As of April 1, the U.S. has more than 185,000 COVID-19 cases and more than 4,000 deaths. As the virus continues to spread and quarantine orders are issued across the nation, laboratories are working diligently to increase the ability to rapidly test for the virus, and federal rules are being temporarily adapted to help speed the process.
Initial U.S. Testing Problems
The ability to test for COVID-19 in the U.S. was hampered at the beginning due to inadequate preparation, lack of governmental response, and initial development of an unreliable test that sent the CDC back to square one. In addition, the CDC has had significant budget cuts, including the dismantling of its pandemic response unit in 2018. Even as we are moving past those hurdles, laboratories are still struggling with a shortage of RNA extraction reagents, personal protective equipment, and swabs and viral transport media needed to collect the samples.
Measures Being Taken in the U.S.
The U.S. now faces concerns that our healthcare system will soon be overwhelmed. As a result to aid in isolating the sick, CMS is temporarily allowing the use of non-hospital spaces for patient care and quarantines. In addition, to increase testing access and reduce exposure, CMS will allow laboratories to perform COVID-19 testing (sample collection) on patients at home and in other community-based settings. Healthcare systems can set up testing sites that are specifically for COVID-19 testing. Furthermore, CMS has approved COVID-19 testing in hospital emergency departments via drive-thru and off-campus test sites.
The FDA Has Not Authorized At-home Specimen Collection
Despite several commercial options that are offering at-home specimen collection for COVID-19, the FDA has not yet authorized any tests for consumer purchase that include self-collection at home.
However, approval has been granted to a self-administered sample collection system that involves patients swabbing their own nostril and handing the collection swab to a healthcare worker for processing. This COVID-19 collection method is from UnitedHealth Group and is intended to reduce the risk to healthcare staff.
CMS Requires Lab Data Reporting
To aid in monitoring COVID-19 and help direct resources, the White House Coronavirus Task Force has requested that hospitals report COVID-19 testing data to the U.S. Department of Health and Human Services (DHHS) alongside their daily reporting of bed capacity and supplies. DHHS has been collecting data from public health labs and private laboratory companies, but until recently, has not collected testing data from academic and hospital in-house laboratories that are performing COVID-19 testing. This data is updated daily and is available to the nation’s 4,700 hospitals to allow the surveillance needed to better prepare for supply and capacity needs.
CDC Offers Weekly Call for Labs
To help laboratories navigate through the COVID-19 crisis, the CDC’s Division of Laboratory Systems is hosting a weekly call (Mondays at 3:00 PM ET) to discuss relevant topics and respond to the laboratory community’s questions about the COVID-19 pandemic.
In a crisis like the COVID-19 pandemic, we need to work together to do our part to try and prevent COVID-19 spread to ourselves and throughout our communities. Orchard is proud to work with our public health labs & customers that are involved in working on the front line by efficiently integrating software tools and providing customer service that promotes timely testing. As always, we intend to keep you informed and be a trusted resource you can turn to for industry-related education. Follow us on Twitter at @OrchardSoftware and feel free to respond to this post by emailing us at firstname.lastname@example.org.
- CMS.gov. Trump Administration Engages America’s Hospitals in Unprecedented Data Sharing. March 29, 2020. Accessed at: https://www.cms.gov/newsroom/press-releases/trump-administration-engages-americas-hospitals-unprecedented-data-sharing
- CDC.gov. Clinical Laboratory COVID-19 Response Weekly Calls. March 2020. Accessed at: https://www.cdc.gov/safelabs/resources-tools/covid-19-weekly-clinical-calls.html/#LOCS0330
- Waddill, K. UnitedHealth Group Unveils Self-Administered COVID-19 Test. March 31, 2020. Accessed at: https://healthpayerintelligence.com/news/unitedhealth-group-unveils-self-administered-covid-19-test