As the country slowly reopens, the U.S. Department of Health and Human Services issued guidance today mandating that laboratories submit additional data to the agency along with their COVIDS-19 test results. The additional data includes demographic information such as age, gender and race.
The guidance standardizes reporting with the intent of providing public health officials access to real-time data as they coordinate their response to the coronavirus pandemic. Data and test results must be submitted to relevant health departments within 24 hours.
Admiral Brett Giroir, M.D., assistant secretary for health and lead for COVID-19 testing efforts, said the additional data will allow health officials to better monitor trends and support epidemiological investigations such as contract tracing. Clinicians, he added, will be informed about the performance of tests in real-world conditions, allowing them to gauge the effectiveness of clinical interventions and outcomes.
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"Access to clear and accurate data is essential … so that we can make the best evidence-based decisions," said Giroir. "It is also critical for us to ensure that there is equitable access, especially for underserved minorities. And without this data, there's simply no way to do that."
Giroir said that such data is typically not reported by hospital laboratories, and rarely by commercial laboratories. Those gaps have made it difficult to get a clear grasp on gender- and race-related trends on a national scale.
He added that labs that fail to report the required data could face penalties, enforced by the FDA under Emergency Use Authorization, but this would only apply to labs, not manufacturers or distributors. Penalties could take the form of warning letters or fines, or – in extreme cases – imprisonment.
"We would enforce this through typical enforcement provisions, some of which are done in accordance with the Department of Justice," said Giroir. "We don't anticipate the need for enforcement, but it's certainly there."
WHAT'S THE IMPACT?
Laboratory data serves not only as important information to support decision-making related to the public health emergency, but also as a critical piece to better understanding the impact on socially vulnerable populations, said HHS. Laboratory testing data, in conjunction with case reports and other data, also provide vital guidance for mitigation and control activities.
Health Information Exchanges can also have a valuable role in this process, and, when possible, all information should be collected using health information technology certified to the Office of the National Coordinator 2015 Edition certification criteria – and all information should be structured in accordance with the U.S. Core Data for Interoperability when available or when possible.
All data transmission should occur electronically using HL7 electronic laboratory reporting implementation guides when possible, but a predefined flat file format may also be acceptable.
THE LARGER TREND
It's been a busy week for HHS, as it announced this week its Office of the Assistant Secretary for Preparedness and Response is providing an additional $250 million to aid U.S. healthcare systems treating patients and responding to the COVID-19 pandemic.
This is in addition to $100 million announced in March. As authorized by the Coronavirus Aid, Relief, and Economic Security Act, HHS has now provided $350 million to health centers and systems for pandemic response.
All told, the CARES Act and the Paycheck Protection Program and Health Care Enhancement Act provided $175 billion in relief funds to hospitals and other healthcare providers, including those on the front lines of the coronavirus response. This funding supports healthcare-related expenses or lost revenue attributable to COVID-19 and ensures uninsured Americans can receive coronavirus treatment.
ON THE RECORD
"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. "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."