Mandatory Department of Health COVID-19 Reporting Requirements for Laboratories and Point of Care
The Centers for Medicare and Medicaid Services (CMS) requires all federally certified laboratories, including waived labs doing point of care testing, to submit COVID-19 test results (for each individual tested) to the Department of Health within 24 hours of results being known or determined. Laboratories and waived labs MUST report all positive, negative, and indeterminate test results for Florida residents.
Reporting must comply with the State of Florida Department of Health (DOH) directives as stated in DOH Emergency Order 20-013, including electronic submission when possible. If electronic submission has not yet been implemented, results must be reported to the applicable Florida County Health Department in a manual, confidential method.
The Florida DOH also issued a memo on October 9, 2020 regarding reports for Long-Term Care facility residents and staff for both COVID-19 test results to DOH. A recent Factsheet from DOH provides the reporting process; please review the DOH COVID-19 Reporting Portal Registration Factsheet issued October 13, 2020.
In addition and effective immediately, laboratories and waived labs must report their CLIA identification number with all results.
Failure to timely report information by a federally certified laboratory (CLIA) or a CLIA waived laboratory is subject to a civil money penalties of $1,000 for the first day of noncompliance and $500 for each additional day of noncompliance.
AHCA administers the CLIA program on behalf of CMS and will conduct onsite investigations for cases of non-compliance. To request assistance with reporting, please email firstname.lastname@example.org.