Allegation of Compliance (AoC)

6132.3 - Allegation of Compliance (AoC) (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) When condition-level noncompliance is determined by CMS or SA surveyor, an AoC is requested. An AoC is an assertion (i.e., allegation) from the laboratory that they are in compliance; hence, no future dates of correction are acceptable for any condition-level deficiency as well as standard-level deficiencies included in the condition on the Form CMS-2567. For any standard-level deficiencies that are not included in the condition, future dates are acceptable. The AoC contains records (documentary materials) that describe or support the laboratory’s compliance. A record includes all recorded information, regardless of form or characteristics, made or received by a federal agency under federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the US Government or because of the informational value of data in them. 44 U.S.C Chapter 33, Section 3301.” All records must be kept the period defined by the federal requirements at DAA-0440-2015-0008, which is 7 years, or by State requirements, if more stringent than federal requirements. There are four elements that are required to be submitted with an AoC. Those four elements are: 1. Documentation describing the corrective actions that have been taken for patients that were identified by the survey and subsequent analysis as having been affected by the deficient practice(s); 2. An explanation as to how the laboratory has identified other patients who may have been affected by the deficient practice(s); 3. A description of the correction(s) that have been put into place and/or the systemic changes that have been made to ensure that the deficient practice does not recur; and 4. A description of how the corrective actions are being monitored to ensure the deficient practice does not recur. In addition to the above four elements, the AoC is a statement or documentation that is: 1. Made by a representative of a laboratory with a history of having maintained a commitment to compliance and taking corrective action when required; 2. Realistic in terms of the possibility of the corrective action being accomplished between the date of the survey and the date of the allegation: and, 3. Indicates resolution of the problem(s).