Maryland Department of Health (MDH)'s COVID-19 reporting requirements have changed. MDH is now using reporting guidance outlined in the HHS COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115 document. Please refer to this document for details of the COVID-19 reporting guidance.
For any COVID-19 results that are required to be reported, results must still be reported within 24 hours.
Requirements
SARS-CoV-2 laboratory reporting requirements are based on
the entity that performs the testing and
the type of test being performed. The following is a summary of these requirements.
1. SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) testing conducted in a facility certified under CLIA to perform moderate- or high-complexity tests
Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories that are certified to perform moderate- or high-complexity testing
must report all test results (i.e., positive, negative, inconclusive)
from NAAT testing (e.g., RT-PCR). This includes, but is not limited to, NAAT testing performed for SARS-CoV-2 by clinical laboratories, including public health, commercial, healthcare system, and academic laboratories.
2. 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. Reporting of negative results is optional. This includes rapid testing conducted in many settings (e.g., screening testing at schools, correctional facilities, employee testing programs, long-term care facilities, and point-of-care testing performed in pharmacies, medical provider offices, and drive-through testing sites).
3. SARS-CoV-2 antibody testing
This guidance does not require entities to report SARS-CoV-2 antibody test results unless required by applicable STLT law or regulation.
MDH does not require antibody results.
4. 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 are also known as
home use and over-the-counter (OTC) tests. Home use tests have been authorized for emergency use by the federal Food and Drug Administration (FDA). Tests from additional test developers may be authorized in the future. Self-administered tests are outside the reporting requirements for laboratories in Section 18115 of the CARES Act as articulated in this guidance; however, these tests are of enormous potential public health and clinical value and utility.
Electronic Formats
MDH can accept COVID-19 test results in multiple formats including an
MDH-specific spreadsheet template (CSV), through the
CDC’s Simple Report web-based reporting tool, and through the
CRISP Point-of-Care Reporting Tool.
All other reportable results can
only be reported electronically by HL7.
HL7 messages
Please refer to
MDH guidance for the Department of Health and Human Services (HHS) HL7 requirements, since additional requirements are requested specifically for COVID-19 data. Ask On Order entry (AOE) questions are not required but if your facility is planning to send them, please refer to
MDH's example COVID-19 message, which includes AOEs.
CSV files
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.
