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.
All allegations of fraud by COVID-19 testing stations are serious. 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.
This news is coming as state and federal officials keep warning about scam take-home tests and fraudulent “pop up” testing sites across the U.S. This is because of a rise in COVID-19-related cases and an increased number of coronavirus test results nationwide, which has led to desperate Americans looking for alternative options.
Center for COVID Control:Authorities close down 2 centers to force testing sites into a ‘pause’
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.
A Centers for Medicare, Medicaid Services report of 81 pages found that the lab was in immediate danger. The report details that employees at the temporary testing locations made many errors when administering tests. These included not using a timer and not incubating the samples properly. They also read the results too soon.
“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. It did not meet state reporting requirements, and it did not receive a state laboratory license.
According to the report, the laboratory received 84 436 samples in November for PCR testing. The test was performed and the results reported by 43,240 patients. 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.
It did not protect patient data, failed to accurately identify patients who submitted samples for PCR testing, and didn’t document any complaints or problems that were reported.
Laboratory director didn’t ensure safe working conditions for employees and failed to provide training on testing. A minimum of 26 specimens shipments to Doctors Clinical Laboratory from off-site locations weren’t properly labeled.
Unable to immediately provide comment, a spokesperson for Center for COVID Control was not available.
Block Club Chicago reported Thursday’s Centers for Medicare & Medicaid Services Investigation for the first time.
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 and a group of regional Better Business Bureau office are investigating the business.
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, an independent laboratory registered with U.S. Food and Drug Administration is located at the same Rolling Meadows Address.
Center for COVID Control:Oregon DOJ and Better Business Bureau are investigating a business
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.
Aleya Siyaj, the founder and CEO of Aleya Siyaj released a statement in which she apologized for “present customer service problems” and cited increased testing demand and shortages as a result of the coronavirus’s surge.
Siyaj stated that “this staffing problem has affected patient wait times and consistent opening hours, as well as delays in reporting test results.” “We truly apologize for this inconvenience and have committed to rectifying it.”
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.
The email that was sent to and signed by an executive assistant from a car washing chain stated that each training should take about one hour.
USA TODAY received concerns from dozens of individuals in 16 states. There have been complaints against the company from the Washington, Oregon, Illinois attorney generals. Thomas Johnson spoke on behalf of Thomas Johnson and stated that the company received the lowest possible grade and customer rating the Better Business Bureau could give to a business.
The Massachusetts Department of Public Health has issued cease-and-desist letters this week to three locations in the state. One site without a business licence was closed by Lakewood in Washington. And the New York State Department of Health ordered the sites to “cease rapid testing and obtain the appropriate approvals.”
How does the Center for COVID Control work? Sites with questionable content highlight the nation’s desire for rapid testing
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.
DCL Corporation received “at most ten” inquiries in the past week. One of them was a Miami resident who wanted to know her coronavirus testing results. Another woman from Miami said that she needed those results for her trip with her family.
In the meantime, Twitter accountThe website of the company was taken down Wednesday. Representatives from Twitter did not respond to repeated inquiries about this matter.
The FBI refused to answer questions about whether its tip-line had received comments regarding the company.
More information on the Center for COVID Control Grace Hauck, a reporter at USA Today, can be reached at [email protected]