CEO SUMMARY: In April, the federal Department of Health and Human Services contracted with eTrueNorth to operate COVID drive-through specimen-collection sites under the Community-Based Testing Sites program. The drive-through sites are an extension of non-COVID testing the company has done since 2016 in partnership with some of the nation’s largest retail pharmacy and grocery chains. Under the HHS contract, eTrueNorth collects COVID specimens from as many as 5,000 patients each day.
WHAT STARTED AS ONE DRIVE-THROUGH COVID SPECIMEN-COLLECTION SITE in Joliet, Ill., has grown to more than 400 sites and more than $90 million in federal contracts for eTrueNorth, a wellness company that coordinates testing at those sites.
By interceding between clinical laboratories and patients who need SARSCoV-2 testing, this small company in Mansfield, Texas, has become the latest example of an innovative company rethinking the traditional way clinical laboratory test services are delivered, and then introducing more efficient and cost-effective production methods.
Beginnings in Drug Stores
In this case, eTrueNorth developed a way to interpose itself into the specimen-collectionstep of the clinical lab testing process. Yet any clinical lab organization with an entrepreneurial nature and out-of-the box thinking could have provided the same service that eTrueNorth delivers under contract with the federal Department of Health and Human Services (HHS).
eTrueNorth does not do any testing for COVID patients. Pre-pandemic, its primary business was to arrange CLIA-waived testing sites in retail stores under contracts with large pharmacy and retail operators such as Walmart, Kroger, Hy-Vee stores, Health Mart pharmacies (a division of McKesson), and other independent pharmacies. Those pharmacy chains are part of eTrueNorth’s eLabNetwork, which does wellness testing (such as hemoglobin A1c, lipids, PT/INR, and pharmacogenetic testing) and onsite tests for medication management.
Until this year, eTrueNorth’s largest client was Walmart, one of the nation’s largest retailers. Since 2016, eTrueNorth has developed CLIA-waived labs in Walmart’s4,300 stores nationwide, eTrueNorth’s President and CEO Coral May said in an interview with The Dark Report.
In April, eTrueNorth acquired a large new client when HHS contracted with the company to operate COVID drive-through specimen-collection sites under the federal Community-Based Testing Sites (CBTS) program. The drive-through sites became an extension of the non-COVID testing the company has done for years, she said.
“In April, we opened our first drivethrough COVID-19 collection site,” she noted. “Today, we coordinate collections at about 400 sites, including very-high volume surge sites in 12 hotspot cities where we have multiple sites in place.
“Those 400 sites are located throughout the United States,” May said. “Some are in geographies that simply don’t have a lot of other COVID-19 testing options. The actual number of sites changes almost daily, depending on what the federal or state governments need.”
At most of those sites, pharmacy staff from its retail partners collect COVID-19 specimens. For surge sites, eTrueNorth provides staff to observe specimen collection. Over the past four months,May estimated that eTrueNorth has collected specimens from more than 500,000 patients. The company cannot disclose the cost per test or what it pays labs for those tests, May said.
Filling a Need
Under the CBTS program, HHS has set up more than 700 federally-backed drive-through specimen-collection sites and has spent $230 million to pay for the tests run at those sites, according to Stat News.
In its role as the coordinator of more than half of the CBTS collection sites, eTrueNorth ships specimens to eight labs, one of which is HealthQuest Esoterics, in Irvine, Calif. Recently, Stat News reported the company was working with Gravity Diagnostics in Covington, Ky., and Reditus Laboratories in Pekin, Ill.
Last week, eTrueNorth said it stopped working with those two labs and added seven more labs to meet a rising demand for testing. It did not disclose the names of the seven new labs. Gravity Diagnostics, HealthQuest Esoterics, and Reditus Labs did not return requests for comment.
All eight labs are CLIA-certified and have the capacity to run the polymerase chain reaction (PCR) tests for SARSCoV-2, the virus that causes the COVID-19 illness. In addition, Michael McEntee, co-founder of eTrueNorth, has been developing a network of clinical labs that can handle 80,000 tests per day, May said.
“This capability is expected to expand to more than 100,000 tests per day with the eight laboratories we have now,” he said.
When choosing labs to do COVID tests, eTrueNorth prefers to contract with independent laboratory companies that have the capacity to do such testing, May said. Hospital labs have other priorities because they need to serve their own inpatients and outpatients first, she explained.
Sites to Meet Surge Demand
The clinical laboratory companies working with eTrueNorth do not need to be near the collection sites, because specimens are shipped overnight for delivery the next morning, and the sites change regularly depending on the need in states where surge testing is required, May said.
“We just finished testing in two Florida sites—one in Jacksonville and the other in Miami,” she noted. “We have sites in Phoenix, and in New Orleans and Baton Rouge in Louisiana. We also have sites in Bakersfield, Calif.; at the Atlanta airport; and in Edinburg, Texas, in the Rio Grande Valley. We have two sites in Houston and two in the surrounding Harris Country area.
“Recently, we began participating in surge sites that can collect specimens from as many as 5,000 patients daily, but that number varies depending on many factors,” May commented.
Volume, TAT Management
Effective coordination at each specimen-collection site helps eTrueNorth manage the demand for testing to ensure that the clinical laboratory companies running the SARS-CoV-2 tests do not get more specimens than they can run in a day or so, she said.
“We know the daily throughput capacity of our laboratory partners, and so we make sure we don’t overwhelm any laboratory beyond that level,” she explained. “Doing that helps to keep our turnaround times predictable, in the range of three to five business days,” May continued.
“From every collection site, we send our COVID-19 specimens for overnight delivery via UPS or FedEx so they arrive the next morning,” explained May. “We monitor turnaround times continuously at each lab facility doing the COVID-19 testing and want to know about any slowdowns. If there are slowdowns, we can take steps during specimen-collection to fix those problems.”
No physician requisitions are needed. All testing is done with a standing order. “Every person who registers at our site gets a one-page voucher that’s essentially a lab requisition,” stated May. “It contains a unique identification number, which becomes the identifier for that patient’s specimen. “Then, the patient prints the voucher and takes it to the test site,” she continued.
“If the patient doesn’t have a printer, he or she can register on their smartphone to get an identification number. That voucher number is part of the identifier that goes onto the specimen tube.
Accessioning at the Lab
“When the tube arrives at the clinical laboratory, the lab will have the ID number, the patient’s date of birth, and the patient’s first and last name. All of that information is similar to what a lab gets on its own requisitions, but it’s different because we adapted the normal test requisition to our needs. The COVID-19 test results go directly to the patients by email or phone,” she added.
Pathologists and clinical lab executive should recognize that eTrueNorth is an example of a new class of entrepreneurial companies that recognize new opportunities to deliver diagnostic testing solutions in unconventional ways. One common attribute of these companies is that they do not perform the tests. Rather, like Uber or eBay, eTrueNorth and similar firms function as a platform that connects consumers with sources of lab tests.
Wellness Protocol Used for Covid-19 Testing
When working with retail pharmacies to do non-COVID testing, eTrueNorth developed a system for patients to register for CLIA-waived tests and then adapted that model for its drive-through specimen-collection operation for COVID patients, according to eTrueNorth’s President and CEO Coral May.
“The way our model works is we have our non-COVID platform that allows individuals to visit one of the retail pharmacy sites and select their test location,” she reported. “Then, they create an appointment within a 10-minute time block.” eTrueNorth has contracts with Walmart, Kroger, and other independent pharmacies.
“We already had the technology so that we could pivot to make it support COVID-19 testing,” she added. “Those patients register on our site, select their preferred pharmacy and then complete the risk assessment from the CDC to determine if they’re eligible for COVID-19 testing.” The federal Centers for Disease Control and Prevention risk assessment asks patients about their symptoms and medical conditions.
“We have appointment scheduling throughout the day, which means we’ve had a maximum of about 20 to 25 cars in line at any one time,” May noted. “The goal is to get people in and out as close to their allotted 10-minute timeframe as we can.
“With the proper planning, and appointment scheduling and if people come at their appointed times, we can significantly reduce the wait time,” she said.
Contact Coral May at CMay@etruenorth.com; Michael McEntee at MMcEntee@etruenorth.com.