I-TEAM: Federal health agency investigating complaints related to COVID-19 testing company

2 years ago 287

JACKSONVILLE, Fla. – Federal officials are investigating galore complaints related to Center for COVID Control, the institution that had been operating a accelerated COVID-19 investigating tract successful downtown Jacksonville, the News4JAX I-TEAM learned Friday.

The Centers for Medicare and Medicaid Services said that it’s actively investigating galore complaints astir aggregate labs and sites tied to Center for COVID Control and that it’s alert of respective alleged instances of misconduct by the company.

Dr. Lee Fleisher, main aesculapian serviceman and manager of the Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services, sent the pursuing statement:

“We instrumentality earnestly immoderate allegations of fraud oregon misbehavior by COVID-19 investigating sites. CMS’s Center for Clinical Standards and Quality investigates these kinds of complaints and is alert of respective alleged instances of misconduct by this company’s labs. We cognize that radical privation to consciousness assured that the investigating sites they sojourn are reputable and the results they person are accurate.

“To beryllium wide – the Center for COVID Control is not a national agency. CMS is actively investigating galore complaints astir aggregate laboratories and investigating sites associated with this backstage company. It is our knowing that the Center for COVID Control voluntarily suspended their operations done January 22. CMS continues our investigations and volition instrumentality compliance and enforcement actions arsenic appropriate.”

The improvement comes aft Center for COVID Control announced Thursday that it’s pausing operations astatine its hundreds of investigating sites crossed the country — including its Jacksonville determination — to instrumentality clip for further unit grooming and to guarantee regulatory compliance.

Since then, the proprietor of the gathering connected Bay Street wherever the Jacksonville tract was operating said Friday that the company’s lease had been terminated.

People who went to the tract connected Friday to get tested were amazed to find signs showing the tract had been permanently closed.

“We’re going to spell to the 48-hour one. I wanted to get tested due to the fact that I didn’t consciousness good, and I request to spell to enactment today. ... I’d similar to cognize earlier I spell to work,” said Jacksonville nonmigratory Mario Canady.

Federal officials are investigating galore complaints related to Center for COVID Control, the institution that had been operating a accelerated COVID-19 investigating tract successful downtown Jacksonville, the News4JAX I-TEAM learned Friday.

The tract opened successful October. The I-TEAM searched metropolis records for an occupational licence for the determination but recovered nothing.

Jacksonville nonmigratory Alexis Erdelyi went to the tract for a accelerated trial a mates of weeks ago.

“I retrieve conscionable reasoning that determination were a batch of radical for conscionable 1 idiosyncratic to beryllium handling connected that, truthful I’m not definite the accuracy of our tests that day,” she said.

According to Center for COVID Control, the Jacksonville tract is 1 of hundreds shuttered crossed the country, though the institution said it has plans to reopen locations aft adjacent week. The determination came amid reports of agelong hold times for investigating and immoderate radical receiving antagonistic trial results earlier adjacent being swabbed.

On Thursday, Center for COVID Control said successful a connection that an summation successful request due to the fact that of the Omicron variant surge has strained unit and has affected their lawsuit work and “diagnostic goals.” The connection went connected to accidental the institution volition usage the intermission to refocus connected its operations and marque definite it is successful compliance with regulatory guidelines. The institution besides said it’s responding to questions from respective nationalist wellness and regulatory agencies.

Complaints astir these sites person poured into Better Business Bureaus astir the country, with some radical successful Southwest Florida telling WINK News that they had antagonistic trial results emailed to them earlier adjacent being swabbed.

In Florida, the lawyer general’s bureau has received astatine slightest 3 complaints.

Federal records amusement the laboratory associated with Center for COVID Control — which is located successful Illinois — has received much than $113 cardinal from the national government.

Sites performing accelerated tests don’t person to process the samples successful a licensed laboratory, but they bash request a Clinical Laboratory Improvement Amendments (CLIA) waiver. But oversight is lax. According to the American Hospital Association, lone 5 percent of investigating sites operating nether a waiver are surveyed to marque definite they are pursuing certification and reporting requirements.

“It besides creates an accidental for radical who aren’t going to walk the benignant of wealth connected mounting up a bully laboratory connected vetting their personnel, connected pursuing the rules to leap successful with nary laboratory experience, with nary investigating acquisition and effort to conscionable marque the profit,” said Natalie Hirt Adams, a erstwhile national prosecutor.

The I-TEAM asked Center for COVID Control if it had a waiver showing it is associated with a laboratory for the Jacksonville investigating site, and the institution responded with the announcement of the intermission successful operations.

Labs operating with waivers are expected to study lawsuit numbers to the Centers for Disease Control and Prevention. The I-TEAM has reached retired to spot whether it’s been receiving results from Center for COVID Control but has not heard back.

Read Entire Article