CHICAGO — The main nationwide coronavirus testing company’s lab under investigation by several 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 US Department of Health and Human Services, is investigating what the Centers for Control of COVID says is the primary laboratory and partner of clinical test vendor, Doctors Clinical Lab.
“We take any allegations of fraud or misconduct by COVID-19 testing sites seriously. CMS Clinical Standards and Quality investigates these types of complaints and is aware of many cases of alleged misconduct by this company’s labs,” said Dr. Lee Fleischer. , chief medical officer and director of the agency’s Center for Clinical Standards and Quality, said in a statement Friday.
This news comes as federal and state officials continue to warn of fraudulent “pop-up” test sites and home test scams across the United States. This prompted desperate Americans to resort 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 several temporary COVID Control testing sites and the “key lab” in November and December and found “non-compliance” with several standards, affecting more than 400,000 tests. The agency said it was awaiting a response from the laboratory on the mentioned “deficiencies”.
An 81-page Centers for Medicare and Medicaid Services report found the lab is in “immediate danger.” At temporary testing sites, staff made many mistakes in administering tests, including not using the timer, not incubating samples long enough and reading results too early, the report details.
According to the agency’s report, “in direct observation, record review, lack of documentation, and interview, the laboratory failed to follow an emergency use authorization to perform” at least four different coronavirus tests.
The report found that the laboratory did not have adequate and appropriate equipment, tools, reagents, materials and supplies for the type and volume of testing it was performing. The laboratory did not comply with state reporting requirements and did not obtain a required state laboratory license.
The report found that over an 11-day period in November, the lab received 84,436 samples for PCR testing and performed and reported 43,240 patient test results. The laboratory manager did not employ sufficient personnel to perform the test within 72 hours after collection and did not have the appropriate freezers to properly store samples.
The laboratory did not maintain the confidentiality of patient information, did not accurately identify patient samples submitted for PCR testing and did not document complaints and problems reported to the laboratory.
The laboratory manager did not ensure a safe environment to protect staff from biological hazards and did not ensure that all staff received appropriate training for testing. At least 26 sample shipments from off-site clinicians’ lab sites were not properly categorized.
A spokesperson for the COVID Control Center did not immediately respond to a request for comment on the agency’s investigation.
Block Club Chicago first reported the Centers for Medicare and Medicaid Services investigation Thursday.
The COVID Control Center, which says it has more than 300 sites nationwide and collects more than 80,000 tests daily, is also under investigation by the Oregon Department of Justice for suspected violations of the Unfair Trade Practices Act. Multiple state health departments, as well as a coalition of the Better Business Bureau’s regional offices, are looking into the company.
The headquarters and mailing address of the COVID Control Center are located in Rolling Meadows, Illinois – a single-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 under the same title as Rolling Meadows.
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A company press release Thursday reported that the COVID Control Center has “paused” testing collection until the end of next week to “train and educate additional staff.”
In the statement, founder and CEO Alya Siyaj apologized for the “current customer service challenges,” citing increased testing demand and staff shortages due to the surge in the coronavirus omicron variant.
“This staffing challenge has affected patient wait times, consistent working hours, and delays in reporting test results,” Siag said. “For this, we truly apologize and are committed to resolving recent customer inconveniences and loss of trust.”
According to an internal email sent to Chicago testing site employees, all site managers, owners, employees, contractors, and employees were required to complete two training courses — one from the Centers for Disease Control and Prevention and one on HIPAA compliance — and upload proof of their training certifications by Friday to the lab. jotform clinicians.
Each training was expected to take about 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 their concerns about the company to USA TODAY. Attorneys general offices in Illinois, Oregon and Washington confirmed that they had received complaints about the company. Company spokesman Thomas Johnson said the company has the lowest score and lowest rating for customer reviews that the nonprofit Better Business Bureau can give for business.
This week, the Massachusetts Department of Public Health issued cease-and-desist letters to three locations in the state. The City of Lakewood, Washington, has closed a site operating without a commercial license. The New York State Department of Health ordered the sites to “stop rapid testing and obtain appropriate approvals.”
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A spokesperson for Magen Buterbaugh said that a Doctors Clinical Lab website 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.
Last week, Buterbo said, “at least ten” people have reached out to DCL to inquire about their coronavirus test results, including a woman in Miami who said she desperately needed the results so she could visit her family.
Meanwhile, a Twitter account Restricted to the company’s website was suspended Wednesday. Twitter representatives did not respond to repeated inquiries about why.
Asked if InfoLine had received any comments about the company, the FBI declined to comment.
Do you have more information about the COVID Control Center? Email us Grace Hook at email@example.com.