Inspectors say Covid test firm didn’t put patient names on specimens

Federal documents obtained by NBC News allege that a Covid testing company with 300 pop-up locations nationwide and its associated lab lacked adequate refrigeration and failed to put the names of patients on specimens or report test results to state officials.

The Chicago-based company, Center for Covid Control, is already under investigation by multiple states and the federal Centers for Medicare and Medicaid Services. The Minnesota attorney general filed a lawsuit against the company on Wednesday alleging the company “either failed to deliver test results, or delivered test results that were falsified or inaccurate.”

The 29-year-old CEO of the company, Aleya Siyaj, and her husband Ali Syed’s previous businesses include an axe-throwing lounge and a donut shop.

The company, which has collected more than 400,000 samples nationwide, voluntarily shut down last week amid complaints about its business practices. A company spokesperson, however, told NBC News that the company planned to start reopening its pop-up locations this weekend.

Federal inspectors visited Center for Covid Control pop-up sites in Illinois, Maryland and Wisconsin as well as its associated lab in Illinois, Doctors Clinical Laboratory, according to an 81-page Centers for Medicare and Medicaid Services inspection document that was first obtained by NBC Bay Area station KNTV.

In late November, inspectors found that staff at pop-up sites who conducted rapid Covid tests did not use timers as a way to track when to review results. Inspectors also noted that on-site staff “confirmed the laboratory did not follow the manufacturer’s package insert instructions.” Employee files for 214 out of 242 testing locations showed the company “failed to provide training and competency evaluation” to perform Antigen tests according to the inspection.

The inspection document also casts doubt on the how the lab labels specimens. Inspectors noted that staff failed to label specimens even though the instructions noted that technicians were supposed to take tubes and “write in permanent marker the date of birth, last name, and first name of the patient.” But inspectors noted that “51 out of 51 patient specimen tubes contained in the box [they examined] were blank.” 

Inspectors also noted the lab lacked appropriate freezers to store the specimens and the staff failed to document complaints from customers who called demanding results.

When inspectors asked on Nov. 18 to see older lab records, they said they were told that “due to an electrical surge all patient test and quality control data stored in the computers prior to Nov. 11, 2021 had been lost,” and there was “no backup procedure” to retain data.

A Center for Covid Control spokesperson told NBC News in an emailed statement, “CMS audited DCL’s lab and DCL has responded to any issues raised,” and he said that the company hired legal counsel in Chicago “to undertake a comprehensive, organization-wide review to ensure full compliance with clinical, operational, HIPAA guidelines and best practices, addressing CMS observations.”

The Minnesota lawsuit is the first filed by a state attorney general, but attorneys general in Illinois and Oregon are also investigating the firm, and the Massachusetts attorney general is reviewing complaints.

In a redacted complaint to the Illinois attorney general obtained by NBC News, a customer reported a staffer said “they were not even sure that they’re actually processing or reporting the results of the PCR test or if they have a real lab that’s doing it.”

Another complainant told the Illinois AG’s office that they took a PCR test with the Center for Covid Control on Dec. 21 and never got the results. The person said when they called to complain they were told the “hold time would be close to 2 hours.”

A spokesperson for Wisconsin’s state health department told NBC News in an email, “We are unable to comment on specific allegations, complaints or investigations. But I can tell you, DHS researches each inquiry or complaint regarding Covid-19 provider testing or billing practices that do not align with current policies.”

$120 million from the federal government

Records from the Department of Health and Human Services, the parent agency of CMS, show that to date Doctors Clinical Laboratory has billed the federal government at least $120 million.

Of the 48,000 medical providers who billed HHS for providing testing, treatment or vaccines to uninsured Americans, Doctors Clinical Laboratory ranks thirteenth in the country.

A company spokesperson told NBC News Wednesday that the company was taking steps to re-open each of its 300 pop-up sites, saying that “a limited number of sites will open as announced on Saturday, Jan. 22, with a second group to open the following Monday or Tuesday, not completely determined which date yet.” 

The spokesperson said that before the sites re-open the company’s management will work on “required compliance issues including staff completion of training modules, certain equipment on site, any locally required business license in place, … and healthy staffing/workforce availability, amongst others.”

A spokesperson for CMS told NBC News via email that the company’s decision to shut down last week was voluntary and not related to a CMS decision. “We continue to review our investigative findings to determine appropriate actions under our authorities,” said the spokesperson. 

Separate companies?

The spokesperson for the company said the Center for Covid Control is a marketing firm that runs pop-up sites and then sends most of the specimens it collects to the separately owned Doctors Clinical Laboratory that conducts PCR testing.

But in late November, federal inspectors noted that when lab staff at Doctors Clinical Laboratory were asked who they worked for, staffers said, “Center for Covid Control.” Lab staff also informed an inspector “that all call center employees are Center for Covid Control employees.”

The inspection also noted that the CEO of the company told the inspectors that “the Center for Covid Control is the management company for Doctors Clinical Laboratory and that a copy of the business agreement would be provided.” But according to the inspection documents, a copy was never provided.

The Center for Covid Control spokesperson said the two companies are “separate” and “they have no cross ownership nor financial interests in the other,” but that the management services agreement between the two companies contains proprietary information and cannot be released.

The spokesperson confirmed that the two companies maintain offices at the same address, but said employees are “clearly employed by one or the other entity; are paid separately; have clearly separate managers” and have “separate employment agreements.”

State business records for Doctors Clinical Laboratory lists Mohammed Shujauddin as president of the company. The company’s voicemail is full and emails to the company’s contact email were not returned in time for this story. The laboratory’s registered address with the state is a Chicago UPS store.

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