The federal government on Tuesday announced an ambitious plan to send point-of-care tests directly to every nursing facility in the country. But unless the building has a specific waiver allowing staffers to perform tests, the facility will not receive the tests, SNN has learned.
Operators must secure a Clinical Laboratory Improvement Amendments (CLIA) waiver in order to receive one of the free units from the federal government, a Department of Health and Human Services (HHS) spokesperson confirmed.
“Facilities that do not have a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver to administer the tests will not receive a testing instrument,” the spokesperson stated in an e-mail. “Each state has facilities that do not have a waiver, and the following states did not have any facilities that met the criteria for receiving an instrument while also having a CLIA waiver: Alaska, Hawaii, Washington, and West Virginia.”
CLIA, a 1988 federal law, governs standards for laboratory tests at health care facilities across the country. Health care facilities can apply for a CLIA waiver directly from the Centers for Medicare & Medicaid Services (CMS) or each state’s CLIA survey agency.
“Facilities in these states will receive allocations when HHS sends the remaining nursing homes instruments and tests, and they obtain a CLIA waiver,” the spokesperson said. “Nursing homes can follow the CMS guidance to obtain a CLIA Certificate of Waiver.”
In general, providers must apply for CLIA waivers for all facilities where they intend to perform tests, according to the waiver guidance provided by the HHS spokesperson.
“As defined by CLIA, waived tests are categorized as ‘simple laboratory examinations and procedures that have an insignificant risk of an erroneous result,'” the guidance reads. “The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer’s applications for test system waiver.”
The CLIA requirements also mandate that applicants pay a certificate fee every two years, perform tests according to manufacturers’ instructions, and notify the applicable state agency of changes in ownership, name, or location of the waived facility.
The approval process, under normal circumstances, takes four to six weeks, according to an explainer from the Arizona Department of Health Services. The Centers for Medicare & Medicare Services (CMS) is working to expedite the process, according to a spokesperson; as soon as a facility names a lab director and submits an application, it can begin performing tests as long as it meets CLIA requirements.
According to the American Health Care Association, about 10% of facilities nationwide do not have the CLIA certification, a spokesperson told SNN.
“Administrator Verma has assured me that the vast majority of nursing homes have a certificate of waiver,” HHS assistant secretary Dr. Brett Giroir said during a Wednesday phone call with operators, referring to CMS chief Seema Verma.
The need for a CLIA waiver adds a wrinkle to the HHS push to provide point-of-care testing units and supplies to the more than 15,000 nursing facilities across the country.
Speaking at a Tuesday press conference in Baton Rouge, La., officials framed the move as a way to speed test results for vulnerable nursing home residents; turnaround times for traditional PCR tests, which must be shipped to third-party labs, have increased in many areas as overall case counts spike in regions that implemented economic reopening plans.
“As you know, the turnaround time is getting a bit longer. And it’s also very expensive,” HHS assistant secretary for health Admiral Brett Giroir said. “So what we’re talking about is a point-of-care, rapid, on-the-spot, 20 tests per hour, instrument — along with tests — to every single of the 15,400 nursing homes in this country.”
In places such as Washington, overcoming the CLIA obstacle could be a matter of working with state authorities.
The Evergreen State is exempt from CLIA, with the state government overseeing all laboratory testing, Washington Health Care Facilities president and CEO Robin Dale told SNN. In general, the state health department allows nursing homes to perform routine tests on site, such as urinalysis and glucose checks, but officials must approve every new test available, Dale said.
“If they distributed those instruments and the tests to facilities in Washington, facilities right now would not have the ability to do that testing,” he said.
Every nursing home in the state, to Dale’s knowledge, has the capacity and approval to perform laboratory testing — but just not COVID diagnostics at this time. The state’s survey agency is working with the federal government to rectify the situation, he said.
Maggie Flynn contributed reporting.