Under the CARES Act and effective August 1st, laboratories that conduct any SARS-CoV-2 testing (e.g., molecular, antigen, antibody) are required to send the results of these tests – positive or negative – via existing public health data reporting methods. Along with test results, laboratories are also required to report additional test-specific data elements (e.g., patient age, ethnicity). Data shall be reported daily and within 24 hours of results being determined. Guidance for these requirements was issued by HHS on June 4.

Laboratory results sent to the IDHW Bureau of Communicable Disease Prevention via existing reporting mechanisms will satisfy federal reporting requirements. The Bureau of Communicable Disease Prevention submits all laboratory results to the CDC electronically. Reporting laboratory results data via IRTS/EmResource does not meet this federal reporting requirement.

In an effort to reduce reporting burden on facilities and public health districts, IDHW continues to encourage facilities to report testing results in an HHS-approved electronic format – either via Health Level 7 (HL7) messaging or the CDC-provided CSV template. For additional information and support in meeting HHS reporting requirements, facilities may contact Dr. Kathryn Turner, Deputy State Epidemiologist.

Additional resources about this COVID-19 laboratory reporting requirement can be found here:

Last week, FEMA issued a temporary final rule designating specific medical resources exclusively for domestic use to ensure front line healthcare workers have the supplies they need during this pandemic. Through December 31, the rule allows FEMA to review and hold for domestic use: masks (both N-95 respirator and surgical); surgical and exam gloves; as well as isolation and level 3 and 4 surgical gowns.

In related news, the FDA released an updated list of supplies and equipment in short supply nationally. Per the CARES Act, manufacturers must notify the FDA of discontinuances or delays that impact the country’s supply chain during this public health emergency. PPE supplies, testing equipment and supplies, and ventilator equipment made up the list of shortage items.

A new saliva-based test for COVID-19 received emergency use authorization (EUA) from the FDA on Saturday. The new test eliminates the need for specialty kits, which are in short supply.

The SalivaDirect test, developed by the Yale School of Public Health, is authorized for use with different combinations of common reagents and instruments allowing it to be processed in most high-complexity labs. Yale announced that it will provide the protocol as an “open source”, meaning that any designated lab could use the protocol to obtain the needed components and process the SalivaDirect test. In addition, collection of the test specimens can be done in any sterile container and be self-collected by the patient under observation of a health care professional, reducing the risk of transmission.

IdahoSTRONG is here to provide Idahoans with resources through the COVID-19 Help Now Line. Behavior and emotional assistance as well as information on a wide range of issues is available via text or telephone.

To access the COVID Help Now Line, call or text (986) 867-1073 or call toll free (866) 947-5186 to speak to a representative. COVID Help Now Line is staffed from 8am to 8pm Mountain Time, 7 days a week. Callers may also leave a message during off hours and receive a return call the following day. Responders do not classify, label, or diagnose people and no records or case files are kept. We are here to listen, and here to help. Let’s keep #IdahoSTRONG.