On July 14, Centers for Medicare and Medicaid (CMS) announced that it will distribute point-of-care (POC) antigen COVID-19 testing devices to every nursing home in the country. However, there are six steps providers must take before using the tests.
- Be sure your public health department or state epidemiologists verify what, if any requirements, guidelines or limitations are in place for using these POC Antigen tests. Because these tests have lower sensitivity and specificity, not all state public health departments allow for their use.
- Review CARES Act reporting requirements and establish a process to report all test results. This is in addition to the reporting completed through the CDC NHSN website and other state reporting requirements.
- Develop a plan, in accordance with state and local guidelines to perform any follow up tests with PCR for those that test negative using the POC testing devices. The antigen method has a higher likelihood of registering false negatives.
- Make sure you have personnel trained to collect the specimen and use the test properly to be compliant with your CLIA certificate. The FDA and CLIA requires that facilities performing waived tests follow the manufacturer’s instructions.
- Make sure you have a process to record all test results and notify the person of the results.
- Incorporate the use of these testing devices into your facility infection prevention and control program and facility assessment.
If you have any questions or concerns regarding this, please do not hesitate to contact us.