JACKSONVILLE, Fla. – Federal officials are investigating numerous complaints related to Center for COVID Control, the company that had been operating a rapid COVID-19 testing site in downtown Jacksonville, the News4JAX I-TEAM learned Friday.
The Centers for Medicare and Medicaid Services said that it’s actively investigating numerous complaints about multiple labs and sites tied to Center for COVID Control and that it’s aware of several alleged instances of misconduct by the company.
Dr. Lee Fleisher, chief medical officer and director of the Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services, sent the following statement:
“We take seriously any allegations of fraud or misbehavior by COVID-19 testing sites. CMS’s Center for Clinical Standards and Quality investigates these kinds of complaints and is aware of several alleged instances of misconduct by this company’s labs. We know that people want to feel confident that the testing sites they visit are reputable and the results they receive are accurate.
“To be clear – the Center for COVID Control is not a federal agency. CMS is actively investigating numerous complaints about multiple laboratories and testing sites associated with this private company. It is our understanding that the Center for COVID Control voluntarily suspended their operations through January 22. CMS continues our investigations and will take compliance and enforcement actions as appropriate.”
The development comes after Center for COVID Control announced Thursday that it’s pausing operations at its hundreds of testing sites across the country — including its Jacksonville location — to take time for additional staff training and to ensure regulatory compliance.
Since then, the owner of the building on Bay Street where the Jacksonville site was operating said Friday that the company’s lease had been terminated.
People who went to the site on Friday to get tested were surprised to find signs showing the site had been permanently closed.
“We’re going to go to the 48-hour one. I wanted to get tested because I didn’t feel good, and I need to go to work today. ... I’d like to know before I go to work,” said Jacksonville resident Mario Canady.
The site opened in October. The I-TEAM searched city records for an occupational license for the location but found nothing.
Jacksonville resident Alexis Erdelyi went to the site for a rapid test a couple of weeks ago.
“I remember just thinking that there were a lot of people for just one person to be handling on that, so I’m not sure the accuracy of our tests that day,” she said.
According to Center for COVID Control, the Jacksonville site is one of hundreds shuttered across the country, although the company said it has plans to reopen locations after next week. The move came amid reports of long wait times for testing and some people receiving negative test results before even being swabbed.
On Thursday, Center for COVID Control said in a statement that an increase in demand because of the Omicron variant surge has strained staff and has affected their customer service and “diagnostic goals.” The statement went on to say the company will use the pause to refocus on its operations and make sure it is in compliance with regulatory guidelines. The company also said it’s responding to questions from several public health and regulatory agencies.
Complaints about these sites have poured into Better Business Bureaus around the country, with some people in Southwest Florida telling WINK News that they had negative test results emailed to them before even being swabbed.
In Florida, the attorney general’s office has received at least three complaints.
Federal records show the lab associated with Center for COVID Control — which is located in Illinois — has received more than $113 million from the federal government.
Sites performing rapid tests don’t have to process the samples in a licensed laboratory, but they do need a Clinical Laboratory Improvement Amendments (CLIA) waiver. But oversight is lax. According to the American Hospital Association, only 5 percent of testing sites operating under a waiver are surveyed to make sure they are following certification and reporting requirements.
“It also creates an opportunity for people who aren’t going to spend the kind of money on setting up a good laboratory on vetting their personnel, on following the rules to jump in with no laboratory experience, with no testing experience and try to just make the profit,” said Natalie Hirt Adams, a former federal prosecutor.
The I-TEAM asked Center for COVID Control if it had a waiver showing it is associated with a lab for the Jacksonville testing site, and the company responded with the announcement of the pause in operations.
Labs operating with waivers are supposed to report case numbers to the Centers for Disease Control and Prevention. The I-TEAM has reached out to see whether it’s been receiving results from Center for COVID Control but has not heard back.