In-house hospital labs requested to aggregate and report numerous categories of COVID-19 test types daily, could become mandatory
In the midst of the COVID-19 pandemic, a federal guideline was issued that hospital-based clinical laboratories must submit a daily report about the COVID-19 tests they perform. These daily reports must be sent to the Federal Emergency Management Agency (FEMA).
On March 29, 2020, Vice President Mike Pence sent a letter on behalf of the White House Coronavirus Task Force outlining daily reporting guidelines for COVID-19 testing that in-house hospital labs should follow. The daily data obtained through this reporting allows for a current overview of COVID-19 testing and allows federal interventions to be based on the best data possible.
While these new reporting guidelines for hospital-based labs provide data that crucially influence the whole-of-government response to the pandemic, they also create an increased workload for hospital and lab administrators, requiring time and resources to correctly implement a workable and efficient process.
COVID-19 Test Reporting Guideline Categories
COVID test data reporting categories include:
- New Diagnostic Tests Ordered
- Cumulative Diagnostic Tests Ordered
- New Tests Resulted
- Cumulative Tests Performed
- New Positive COVID-19 Tests
- Cumulative Positive COVID-19 Tests
- New Negative COVID-19 Tests
- Cumulative Negative COVID-19 Tests
Stay Alert for Changes, Reporting to Become Mandatory
The test categories above are subject to change and may not reflect updates that have occurred since the publication of this brief.
While not explicitly required now, labs should begin reporting these data in anticipation of a shift to mandatory reporting of COVID-19 test data.
The COVID-19 STAT Intelligence Briefings Service spoke with specialists who assist medical laboratories in responding to lab test reporting guidelines, about what to expect, and how to work through the challenges.
Michigan-based Visiun is a lab data analytics firm that provides services that enable labs to leverage their data to optimize operations. Visiun has released a tool that aggregates the necessary data and prepares it for reporting, even distinguishing trending COVID-19 test volumes and high-volume areas based on ZIP codes, according to the company.
For the request for COVID-19 lab test data reporting, Tim Bickley, Visiun’s Vice President of Sales (Left), gave this advice:
“Be familiar with the nuances of which data your lab reports. There are nuances here, depending on the methodology the lab uses for testing COVID.
It could be an inconclusive result: If so, how are those counted? Is a repeat test on a patient positive? Did the attending physician order another COVID test too soon?”
Understanding how to handle the nuances of COVID-19 test data can help hospital and health system laboratories develop a reporting system, and save time and resources later.
Vendors Can Help Hospital Laboratories with Federal COVID-19 Reports
“A hospital laboratory shouldn’t think it must solve these problems alone,” Clymer explained. “The lab’s vendors certainly should be brought in to take advantage of their experience and set up the daily federal COVID reporting in ways that are easier and more efficient. Vendors can be a big asset.” Sunquest has already released a COVID-19 reporting tool that integrates with its existing systems and allows its clients to create a report in seconds, added Clymer. Sunquest has also developed ad hoc report writer templates.
Interoperability and connectivity with the laboratory information system (LIS) are important factors for accessing and reporting clinical lab test data. Reaching out to your LIS vendor could greatly reduce your workload and save time in organizing a COVID-19 reporting system, Clymer said.
The pressure on medical lab performance and workload continues to intensify. A new federal requirement that hospital labs submit a daily COVID-19 test report is the latest example. It is why the one thing that labs should plan for, according to Michelle Del Guercio, VP of Marketing at Sunquest, is change.
“Both hospital laboratories and independent clinical laboratories are in a state of flux right now,” observed Del Guercio. Both Del Guercio and Clymer noted that reporting requirements could change at any time. Thus, even as labs focus on meeting current reporting requirements, they should also stay alert for revisions and updates to these new federal COVID-19 lab test reporting guidelines.
— By Caleb Williams, Editor, COVID-19 STAT
Related Resources:
Federal Request for COVID-19 Data, hospital association issues notice to stakeholders
Coronavirus (COVID-19) Pandemic: HHS Letter to Hospital Administrators, published at fema.gov
Text of a Letter from the Vice President to Hospital Administrators, March 29
