Laboratories are required to report to state and local public health authorities in accordance with applicable state or local law. Additionally, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (CARES Act Section 18115pdf iconexternal icon) and its implementation guidance require every laboratory to report every test it performs to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (e.g., viral, serology). Tests must be reported 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 DLSinquiries@cdc.gov.
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. Additional technical guidance on implementing the COVID-19 laboratory reporting requirement to comply with the CARES Act Section 18115pdf iconexternal icon is forthcoming.
All laboratories with a Clinical Laboratory Improvement Amendments (CLIA)external icon certificate must report the results of the COVID-19 tests that they conduct to the appropriate state or local public health department. Laboratories are defined as
- Laboratories that perform clinical diagnostic testing under CLIA,
- non-laboratory COVID-19 testing locations, and
- other facilities or locations offering point-of-care testing or in-home testing related to COVID-19.
Laboratories must report data for all testing completed, which includes viral and antibody testing, for each individual tested. This data must be reported within 24 hours of test completion, on a daily basis, to the appropriate state or local public health department, based on the individual’s residence.
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 ordering provider or patient, as applicable.
- Submit laboratory testing data to state and local public health departments through a centralized platform (such as the Association of Public Health Laboratories’ AIMS platformexternal icon), 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.
Public health departments will submit de-identified data to CDC on a daily basis, using either Health Level 7 (HL7) messaging or the CDC-provided CSV format.
Complete laboratory data must include 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 name (Last name, First name, Middle Initial)
- Patient street address
- Patient phone number with area code
- Patient date of birth
- Patient age
- Patient race
- Patient ethnicity
- Patient sex
- Patient residence zip code
- Patient residence county
- Ordering provider name and NPI (as applicable)
- Ordering provider address
- Ordering provider phone number
- Ordering provider zip
- 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)
To protect patient privacy, 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, positivity trends, testing coverage, and will help identify supply chain issues for reagents and other materials.
Anyone who orders a COVID-19 test, collects a specimen, or performs a laboratory test must make every reasonable effort to collect complete demographic information as well as responses to the following “ask on order entry” (AOE) questions. These data elements are critical for the COVID-19 public health response, and including them with test orders enable the laboratories that perform the test to report the information to state and jurisdictional health departments, as required. When information is not available, the healthcare providers (or their designees) who ordered the COVID-19 test and laboratories performing those tests should consider leveraging other information sources to obtain these data (e.g., health information exchanges, employee records, school records).
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 viral 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 external icon for SARS-CoV-2 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 requested through the LOINCexternal icon.
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@example.com.
New guidance from HHSpdf iconexternal icon 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 deidentified data to CDC.
Yes, the CARES Act and the implementing guidance require all clinical laboratories and testing providers that perform diagnostic testing under a Clinical Laboratory Improvement Amendments (CLIA) certificate to report the results of any test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (e.g., viral, antibody), not just positive tests, to state or local public health departments. Laboratories that conduct surveillance testing for SARS-CoV-2 must not report their results as diagnostic results to state or local public health departments.
Yes, all data fields are expected to be collected and reported to state and local public health departments in the electronic laboratory report messages.
Yes, CDC will still accept the data. CDC recognizes that in many cases, this information is not provided in testing orders.
The new HHS guidance aims to increase the reporting of important data elements, such as race and ethnicity. 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 and should include such data when ordering a laboratory test to enable the entities performing the test to report these data to state and local public health departments.”
Laboratory data reported to state and jurisdictional health departments will be used to help track the spread of COVID-19 and identify areas that are highly impacted by the infection. The data will also be used to track when the spread of infection appears to be slowing down by location. On a national level, the deidentified data shared with CDC will contribute to understanding national disease incidence and prevalence, positivity trends, and testing coverage, and will help identify supply chain issues for reagents and other materials.
In general, no. Laboratories are not responsible for reporting these data. However, state health department rules and regulations apply and may differ from this general guidance.
The reporting requirements differ for laboratories and research clinicians:
Laboratories are not responsible for reporting these data since laboratories do not have the patient-identifying information required for compliance with reporting requirements. However, state health department rules and regulations apply and may differ from this general guidance.
In clinical trials, research clinicians who are responsible for clinical care of trial participants are responsible for linking de-identified specimen test results to participant demographic information and are required to report the positive results daily to the appropriate state or local public health department based on the patient’s residence. Demographic information required for reporting is detailed in HHS’s June 4, 2020 guidanceexternal icon.
Research clinicians are not required to report negative test results. However, state health department rules and regulations apply and may differ from this general guidance.
If a clinician receives COVID-19 test results from duplicate specimens that were collected in the same manner and tested with different test methods (e.g., different platforms) or in different CLIA laboratories, the clinician should not report both results. In the case of two positive test results, the clinician should report the result that is provided first. In the case of discrepant test results, the clinician should report the positive result. However, state health department rules and regulations apply and may differ from this general guidance.
If the clinician requests COVID-19 testing for study participants independent of research activities or for clinical management, results should be reported to the appropriate state or local public health department.