CHICAGO: The main laboratory of a national coronavirus testing company under multi-state investigation it is now the focus of a federal agency investigating allegations of misconduct on the site.
The Centers for Medicare & Medicaid Services, part of the US Department of Health and Human Services, is investigating what the COVID Control Center says it’s its main laboratory and clinical 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 Quality and Standards investigates these types of complaints and is aware of several alleged cases of misconduct by COVID-19 testing sites. of 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 of fraudulent “pop-up” testing sites and take-home testing scams across the U.S. The companies have sprung up amid a surge in COVID-19 cases and a national shortage of coronavirus tests, prompting desperate Americans to turn to questionable alternatives.
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The Centers for Medicare & 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 surveyed several 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 awaiting a response from the lab on the cited “deficiencies.”
An 81-page report from the Centers for Medicare and Medicaid Services found the lab to be in “immediate danger.” At temporary testing sites, employees made numerous mistakes administering tests, including not using a timer, not incubating samples long enough and reading results too soon, the report details.
“On direct observation, record review, lack of documentation, and interview, the lab did not comply with the Emergency Use Authorization 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 tests it performs. The laboratory did not meet state reporting requirements and did not obtain the required state laboratory license.
Over 11 days in November, the lab received 84,436 samples for PCR testing and performed and reported results on 43,240 patients, according to the report. The laboratory director did not employ a sufficient number of staff to perform the tests within 72 hours of collection and did not have adequate freezers to properly store the samples.
The laboratory failed to maintain the confidentiality of patient information, failed to accurately identify patient samples submitted for PCR testing, and failed to document complaints and issues reported to the laboratory.
The laboratory director failed to ensure a safe environment to protect employees from biohazards and failed to ensure all staff had adequate testing training. At least 26 off-site Doctors Clinical Laboratory sample shipments were not properly labeled.
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 research from the Centers for Medicare & Medicaid Services on 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 under suspicion of violations of the Unfair Trade Practices Act. Multiple state health departments, as well as a coalition of Better Business Bureau regional offices, are investigating the company.
The primary and mailing address for the Center for COVID Control is in Rolling Meadows, Illinois, a one-story commercial office building about 15 miles northwest of Chicago’s O’Hare International Airport. Doctors Clinical Lab is registered with the US Food and Drug Administration as an independent laboratory and is listed at the same address as Rolling Meadows.
COVID Control Center:Business under investigation by Oregon DOJ, Better Business Bureau
The Center for COVID Control “Paused” Evidence Collection Friday through the end of next week “for additional staff training and education,” according to a company news 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 office hours, and delays in reporting test results,” Siyaj said. “For this, we sincerely 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 testing site, all site managers and owners, employees, contractors and staff members were asked to complete two trainings, one from the Centers for Control and Disease Prevention and HIPAA compliance, and upload proof of their training certificates by Friday to a public Physician Clinical Laboratory form.
Each training was expected to last about an hour, according to the email, which was sent and signed by the executive assistant of a chain car wash.
Dozens of people in 16 states have reported concerns about the company to USA TODAY. The offices of the attorneys general of Illinois, Oregon and Washington confirmed having received complaints about the company. The company has the lowest rating and lowest customer review rating the nonprofit Better Business Bureau can give a business, 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 that operated without a business license. And the New York State Department of Health has ordered sites to “suspend rapid testing and obtain appropriate approvals.”
What is the COVID Control Center? Questionable sites highlight the nation’s thirst for rapid tests
TO website for Doctors Clinical Lab and emails sent to some test recipients a trademark logo which belongs to the DCL Corporation, a pigment supplier that issued a cease and desist letter regarding the trademarked logo on Monday, spokesman Magen Buterbaugh said.
In the past week, “at least ten” people have contacted the DCL Corporation to inquire about their coronavirus test results, Buterbaugh said, including a woman in Miami who said she was desperate for the results so she could visit family.
Meanwhile, a Twitter account linked to the company’s website was suspended on Wednesday. Twitter representatives did not respond to repeated queries as to why.
When asked if its tip line had 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 [email protected].
George is Digismak’s reported cum editor with 13 years of experience in Journalism