HHS updated its guidance on the data that should be reported by laboratories as part of the COVID-19 test results.
The agency aims to obtain near real-time data with the reporting requirements to inform decision-making around COVID-19 as the country begins to reopen. The reporting requirements are designed to help the agency monitor disease incidence and trends, as well as initiate epidemiologic case investigations, contact tracing assistance and anticipate supply chain issues.
“The requirement to include demographic data like race, ethnicity, age, and sex will enable us to ensure that all groups have equitable access to testing, and allow us to accurately determine the burden of infection on vulnerable groups,” said ADM Brett P. Giroir, MD, Assistant Secretary for Health. “With these data we will be able to improve decision-making and better prevent or mitigate further illnesses among Americans.”
Six things to know:
1. Under the new requirements, all laboratories, including those that are operating as temporary or overflow locations, must report data for all tests completed within 24 hours of obtaining the results.
2. Labs can report data to HHS through state or local health departments or through a centralized platform, such as the Association of Public Health Laboratories’ AIMS platform.
3. There are 18 required elements of the data:
· Test ordered using LOINC codes provided by the CDC
· Device identifier
· Test result using LOINC and SNOMED codes
· Test result date
· Accession number and specimen ID
· Patient age
· Patient race
· Patient ethnicity
· Patient sex
· Patient residence ZIP code
· Patient residence county
· Ordering provider name and NPI
· Ordering provider ZIP code
· Performing facility name and/or CLIF number if it’s known
· Performing facility ZIP code
· Specimen source
· Date test was ordered
· Date the specimen was collected
State and local health departments are collecting information including the patient’s name, address, phone number and date of birth, but the CDC isn’t collecting that information.
4. The agency will also collect data on whether the test is the first test, the patient is employed in healthcare and whether they were hospitalized or received treatment in the ICU. IT is also collecting information about whether the individual is in a “congregate care setting” including nursing homes.
5. The CDC is requesting the information be made available in reporting as soon as possible, no later than Aug. 1. The information should be collected using health IT certified to the ONC 2015 Edition certification criteria.
6. HHS recommended that lab results be transmitted back to the ordering provider when possible through the EHR, but did not require it.