Following outcries from lawmakers and the public about the lack of demographic data for COVID-19 testing, the Trump administration is now requiring laboratories to collect demographic data like race, ethnicity, and sex when reporting test results.
Data shows black Americans have been disproportionately harmed by the pandemic, Admiral Brett Giroir, M.D., assistant secretary at the Department of Health and Human Services, who is leading the White House testing response, said during a conference call with reporters Thursday.
HHS will now require laboratories to report the age, race, ethnicity, sex, zip code and type of test performed on patients when reporting COVID-19 test results to the Centers for Disease Control and Prevention, Giroir said.
“This is only one small component of my office’s efforts to combat health disparities that have plagued our nation for decades, but it is an important foundational component related to COVID-19 that we will continue to build on in the future,” Giroir said.
The requirement, which goes into effect Aug. 1, pertains to both diagnostic and serological COVID tests.
The requirement to include demographic data like race, ethnicity, age, and sex will enable HHS to ensure that all groups have equitable access to testing, and allow the department to accurately determine the burden of infection on vulnerable groups, Giroir said.
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"You look at the African-Americans hospitalization rate and mortality rate being three, four, six times that of white Americans, depending on the studies that you read and really understanding who’s being tested, the results of those tested and the demographics are just critical to our public health response,” he said. “We take this deadly seriously."
Before discussing the new guidance with reporters, Giroir addressed tragic incidents of police brutality that disproportionately impact African Americans including the deaths of George Floyd and Breonna Taylor and Ahmaud Arbery, who was killed by a vigilante.
"We must and will continue to acknowledge racial disparities within minority communities," Giroir said.
The new HHS guidance standardizes reporting to ensure that public health officials have access to comprehensive and nearly real-time data to inform decision making in their response to COVID-19, HHS officials said in a statement.
As the country begins to reopen, access to clear and accurate data is essential to communities and leadership for making decisions critical to a phased reopening.
Lawmakers have been pressing HHS to collect racial and ethnic demographic data on testing and treatment for the COVID-19 to identify and address racial disparities.
"Lack of information will exacerbate existing health disparities and result in the loss of lives in vulnerable communities," United States Senator Cory Booker, D-N.J., along with Senators Elizabeth Warren, D-Mass., Kamala D. Harris, D-Calif. and Congresswoman Ayanna Pressley, D-Mass., and Congresswoman Robin Kelly, D-Ill. wrote in a letter back in April.
The new reporting requirements will provide the information needed to better monitor disease incidence and trends by initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and anticipating potential supply chain issues, officials said.
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“HHS and the entire Trump Administration are deeply concerned that COVID-19 is having a disproportionate impact on certain demographics, including racial minorities and older Americans,” said HHS Secretary Alex Azar in a statement. “High-quality data is at the core of any effective public health response, and standardized, comprehensive reporting of testing information will give our public health experts better data to guide decisions at all levels throughout the crisis.”
Giroir said most hospital laboratories do not currently report these demographic fields with COVID-19 test results and commercial laboratories "rarely" report this data.
Public health laboratories, which represent a small portion of overall testing, report racial demographic data about 20% of the time, he said.
"Overall, we generally don’t get these at a national level and it’s essential for us to conduct our business," he said.
The new guidance could be enforced by the Food and Drug Administration under its authority as part of the Emergency Use Authorization for COVID-19 testing and labs could be penalized for not complying, Giroir said.
"The FDA has a range of compliance enforcement tools from warning letters to criminal fines," he said.
Shannon Sartin, chief technology officer at the Center for Medicare & Medicaid Innovation, said most larger labs with more robust technology have the capability to comply quickly with the new requirements.
"There are some smaller laboratories that are still faxing and creating workarounds. We believe there are opportunities to leverage other external systems to be able to gather and share this data," Sartin said.
Laboratories and testing sites can report testing data directly to state or local public health departments or to a centralized platform, such as the Association of Public Health Laboratories’ AIMS platform, Sartin said.
Public health departments also can leverage health information exchanges in gathering demographic data, said HHS official Donald Rucker, M.D., who leads the Office of the National Coordinator for Health IT.
"We want to empower all parts of the public health infrastructure to move on this data. State and regional HIEs have a lot of infrastructure to hep labs with reporting data and have the ability to also merge pre-existing data with lab results to give that richness of demographic information on race and ethnicity," Rucker said.