It has come to our attention that many assisted living/senior living communities are doing their own COVID-19 testing on staff and residents. Please be aware in order to administer these tests you MUST apply for and obtain a CLIA WAIVER. A template for CLIA WAIVER policy and procedure is attached as are the required application forms. You may add that anyone performing the point of care tests should be skill validated for the specific device that will be used, with return demonstration, and the documentation for that training placed in their employee file.
It is advised you check with your company or corporate office before submitting the attached application.
Although it is a federal form (CMS116) the states process the forms and some have additional requirements. Check with the state agency listed in the attachment to ascertain what else you might need.
You should estimate around 6-12 weeks for processing.
If you have any questions PLEASE use the contact form on alnursing.org to contact a board member.
The American Health Care Association and National Center for Assisted Living (AHCA/NCAL) released the following statement in response to the recommendations by the Centers for Disease Control and Prevention (CDC) as well as the Food and Drug Administration (FDA) to approve booster shots of the Moderna and Janssen (Johnson and Johnson) COVID-19 vaccines for certain individuals, including residents and health care workers in long term care.
The following statement is attributable to David Gifford, MD, chief medical officer of AHCA/NCAL:
“Once again, we appreciate the FDA and CDC for thoroughly examining the data and following the science to help protect Americans, including our nation’s most vulnerable, from COVID-19. All long term care residents and staff members will now be eligible to receive a booster shot thanks to these expanded recommendations.
“Additionally, the ability to mix-and-match vaccines for the booster dose will make it easier for long term care facilities to swiftly access these vaccines for their residents and staff.
“The rollout of the Pfizer booster shot has gone incredibly well in long term care, and we are confident that adding Moderna and Johnson and Johnson into the mix will catapult our efforts. We appreciate the partnership of federal and state governments, as well as long term care pharmacies and other vaccine providers, to make these vaccination efforts in nursing homes and assisted living communities efficient and successful.”
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BREAKING: J&J’s COVID vaccine pause ‘essentially halts’ skilled nursing, assisted living shots Publish Date April 13, 2021 COVID-19 vaccinations are essentially at a standstill in U.S. nursing homes and assisted living communities due to federal officials’ call today for a pause on the use of the Johnson & Johnson vaccine.