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Clarifications Regarding Recent Advisory to Limited Service Laboratories

As reported last week, the Department of Health (DOH) issued an updated guidance document, dated April 1st, addressed to Clinical Laboratories and Limited Service Laboratories (LSLs). The guidance, which impacts certain members that have LSLs, announced some Electronic Clinical Laboratory Reporting System (ECLRS) reporting requirements that went into effect on April 4th.

LeadingAge NY had inquired about the implications of the guidance for nursing homes and adult care facilities (ACFs). The Clinical Laboratory Evaluation Program (CLEP) has clarified that the last bullet of the Advisory, excerpted below, applies only when:

  • the COVID-19 test is approved for at-home or over-the-counter use;
  • staff assist only those residents who cannot otherwise perform the test themselves.

This does not apply to situations where the staff are performing the testing on all residents, regardless of ability, or when the COVID-19 test is not approved for at-home or over-the-counter use.

Last bullet of the Advisory:

Individuals that use home use tests that are entirely self-administered (i.e., a test that allows for self-collection and testing at home, also known as home use or over the counter tests) are not required to report their test results. In accordance with federal guidance, this includes congregate residence settings where an at home or over the counter test is used to test residents who are unable to test themselves. For additional information on the use of over the counter tests, see the Over-The-Counter (OTC) Home Testing and CLIA Applicability Frequently Asked Questions document issued by the Centers for Medicare and Medicaid Services.

Members are reminded that these changes relate to ECLRS reporting only and do not affect other reporting requirements.

Contact: Diane Darbyshire, ddarbyshire@leadingageny.org, 518-867-8828