State Operations Manual (Pub. 100-07), Ch. 6 § 6136.3
Noncompliance Based on an Unacceptable AoC
6136.3 – Noncompliance Based on an Unacceptable AoC
(Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25)
In situations where it is determined that a laboratory has failed to comply with one or
more CLIA conditions (condition-level deficiencies), the SA requests an AoC and
acceptable evidence of correction. If after two submissions, the laboratory fails to submit
a credible AoC and acceptable evidence of correction, the SA notifies CMS.