On July 14th, the Trump Administration announced an initiative for rapid point-of-care diagnostic test instruments & tests to be distributed to all approved nursing homes operating under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, Certificate of Compliance or Certification of Accreditation. The FDA has granted Emergency Use Authorization to two antigen detection tests for rapid detection of SARS-CoV-2. This initiative is a one-time procurement of devices and tests targeted to facilitate on-site testing among nursing home residents and staff. The Center for Medicare and Medicaid Services has published a Frequently Asked Questions document for skilled nursing facilities and nursing homes which explains who will receive the tests, how the distribution will be handled, reporting requirements and how training and safety precautions will be provided to staff.
CMS Answers Questions on CLIA Certified Nursing Home Antigen Testing
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