Failure to Update CLIA Certificate After Change of Ownership
Penalty
Summary
The facility failed to update its Clinical Laboratory Improvement Amendments (CLIA) certificate within 30 days following a change in ownership, as required by regulations. Approximately seven months after the new owner acquired the facility, the CLIA Certificate of Waiver and the CLIA Certificate of Compliance remained in the name of the previous owner and previous laboratory service owner, respectively. During an interview, the facility's Administrator acknowledged that the facility was still operating under the previous owner's waiver as part of the transition. The State CLIA Department confirmed that the facility was out of compliance and should have requested a revised CLIA certificate using the CMS-116 application within the required timeframe.