ODH Issues Reporting Requirements for Antigen Devices
LeadingAge Ohio reached out to the Ohio Department of Heath (ODH) regarding the reporting requirements for tests administered using a point-of-care (POC) antigen test. ODH confirmed that as nursing homes begin conducting their own antigen testing on-site, they will be required to register as a lab and report aggregate test results via the lab reporting portal on the ODH website, in addition to reporting positive results to the local health department (LHD). The aggregate reporting is due daily by 11am, and the positive case/line level reporting must be made within 24 hours of case identification.
Previously, providers had been accustomed to reporting positive cases to the local health department, but with the advent of the POC devices, they now fall under a second reporting requirement in Ohio, outlined in a May 13 Director’s order.
Once providers have registered, they will receive a confirmation email from ODH, which will include the following instructions:
For the case/line level reporting, your facility must report positive and inconclusive results to the local health department (LHD) where the patient resides within 24 hours of case identification (i.e. time the test is resulted). This is generally completed by faxing the confidential case report form to the LHD. To identify the LHD where the patient resides, you may use the LHD address tool. If the patient resides out of state (e.g. staff person), you must report those results to the appropriate state health department where that person resides. ODH will alert all facilities when they are ready to start receiving negative test results as the case level. Once negatives are required to be reported, ODH recommends that you setup an electronic laboratory reporting (ELR) data feed to reduce burden on the LTCF, LHD, and ODH to receive your data daily, securely, and most efficiently. This involves setting up a secure connection with ODH and working on a CSV format to send COVID results electronically. If interested, complete the attached SFTP request form.
For aggregate count reporting, your facility must report ALL COVID results daily by 11 am ET. You do not need to start the daily reporting until you start testing in-house. If you collect specimens in your facility, but then send them for testing to a reference lab (e.g. Quest, LabCorp, local hospital, etc.), then you do NOT report these counts. The performing laboratory is responsible for reporting those aggregate counts.
The confirmation email will also include a screenshot of the data entry field, with notes on areas where a provider should be meticulous in data entry. Notably, since there is no authentication to enter the portal, they should ensure they select the correct lab from the drop down. Furthermore, all test results from the Quidel and BD machines should be recorded as non-diagnostic tests. A nursing home will NOT enter any data for PCR test results they receive, as these would be recorded by the lab processing the tests. The form requires this field to be filled out, though, so a nursing home should enter ‘0’ in each of the five fields pertaining to diagnostic tests before entering the information on antigen tests in the fields for non-diagnostic tests.
Some additional resources include: