Summary of Recent Changes
As of December 26, 2020:
- To whom long-term care facilities (LCTFs) should report point-of-care antigen testing data under “Who must report” and “How to report”.
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 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.
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.
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.
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.
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.
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.
Data reporting requirements
HHS developed this guidance in response to the CARES Act, which requires every testing site to report results (both positive and negative results) for every test it performs to detect SARS-CoV-2 or to diagnose a possible case of COVID-19. State and local public health departments have required laboratories to report COVID-19 testing results since the beginning of the COVID-19 public health emergency; however, the requirements for patient information and other data elements have varied across states. The new HHS guidance aims to increase the reporting of important data elements, (e.g., patient age and residence zip code) to inform contact tracing, control, and mitigation efforts.
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 disease. The data will also be used to track the spread of disease by location.
On a national level, the de-identified data shared with CDC will contribute to understanding national disease incidence and prevalence, case rate positivity trends, and testing coverage, and will help identify supply chain issues for reagents and other materials
Laboratories are not required to report to both state or local health departments and HHS. The CARES Act requires laboratories to report all data to state or local public health departments using existing public health data reporting channels (in accordance with state law or policies). The state health departments will provide these data to HHS.
Starting on August 1, 2020, laboratories are expected to make every reasonable effort to report required data elements to the appropriate state or local public health department, as required by HHS guidance.
Yes, testing sites must report all of the 18 required data elements per the June 4 HHS Guidance. The CARES Act is federal law and laboratories must comply with the guidance for laboratory reporting. Please email any questions related to CMS enforcement of the new rule to LabExcellence@cms.hhs.gov.
Anyone who orders a COVID-19 test, collects a specimen, or performs a laboratory test should make every reasonable effort to collect complete demographic information and responses to the “ask on order entry” (AOE questions). Ordering providers should make every effort to collect this critical information from patients during the specimen collection process and provide it to the laboratories performing the test.
When information is not available, the healthcare providers (or their designees) who ordered the COVID-19 test and laboratories performing those tests should consider using other information sources to obtain these data, such as health information exchanges, employee records, and/or school records.
Yes, the CARES Act requires 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., molecular, antigen, antibody), not just positive tests, to state or local public health departments. Results from surveillance testing for SARS-CoV-2 should not be reported to state or local public health departments.
No, facilities that conduct tests for individuals from multiple states must report results to the appropriate state or local health department based on the patient’s residence. If the patient’s address isn’t available, results should be reported based on the provider’s location.
Facilities that conduct tests for individuals who are temporarily living away from their permanent residence, such as students in college or active duty military personnel, should report to the state health department based on the individual’s temporary address near their college campus or military installation.
The testing site that performs the COVID-19 test is responsible for reporting to the appropriate state or local public health department. Please note that state licensure requirements, as well as accrediting organizations’ standards for reporting SARS-CoV-2 test results, might be more stringent than CLIA and require dual reporting. These more stringent requirements must be followed.
Exceptions for the performing reporting requirements might include a hospital system that centralizes data, i.e., a reference lab that has no connection to the patient’s state but sends the data real time to the facility that referred the specimen that does have that connection, etc.
Laboratories need to report test results to the state where the individual is temporarily living or visiting.
Clinicians and laboratories should contact their state or local public health department directly for more information on reporting requirements and the method for reporting.
Technical aspects of reporting
Yes, state or local health departments will still accept these data. Public health recognizes this information is not always provided in test orders. However, every effort should be made to collect complete data.
The DI for some tests can be found in the National Institute of Health’s (NIH) Access GUDID Databaseexternal icon. For a specific DI not located in the Access GUDID Database, contact the device manufacturer to obtain the DI. If the manufacturer does not yet have the DI for the device you are using, contact SHIELD-LabCodes@fda.hhs.gov for assistance.
“Ask on order entry” (AOE) questions and other data elements
If test orders are placed electronically, healthcare facilities and laboratories should ensure that the laboratory test order interface can collect or transfer complete demographic data and answers to AOE questions. Healthcare facilities and laboratories should work with their electronic health record or laboratory information management system vendors to improve the order processes and information exchange between the healthcare provider and the laboratory.
If test orders are not placed electronically, submission forms (web based or paper) should be updated to include the data elements described in the CARES Act Section 18115 guidancepdf iconexternal icon.
Every effort should be made to collect this information because these data are critical for state and local public health departments to plan and execute COVID-19 control and mitigation efforts. These elements should be collected and be conformant with the HL7 Version 2.5.1 Lab Order Interface Implementation Guideexternal icon and associated standards.
Yes, all data related to the AOE questions should be collected and reported to state and local public health departments in the electronic laboratory report messages.
Clinical research trial and study reporting
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 they do not have the patient-identifying information required to comply 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’ 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 SARS-Cov-2 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 SARS-Cov-2 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.