The Health Department has used multiple laboratories for COVID-19 testing, prompting questions about its choice of firms.
Knox County has had a contract with a locally owned laboratory for processing COVID-19 tests since March, but the Health Department has used the firm sparingly in recent months even as case counts soar and test turnaround times rise.
The time it takes to process COVID-19 tests is only one factor in turnaround times for laboratories.
The reasons are rooted in the complexity, uncertainty and ever-shifting circumstances of dealing with the novel coronavirus as the pandemic has unfolded, a situation made more critical as Knoxville has become the No. 1 city its size in the country for new COVID-19 cases per capita.
In March, Knox County Commission approved a contract with Integrity Laboratories to provide COVID-19 testing at its Northwest Knox County facility for $51.50 per test. The contract was amended in October to pay the company $100 per test, retroactive to July, to align with Medicare’s reimbursement rate for uninsured patients.
Both the Health Department and the Knox County Sheriff’s Office have used Integrity Laboratories’ services, but the Health Department has used other labs for the bulk of its testing in recent months.
Commission Chairman Larsen Jay and Integrity Laboratories President and CEO Christian Clevenger said they’re perplexed by the Health Department’s actions.
“If we have local labs that have turnaround times of 24 to 48 hours, that would give people faster results so they can take more preventative measures,” Jay said. “I just want to understand why we're going somewhere else.”
Clevenger said speed is of the essence with COVID-19, and asserted Integrity, which was the fourth commercial laboratory in the nation to receive testing approval from the U.S. Food and Drug Administration, can get test results in 24 hours or less. He also said Integrity’s tests are more sensitive than tests conducted at most commercial labs, which means they can detect the coronavirus sooner after exposure.
“Integrity Laboratories has the ability to enhance patient outcomes,
to enhance turnaround times, and we have FDA approval,” Clevenger said. “So it's just hard to wrap your mind around why they would be sending it anywhere but in their backyard.”
The Health Department’s guidelines call for people to quarantine between the time they give samples until the time they receive the results. Clevenger and Jay said that people won’t won’t quarantine if the wait is too long.
That means that people who end up testing positive — the rolling seven-day positivity rate for December has ranged between 16 and 25 percent — can spread the virus if they ignore or break quarantine.
“You can't get people to quarantine for four to five days,” Clevenger said. “It kind of hits home, especially now when you realize Knox County has been called the No. 1 hotspot in the country for the contraction of COVID-19.”
Overall reporting times for test results have been rising countywide. For the past month, it’s taken close to seven days, on average, for test results to be reported to the Health Department. Those times are for tests from samples collected from all providers — doctor’s offices and clinics, as well as the Health Department and hospitals.
Turnaround times can vary from lab to lab, a situation exacerbated when results are routed through the state’s reporting system, which has been slow to relay results to the counties, Health Department officials have said.
The Knox County Health Department says it has been getting results for its tests promptly and has changed labs as necessary to keep wait times short. “Currently, our turnaround time is less than 48 hours,” said Health Department spokesperson Kelsey Wilson.
The overall test reporting slowdown has prompted the Health Department to suspend contact tracing for anyone waiting longer than six days to get results. Dr. Martha Buchanan, the department’s director, said during a news briefing earlier this month that high case volumes, lagging laboratory processing times and the sluggish reporting at the state level led to the decision.
The Health Department has used at least three labs during the course of the pandemic — American Esoteric Laboratories (AEL), PathGroup Inc. and Integrity Laboratories.
“It's not uncommon to have several different contracts with labs,” Wilson explained.
At the beginning of the pandemic, the Health Department used AEL because it was already under contract and it was already integrated with the Health Department’s Electronic Health Records (EHR) system. Wilson said Integrity Laboratories didn’t have the capacity initially for extensive use and PathGroup was used only for off-site testing.
“During the summer, AEL had some increases in turnaround time,” Wilson said. “At that time, PathGroup could not handle additional capacity. We then began utilizing Integrity.”
Invoices provided by the Knox County Finance Department show the county paid Integrity $29,261.97 from March through November, with the bulk of the payments coming in the summer. The Sheriff’s Office has paid Integrity $54,785.87 for the testing of inmates at the jail.
According to Wilson, Integrity was fast enough but there were problems behind the scenes, particularly with incompatible Electronic Health Records systems that slowed data processing of the results.
“The turnaround time was less than 48 hours, but the lab order portal wasn't as user friendly and slowed our throughput quite a bit,” she said. “Additionally, they are not integrated with our EHR, which adds additional work for our team on the backend of the process. Integrity also does not have a patient portal; therefore, our medical records department and phone bank were overwhelmed with calls for records and results.”
Clevenger said his offers to align his company’s Electronic Health Records system with the Health Department’s system went unheeded. “We tried to integrate with them, but they did not seem interested in working with a different lab,” he said.
The Health Department began using PathGroup again in the early fall, but recently switched back to AEL when PathGroup’s response times began lagging. After the contract was amended in October, Clevenger said, Integrity created greater capacity to handle the anticipated increase in volume, but the stream of test samples slowed instead.
Though the Health Department is now getting test results back within two days and the EHR issue remains, Clevenger said Integrity could shave off more time and get the results faster, which would allow those testing negative for COVID-19 to get back to work sooner.
“The decision doesn't have the patient's best interest in mind because it's not the right decision for the patient,” he said.
AEL is a subsidiary of Sydney, Australia-based Sonic Healthcare Ltd., which has a facility on Strawberry Plains Pike. PathGroup Inc. is a Nashville-based firm with a facility in Turkey Creek. Integrity Laboratories is locally owned, another factor Clevenger believes should favor his company.
Jay said he’s glad the Health Department’s turnaround time is faster than the county average, but said officials need to do a better job communicating that to the public.
He said he doesn’t care who does the testing as long as the Health Department gets the results quickly. “Waiting around seven days is just atrocious right now,” Jay said.