CMS to Resume Routine Laboratory Inspections

Publication Date: Aug 31, 2020

The Centers for Medicare & Medicaid Services (CMS) announced on Aug. 17 via a memo to state survey agency directors that the Agency is resuming routine inspections and surveys of healthcare facilities, including clinical laboratories. The memorandum stated that CMS is issuing updated guidance for the re-prioritization of routine State Survey Agency (SA) Clinical Laboratory Improvement Amendments (CLIA) survey activities, subject to the SA’s discretion, in addition to lifting the restriction on processing CLIA enforcement actions, and issuing the Statement of Deficiencies and Plan of Correction (Form CMS-2567).

Among the reprioritized activities that CMS is urging are the performance of on-site surveys, enforcement actions or PT desk reviews that have been on hold from either before the March 23, 2020 memo or after the memo was issued. CMS’s Division of Clinical Laboratory Improvement & Quality (DCLIQ) will follow up with Frequently Asked Questions and additional updates in the near future. That said, the Agency announced that validation surveys on accredited laboratories and Provider Performed Microscopy Project surveys will not resume at this time. CLIA questions should be addressed to: LabExcellence@cms.hhs.gov.

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