CHICAGO — The main lab of a national coronavirus testing company under investigation by multiple states is now the focus of a federal agency investigating allegations of misconduct at the site.
The Centers for Medicare and Medicaid Services, part of the U.S. Department of Health and Human Services, is investigating what the Center for COVID Control says is its primary clinical and laboratory testing provider partner, Doctors Clinical Lab.
“We take any allegations of fraud or misconduct by COVID-19 testing sites seriously. The CMS Center for Clinical Standards and Quality investigates these types of complaints and is aware of several suspected cases of ‘misconduct on the part of this company’s laboratories,’ Dr. Lee Fleisher, chief medical officer and director of the agency’s Center for Clinical Standards and Quality, said in a statement Friday.
The news comes as federal and state officials continue to warn of fraudulent “pop-up” testing sites and home testing scams across the United States. prompting desperate Americans to turn to questionable alternatives.
Centers for Medicare and Medicaid Services provide health coverage to more than 100 million people through Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace.
The agency said it conducted surveys at several Center for COVID Control temporary testing sites and “the main lab” in November and December. The agency found “non-compliance” and said it was awaiting a response from the lab to the cited “shortcomings”.
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An 81-page report from the Centers for Medicare and Medicaid Services found the lab was in “immediate danger.” The report details employee errors in administering the tests, including not using timers, not incubating samples long enough and reading results too early.
“Based on direct observation, review of records, lack of documentation, and maintenance, the lab failed to follow emergency use authorization to perform” at least four different coronavirus tests, according to an agency report.
A spokesperson for the Center for COVID Control did not immediately respond to requests for comment on the agency’s investigation.
Block Club Chicago first reported the Centers for Medicare and Medicaid Services investigation Thursday.
The Center for COVID Control, which says it has more than 300 locations nationwide and collects more than 80,000 tests a day, is also being investigated by the Oregon Department of Justice on suspicion of violations of unfair trade practices law. Several state health departments, as well as a coalition of Better Business Bureau regional offices, are looking into the company.
The Center for COVID Control’s primary and mailing address is in Rolling Meadows, Illinois – a one-story commercial office building approximately 15 miles northwest of Chicago’s O’Hare International Airport. Doctors Clinical Lab is registered with the United States Food and Drug Administration as an independent laboratory and is listed at the same Rolling Meadows address.
COVID Control Center:Company under investigation by Oregon DOJ, Better Business Bureau
The Center for COVID Control has “suspended” Friday’s test collection until the end of next week “for additional staff training and education,” according to a company press release Thursday.
In the statement, founder and CEO Aleya Siyaj apologized for “current customer service challenges”, citing increased demand for testing and staffing shortages due to the rise of the omicron variant of the coronavirus.
“This staffing challenge has impacted patient wait times, consistent hours of operation, and delays in reporting test results,” Siyaj said. “For this, we truly apologize and are committed to resolving these recent customer inconveniences and loss of trust.”
According to an internal email sent to employees at a Chicago test site, all site managers and owners, employees, contractors and staff were asked to complete two trainings – one from the Centers for Disease Control and Prevention and one on HIPAA compliance – and to upload proof of their training certificates by Friday to a public clinical lab jotform of physicians.
Each training was supposed to last about an hour, according to the email sent and signed by the executive assistant of a car wash chain.
Dozens of people in 16 states have raised concerns about the company with USA TODAY. The attorney general’s offices in Illinois, Oregon and Washington have confirmed they have received complaints about the company. The company has the lowest rating and lowest rating the nonprofit Better Business Bureau can give a company, spokesman Thomas Johnson said.
This week, the Massachusetts Department of Public Health issued cease and desist letters to three sites in the state. The city of Lakewood, Washington, closed a site operating without a business license. And the New York State Department of Health has ordered sites to “cease rapid testing and obtain appropriate approvals.”
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A website for Doctors Clinical Lab and emails sent to some test recipients feature a trademark logo belonging to DCL Corporation, a pigment supplier that issued a cease and desist letter regarding the trademark logo on Monday, said spokesman Magen Buterbaugh.
Over the past week, “at least ten” people have contacted DCL Corporation asking for their coronavirus test results, Buterbaugh said, including a Miami woman who said she was desperate for results in order to to be able to visit his family.
During this time, a Twitter account linked to the company’s website was suspended on Wednesday. Twitter representatives did not respond to repeated requests to find out why.
When asked if its whistleblower line had received any comments about the company, the FBI declined to comment.