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How to write a CLIA plan of correction
A plan of correction answers each deficiency on Form CMS-2567 with four things: what was done for the patients or records cited, how other patients who could be affected were identified, what was changed in the system so the problem does not recur, and how the correction will be monitored. Each deficiency also needs a completion date and the title of the person responsible.
A citation can be answered. A clear, dated response that covers all four points is what closes it.
Reviewed 11 Nov 2026 against the sources linked below. General information, not regulatory or legal advice.
- Responds to
- Form CMS-2567
- Deadline
- In your cover letter, usually 10 days from receipt
- Per deficiency
- Four points, a date, a responsible title
- Signed by
- Laboratory director
- Attach
- Evidence of what was done
The four points, one deficiency at a time
- What was done for the patients or records cited. Say whether results were affected and how you know. If they were, say what was done: repeat testing, corrected reports, notifying the ordering provider.
- How other affected patients were identified. The surveyor cited examples. Describe the look-back that found the rest, the period it covered and what it showed.
- What was changed in the system. A revised procedure, a new log, a calendar reminder, a change in who is responsible. Retraining on its own is rarely accepted.
- How the correction will be monitored. Who checks, what they check and how often, and where the check is recorded.
Answer every part of every tag. One D-tag can hold several findings, and each needs all four points.
Wording that works
| Gets sent back | Gets accepted |
|---|---|
| "Staff were reminded to record temperatures." | "On 14 Nov 2026 the refrigerator log was replaced with a log that shows the acceptable range from the package insert and an action column. The lead technologist reviews and initials the log each Monday. The technical consultant reviews it monthly on the QA checklist." |
| "Competency assessments will be completed going forward." | "The two overdue assessments were completed on 12 Nov 2026 by the technical consultant, covering all six procedures. All other personnel files were reviewed on 13 Nov 2026 and no other assessment was overdue. Due dates are now tracked in a spreadsheet reviewed on the first working day of each month." |
| "The expired reagent was discarded." | "The expired vial was discarded on the day of the survey. Patient runs between the expiration date and the survey were reviewed. Quality control was acceptable on each run and no results were affected. All reagent storage was checked the same day. Expiration dates are now checked on the first of each month and recorded on the lot log." |
The examples show the shape of an answer. Yours has to describe what your laboratory actually did, with your dates.
Before you send it
- Every deficiency, and every part of it, has all four points.
- Every correction has a date. Completed items say when. Open items say by when.
- Titles are used in place of personal names, and no patient is identified.
- Evidence is attached: the revised procedure, the training sign-in sheet, the completed log.
- The director has signed and dated page one.
- You kept a copy. Surveyors check at the next visit that the plan was carried out.
What is a CLIA plan of correction?
It is the laboratory's written response to the deficiencies listed on Form CMS-2567, the Statement of Deficiencies it receives after a survey. For each deficiency it says what was done, how other affected results were found, what was changed so it does not happen again, and how the laboratory will check that the fix holds.
How long do I have to respond?
The cover letter that arrives with the form gives your date. Ten days from receipt is the usual figure. If you cannot finish a correction in that time, you still send the plan on time and give a realistic completion date for the open item.
Who signs it?
The laboratory director, or the person your cover letter names. The signature and date go on the first page of the form.
Why do plans of correction get sent back?
The common reasons are a response that leaves out one of the four points, a promise with no date, a fix for the one cited example with nothing about other patients who may have been affected, and "staff were re-educated" with no change to the system that let the problem happen.
Should I argue with the finding in the plan?
No. The plan of correction is where you say what you did. If you believe a finding is wrong, raise it with the State agency or accreditation organization in the way your cover letter describes, and keep it out of the plan.
A template for the response
The IR-04 Plan of Correction Template in the Inspection Readiness Kit lays out one block per deficiency with the four points, completion date and responsible title. To find problems before a surveyor does, use the free readiness check.
Sources
- Oregon Health Authority: writing a plan of correction for CLIA deficiencies (PDF)
- CMS: Clinical Laboratory Improvement Amendments
- 42 CFR Part 493, Subparts Q and R (inspection and enforcement), on eCFR
Summaries on this page are ours and are written for convenience. The regulation and the agency documents control.
Your State agency or accreditation organization may ask for a particular format. Follow the instructions that came with your Form CMS-2567.