The Coronavirus Support, Reduction, and Financial Safety (CARES) Act and its June 4 implementation steerageexterior icon require each CLIA licensed COVID-19 testing website to report each diagnostic and screening take a look at end result (each constructive and destructive outcomes) carried out to detect SARS-CoV-2 or to diagnose a potential case of COVID-19 (e.g., molecular, antigen, antibody) to the suitable state or native public well being division, primarily based on the person’s residence. Laboratories that presently report on to CDC ought to proceed sending these information to CDC. E mail inquiries to DLSinquiries@cdc.gov.
The general public well being response to COVID-19 is dependent upon complete laboratory testing information. These information will contribute to understanding COVID-19’s affect and testing protection and might contribute to the identification of provide chain points for reagents and different supplies. The data under outlines reporting necessities for laboratories.
All COVID-19 testing websites should
- have a Medical Laboratory Enchancment Amendments (CLIA)exterior icon certificates,
- meet all necessities to carry out testing, together with solely utilizing FDA-authorized take a look at techniques in keeping with their directions to be used, and
- report each the constructive and destructive outcomes of COVID-19 diagnostic and screening checks that they carry out to the suitable state or native public well being division.
COVID-19 testing websites are outlined as
- laboratories that carry out medical diagnostic or screening testing underneath CLIA,
- non-laboratory COVID-19 diagnostic or screening testing areas, and
- different services or areas providing COVID-19 point-of-care diagnostic or screening checks, or in-home diagnostic or screening checks.
Testing websites should report information for all diagnostic and screening testing accomplished, which incorporates molecular, antigen, and antibody testing for every particular person examined. These information have to be reported every day, inside 24 hours of take a look at completion, to the suitable state, tribal, native, or territorial public well being division primarily based on the person’s residence. (See concerns for reporting within the incessantly requested questions under.)
CMS-certified long-term care services are required by the Division of Well being and Human Providerspdf iconexterior icon (HHS) to make use of the Nationwide Healthcare Security Community (NHSN) to report SARS-CoV-2 point-of-care antigen take a look at information, and different on-site COVID-19 laboratory testing information, to applicable federal and state well being authorities.
Testing websites that carry out COVID-19 surveillance testing on de-identified samples, no matter their CLIA standing, mustn’t report the outcomes of their surveillance testing to state, tribal, native, and territorial public well being departments. If at any time a facility intends to report a patient-specific take a look at end result, it should first get hold of a CLIA certificates and meet all necessities to carry out testing. For extra data, see the Middle for Medicare and Medicaid Service’s (CMS) Analysis Testing and Medical Laboratory Enchancment Amendments of 1988 (CLIA) Rulespdf iconexterior icon.
For definitions of COVID-19 diagnostic, screening, and surveillance testing, see CDC’s Interim Steering for Use of Pooling Procedures in SARS-CoV-2 Diagnostic, Screening, and Surveillance Testing.
The way to report
Laboratory information parts could also be reported within the following methods:
- Submit laboratory testing information on to state or native public well being departments in keeping with state/or native legislation or coverage. Information have to be despatched utilizing current reporting channels to make sure speedy initiation of case investigations, and concurrent reporting of outcomes have to be shared with the ordering supplier or affected person, as relevant.
- Submit laboratory testing information to state and native public well being departments by a centralized platform, the place the info will then be routed to the suitable state and native authorities and routed to CDC after removing of personally identifiable data in keeping with relevant guidelines and rules.
- Submit laboratory testing information by a state or regional Well being Info Alternate (HIE) to the suitable state or native public well being division after which to CDC as directed by the state.
- CMS-certified long-term care services shall submit point-of-care SARS-CoV-2 testing information, together with antigen testing information, to NHSN. This requirement to submit information to CDC’s NHSN applies solely to CMS-certified long-term care services. Check information submitted to NHSN shall be reported to applicable state and native well being departments utilizing commonplace digital laboratory messages. Different varieties of LTC services could voluntarily report testing information in NHSN for self-tracking or to meet state or native reporting necessities, if any.
Public well being departments will submit de-identified information to CDC each day, utilizing both Well being Stage 7 (HL7) messaging or the Nationwide ELR Flat File and HL7 Generator devicezip iconexterior icon.
Laboratories ought to make each cheap effort to offer the next information parts to state and jurisdictional well being departments.
- Check ordered – use harmonized LOINC codes offered by CDC
- Gadget Identifier
- Check end result–use applicable LOINC and SNOMED codes, as outlined by the Laboratory In Vitro Diagnostics (LIVD) Check Code Mapping for SARS-CoV-2 Checks offered by CDC
- Check End result date (date format)
- Accession # / Specimen ID
- Affected person age
- Affected person race
- Affected person ethnicity
- Affected person intercourse
- Affected person residence zip code
- Affected person residence county
- Ordering supplier title and nonpharmaceutical interventions (as relevant)
- Ordering supplier zip code
- Performing facility title and CLIA quantity
- Performing facility zip code
- Specimen Supply – use applicable LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed different codes
- Date take a look at ordered (date format)
- Date specimen collected (date format)
The next further demographic information parts also needs to be collected and reported to state or native public well being departments.
- Affected person title (Final title, First title, Center Preliminary)
- Affected person road handle
- Affected person cellphone quantity with space code
- Affected person date of start
- Ordering supplier handle
- Ordering supplier cellphone quantity
To guard affected person privateness, any information that state and jurisdictional well being departments ship to CDC shall be deidentified and won’t embrace some patient-level data. The deidentified information shared with CDC will contribute to understanding COVID-19’s affect, case fee positivity tendencies, testing protection, and can assist establish provide chain points for reagents and different supplies.