CDC Provides Additional Supporting Information on New Data Reporting Requirements for Clinical Laboratories

Clinical laboratories must abide by federal SARS-CoV-2 test reporting requirements.
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CDC answers questions from clinical laboratories about news HHS data reporting requirements.

In its weekly Clinical Laboratory COVID-19 Response Call on June 8, 2020, the Centers for Disease Control and Prevention (CDC) provided additional information for clinical laboratories with questions about the new US Department of Health and Human Services (HHS) data reporting guidelines. These guidelines were released June 4, 2020, and provided clinical laboratories with guidance on what data they should be reporting to comply with the recent Coronavirus Aid, Relief, and Economic Security (CARES) Act. Jason Hall from the CDC’s Division of Preparedness and Emerging Infections presented on this topic.

Hall discussed the definition of laboratory in this new guidance. “This updated guidance that came out last week also clarifies what is meant by laboratories,” Hall told listeners. “So it’s basically all testing entities, such as laboratories. It could be pharmacies. It could be the drive-throughs.”

Also addressed, the data reporting timeframe that clinical laboratories should consider: “Broadly, laboratories and testing entities should report data for all testing completed for each individual tested within 24 hours of their results being known or determined to the appropriate state or local public health departments, based on an individual’s residence.”

Hall also answered questions about situations where clinical laboratories have difficulty in collecting the required data. “So the guidance states that any person or entity ordering a diagnostic or serologic test, collecting a specimen, or performing a test should make every reasonable effort to collect complete demographic information,” Hall said. “[They] should include such data when ordering that test to enable the entities performing the test to report them to state and local health departments. So the guidance is meant to cover every point in the chain—not just the laboratories, but those that are ordering from them, as well.”

An audience member questioned Hall about whether the testing lab or the ordering lab was responsible for reporting. “So in all states the testing lab is expected to report,” Hall answered “It’s often that—when a test is referenced out to another—that, if it’s a laboratory that referenced it out to another one, but the order was placed within, that they’ll feel the need to report, too.”

Related Resources:

Clinical Laboratory COVID-19 Response Weekly Calls

Transcript June 8 CDC COVID-19 Clinical Laboratory Call

HHS CARES Act Reporting Guidelines for Clinical Laboratories


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