CMS resumes inspections of labs, providers

Aug. 18, 2020

The Centers for Medicare & Medicaid Services (CMS) announced that it will resume routine inspections of labs, providers and suppliers, according to a press release.

CMS issued an updated guidance for the re-prioritization of routine state survey agency activities related to the Clinical Laboratory Improvement Amendments (CLIA). The agency said the updated guidance will provide flexibility and discretion to state survey agencies so that they can resume their survey activities based on the status of COVID-19 infections in their states.

CMS has recommended to state surveyors that they follow the following list when prioritizing onsite surveys:

·        Complaints that represent situations in which immediate corrective action is necessary because the laboratory’s noncompliance with one or more condition-level requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health or safety of the general public (including, but not limited to injury or harm related to COVID-19) and any revisit to resolve current enforcement actions.

·         Recertification actions for certificates that have been extended to August 31, 2020, and any other soon to expire certificates.

·         Initial certifications.

·         Other complaints per Chapter 5 of the SOM (State Operations Manual).

For providers, the agency also released an updated guidance directing the resumption of onsite revisit surveys, non-immediate jeopardy complaint surveys and annual recertification surveys of providers, such as nursing homes and hospitals.

CMS had previously suspended certain routine inspections as part of its response to the COVID-19 pandemic to prioritize infection control and immediate jeopardy situations and to give healthcare providers and suppliers time needed to respond to the spread of COVID-19.

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