REMINDER: Reporting Requirements for All COVID-19 Antigen Tests in Assisted Living Facilities

Community , Family Care , Regulatory ,

COVID-19 is a reportable disease in Wisconsin. Assisted Living Facilities (ALFs) must report all suspected and confirmed cases of COVID-19 to Local/Tribal Health Departments (LTHD) within 24 hours. All facilities, including ALFs, must also meet state and federal reporting requirements for all point-of-care test results as indicated below.

Federal reporting requirements:

  • ALFs that received, and are using, point-of-care antigen testing supplies (e.g., BinaxNOW) are required to report both positive and negative test results to the U.S. Department of Health and Human Services (HHS) in accordance with CMS Memo QSO -21-10-CLIA CLIA Surveyor Guidance in Section E, pages 13-15.
  • ALFs using BinaxNOW COVID-19 antigen tests must report all test results the same day they perform the test.
  • The federal Centers for Medicare & Medicaid Services (CMS) has directed state agencies to perform surveys of 5% of labs performing COVID-19 testing and holding Certificates of Waiver and Provider Performed Microscopy certificates over the next 3 years. The guidance from CMS Memo QSO -21-10-CLIA CLIA Surveyor Guidance in Section E, pages 13-15, outlines the CLIA reporting requirements, along with the requirement that providers have policies on their reporting process. There are possible civil money penalties that may be imposed by CMS if a provider is not reporting results of testing. If a provider holds a federal CLIA certificate, and they are not reporting results, citations may occur at the federal level.

State reporting requirements:

  • ALFs are required to report all positive laboratory test results from point-of-care antigen tests (e.g., BinaxNOW COVID-19 Antigen Tests) to the LTHD within 24 hours; however, only calling, emailing or faxing results to the LTHD does not meet your federal reporting requirements under your CLIA waiver and can impede outbreak investigations.
  • ALFs are not required to report negative results to LTHDs or to the Wisconsin Department of Health Services (DHS) at this time.
  • Guidance about COVID-19 reporting requirements may be found at DHS COVID-19 Health Care Providers - Reporting and Surveillance.

Preference - Report to all organizations at the same time:

ALFs that wish to have results sent to LHDs, DHS, and CDC (a branch of HHS) simultaneously to meet the state and federal reporting requirements, may report all results (i.e., positive and negative) electronically by Web-based Laboratory Reporting (WLR) or pre-existing Electronic Laboratory Reporting (ELR) connections.

For more information on the use of COVID-19 antigen tests and reporting requirement, please refer to Health Alert #17.