Maryland Department of Health (MDH) uses reporting guidance outlined in the HHS COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115 document. While the federal reporting requirement has ended, Maryland continues to require laboratory reporting of COVID-19 results under state regulations.
Summary of Reporting Requirements
Type of Testing | Is Reporting Required Under this Guidance? - Positive Results | Is Reporting Required Under this Guidance? - Negative & Inconclusive Results | Example Settings |
SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) testing conducted in a facility certified under CLIA to perform moderate- or high-complexity tests | Required | Required | Clinical laboratories, including public health, commercial, healthcare system, and academic laboratories. |
All other SARS-CoV-2 testing not otherwise specified, except antibody and self-administered testing | Required | Not required | Rapid testing, including but not limited to testing at schools, correctional facilities, employee testing programs, long-term care facilities, point-of-care testing performed in pharmacies, medical provider offices, and drive-through testing sites. |
SARS-CoV-2 antibody testing | Not required | Not required | |
Self-administered SARS-CoV-2 home use tests, not including self-collected specimens where the test is performed at a laboratory | Not required | Not required | Home use and over-the-counter (OTC) tests |
Requirements
SARS-CoV-2 laboratory reporting requirements are based on the entity that performs the testing and the type of test being performed. All reportable COVID-19 results must be reported within 24 hours. The following is a summary of these requirements.
- SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) testing conducted in a facility certified under Clinical Laboratory Improvement Amendments (CLIA) to perform moderate- or high-complexity tests
- CLIA-certified laboratories that are certified to perform moderate- or high-complexity testing must report all test results (positive, negative, and inconclusive). This includes, but is not limited to, NAAT testing (e.g., RT-PCR) performed for SARS-CoV-2 by clinical laboratories, including public health, commercial, healthcare system, and academic laboratories.
- All other SARS-CoV-2 testing, except antibody and self-administered testing
- Entities conducting all other SARS-CoV-2 testing (e.g., testing conducted in a setting operating under a CLIA certificate of waiver, non-NAAT testing conducted in a facility certified under CLIA to perform moderate- or high-complexity tests) except antibody and self-administered testing, must report positive test results. This includes rapid testing, such as screening testing at schools, correctional facilities, employee testing programs, long-term care facilities, point-of-care testing performed in pharmacies, medical provider offices, and drive-through testing sites.
- SARS-CoV-2 antibody testing
- MDH does NOT require antibody test results.
Self-administered SARS-CoV-2 home use tests, not including self-collected specimens where the test is performed at a laboratory
- Home use tests are considered entirely self-administered if the test allows for self-collection and testing at home. These tests, also known as home use and over-the-counter (OTC) tests, do NOTnot need to be reported to MDH. However, if a self-collected specimen is sent to a laboratory for testing, the laboratory must report the results. Additionally, individuals may voluntarily report self-administered test results through the MakeMyTestCount platform.
Electronic Formats
MDH accepts COVID-19 test results in multiple formats, including the following:
- HL7 messages
- MDH-specific spreadsheet template (CSV)
- If your facility/laboratory will be using the MDH COVID-19 CSV template, please review the data dictionary prior to sending results to make sure that data is in the correct format. Data should be as complete as possible. Please do not delete columns or change any formatting of the template. Make sure to send the file as .CSV and not as Excel (.XLSX) or any other format.
- CDC’s Simple Report web-based reporting tool
- CRISP Point-of-Care reporting tool (MD providers only)
Please note that all other reportable results can only be reported electronically by HL7.
