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Federal records raise new questions about questionable COVID testing lab

Records do not show owner applied to conduct tests
Paul's travel certificate WFTS.png
Posted at 9:21 AM, Sep 15, 2022
and last updated 2022-09-15 18:24:55-04

SAFETY HARBOR, Fla.  — As Florida navigated a pandemic, COVID-19 testing became a top priority. But not every testing site followed the rules.

As the dust now settles, problems with regulation are coming to light — suggesting lessons need to be learned before a future health emergency.

We first reported in March how a Safety Harbor health clinic offered questionable “15-minute” PCR COVID tests to international travelers. Now the I-Team has uncovered new information that raises more concerns about that clinic and the state’s oversight of COVID testing labs.

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Federal documents do not indicate clinic ever applied to perform PCR tests

When we first visited Remedies Health and Wellness Clinic in Safety Harbor in January, the sign out front said, “Rapid PCR COVID tests. Results in 15 minutes.” But new documents obtained through a Freedom of Information Act (FOIA) request indicate the clinic never applied for or received permission to perform PCR tests.

Paul Gelsleichter went to Remedies last October for a PCR test he needed to board a flight to Europe.

At that time, negative PCR test results were required to enter dozens of countries. Gelsleichter’s test was administered by remedies owner Tracy Greene, a licensed advanced practice registered nurse.

“I told her I came over from the airport. She said 'oh, I’ll get you right in and out, so you don’t miss your flight,'” Gelsleichter said.

He said Greene swabbed his nose and handed him a certificate within 15 minutes, which said he tested negative on a PCR test and was safe for travel.

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Paul Gelsleichter.
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Paul Gelsleichter's travel documentation shows negative COVID testing results for PCR test.

PCR tests can detect COVID infections days earlier than rapid antigen tests.

Records we obtained from the CDC show Remedies only applied to conduct antigen testing, a fast, inexpensive and less accurate form of testing. It's the same type used in disposable home test kits.

In March, University of Tampa Biochemistry Professor Dr. Scott Whitherow explained why PCR tests are better.

“The rapid test might not pick it up, whereas the PCR test would,” Whiterow said.

That’s why PCR tests were required for travel to many countries in 2020, 2021 and earlier this year.

In January, I-Team Investigator Adam Walser went to Remedies to get tested. Photojournalist Matt McGlashen shot video of the test being administered from across the parking lot.

Greene wasn’t wearing a mask or gloves.

Greene swabbed my nose, collected $125, and notified me 27 minutes later that I tested negative.

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Tracy Greene and "Johnny Cash." She wore no gloves or mask when collecting samples.

“Twenty-seven minutes — none of the devices or instruments or protocols or techniques that I’ve seen have been able to do that using PCR,” Whiterow said.

Greene provided a signed certificate which included her health care license number. Walser identified himself as a reporter and said we had been told by experts it was doubtful that she would be able to perform a PCR test in less than 30 minutes.

“No, it’s not because I have a lab. I bought the equipment, I have a lab in there. I don’t have to send it out,” Green said.

Application left questions unanswered

Greene refused to show us that lab.

At that time, the Omicron variant was raging in Florida and a shortage of testing supplies, like cassettes, meant PCR tests often weren’t available.

But Greene claimed her small clinic was well-stocked.

“I just had 2,500 of them delivered on Monday,” Greene said.

We were unable to get answers about the exact type of test she claimed to offer.

The state couldn’t get answers either.

A letter from the state said the initial application from Remedies was incomplete and didn’t provide the name and manufacturer of the lab test or the testing device.

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After multiple requests for additional information, a letter informed Remedies that its application was entered into a state database, reminding the clinic that all testing results must be reported to the Florida Department of Health.

Records show Remedies wasn’t inspected for more than a year, but Greene told me a different story.

“That’s our inspection where we passed the inspection. This is from the state,” Greene said, showing me a document she said was a report related to the inspection of her lab.

It turned out that that inspection report was for a different lab belonging to Main Street Pharmacy, which operates in the same building.

“There was no problem whatsoever. Everything was compliant and on the up-and-up and done,” Greene told us at the time.

That pharmacy was compliant, but a DOH spokesperson confirmed to the I-Team that it had no records indicating Remedies reported any COVID test results, as required by law.

The honor system

“It is the honor system. And I think patients rely on and trust health care providers that they know what the applicable health care regulations are and that they’re complying with them,” said Dr. Kathryn Drabiak, Co-Director of the Law and Medicine Program at U.S.F’s School of Medicine.

Drabiak said that while the state is supposed to regularly inspect labs, that wasn’t the case during the pandemic.

“There are limited resources, and so if it’s something like a health department, they’re trying to figure out how do we use the limited resources,” she said.

Remedies was finally inspected on March 17 of this year, two months after we first brought the clinic to the state’s attention.

By that time, Remedies had moved out.

The inspection report said Remedies was “in compliance” because “at the time of the survey the laboratory was not testing” and “has voluntarily terminated their certificate of waiver.

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The Florida Department of Health said a complaint was referred to the Florida Attorney General’s Office, which confirmed receiving it but took no action since, “Greene is no longer operating Remedies.”

“She should certainly be warned or chastised in some way,” Gelsleichter said.

No complaints and another clinic

Greene’s record shows she has had no complaints or disciplinary actions.

She opened another clinic in Dunedin earlier this year.

Records show she operates a lab there that hasn’t been inspected.

We sent Greene a list of questions about the lack of a waiver to perform PCR testing and the DOH saying it had no COVID test reports from Remedies.

Her attorney replied that he has “no comment on any of the allegations.”

Paul Gelsleichter believes the state needs to better enforce its own rules for all of our sakes.

“This could have been a disaster had I been positive,” he said.

If you have a story you think the I-Team should investigate, email us at adam@abcactionnews.com.