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How to Report COVID-19 Laboratory Data
Summary of Recent Changes
Summary:
The Coronavirus Aid, Relief, and Economic Security (CARES) Act and its June 4 implementation guidanceexternal icon require every CLIA certified COVID-19 testing site to report every diagnostic and screening test result (both positive and negative results) performed to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody) to the appropriate state or local public health department, based on the individual’s residence. Laboratories that currently report directly to CDC should continue sending these data to CDC. Email questions to [email protected].
The public health response to COVID-19 depends on comprehensive laboratory testing data. These data will contribute to understanding COVID-19’s impact and testing coverage and can contribute to the identification of supply chain issues for reagents and other materials. The information below outlines reporting requirements for laboratories.
Who must report
All COVID-19 testing sites must
- have a Clinical Laboratory Improvement Amendments (CLIA)external icon certificate,
- meet all requirements to perform testing, including only using FDA-authorized test systems according to their instructions for use, and
- report both the positive and negative results of COVID-19 diagnostic and screening tests that they perform to the appropriate state or local public health department.
COVID-19 testing sites are defined as
- laboratories that perform clinical diagnostic or screening testing under CLIA,
- non-laboratory COVID-19 diagnostic or screening testing locations, and
- other facilities or locations offering COVID-19 point-of-care diagnostic or screening tests, or in-home diagnostic or screening tests.
Testing sites must report data for all diagnostic and screening testing completed, which includes molecular, antigen, and antibody testing for each individual tested. These data must be reported daily, within 24 hours of test completion, to the appropriate state, tribal, local, or territorial public health department based on the individual’s residence. (See considerations for reporting in the frequently asked questions below.)
CMS-certified long-term care facilities may submit point-of-care SARS-CoV-2 testing data, including antigen testing data, to CDC’s National Healthcare Safety Network (NHSN). This CDC- and CMS-preferred pathway to submit data to CDC’s NHSN applies only to CMS-certified long-term care facilities. Test data submitted to NHSN will be reported to appropriate state and local health departments using standard electronic laboratory messages. Other types of LTC facilities may also report testing data in NHSN for self-tracking or to fulfill state or local reporting requirements, if any. While NHSN is the CDC- and CMS-preferred pathway, Medicare and Medicaid-certified LTC facilities may submit data through the other mechanisms described in the Current Methods of Submission section of HHS Laboratory Reporting Guidance pdf icon[PDF]external icon to meet the reporting requirements.
Testing sites that perform COVID-19 surveillance testing on de-identified samples, regardless of their CLIA status, should not report the results of their surveillance testing to state, tribal, local, and territorial public health departments. If at any time a facility intends to report a patient-specific test result, it must first obtain a CLIA certificate and meet all requirements to perform testing. For more information, see the Center for Medicare and Medicaid Service’s (CMS) Research Testing and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulationspdf iconexternal icon.
For definitions of COVID-19 diagnostic, screening, and surveillance testing, see CDC’s Interim Guidance for Use of Pooling Procedures in SARS-CoV-2 Diagnostic, Screening, and Surveillance Testing.
Association of Public Health Laboratories (APHL), in collaboration with the Council of State and Territorial Epidemiologists (CSTE), CDC, and other public and private partners, has developed the National Electronic Laboratory Reporting (ELR) Flat File and HL7 Generator Toolzip iconexternal icon to assist laboratories with reporting.
How to report
Laboratory data elements may be reported in the following ways:
- Submit laboratory testing data directly to state or local public health departments according to state/or local law or policy. Data must be sent using existing reporting channels to ensure rapid initiation of case investigations, and concurrent reporting of results must be shared with the ordering provider or patient, as applicable.
- Submit laboratory testing data to state and local public health departments through a centralized platform, where the data will then be routed to the appropriate state and local authorities and routed to CDC after removal of personally identifiable information according to applicable rules and regulations.
- Submit laboratory testing data through a state or regional Health Information Exchange (HIE) to the appropriate state or local public health department and then to CDC as directed by the state.
- CMS-certified long-term care facilities may submit point-of-care SARS-CoV-2 testing data, including antigen testing data, to CDC’s National Healthcare Safety Network (NHSN). This CDC- and CMS-preferred pathway to submit data to CDC’s NHSN applies only to CMS-certified long-term care facilities. Test data submitted to NHSN will be reported to appropriate state and local health departments using standard electronic laboratory messages. Other types of LTC facilities may also report testing data in NHSN for self-tracking or to fulfill state or local reporting requirements, if any.
Public health departments will submit de-identified data to CDC on a daily basis, using either Health Level 7 (HL7) messaging or the National ELR Flat File and HL7 Generator toolzip iconexternal icon.
For more information on the data elements included in the June 4 HHS guidance, as well as technical specifications that support implementation, see HHS’s COVID-19 Lab Data Reporting Implementation Specificationspdf iconexternal icon.
What to report
Laboratories should make every reasonable effort to provide the following data elements to state and jurisdictional health departments.
- Test ordered – use harmonized LOINC codes provided by CDC
- Device Identifier
- Test result–use appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC
- Test Result date (date format)
- Accession # / Specimen ID
- Patient age
- Patient race
- Patient ethnicity
- Patient sex
- Patient residence zip code
- Patient residence county
- Ordering provider name and nonpharmaceutical interventions (as applicable)
- Ordering provider zip code
- Performing facility name and CLIA number
- Performing facility zip code
- Specimen Source – use appropriate LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed alternative codes
- Date test ordered (date format)
- Date specimen collected (date format)
The following additional demographic data elements should also be collected and reported to state or local public health departments.
- Patient name (Last name, First name, Middle Initial)
- Patient street address
- Patient phone number with area code
- Patient date of birth
- Ordering provider address
- Ordering provider phone number
To protect patient privacy, any data that state and jurisdictional health departments send to CDC will be deidentified and will not include some patient-level information. The deidentified data shared with CDC will contribute to understanding COVID-19’s impact, case rate positivity trends, testing coverage, and will help identify supply chain issues for reagents and other materials.
How to report using standard terminology
CDC has posted a LOINC In-Vitro Diagnostic (LIVD) Test Code Mapping Guide for COVID-19 test results for tests with emergency use authorization from the U.S. Food and Drug Administration (FDA) that can be used by clinical laboratories and instrument manufacturers. This specification supports the use of standardized LOINC and SNOMED Clinical Terms (CT) codes to improve the accuracy of reporting tests for the SARS-CoV-2 virus. Using these harmonized LOINC and SNOMED-CT codes helps ensure that the same type of test is represented uniformly across the United States.
For those COVID-19 tests that have not yet received FDA emergency use authorization, CDC encourages test developers and laboratories that use COVID-19 tests to work together to obtain appropriate and interoperable LOINC and SNOMED-CT codes for reporting purposes.
LOINC codes must be used to represent the “question” a test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes must be used to represent the diagnostic “answer” (e.g., what was detected?). More background on these terminology standards can be found here:
Whenever possible, laboratories must use standard codes that already exist. Before requesting a new code, search the list of currently available LOINC codes for COVID-19 tests. If a LOINC test code cannot be identified whose attributes appropriately match the test for which coding is needed, new terms can be submitted, and a new code can be requested through LOINCexternal icon.
Technical assistance for electronic reporting
Click map to view the status of electronic laboratory data conversion by state.
Electronic reporting options are available to reduce the burden on providers reporting test results. Laboratories that are not currently reporting electronically to their state or local health department and want assistance in establishing electronic reporting can contact CDC’s Emergency Operations Center, Laboratory Reporting Working Group at [email protected].
Resources
Below is a list of COVID-19 resources for laboratories:
HHS Guidance
CDC Resources
- How to Report COVID-19 Laboratory Data
- COVID-19 Information for Laboratories
- Frequently Asked Questions About COVID-19 for Laboratories
- CDC’s Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
Technical Implementation Resources
- COVID-19 Lab Data Reporting Implementation Specificationspdf iconexternal icon
- LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests
- National ELR Flat File and HL7 Generator Toolexternal icon
- Interoperability Standards Advisory for COVID-19 Pandemicexternal icon
CMS Resources
Frequently Asked Questions on Laboratory Data Reporting Guidance for COVID-19 Testing
New guidancepdf iconexternal icon from the Department of Health and Human Services (HHS) specifies what data must be reported to comply with the COVID-19 laboratory reporting requirement in CARES Act Section 18115. The new guidance requires facilities and ordering providers to gather more complete patient demographic information to send to state and local public health departments. State and local health departments will then forward the de-identified data to CDC.