The following are frequently asked questions about the RADx® MARS program and HL7v2.
RADx® MARS
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) established RADx MARS to promote a standards-based approach to reporting at-home test results and to establish best practices for future reporting of remote diagnostics.
Reporting entities have a choice of sending test results to one of two hubs: (1) AHPL AIMS or (2) CDC ReportStream. In either scenario, the cost to the reporting system for onboarding and test result transmission to state and federal systems is $0. To participate in the RADx MARS program, the reporting entity must send messages that conform to a standard HL7v2 specification.
NIBIB can fund APHL for up to 3 years, per a contract that was awarded in March 2022. This will allow adequate time for ReportStream to grow its connectivity to state health systems and for reporting systems to make educated decisions in choosing a hub as the home diagnostics and reporting landscape evolves. Use of the RADx MARS HL7v2 specification will facilitate interoperability of the reporting messages between different hubs. After NIBIB stops funding APHL, reporting entities who are sending data through APHL will have the option of remaining with APHL or switching to ReportStream. The former may carry a cost, whereas the latter is free. Transitioning from APHL to ReportStream involves minimal effort.
Yes, the HL7v2 specification was built to allow communication of data required at both state and federal levels and is consistent with FDA, CDC, and HHS requirements. The specification was also designed to be accepted by all states and territories. Whether or not a message is sent to a particular state depends on that state's preferences for OTC reporting. The reporting systems need only to send a single HL7v2 message per test result to the hub. The hub sends messages to states that desire it. The hub also de-identifies the messages and sends them to the federal health system, HHS Protect.
Yes, RADx MARS has a FHIR specification that was balloted through the HL7 community. However, public health systems generally do not support FHIR messaging at this time. Therefore, the MARS HL7v2 specification must be used for public health reporting to ensure interoperability with state health systems.
Yes, RADx MARS has adopted state and federal guidelines about what information apps should collect from users who agree to report their test results. Apps should enable users to report anonymously or opt to out of reporting altogether.
RADx MARS staff will work with reporting entities to review app front end design as part of the onboarding process. We emphasize the importance of a good UI/UX, in order to make reporting easy for users. Any changes made to an app may need to be reviewed by the FDA.
CDC keeps track of state preferences and makes this information available to the hubs. The hubs will relay the test results to states based on their preferences.
No, the county FIPS code is not used to determine routing to a jurisdiction. This is typically done by zip code or by state code, depending on the hub.
HL7v2
If PID 13.6 (Patient phone area code) and PID 13.7 (Patient phone) are unknown or a non-US phone number, use '1' in place of the numbers: 111^1111111
The upper limit for single batch HL7 files (for the AIMS Hub) is 9,999 messages.
If email address is known and phone number unknown, please use INTERNET for PID 13.3. If phone number known and email address unknown, use PH for PID 13.3. If both are known, use the repeating character. It should look like: ~ ^^PH^^^222^2222222~^^Internet^name@email.com
Yes, some state and local public health jurisdiction systems cannot ingest an OBX-17.1 (Device Identifier) that is greater than 20 characters. If Device Identifier information is greater than 20 characters, use the NTE segment to repeat the Device Information in full.
The NTE segment should come immediately after the OBX segment.
OBX sets are created by entering a sequential digit in brackets immediate after OBX (e.g., OBX[2]). The use of the digit is not standardized to any given Ask-on-Order-Entry (AOE), so they should be used as needed. For example, if there are two AOEs that need to be reported, then use OBX[2] for one and OBX[3] for the next. OBX[1] is always reserved for the test result information.
Yes, time zones are required. If time zone is unknown, please use <+0000>.