New COVID-19 data reporting requirements for clinical laboratories generate national controversy as they go into effect.
A recently announced change to COVID-19 data reporting requirements has been released that will alter how hospital-based laboratories would report their COVID-19 testing results.
Previously, clinical laboratories would report COVID-19 related data that was required to be reported to the National Healthcare Safety Network (NHSN). This healthcare-associated infection tracking system is run by the Centers for Disease Control and Prevention (CDC) and has been used to track the spread of COVID-19 since the United States began tracking the disease.
On July 10, 2020, US Department of Health and Human Services (HHS) released new guidelines for reporting COVID-19 data in a document titled “COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting.”
The guidelines release by HHS clearly state, “As of July 15, 2020, hospitals should no longer report the Covid-19 information in this document to the National Healthcare Safety Network site.”
The HHS guidelines provide information to laboratories on how to correctly report the required data and provide them with the option of reporting data to their state if their state has assumed reporting responsibility. Otherwise, clinical laboratories are instructed to report their data via a unique link that will be sent to the hospital points of contact (POC). This will direct the POC to a hospital-specific secure form that can then be used to enter the necessary information.
The Rationale for Changing COVID-19 Data Reporting
Michael Caputo, Assistant Secretary for Public Affairs at HHS, said in a statement, “The new faster and complete data system is what our nation needs to defeat the coronavirus and the CDC, an operating division of HHS, will certainly participate in this streamlined all-of-government response. They will simply no longer control it.
“Today, the C.D.C. still has at least a week lag in reporting hospital data. America requires it in real time,” Caputo told the New York Times.
COVID-19 Data Controversy
The change in the way data is reported was not widely recognized until it was reported on by the New York Times on July 14, 2020. Initial reporting placed a political spin on the change. The New York Times emphasized in the first paragraph of their article, “The move has alarmed health experts who fear the data will be politicized or withheld from the public.” After the New York Time’s article, many other news outlets picked up the story with the same perspective.
Initial fears of politicalization of the data seemed to center around the misconception that the CDC would no longer have access to the data and that the data would no longer be available to the public.
The same day that the story was published by the New York Times, CDC Director Robert R. Redfield, along with HHS Chief Information Officer Jose Arrieta, released a joint statement to clarify this change.
Robert R. Redfield, Director of the Centers for Disease Control and Prevention (CDC), described the CDC data bypass, using TeleTracking, as streamlining the process of COVID-19 disease tracking.
Redfield discussed the benefits of the change. “This reduces the reporting burden. Streamlining reporting enables us to distribute scarce resources using the best possible data,” Redfield explained. “TeleTracking also provides rapid ways to update the type of data we are collecting—such as adding, for instance, input fields on what kind of treatments are being used. In order to meet this need for flexible data gathering, CDC agreed that we needed to remove NHSN from the collection process, in order to streamline reporting.”
COVID-19 Data Ecosystem Status
Redfield also explained, “To accomplish this, we have not changed the data ecosystem; we have merely streamlined the data collection mechanism for hospitals on the frontlines.” He further emphasized, “No one is taking access or data away from CDC. This has no effect on CDC’s ability to use this data and continue churning out the daily data, the MMWRs, and the guidance we publish. In fact, the new infrastructure we have now actually provides our CDC team with easier access to a much broader variety of data sets than they would have without it.”
Initially, several COVID-19 data reporting options were available for collecting hospital capacity and lab test utilization data, included submitting data to TeleTracking, completing the CDC’s modified for COVID-19 NHSN module daily, authorizing the health IT vendor or other third-party to share information directly with HHS, or publishing to the hospital or facility’s website.
Clinical laboratories will need to watch for additional changes in federal reporting requirements for COVID-19. Discussions and disputes about the implications and consequences of new federal guidance will continue as the pandemic evolves amid agile technology.
—By Caleb Williams, Editor, COVID-19 STAT
COVID-19 Guidance for Hospital Reporting and FAQs For Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting
April 10 Coronavirus (COVID-19) Pandemic: HHS Letter to Hospital Administrators
National Healthcare Safety Network (NHSN)
New York Times: Trump Administration Strips C.D.C. of Control of Coronavirus Data
Prepared Remarks from HHS Media Call with CDC Director Redfield and CIO Arrieta on COVID-19 Data Collection