New U.S. Data Rules Aim at Clearing Up Jumbled Virus Picture

(Bloomberg) -- Laboratories will be required to report more details to the government about people who take coronavirus tests, including information on race, gender and zip code, under new guidance issued on Thursday by the U.S. Department of Health and Human Services.

Incomplete data on who is getting sick and where they live has made it harder to track infections and contain the pandemic. Those shortcomings have also helped obscure signs that communities of color have been disproportionately affected by the virus.

The new guidance focuses on standardizing the reporting of testing data to the Centers for Disease Control and Prevention, requiring that age, ethnicity and type of test performed, among other details, be reported to health agencies. Laboratories must comply by Aug. 1. The data will be made public, officials said.

Brett Giroir, an HHS official who has overseen the Trump administration's efforts to ramp up testing, said “most of these fields are not reported at all by hospital laboratories and rarely by large commercial laboratories,” which have performed the bulk of U.S. Covid-19 testing. Only public-health laboratories are reporting race, and then just 20% of the time, Giroir said.

“Overall, we generally don't get these at a national level,” Giroir said. The change is geared at “putting together the data ecosystem in a coherent, logical, nearly real-time way,” he said.

Race has been a particular blind spot in U.S. virus data. Today, 47 states report confirmed cases by race, 43 states report it for deaths, and only four states report the breakdown for testing, according to Johns Hopkins University's coronavirus resource center. That has given rise to concerns that communities of color may not be sufficiently accessing testing, distorting the country's understanding of how many people are getting sick.

It's likely that tracking for race, zip code and other factors will only apply moving forward, leaving a swathe of U.S. virus-testing data incomplete. HHS didn't anticipate a need to report retroactively, Giroir said.

‘As Quickly as Possible'

Giroir said HHS's authority to issue the guidance came from the Coronavirus Aid, Relief and Economic Security (CARES) Act, which was signed into law at the end of March.

Giroir said his team had been working on the guidance for several weeks, and it look longer to write because the law didn't outline any enforcement mechanisms. The Food and Drug Administration will have the ability to enforce the guidance and could require labs to report the data as part of their emergency-use authorization, Giroir said.

“I think it's coming at the right time, and we did it as quickly as possible given good government standards and the due diligence that you would expect out of a federal administration,” Giroir said.

Labs will need to submit the data to their local or state health department within 24 hours, and those health departments will submit it to the CDC daily, Giroir said. The administration believes many labs will be able to comply with the requirements ahead of the deadline, he said.

The new guidance should also give the government information about types of coronavirus tests being done and the machines they're being run on, helping with supply-chain planning, according to Giroir. Supply shortages have limited U.S. testing efforts for months.

Giroir said the data could also provide physicians a picture of how well tests work in real-world conditions. Those results will likely be watched closely due to concerns about false negatives, even though diagnostic tests are thought to be particularly accurate.