The Centers for Medicare & Medicaid Services (CMS) recently issued guidance regarding COVID-19 testing in the workplace.
CMS regulates clinical laboratory testing under the federal Clinical Laboratory Improvement Act (CLIA). A laboratory or clinical setting, such as a physician’s office, must obtain CLIA certification to perform laboratory testing. Some over-the-counter (OTC) tests are approved by the Food and Drug Administration (FDA) for home use. The CMS guidance addresses the use of OTC home tests in the workplace.
The guidance clarifies that a test authorized for home use by the FDA may be used in non-CLIA certified locations, such as a workplace, provided the test is self-administered and self-read. The guidance provides that “if the individual performs and interprets their own test and then shows their test result to someone else (e.g. employer) as proof of their result,” CMS does not consider this to be interpretation or reporting and CLIA certification is not required.
However, if an employer has staff perform or interpret the test, then the employer must have a CLIA certificate, even if using a test that is FDA-approved for home use. The guidance notes that an employer’s staff may assist with the self-administration of a home test, so long as the test is performed by the individual and the staff member does not perform or interpret the test.
This guidance is important alongside the Occupational Safety and Health Administration Emergency Temporary Standard that specifically states which tests qualify as approved tests:
- Cleared, approved, or authorized, including in an Emergency Use Authorization (EUA), by the FDA to detect current infection with the SARS-CoV-2 virus (e.g., a viral test);
- Administered in accordance with the authorized instructions; and
- Not both self-administered and self-read unless observed by the employer or an authorized telehealth proctor. Examples of tests that satisfy this requirement include tests with specimens that are processed by a laboratory (including home or on-site collected specimens which are processed either individually or as pooled specimens), proctored OTC tests, point of care tests, and tests where specimen collection and processing is either done or observed by an employer.
Under the third criterion, when an employer relies on an OTC home test at a workplace without CLIA certification, the employer must ensure the test is “observed by the employer or an authorized telehealth proctor” to qualify under the OSHA regulations. Again, the observer cannot perform or interpret the test result but may merely receive the test result as evidence of a positive or negative test.
If an employer contracts with a health care provider to perform COVID-19 testing onsite at the workplace, the health care provider is likely testing under a CLIA certificate with the workplace being a temporary testing site as permitted by CMS guidance during the public health emergency.
If the health care provider is not testing under a CLIA certificate, however, and is using OTC home testing kits, then it would also be subject to the guidance requirements. Employers contracting with health care providers for workplace COVID-19 testing should confirm that such providers have a CLIA certificate or are using OTC home tests in accordance with the CMS guidance.
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