On Tuesday, July 14, 2020, CMS announced a plan to send point-of-care tests directly to every nursing facility in the country. Based on the Clinical Laboratory Improvement Amendments (CLIA) however, unless the building has a specific waiver allowing staffers to perform tests, the facility will not receive the units. Facilities must secure a CLIA waiver in order to receive one of the free units.
In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. To be “waived” means that certain tests can be performed without the need for the conduct of more stringent standards imposed by CLIA. The FDA classifies as “waived” those tests that employ relatively simple methodologies such that when performed properly, these tests are least likely to yield erroneous results.
According to information provided by CMS in QSO-20-21-CLIA, The CLIA program is unable to approve section 1135 waiver requests with respect to waivers of CLIA program requirements. The section 1135 waiver authority is only applicable to specified programs (or penalties) authorized by the Social Security Act (SSA). The CLIA program does not fall into this category of programs.
For beneficiaries who are in a nursing home, Medicare pays labs to send technicians to a nursing home when a beneficiary is not in a Part A skilled nursing stay, to collect a lab sample. While a nurse could collect a lab sample as part of a normal routine, processing that lab sample onsite for the purposes of testing can only be done if the required CLIA waiver is in place for the respective facility.
If you would like to submit for a CLIA waiver to perform COVID-19 testing onsite at your facility, please reference materials linked below on the process for completing the application.
Greg Seiple, RN is the VP of Clinical Informatics at Team TSI with over 25 years’ experience in Clinical Services and Operations on the Skilled Nursing side having served at a Vice President or Senior Vice President of Clinical Services for several long term care companies during his career. Greg is also an adjunct instructor for Penn States Nursing Home Administrators course taught at the main campus in State College, PA.