567. Use the deadline in your letter, and call the agency before it passes if you need more time.

Who signs the plan of correction? The laboratory director or another authorized lab official signs and dates it.

What is the difference between a PoC and an allegation of compliance? A PoC describes corrections and completion dates for standard-level findings. An AoC states that condition-level noncompliance is already corrected, with evidence.

Can a plan of correction be rejected? Yes. Vague responses, a missing look-back, or no monitoring step are common reasons. The agency can ask for a revised plan.

Do accredited labs write a PoC? CAP, COLA and The Joint Commission have their own deficiency response processes. A CMS validation survey uses the CMS-2567 process.

What happens if condition-level deficiencies are not corrected? CMS can impose sanctions under 42 CFR 493 Subpart R. These include civil money penalties, directed plans of correction, or limitation, suspension or revocation of the CLIA certificate.

Work with Sound Lab Consultants

Sound Lab Consultants (SLC) is a clinical laboratory consulting company. It provides CLIA compliance, lab startup and licensing, quality management, laboratory director and consultant personnel, and deficiency resolution services to labs nationwide. SLC works with labs accredited by CAP, COLA and The Joint Commission and prepares them for those inspections. Mailing address: PO Box 2135, Chandler, AZ 85244.

Last reviewed Oct 2026 · Sound Lab Consultants CLIA team · General information, not legal advice.