Federal Statute and Guidance | Covid-19 | Sep 1, 2020
CMS Issues Guidance on Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories and Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
CMS issued guidance in coordination with its release of the interim final rule with comments (IFC) regarding new/modified Clinical Laboratory Improvement Amendments (CLIA) regulations related to laboratory reporting of COVID-19 test results. The guidance emphasizes that health care facilities using Point of Care COVID-19 testing devices under a CLIA Certificate of Waiver, including nursing homes, pharmacies, or other settings will be required to report test results under the IFC. The guidance also enumerates the mandatory citations and civil monetary penalties that will apply to CLIA-certified laboratories who fail to meet the IFC requirements.