Federal inspectors allege Covid testing company failed to put patient names on samples

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Federal documents obtained by NBC News allege that a Covid testing company with 300 pop-up sites nationwide and its associated lab lacked adequate refrigeration and did not put patient names on samples or release test results. to state officials.

The Chicago-based company, Center for Covid Control, is already under investigation by multiple states and the Centers for Medicare and Medicaid Services, or CMS. The Minnesota attorney general sued the company on Wednesday, alleging it failed to provide test results or provided falsified or inaccurate test results.

Previous businesses of CEO Aleya Siyaj, 29, and her husband, Ali Syed, include an ax throwing parlor and donut shop.

The company, which has collected more than 400,000 samples nationwide, voluntarily shut down last week due to complaints about its business practices. A company spokesperson, however, said the company plans to begin reopening its pop-up locations this weekend.

Federal inspectors visited the Center for Covid Control’s pop-up sites in Illinois, Maryland and Wisconsin, as well as its associated laboratory in Illinois, Doctors Clinical Laboratory, according to an 81-page CMS inspection document that has was first obtained by Block Club Chicago, a nonprofit news organization.

In late November, inspectors discovered that staff at pop-up sites who were carrying out rapid Covid tests were not using timers to know when to review the results. Inspectors also noted that on-site staff members confirmed that the laboratory had not followed the instructions in the manufacturer’s package insert. Employee records at 214 of the 242 testing sites showed the company failed to provide training and skills assessment to perform antigen testing, the inspection said.

The inspection document also casts doubt on how the lab labels specimens. Inspectors noted that staff members had not labeled the samples even though the instructions stated that technicians were supposed to take tubes and write in permanent marker the patient’s date of birth, name and surname. But inspectors noted that 51 of the 51 patient sample tubes in the box [they examined] were blank.

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Inspectors also noted that the lab did not have adequate freezers to store samples and that staff members had not documented customer complaints that called for demanding results.

Inspectors said when they asked to see old lab records on November 18, they were told that due to an electrical surge, all patient testing and quality control data stored in computers prior to November 11, 2021 had been lost and there was no backup procedure to retain the data.

A spokesperson for the Center for Covid Control said in an emailed statement that CMS had audited the DCL laboratory and that DCL had responded to all issues raised and that the company had engaged legal counsel in Chicago to undertake a review. comprehensive organization-wide to ensure full compliance with clinical, operational, HIPAA guidelines and best practices, taking into consideration CMS observations.

HIPAA is the federal law that protects the privacy of people’s medical records and other health information.

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

In a redacted complaint to the Illinois Attorney General obtained by NBC News, a client reported that a staff member said he wasn’t even sure he was actually processing or reporting PCR test results. or if he had a real lab that did it.

Another complainant told the Illinois Attorney General’s office that he took a PCR test with the Center for Covid Control on December 21 and never got the results. The person said that when she called to complain she was told the wait time would be almost 2 hours.

A spokesperson for the Wisconsin Department of Health Services said in an email: We are unable to comment on specific allegations, complaints or investigations. But I can tell you that DHS investigates every request or complaint regarding Covid-19 vendor testing or billing practices that do not comply with current policies.

$120 million from the federal government

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

Of the 48,000 medical providers who have billed HHS to provide tests, treatments or vaccinations to uninsured people, Doctors Clinical Laboratory ranks 13th in the nation.

NM: People line up for free COVID-19 tests amid surge in Omicron variant (Sam Wasson/Sipa USA via AP)

A spokesperson said on Wednesday the company was taking steps to reopen each of its 300 pop-up sites, saying a limited number of sites will open as announced on Saturday, January 22, with a second batch opening on Monday or Tuesday. next, not yet fully determined what date.

The spokesperson said that before sites reopen, company management will work on required compliance issues, including completion of staff training modules, certain on-site equipment, any business licenses required locally. in place…and healthy staffing/workforce availability, among others.

A CMS spokesperson said by email that the company’s decision to close last week was voluntary and not related to any decision by CMS. We continue to review the findings of our investigation to determine appropriate actions under our authorities, the spokesperson said.

Separate companies?

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

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

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

The Center for Covid Control spokesperson said the two companies are separate and have no cross-ownership or financial interests in the other, but the management services agreement between them includes proprietary information and cannot be disclosed.

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

State business records for Doctors Clinical Laboratory list Mohammed Shujauddin as the company’s president. The company’s voicemail was full and emails to the company’s contact email address were not answered in time for this article. The laboratories state registered address is a UPS store in Chicago.

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