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COVID-19 Test Reporting Requirements
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About COVID-19 test reporting: COVID-19 lab reporting
COVID-19 test reporting changes, effective May 12, 2023
How to submit COVID-19 test results
- Organizations with electronic laboratory reporting
- Federally certified nursing facilities
- All other organizations submitting test results to MDH
- Questions about COVID-19 test reporting
COVID-19 Case Reporting
More resources
The Minnesota Department of Health (MDH) updated state COVID-19 test result reporting requirements in a notice issued by the Commissioner of Health and published in the State Register on May 1, 2023. For more information, review COVID-19 test reporting changes, effective May 12, 2023.
About COVID-19 test reporting:
COVID-19 lab reporting
Reporting COVID-19 test results is one way partner organizations help MDH monitor COVID-19. Partners that help test and then report the test results to MDH include long-term care settings, colleges and universities, K-12 schools, corrections facilities, shelters, medical laboratories, and hospitals. This page summarizes state COVID-19 test result reporting requirements and offers resources for sites performing testing, some of which may have limited experience reporting test results.
Self-administered home use tests (excluding self-collected specimens where the testing is performed at a laboratory) and antibody (serology) results are not reportable to MDH through laboratory or case reporting requirements.
COVID-19 test reporting changes, effective May 12, 2023
The federal COVID-19 Public Health Emergency (PHE) is expiring at the end of the day on May 11, 2023. Since March 27, 2020, federal law (the Coronavirus Aid, Relief, and Economic Security or “CARES” Act) required “[e]very laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19” to report the results. The end of the PHE also ends the CARES Act authority for the U.S. Department of Health and Human Services (HHS) to require test results reporting for COVID-19.
Minnesota state law still requires reporting of specific communicable diseases to MDH. The Minnesota Commissioner of Health released a supplemental notice of test results reporting for COVID-19 that was published in the State Register on May 1, 2023. The supplemental notice requires reporting of only positive results from tests for COVID-19 for both Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories and entities operating under CLIA certificates of waiver, Reporting of COVID-19/SARS-CoV-2 under the Minnesota Communicable Disease Rules, Chapter 4605.7080.
- Positive results for COVID-19 tests conducted on or after May 12, 2023 are required to be reported to MDH. This includes non-NAAT, NAAT, and any results of COVID-19 variant testing.
- Non-positive results for COVID-19 tests of any type (NAAT or non-NAAT) conducted on or after May 12, 2023 do not need to be reported to MDH.
- Serology (Antibody) COVID-19 testing does not need to be reported to MDH.
- Laboratory “ask-on-order-entry” questions, such as “patient’s first test” and “whether patient was admitted to intensive care unit” do no need to be reported to MDH.
- A summary of the new COVID-19 test result reporting requirements under state law can be found in the table below, as well as in the Frequently Asked Questions (FAQ) on the MDH Supplemental Notice for Reporting SARS-CoV-2 Test Results (PDF).
Test Result Reporting Requirements for SARS-CoV-2 New Under State Law Effective May 12, 2023
CLIA Certificate Type | Test Platform | Reporting of SARS-CoV-2 Positive Results | Reporting of SARS-CoV-2 Negative and Inconclusive Results |
---|---|---|---|
Certificate of Waiver | Molecular (NAAT) | Required | Do not report |
Antigen | Required | Do not report | |
Serology (Antibody) | Do not report | Do not report | |
All other CLIA Certified Laboratories | Molecular (NAAT) | Required | Do not report |
Antigen | Required | Do not report | |
Serology (Antibody) | Do not report | Do not report |
As a reminder, if sequencing is performed, laboratories are also required to submit sequencing data to MDH regardless of whether the underlying test was NAAT or non-NAAT test.
Nucleic Acid Amplification Tests (NAATs) include PCR and tests that involve "isothermal amplification." For more information, refer to CDC: Nucleic Acid Amplification Tests (NAATs). These tests include Abbott ID Now and Cue.
Non-NAATs include antigen tests such as BinaxNOW, BD Veritor, and Quidel Sofia. For more information, refer to CDC: Guidance for Antigen Testing for SARS-CoV-2 for Healthcare Providers Testing Individuals in the Community.
In general, any organization that administers a COVID-19 test onsite or interprets or processes results from test specimen must have a CLIA certification or certification of waiver. CLIA certificates of waiver provide non-laboratory settings—like workplaces, schools, child care, and congregate-living environments—an option to offer and administer certain COVID-19 tests, which are typically simple and easy to perform without specialized equipment or a medical or laboratory background. Most tests authorized for use under a certificate of waiver are antigen tests, though certain NAATs—such as Cue—may also be performed under a certificate of waiver. More complex tests generally require a higher-level CLIA laboratory certification.
For more information about CLIA certification, refer to:
- Clinical Laboratory Improvement Amendment (CLIA) Frequently Asked Questions
- Minnesota Clinical Laboratory Improvement Amendment (CLIA)
You can use the search tool below to determine the CLIA certification for your facility or setting.
- Go to CDC: CLIA Laboratory Search.
- Enter in your facility name or CLIA number if you know it. For Minnesota facilities, CLIA numbers will start with "24D."
- If you are having trouble finding your name, choose "show" next to Advanced Search and add in additional search criteria with the Laboratory name and CLIA number empty.
- Select Search.
Review the facility or facilities that are returned to identify the correct site(s). The column "Certificate Type" indicates the facility's level of CLIA certification (e.g., certificate of waiver, accredited).
Demographic information helps the state and partners understand where COVID-19 is present and how it may be spreading. This information also helps to characterize the populations most impacted by COVID-19 and whether the demographics of those impacted is shifting.
Demographic information is included in what to report under Minnesota law when reporting an infectious disease (Communicable Disease Reporting Rule).
How to submit COVID-19 test results
Organizations with electronic laboratory reporting
For organizations that can create and submit Health Level 7 International (HL7) electronic laboratory reports (ELR).
Some partners have a laboratory information system/laboratory information management system that can create messages that meet Health Level 7 International (HL7) standards for sending health information from one health organization to another. All reportable COVID-19 test results must be sent to MDH within 24 hours.
Laboratories registered for the federal Promoting Interoperability Program that want to submit data electronically through their laboratory information system should review guidance at MDH Electronic Laboratory Reporting (ELR) and Reporting Interoperability. Contact health.ElectronicDiseaseReporting@state.mn.us to start the electronic laboratory reporting process.
Facilities that do not meet Promoting Interoperability Program requirements, but have the ability to report results using HL7 standards should review the Minnesota Electronic Laboratory Reporting HL7 2.5.1 Implementation Guide (PDF), and contact health.ElectronicDiseaseReporting@state.mn.us to ask to start the process.
Health Level Seven International (HL7) is a not-for-profit agency that develops standards for electronic health information. To streamline how data is processed, MDH works with facilities so they submit data in an organized way. HL7 is one of the international organizations that creates and supports standards for submitting consistent data using electronic laboratory reporting.
Learn more about HHS: Proposed HHS ELR Submission Guidance when using HL7 v2 Messages.
Facilities that do not meet the requirements for the Promoting Interoperability Program (formerly called Meaningful Use), but have the ability to report using HL7 standards should review the Minnesota Electronic Laboratory Reporting HL7 2.5.1 Implementation Guide (PDF) and contact health.ElectronicDiseaseReporting@state.mn.us to ask about starting the process.
Federally certified nursing facilities
For long-term care facilities (LTCF) that are federally certified nursing settings and that report directly to the Centers for Disease Control and Prevention (CDC).
Federally certified nursing facilities can report results of COVID-19 tests done at the point of care using the CDC: LTCF COVID-19 Module. This secure online reporting system for long-term care facilities is part of the CDC National Healthcare Safety Network (NHSN) infection tracking system. Test results must be submitted within 24 hours of being completed; results are shared with MDH.
- Facilities must first enroll with the national network to submit test results for residents and facility personnel. More information is available in the CDC: NHSN 5-Step Enrollment for Long-Term Care Facilities. Facilities that are enrolled already should not enroll again when starting to report results of tests done at the point of care.
- Federally certified nursing facilities and other LTCF that wish to report test results done at the point of care to the NHSN but have access only to the COVID-19 Module's Secure Access Management Service (SAMS) grid card need to upgrade their SAMS access from level 1 to level 3:
- Learn more at CDC: LTCF COVID-19 Module Enrollment.
- Contact nhsn@cdc.gov. Type “Requesting a SAMS Level 3 invitation” into the subject line of the email. Include your first name, last name, Facility address, facility telephone number, and Facility CMS Certification Number (CCN) in the email body.
- If you are waiting for level 3 security to submit test results to CDC, please sign up and submit results utilizing CDC's SimpleReport until you get level 3 access.
- Training documentation and videos for the NHSN point of care test reporting tool are available on the LTCF COVID-19 Module website under “Recent Trainings.”
All other organizations submitting test results to MDH
Other sites who may be operating under a CLIA certificate of waiver, such as schools or congregate living facilities, offer COVID-19 testing on-site. These sites can CDC: SimpleReport to report facility-administered positive COVID-19 test results to MDH.
- Simple Reports is a free, fast, and simple way for your organization to report COVID-19 results to MDH. Simple Reports offers a user interface for single or small batch test result reporting and utilizes a spreadsheet reporting template for bulk upload (the spreadsheet is like RePortal, but the Simple Report spreadsheet must be used). Resources for account creation and training are available directly through CDC: SimpleReport. SimpleReport is operated by the CDC and they have a support team available to answer questions or assist with troubleshooting.
Questions about COVID-19 test reporting
- Contact health.ElectronicDiseaseReporting@state.mn.us if you still have COVID-19 reporting questions.
COVID-19 Case Reporting
Minnesota law also has requirements for reporting cases of COVID-19, which are separate from the COVID-19 test result reporting requirements discussed on this page. Follow the instructions on Reporting COVID-19/SARS-CoV-2 Infections.
Self-administered home use tests (not including self-collected specimens where the test is performed at a laboratory) and antibody (serology) findings are not reportable to MDH through laboratory or case reporting requirements.
More resources
- Reporting COVID-19/SARS-CoV-2 Infections
Required disease reporting for COVID-19. - COVID-19 Testing
Information on testing options, who should get tested, and what to do while waiting for results. - CDC: How to Report COVID-19 Laboratory Data
- White House: Statement of Administration Policy: H.R. 382 – A bill to terminate the public health emergency declared with respect to COVID-19; H.J. Res. 7 – A joint resolution relating to a national emergency declared by the President on March 13, 2020