Federal inspectors have raised many red flags about the COVID testing company “Center for COVID Control” and a partner lab.
CCC operates test sites around the country, including three in the San Francisco Bay Area – one each in San Jose, Mountain View, and San Ramon. People have complained about not getting results.
Federal inspectors visited the company’s lab contractor, Doctors Clinical Laboratory, in several states, including Illinois, Maryland, and Wisconsin. In an 81-page report, in case after case, Medicare & Medicaid Services inspectors found failures.
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Unlabeled Specimens
For example: a 51-sample shipment from Center for Covid Control. The inspector said “51 out of 51 sample tubes were not labeled with either a patient name or unique identifier,” which means there’s likely no way to know whose was whose.
That same shipment “did not contain any type of refrigerated packs to maintain shipping temperature,” according to the report. That’s an issue because the inspector noted that one of the lab’s equipment suppliers requires techs to “store specimens at 2 to 8 degrees celsius for up to 72 hours after collection.”
Local
The report says lab workers also failed to follow directions. Sometimes reading test results too early or too late.
The report noted an 11-day stretch in November when the lab got about 84,000 samples. It didn’t have enough people to process them all or deep freezers to store them. So, it was unable to test about half of them -- 41,196 -- “within the 72 hour time frame” required for tests to be valid.
One Company or Two?
NBC Bay Area called doctors Clinical Laboratory for its take. The operator answered the phone “Center for COVID Control” and referred us to CCC.
CCC’s spokesman told us “the companies are separate, no cross ownership.”
The federal inspector, however, says the CCC’s CEO told them that Doctors Clinical Lab’s “data entry and processing staff are employees of Center for COVID Control.”
Either way, we asked CCC why it continued to use a lab that wasn’t able to keep up. We did not get a response to that question.
CMS said it’s investigating. It “identified non-compliance and is waiting for a response from the laboratory to the deficiencies cited.”
Temporary Closure
A couple of cities and states have shut down Center for Covid Control offices. The company says it voluntarily paused operations at the rest -- including the three in the Bay Area -- until Saturday for "additional staff training in sample collection and handling" and to "ensure compliance with regulatory guidelines."
NBC Bay Area asked the California Department of Public Health if Center for COVID Control is free to re-open in California. It said it “cannot comment on an ongoing investigation.”
We’ll find out on Saturday.
Advice for Patients
So, what do you do if you got tested at Center for COVID Control? If you don’t trust your results, Santa Clara County’s health department tells us you should get tested again.
“Anyone who feels their test was not legitimate should feel free to sign up for another test,” a spokesperson said.
