State Operations Manual (Pub. 100-07), Ch. 6 § 6136
Evaluation of Compliance
6136 - Evaluation of Compliance
(Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25)
The CLIA requirements establish a single set of conditions and standards for all
laboratories. CLIA certification is required for payment for laboratory services
under the Medicare and Medicaid programs.
During the laboratory survey, the SA compiles all information required to determine
compliance, and completes all official reports of survey findings. Survey findings under
CLIA requirements are determinations made by surveyors. When the survey reports and
the Form CMS-1539 are entered into the CLIA Data System, an official determination of
CLIA compliance is made.