State Operations Manual (Pub. 100-07), Ch. 6 § 6136.3

Noncompliance Based on an Unacceptable AoC

Last amended: 2025Year: 2025Length: 68 wordsOfficial source
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.
State Operations Manual (Pub. 100-07), Ch. 6 § 6136.3: Noncompliance Based on an Unacceptable AoC | Justis AI