CHICAGO – The principal lab for a nationwide coronavirus testing company under investigation by several states is now the focus of a federal agency probing 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 lab and clinical testing vendor partner, Doctors Clinical Lab.
"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," 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 about fraudulent "pop-up" testing sites and take-home test scams across the U.S. The ventures have cropped up amid a surge of COVID-19 cases and a national shorage of coronavirus tests, prompting desperate Americans to turn to questionable alternatives.
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The Centers for Medicare and Medicaid Services provides 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 multiple temporary Center for COVID Control testing sites and "the main laboratory" in November and December and found "non-compliance" with numerous standards, affecting more than 400,000 tests. The agency said it was waiting for a response from the lab to the "deficiencies" cited.
An 81-page Centers for Medicare and Medicaid Services report found the lab was in "immediate jeopardy." At the temporary testing sites, employees made numerous errors in administering tests, including not using a timer, not incubating samples for long enough and reading results too early, the report details.
"On direct observation, record review, lack of documentation, and interview, the laboratory failed to follow the Emergency Use Authorization for performing" at least four different coronavirus tests, according to an agency report.
The report found the lab did not have appropriate and sufficient equipment, instruments, reagents, materials and supplies for the type and volume of testing it performs. The lab did not comply with state reporting requirements and did not obtain a required state lab license.
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Over 11 days in November, the lab received 84,436 samples for PCR testing and performed and reported 43,240 patient test results, the report found. The lab director did not employ a sufficient number of staff to perform the testing within 72 hours after collection and did not have the proper freezers to correctly store the samples.
The lab did not maintain confidentiality of patient information, did not accurately identify patient samples submitted for PCR testing and did not document complaints and problems reported to the lab.
The lab director did not ensure a safe environment to protect employees from biological hazards and did not ensure all personnel had the appropriate training for testing. At least 26 specimen shipments from Doctors Clinical Laboratory off-site locations were not properly labeled.
A spokesperson for the Center for COVID Control did not immediately respond to request 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 under investigation by the Oregon Department of Justice on suspicion of Unfair Trade Practices Act violations. Multiple state health departments, as well as a coalition of regional Better Business Bureau offices, are looking into the company.
The Center for COVID Control's principal and mailing address is in Rolling Meadows, Illinois – a one-story commercial office building about 15 miles northwest of O'Hare International Airport in Chicago. Doctors Clinical Lab is registered with the U.S. Food and Drug Administration as an independent lab and is listed at the same Rolling Meadows address.
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The Center for COVID Control "paused" test collection Friday through the end of next week "for additional staff training and education," according to a company press release Thursday.
In the release, founder and CEO Aleya Siyaj apologized for the "present customer service challenges," citing increased demand for testing and staffing shortages due to the surge of the omicron variant of the coronavirus.
"This staffing challenge has impacted patient wait times, consistent opening hours and delays on reporting test results," Siyaj said. "For this, we truly apologize and are committed to resolve these recent customer inconveniences and loss of confidence."
According to an internal email sent to employees of a Chicago testing site, all site managers and owners, employees, contractors and staff members 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 certificates by Friday to a public Doctors Clinical Laboratory jotform.
Each training was expected to take approximately one hour, according to the email, which was sent and signed by the executive assistant of a car wash chain.
Dozens of people across 16 states have reported concerns about the company to USA TODAY. The offices of the attorney generals of Illinois, Oregon and Washington confirmed they have received complaints about the company. The company has the lowest grade and lowest customer review rating that the nonprofit Better Business Bureau can give a business, spokesperson 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, shut down a site operating without a business license. And the New York State Department of Health ordered the sites to "cease rapid testing and obtain the appropriate approvals."
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A website for Doctors Clinical Lab and emails sent to some test recipients feature a trademarked logo that belongs to the DCL Corporation, a pigments supplier that issued a cease-and-desist letter regarding the trademarked logo Monday, spokesperson Magen Buterbaugh said.
In the past week, "at least ten" people have reached out to DCL Corporation asking 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 tied to the company's website was suspended Wednesday. Twitter representatives did not answer repeated inquires about why.
Asked if its tip line has received any comments about the company, the FBI declined to comment.
Have more information about the Center for COVID Control? Email reporter Grace Hauck at firstname.lastname@example.org.
This article originally appeared on USA TODAY: Center for COVID Control's Doctors Clinical Lab under investigation