CMS-2567: Reading Deficiencies and Writing a Plan of Correction
A CLIA survey with findings ends in Form CMS-2567, the statement of deficiencies. This guide reads the form box by box, sets out the 10-day clock, shows what CMS counts as an acceptable plan of correction with a worked example, and follows the Subpart R path for findings left open. Every rule here was read from CMS's survey manual and 42 CFR 493 on 23 October 2026.
How a CMS-2567 is laid out
Form CMS-2567 is the “Statement of Deficiencies and Plan of Correction”. The surveyor fills the left half; you fill the right half and sign the last page. This is the form's own layout, with one made-up citation in it.
X1Provider/Supplier/CLIA identification number
12D3456789
X2Multiple construction
X3Date survey completed
the last day on site
Name of facility surveyed, facility address, accrediting organization performing survey (if applicable)
| (X4) ID prefix tag | Summary statement of deficiencies | ID prefix tag | Plan of correction | (X5) Completion date |
|---|---|---|---|---|
| D5413 | § 493.1252(b) Based on a review of temperature logs and an interview with the testing person, the lab had no written acceptable range for the reagent refrigerator for the months reviewed. | D5413 | The manufacturer's storage range written into the procedure; logs reviewed for affected runs; daily sign-off and a monthly director review. See the four elements below. | a dated day |
- X1Your CLIA number, ten characters with a D in third place. When several sites share one number, the summary text names the site each finding came from.
- X3The date survey completed. The 12-month limit on every correction date counts from this box, not from the day the form arrives.
- X4The D-tag. Proficiency testing tags sit in the D2000s, the quality systems of Subpart K in the D5000s (D5200 general systems, D5300 preanalytic, D5400 analytic, D5800 postanalytic), and personnel in the high D5900s and the D6000s.
- SummaryThe regulation cited, then the evidence: what the surveyor read, saw or was told. Read it for the scope, one record or every record, because the plan has to cover the same scope.
- X5Your completion date, one per tag. An explicit date is required; a correction already made gets the date it was made.
- X6The laboratory director's or an authorized official's signature, title and date. The State Agency checks for it before it accepts the plan (SOM § 6134).
A finding written under a condition, such as Analytic Systems at § 493.1250 (D5400), carries more weight than the standard-level tags beneath it, and changes what you send back: see plan or allegation below.
The deadlines
10 calendar days
to complete and return a plan of correction or credible allegation of compliance, counted from receipt
12 months
the latest correction date a plan may carry, counted from the date survey completed (X3)
The 10 calendar days start when the form reaches you, by email, post or fax, not when the surveyor leaves. If you need longer to work out the fix, CMS's manual tells the State Agency to ask for a preliminary plan within the 10 days, “as precisely as present information permits”, followed by a more specific one. A revisit to verify correction happens only once the agency has an acceptable plan.
The form is public. The findings and your plan can be released, with patient names, complainants and other identifying details blocked out, after you have had a chance to review them. Write every line as if a competitor will read it. CMS's manual says a plan must never allude to another laboratory or malign an individual.
Diary the day it arrives
Log the receipt date the day the CMS-2567 lands and count 10 calendar days, weekends included. Immediate jeopardy runs on shorter time frames of its own (SOM § 6284).
What an acceptable plan of correction contains
The laboratory must submit a plan of correction that is acceptable to CMS in content and time frames.
CMS's manual spells out “acceptable”. You write the plan opposite the D-tag it answers, with an expected completion date, and it must carry four elements. The right-hand column shows what each looks like for the made-up storage citation above.
| No. | Required element | For the D5413 example |
|---|---|---|
| 1 | Corrective action for patients the survey found affected | Runs from the unmonitored weeks listed; the director's review of each, and any report corrected and re-sent. |
| 2 | How you identified other patients who may have been affected | Every test using reagents from that refrigerator in the period, pulled from the LIS by date and instrument. |
| 3 | The correction or systemic change, so it does not recur | Acceptable range from the package insert written into the procedure manual; the log form now prints the range. |
| 4 | How the corrective action is monitored | Daily sign-off by the tester; monthly review by the technical consultant, filed with the QC records. |
The manual adds that the plan “must be specific and time frames stated and realistic”. Corrections may be dated after the day you submit, but every date must fall “within 12 months after the ‘date survey completed’”. A fix already in place gets the date it was made. The director or another authorized official signs and dates the form, and the State Agency checks all four elements and the signature before it accepts the plan.
You may also disagree. The manual lets a lab enter its disagreement with a finding and attach documentation that the requirement is met. If the agency does not resolve it, put the protest in writing in a form fit for public release, and still give a plan and a time frame.
Takeaway
Plan of correction or allegation of compliance
The 2567 asks for one of two things, and which one depends on the level of the finding. A plan of correction says what you will fix and by when. An allegation of compliance says you have already fixed it.
| Aspect | Plan of correction | Allegation of compliance |
|---|---|---|
| Asked for when | The findings are standard-level | A condition is out of compliance |
| Future dates | Allowed, within 12 months of the date survey completed | None for the condition or the standards cited under it; standards outside the condition may carry future dates |
| Must contain | The four elements | The same four elements, plus a statement that is realistic, shows the problem resolved, and comes from a lab with a record of correcting when required |
| How it is checked | An offsite follow-up within 12 months, normally by email, post or phone | An onsite revisit, except for PT enrollment, unsuccessful PT and personnel qualification conditions, which are checked offsite |
Four conditions are cited whenever they are not met, harm or no harm: proficiency testing enrollment, proficiency testing referral, unsuccessful proficiency testing participation and personnel qualifications. Each one, once cited, calls for an allegation rather than a plan. Source: SOM Chapter 6, §§ 6130.5 and 6132.3.
The same plan twice
A repeat deficiency is one cited again after a prior survey. If your plan for it matches the plan you sent last time, CMS's manual says it is not acceptable. The State Agency gives no more than one further chance before it can send the case to CMS for enforcement (SOM § 6134.1). Fix the cause, not the record.
If the plan is missed: the Subpart R path
Enforcement sits in Subpart R of 42 CFR 493. What happens next turns on the level of the finding, and on one date: 12 months after the last day of the inspection.
| Level of finding | First action | If it is not corrected |
|---|---|---|
| Standard-level only§ 493.1816 | Submit a plan of correction acceptable to CMS in content and time frames. | Not corrected within 12 months after the last day of inspection: CMS cancels the lab's approval to receive Medicare payment and gives notice of intent to suspend, limit or revoke the certificate, with the right to a hearing. |
| Condition-level, no immediate jeopardy§ 493.1814 | CMS may cancel Medicare approval or suspend, limit or revoke the certificate. If it imposes neither, it imposes one or more alternative sanctions; for unsuccessful PT it may require training and technical assistance instead (§ 493.1838). | Not corrected within 12 months after the last day of inspection: Medicare approval is cancelled and, after a revisit, CMS proposes to suspend, limit or revoke the certificate. |
| Immediate jeopardy§ 493.1812 | The lab must act at once to remove the jeopardy; CMS may add alternative sanctions. | Jeopardy still there on revisit: CMS suspends or limits the certificate no earlier than 5 days after notice, and may later revoke it. CMS may also go to court to stop the testing. |
The sanctions. The principal CLIA sanctions are suspension, limitation or revocation of the certificate (§ 493.1806); a Medicare lab can also lose its approval to be paid (§ 493.1807). The alternatives are a directed plan of correction (§ 493.1832), State onsite monitoring and a civil money penalty (§ 493.1834), plus suspension of part or all of a Medicare lab's payments. Alternative sanctions are not used on a lab with a certificate of waiver.
The notices. Before an alternative sanction, CMS sends written notice of the noncompliance, the sanction and its rationale, and gives at least 10 days to respond (§ 493.1810(a)). A civil money penalty starts to accrue 5 days after the notice of intent when there is immediate jeopardy and 15 days after it when there is not. Its range is set in § 493.1834 and adjusted annually under 45 CFR part 102.
The way back. If at a revisit you show credible evidence that you were compliant earlier, the sanctions lift as of that earlier date (§ 493.1820(b)). Once every condition is fixed, CMS may accept a revised plan for leftover standard-level findings, but not beyond 12 months from the last day of the original inspection. A lab has 60 days from a notice of sanction to request a hearing before an administrative law judge (§ 493.1844).
Proposed, not in force
CMS's proposed rule CMS-3478-P (8 October 2026; comments close 7 December 2026) would rescind the 6-month wait before reinstatement after PT failure and keep alternative sanctions, including patient notification, running until a certificate is revoked rather than when it is suspended or limited (Federal Register). Today's text above stays the rule until a final rule says otherwise.
Takeaway
The D-tags cited most in 2024
CMS publishes the citations it writes most. These are its 2024 lists: the ten most frequent standard-level tags, then the two most frequent conditions. “Labs” is the number of labs cited, and the share is CMS's percentage of all labs (CMS Top 10, 2024).
| D-tag | What was cited | Labs | Share | Read next |
|---|---|---|---|---|
| Standard-level | ||||
| D5413 | Storage and operating conditions defined, monitored and documented§ 493.1252(b) | 818 | 5.0% | Temperature monitoring |
| D5209 | Competency assessment policies§ 493.1235 | 778 | 4.8% | Competency rules |
| D5401 | Procedure manual available and followed§ 493.1251(a) | 635 | 3.9% | |
| D5403 | Procedure manual contents§ 493.1251(b) | 609 | 3.7% | |
| D5417 | Expired, deteriorated or substandard supplies in use§ 493.1252(d) | 607 | 3.7% | Inventory software |
| D5217 | Twice-yearly accuracy check for tests without PT§ 493.1236(c)(1) | 548 | 3.4% | PT guide |
| D5421 | Performance verified on an unmodified FDA-cleared test system§ 493.1253(b)(1) | 451 | 2.8% | |
| D6016 | Director ensures PT samples are tested as Subpart H requires§ 493.1407(e)(4)(i) | 451 | 2.8% | Director rules |
| D5429 | Maintenance as the manufacturer defines it§ 493.1254(a)(1) | 449 | 2.8% | |
| D5805 | Test report content§ 493.1291(c) | 417 | 2.6% | What an LIS must print |
| Condition-level | ||||
| D2016 | Successful participation in proficiency testing§ 493.803 | 738 | 4.39% | PT guide |
| D6000 | Moderate complexity laboratory director§ 493.1403 | 709 | 4.22% | Director services |
Five of the ten standard-level tags (D5413, D5209, D5401, D5403, D5805) turn on what is written down: criteria, policies, the manual, the report. Those are the easiest to find before a surveyor does: walk the CLIA inspection checklist against your own files, and read what to expect on survey day. If a director finding (D6000 or D6016) is on your form, the lab director and consulting services comparison covers who can step in.