The Center for COVID Control Physicians’ Clinical Laboratory is being investigated
CHICAGO – The main laboratory for a nationwide coronavirus testing company that has been investigated by several states, is now in focus for a federal agency that investigates allegations of misconduct on the spot.
The Centers for Medicare and Medicaid Services, part of the US Department of Health and Human Services, are investigating what the Center for COVID Control says is its primary provider of laboratory and clinical testing, the Doctors Clinical Lab.
“We take seriously all allegations of fraud or misconduct from covid-19 test sites. The CMS Clinical Standards and Quality Center investigates this type of complaint and is aware of several alleged cases of misconduct from this company̵[ads1]7;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 government officials continue to warn of fake “pop-up” test sites and test scams taking home across the United States. Businesses have emerged amid a wave of COVID-19 cases and a nationwide spate of coronavirus tests, prompting desperate Americans to turn to dubious alternatives.
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The Medicare and Medicaid Services Centers 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 investigations at several temporary test sites for the COVID control center and the “main laboratory” in November and December and found “non-compliance” with a number of standards, affecting more than 400,000 tests. The agency said it was awaiting a response from the laboratory to the “deficiencies” that were cited.
An 81-page report from the Centers for Medicare and Medicaid Services found that the laboratory was in “immediate danger.” At the temporary test sites, employees made a number of mistakes by administering tests, including not spending a timer, not incubating samples long enough and reading the results prematurely, the report says.
“Through direct observation, journal review, lack of documentation and interview, the laboratory failed to follow the authorization for emergency use to perform” at least four different coronavirus tests, according to an agency report.
The report found that the laboratory did not have appropriate and sufficient equipment, instruments, reagents, materials and supplies for the type and volume of testing it performs. The laboratory did not comply with the state’s reporting requirements and did not obtain a required state laboratory license.
During 11 days in November, the laboratory received 84,436 samples for PCR testing and performed and reported 43,240 patient test results, the report found. The laboratory director did not employ a sufficient number of employees to perform the test within 72 hours of collection and did not have the correct freezers to store the samples properly.
The laboratory did not maintain confidentiality of patient information, did not identify patient samples submitted for PCR testing accurately, and did not document complaints and problems reported to the laboratory.
The director of the laboratory did not provide a safe environment to protect employees from biological hazards and did not ensure that all personnel had the proper training for testing. At least 26 sample shipments from Doctors Clinical Laboratory off-site locations were not properly marked.
A spokesman for the Center for COVID Control did not immediately respond to a request for comment on the agency’s investigation.
Block Club Chicago first reported the investigation from the Centers for Medicare and Medicaid Services on Thursday.
The COVID Control Center, which says it has more than 300 locations across the country and collects more than 80,000 tests a day, is also under investigation by the Oregon Department of Justice on suspicion of violating the Unfair Commercial Practices Act. Several state health departments, as well as a coalition of regional Better Business Bureau offices, are looking at the company.
The Center for COVID Controls’ principal and mailing address is in Rolling Meadows, Illinois – a one-story commercial office building approximately 150 miles northwest of O’Hare International Airport in Chicago. Doctors Clinical Lab is registered with the US Food and Drug Administration as an independent laboratory and is listed at the same Rolling Meadows address.
COVID Control Center:Business under investigation by Oregon DOJ, Better Business Bureau
The COVID Control Center “paused” the test collection Friday until the end of next week “for further staff training and education,” according to a press release from the company on Thursday.
In the release, founder and CEO Aleya Siyaj apologized for the “current customer service challenges”, citing increased demand for testing and staffing shortages due to the increase in the omicron variant of the coronavirus.
“This staffing challenge has affected patient waiting times, consistent opening hours and delays in reporting test results,” Siyaj said. “For this, we truly apologize and are committed to addressing these recent customer disadvantages and the loss of trust.”
According to an internal email sent to employees at a test site in Chicago, all site managers and owners, employees, contractors and employees were asked to complete two trainings – one from the Centers for Disease Control and Prevention and one on HIPAA compliance – and upload proof of their training certificate by Friday to a public medical laboratory medical form.
Each workout was expected to take about an hour, according to the email, which was sent and signed by the director of a car wash chain.
Dozens of people in 16 states have reported concerns about the company to the United States TODAY. The offices of the State Attorneys in Illinois, Oregon and Washington confirmed that they have received complaints about the company. The company has the lowest rating and the lowest customer rating that a nonprofit Better Business Bureau can give a business, said spokesman Thomas Johnson.
This week, the Massachusetts Department of Public Health issued a letter of cessation and relinquishment to three locations in the state. The city of Lakewood, Washington, closed a website that operates without a business license. And the New York State Department of Health ordered the sites to “stop testing quickly and obtain appropriate approvals.”
What is the COVID Control Center? Doubtful websites put the spotlight on the nation’s thirst for quick testing
A website for Doctors Clinical Lab and emails sent to some test recipients have a trademarked logo belonging to DCL Corporation, a pigment supplier that issued a stop-and-give letter regarding the trademarked logo on Monday, said spokesman Magen Buterbaugh.
In the past week, “at least ten” people have contacted DCL Corporation and asked about their coronavirus test results, Buterbaugh said, including a woman in Miami who said she was desperate for results so she could visit her family.
Meanwhile, a Twitter account linked to the company’s website was suspended on Wednesday. Twitter representatives did not respond to repeated inquiries as to why.
When asked if the tip line has received any comments about the company, the FBI declined to comment.
Do you have more information about the COVID Control Center? Email reporter Grace Hauck at ghauck@usatoday.com.
