Florida Today is reporting a sudden spike in “inconclusive” COVID-19 test results reported in Brevard County were the result of a coding error, according to county health officials on Wednesday after initially pointing the finger at OMNI Healthcare on Tuesday.
OMNI categorically denied receiving inconclusive test results from any of its contracted labs. The problem, according to OMNI President Dr. Craig Deligdish, came from Bio Reference Labs, a contractor they dropped on April 10.
“The lab apparently had technical problems," OMNI President Dr. Craig Deligdish told FLORIDA TODAY in a text message. The technical problems generated invalid test results that were then erroneously coded as inconclusive by the Florida Department of Health, he said.
Bio Reference Labs did not respond to inquiries from FLORIDA TODAY.
“They use the Roche analyzer which had issues. They lied to us. They figured out the problem,” Deligdish said, noting that the other lab they contract with, Viracor-Eurofins Laboratories, has had no issues, processing some 2,000 specimens.
Roche, the world's largest biotech firm, was the third manufacturer to be approved for COVID-19 test kits in the USA, through an emergency use authorization on March 12 from the FDA. The company did not immediately respond to a request for comment.
Issues with testing have plagued the nation’s response to the coronavirus pandemic from the get-go, including flawed testing protocols initially issued by the Centers for Disease Control and Prevention (CDC).
"OMNI has not received a single inconclusive result from either of its two laboratories," Deligdish wrote in an earlier email earlier Wednesday.
Meanwhile, patients started posting in recent days on social media platforms about getting “inconclusive” test results from OMNI’s drive-thru test facility and being offered a re-test free of charge.
On Wednesday morning, the FDOH daily COVID-19 report counted 391 inconclusive test results in Brevard, accounting for nearly a third of the state's total number of inconclusive results. This compared to just 12 such results four days ago on April 11. By Wednesday afternoon, Brevard's numbers dropped down to just three inconclusive results.
What exactly was behind the sudden rise and then sudden drop in numbers, is still unclear. Answers have been contradictory and until Wednesday both the FDOH and OMNI were tight lipped.
"When a test is reported as inconclusive it is because the test cannot confirm a negative or positive result," Anita Stremmel, a spokeswoman with Florida Department of Health in Brevard, told FLORIDA TODAY Tuesday via email. "This can be due to various factors."
But Stremmel's email provided no clear indication of what specifically was causing so many inconclusive tests in Brevard.
In a Wednesday email Stremmel said that "the Department’s Bureau of Epidemiology is investigating the cause of the inconclusive test results in Brevard County."
In emails forwarded to FLORIDA TODAY on Wednesday minutes later, Maria Stahl the chief administrator for the Florida Department of Health in Brevard County, said a "coding issue" was to blame for the spike in reported numbers.
She wrote that according to an official in the epidemiology bureau the "invalid" results would be removed from the inconclusive category.
"This should be reflected in this afternoon's report," Stahl wrote hours before the results reset.
No explanation was provided of what an "invalid" versus an "inconclusive" test means, such as if one is solely due to operator error, but the end result appears the same: people had to be re-tested.
Deligdish blamed the FDOH's system for reporting the lab's technical problems as "inconclusive" results. In an email sent Tuesday to a county commissioner's aide in response to a citizen's query, Stahl had attributed the inconclusive results to OMNI.
"The number jumped up yesterday as OMNI cases started reporting out," Stahl said in her email. "The state has told us to count these as not a case and it is up to the provider to retest."
Jessicah Nichols, a 41-year-old Melbourne Village resident, was among the dozens of Brevardians who was told their COVID-19 test from OMNI was inconclusive.
Nichols, speaking to FLORIDA TODAY Wednesday, said after feeling an onset of fatigue starting on April 2, and then a fever of about 100.3 degrees on April 5, as well as shortness of breath and a tightness in her chest, she called her doctor and obtained a script for a test the next day.
Her doctor ordered her to a different provider at first, but after Nichols read news reports about significant test delays from commercial providers as well as about the opening of OMNI's test site which promised results in 1-2 days she got the OK from her doctor and called to make an appointment with OMNI.
“It was just way too tempting,” she said.
She got an 8 a.m. testing time on OMNI's first day of testing and was the 14th car to arrive.
"They all seemed to have their ducks in a row as far as I could tell," she said.
After a "painful but not terrible" swab she went home and waited.
Three days later she called OMNI's hotline and got a pre-recorded message telling her to "wait for your phone call."
Email inquiries by Nichols proved unfruitful. OMNI stopped responding.
On Tuesday, April 14, a full week since her test, Nichols called the hotline again.The message changed, she said, instructing her to leave her name and number and expect a call back.
"Within five minutes I got a phone call that said my results were inconclusive," she said. OMNI told her to come get re-tested free of charge which she did immediately.
"They redid the swab and it was crazy aggressive, it hurt for hours," she said.
Nichols is still waiting for her new results but what concerns her is that given the quick call back she suspects OMNI had known she needed to be retested for days but didn't inform her until she called.
"Why was I not notified the second they knew it was wrong? For all they know I could have been exposing tons of people… they didn’t know I was doing a good job self-quarantining," she said. “It seemed kinda negligent.”
Over the past several days, data from FDOH shows that one of the labs OMNI used, Bio Reference Laboratories, saw a similar spike in inconclusive test results being reported.
"On April 10, OMNI discontinued referring specimens to Bioreference Lab, a subsidiary of OPKO Health. (BRL) Although BRL committed to a 24-48 hour (turnaround time), it has been taking BRL in excess of 4 days to report results from the time specimens were obtained," Dr. Deligdish wrote in an email over the weekend.
OMNI first opened its testing site in Melbourne on April 7 and said it has tested over 3,000 people and has sufficient supplies to test 10,000.
Bobby Block contributed to this report.