Follow-Up on AoC/PoCs and Revisit Survey

6134.2 - Follow-Up on AoC/PoCs and Revisit Survey (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) If possible, the follow-up/revisit survey is to be conducted by a member of the survey team that made the findings. When a laboratory has failed to comply with one or more CLIA condition-level deficiencies, the SA performs an onsite follow- up/revisit survey after the laboratory makes a credible AoC. When conducting an onsite follow-up/revisit survey, the SA verifies compliance with the federal regulations. In some cases, the condition-level deficiencies may allow for electronic transmission mail (e-mail), mail, or telephone contact in place of an onsite visit, (e.g., the laboratory agreed to amend its written policies). An onsite follow-up/revisit survey is not required for mandatory condition-level deficiencies related to PT enrollment 42 CFR § 493.801, unsuccessful participation in PT 42 CFR § 493.803, and personnel qualifications in subpart M – Personnel for Nonwaived Testing, 42 CFR §493.1351 through 42 CFR §493.1495. An onsite follow-up/revisit survey is performed for condition-level deficiencies related to personnel responsibilities in subpart M – Personnel for Nonwaived Testing, 42 CFR §493.1351 through 42 CFR §493.1495. If the condition-level deficiencies indicate a potential risk to the quality of patient test results, an onsite follow-up/revisit survey must be performed. If the laboratory does not give the SA a credible AoC for outstanding condition-level deficiencies, an onsite follow-up/revisit is required prior to the imposition of principal sanctions. Within 12 months of the original survey, the SA conducts an offsite follow-up/revisit survey for any standard-level deficiencies not associated with a condition-level deficiency. This offsite follow-up/revisit survey is normally conducted by e-mail, mail, or telephone. An onsite follow-up/revisit survey of standard-level deficiencies is warranted in rare circumstances such as when the laboratory-provided evidence of correction does not verify correction of the deficiency and/or the documentation provided indicates potential risk to the quality of patient test results. An offsite follow-up/revisit survey is performed following citation of mandatory condition-level deficiencies related to PT enrollment 42 CFR § 493.801, unsuccessful participation in PT 42 CFR § 493.803, and personnel qualifications in subpart M – Personnel for Nonwaived Testing, 42 CFR §493.1351 through 42 CFR §493.1495. The SA may consult with CMS for a determination regarding the appropriate type of follow-up/revisit. Any additional onsite follow-up/revisit surveys must be approved by CMS. The SA may consult with CMS for a determination regarding cases that are unclear. The SA obtains appropriate documentary verification (or onsite verification if warranted) before reporting a citation as corrected in the CLIA Data System. If, at the time of the revisit, some deficiencies have not been corrected, the SA completes another Form CMS-2567 for the revisit survey summarizing the deficiencies not corrected by using the appropriate data prefix tag number. The SA must ask the laboratory to provide a revised PoC or AoC with a new completion date. The SA sends a copy of the Form CMS-2567 and allows the laboratory 10 calendar days to complete and return a PoC or AoC for any remaining deficiency(ies). The SA inputs the revised data into the ASPEN system. If failure to correct deficiencies results in the laboratory no longer being in compliance, the SA documents the case for enforcement action and forwards the case to CMS. • The SA is required to complete a Form CMS-2567 for every revisit survey. The CMS-2567 will document new deficiencies, uncorrected deficiencies with new findings of noncompliance, or a statement that the laboratory is in compliance. • For example, a deficiency statement for no deficiencies on a revisit survey: A (onsite/offsite) revisit survey was completed on XXX (date) for all previous deficiencies cited on XXX (date of original survey). All deficiencies have been corrected, and no new noncompliance was found. The facility is in compliance with 42 CFR Part 493, Requirements for Laboratories. • For example, a deficiency statement for new deficiencies on a revisit survey: A (onsite/offsite) revisit survey was completed on XXX (date) for all previous deficiencies cited at the (initial/recertification/validation/complaint/focused complaint) survey performed on XXX (date of original survey). All deficiencies related to the (initial/recertification/validation/ complaint/focused complaint) survey have been corrected. New noncompliance was found. In any event, the SA must record the survey findings in ASPEN within 45 days from the date of the survey; follow-up/revisit information can be entered into ASPEN at any time thereafter.