COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

HHS Releases New COVID-19 Reporting Requirements for In-House Clinical Laboratories

Clinical laboratories must abide by federal SARS-CoV-2 test reporting requirements.
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New guidelines released by HHS went into effect July 15, 2020.

US Department of Health and Human Services (HHS) released new guidelines for hospitals and in-house clinical laboratories to follow when reporting COVID-19 data. These guidelines were released July 10, 2020, and went into effect July 15.

The initial section of these guidelines speaks to hospitals’ reporting of capacity and utilization data. The guidelines then answer several questions that in-house laboratories may have. These questions and a brief summary of their answers are listed below:

How should hospitals that perform “in house” laboratory testing report this data?
A unique link will be sent to the hospital points of contact that allows access to a hospital-specific secure form. In some situations the labs can provide data directly to their state.

What data should hospitals with in-house laboratory testing expect to submit to the portal?
New Diagnostic Tests Ordered
Cumulative Diagnostic Tests Ordered
New Diagnostic Tests Resulted
Cumulative Diagnostic Tests Performed
New Positive COVID-19 Diagnostic Tests
Cumulative Positive COVID-19 Diagnostic Tests
New Negative COVID-19 Diagnostic Tests
Cumulative Negative COVID-19 Diagnostic Tests
New Serological Tests Ordered
Cumulative Serological Test Ordered
New Tests Performed
Cumulative Tests Performed
New Positive Serological Tests
Cumulative Positive Serological Tests
New Negative Serological Tests
Cumulative Negative Serological Tests

How often should hospitals submit the data? 
Daily by 5 p.m. Eastern

How should hospitals that perform a portion of tests “in house” and send a portion of tests to commercial labs and/or State Public Health Labs report this data?
In house test results should be reported through the HHS Protect System. Tests that are sent to approved commercial labs* or to your State Public Health lab do not need to be reported through the HHS Protect System.

Do hospitals that send tests to commercial laboratories need to report data using this system?
Unless an approved commercial laboratory* is used, yes.

Do hospitals that send tests to State Public Health Laboratories need to report data using this system?

How should hospitals that perform a portion of tests “in house” and send a portion of tests to commercial labs and/or State Public Health Labs report this data?
Labs should report all test data unless sent to an approved commercial lab or their State Public Health lab.

*There are six commercial labs that hospitals are not required to send data on when outsourcing tests to these labs. These include: 
BioReference Laboratories
Quest Diagnostics
Mayo Clinic Laboratories
ARUP Laboratories
Sonic Healthcare

The information in this brief is only a summary of the guidelines. For full details, readers should visit the guidelines here.

Related Resource:

HHS: COVID-19 Guidance for Hospital Reporting and FAQs for Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting


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Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

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