CMS-2567 Plan of Correction: How to Respond, With Examples
A CLIA plan of correction answers each deficiency on your CMS-2567. For each tag, say what was fixed, how you found other affected patients or results, what system change prevents recurrence, who monitors it and how, and the completion date. Submit it by the date in your letter. Condition-level findings need a credible allegation of compliance with evidence.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice. Always follow the instructions and deadlines in your own letter.
Key facts and official sources
Standard-level deficiencies need a plan of correction acceptable to CMS in content and timeframes, and must be corrected within 12 months of the last day of inspection. Source: 42 CFR 493.1816
For condition-level noncompliance, CMS gives written notice of any proposed sanction and allows at least 10 days to respond. Sanctions are lifted after compliance is verified, which can be based on a credible allegation of compliance. Source: 42 CFR 493.1810
Under the current SOM Chapter 6, the State Agency sends Form CMS-2567 within 10 working days. Source: CMS QSO-25-13-CLIA
What is a CMS-2567?
Form CMS-2567, the Statement of Deficiencies and Plan of Correction, lists every deficiency the surveyor cited. Each one has a D-tag, the regulation it relates to, and the evidence the surveyor found. The right-hand column is where the lab writes its plan of correction. Condition-level tags, such as D2016 or D6000, mean an entire CLIA condition was not met. Those carry possible sanctions under 42 CFR 493 Subpart R.
How long do you have to respond?
Use the deadline in your cover letter. Many state agencies ask for the plan of correction or allegation of compliance within 10 calendar days of receiving the CMS-2567, but don't assume. If you can't meet the date, contact the surveyor's office before it passes.
What are the five parts of an acceptable plan of correction?
Correction for affected patients or results. What you did for the cases the surveyor found.
Identification of others. How you looked for other patients, results or records with the same problem, and what you did for them.
Systemic change. The procedure, training, staffing or system change that prevents recurrence.
Monitoring. Who checks the fix (by title, not personal name), how, how often, and what happens if problems recur.
Completion date. A specific date for each tag.
Annotated examples
Illustrative example. These are not real survey findings. Adapt each one to the facts in your own CMS-2567.
Example 1: D2016 Successful Participation (PT)
Finding (illustrative): the lab was unsatisfactory for one chemistry analyte in two consecutive PT events.
Weak POC: "Staff were retrained. PT will be reviewed."
Stronger POC:
Investigated both events and documented the root cause (for example, calibration drift on one analyzer).
Reviewed patient results for the analyte from the first failed event forward and issued corrected reports where needed.
Recalibrated the analyzer and verified calibration.
Added a technical consultant review of each PT event within 7 days of receiving the results.
The technical consultant monitors the next two PT events and monthly QC review, and reports to the lab director.
Completion date: [date].
Evidence to attach: PT reports, investigation record, calibration verification, corrected reports, revised procedure.
Example 2: D6000 Moderate Complexity Laboratory Director
Finding (illustrative): the director did not ensure PT failures were investigated, or QC corrective actions documented.
Weak POC: "Director will provide better oversight."
Stronger POC:
The director reviewed all open PT and QC issues and documented corrective action for each.
The director adopted a written monthly review checklist covering PT, QC, competency and onsite visit records, and signs it each month.
Duties delegated to the technical consultant are documented in writing.
Director onsite visits are logged as §493.1407(c) currently requires.
The lab director monitors with a quarterly audit for 12 months.
Completion date: [date].
Evidence to attach: signed checklists, delegation document, onsite visit log, completed corrective actions.
Example 3: D5400 Analytic Systems (QC)
Finding (illustrative): patient results were reported on days when one control level was out of range, with no corrective action recorded.
Weak POC: "QC will be run correctly."
Stronger POC:
Identified every affected run since the last acceptable QC.
Reviewed and corrected the patient results.
Revised the QC procedure so patient results are held until QC is acceptable.
Trained and documented all testing personnel.
Added a QC corrective action log.
The supervisor reviews QC daily, and the technical consultant reviews it monthly.
Completion date: [date].
Evidence to attach: look-back list, corrected reports, revised SOP, training sign-offs, completed logs.
What is the difference between a POC and an allegation of compliance?
Response: Standard-level deficiency: Plan of correction; Condition-level deficiency: Credible allegation of compliance, with evidence
Correction: Standard-level deficiency: Within the accepted timeframe, and no later than 12 months; Condition-level deficiency: Must be verified before sanctions are lifted. A revisit may occur
Risk if ignored: Standard-level deficiency: Medicare cancellation and certificate action after 12 months; Condition-level deficiency: Principal or alternative sanctions
Why do plans of correction get rejected?
Personal names instead of position titles
"Retrain staff" with no root cause, look-back or monitoring
Missing completion dates, or dates that are too far out
Fixing the examples cited but not checking for other affected results
No evidence attached for condition-level tags
Frequently asked questions
Can we use one POC for several tags?
Each tag needs its own response. You can cross-reference a shared corrective action, but explain how it fixes each deficiency.
Who signs the CMS-2567?
The lab director or another authorized official, as your letter instructs.
Does a plan of correction admit fault?
A POC is how you show correction. If you disagree with a finding, discuss it with the surveying agency and check your appeal rights in the notice before you submit.
Do COLA and CAP deficiency responses work the same way?
The principles are the same, but accreditors set their own forms and deadlines. Follow your accreditor's instructions.
Can a consultant write our POC?
Yes. The lab remains responsible for the content, and the corrections must actually be carried out.
Get help with your CMS-2567
Sound Lab Consultants drafts plans of correction and allegations of compliance, gathers evidence of correction, and provides interim lab director and technical consultant coverage.