Form CMS-2567: Statement of Deficiencies and Plan of Correction
On June 18, 2025, CMS published an update to its practices on the release of CMS-2567 in QSO-25-19-All. This form will now be publicly released within 14 days after receipt by the provider, supplier, or lab — this change effectively allows immediate release upon receipt by the provider/supplier/lab. Labs generally have ten days to develop and submit a response to the findings, which may include Plan of Correction (POC) and/or Allegation of Compliance (AOC). This is not changing.
Previous practice by CMS held the public release of CMS-2567 for up to 90 days after the completion of a survey or until a POC or AOC had been approved by CMS.
CMS-2567 is the record of the survey where the surveyor(s) documents and justifies the determination of compliance for CLIA certification. The information/survey findings serve as the basis for the laboratory to analyze its deficient practices or system failures and to develop plans of correction. CMS-2567 may also document deficient practices identified by means other than an on-site survey (e.g., an off-site review of unsuccessful proficiency testing scores).
Enforcement and Clarification of Personnel Regulations
On June 23, 2025, CMS published circumstances that it will be exercising enforcement discretion (authority of regulatory agencies to determine how and when to enforce regulations) regarding new personnel regulations that went into effect December 28, 2024. The following is communicated in QSO-25-21-CLIA:
- CMS will be exercising enforcement discretion in the following limited circumstances with respect to certain regulatory personnel qualification requirements and plans to address these changes in future notice-and-comment rulemaking:
- CMS will allow laboratory directors qualifying under 42 CFR 493.1405(b)(2) to have either at least 1 year of experience directing or supervising nonwaived laboratory testing or 20 continuing education (CE) credit hours in laboratory director responsibilities.
- CMS will not require the additional 20 CE credit hours currently required under §493.1405(b)(3)(ii), 493.1405(b)(4)(iv), 493.1405(b)(5)(iv), 493.1443(b)(2)(iii), and 493.1443(b)(3)(iv). As such, any individual previously qualified as a clinical consultant will be able to continue to qualify without taking an additional 20 CE credits.
- CMS will allow for individuals qualified as technical supervisors under §493.1449(f)(2)(i) to qualify as high-complexity laboratory directors for testing in dermatopathology.
- In addition, CMS is clarifying the following and plans to address in future notice-and-comment rulemaking:
- “An approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” as required under §493.1405(b)(3)(i)(B)(2), 493.1405(b)(4)(i)(C)(2), 493.1443(b)(3)(i)(B)(2), and 493.1449(c)(4)(i)(C)(2) does not need to be on human subjects, as most research is performed on animal models.
- The requirements under §493.1443(b)(3)(iii) for high-complexity laboratory directors to require a total of two, not four, years of laboratory training or experience and laboratory experience directing or supervising high complexity testing.
These and other CMS memos can be viewed at https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/policy-memos/policy-memos-states-and-cms-locations.
I welcome your comments and questions — please send them to me at
