San Francisco city officials are investigating a California company that may have operated illegal coronavirus testing sites throughout the city.
The City Attorney’s Office sent a letter to Community Wellness America Monday asking for the company’s cooperation into an investigation about its legitimacy to administer tests after city employees raised concerns about testing sites near Golden Gate Park, Dolores Park and other locations in the city.
“We have reason to believe that Community Wellness America is associated with an unlawful COVID-19 test site in San Francisco,” City Attorney David Chiu said in the letter.
The company has previously run afoul of COVID testing regulations in the Bay Area as well as other parts of California.
According to the letter, an individual offering the tests last week had an expired Clinical Laboratory Improvement Amendments (CLIA) license.
Dr. Steve Sterling, a San Diego physician and CEO of Community Wellness America, did not respond to multiple requests from The Chronicle for comment.
Private COVID-19 testing operations are required to obtain a valid CLIA license from the U.S. Centers for Medicare and Medicaid Services and must be able to provide it when asked, a spokesperson for the San Francisco Department of Public Health said.
Labs are required to have CLIA licenses to help officials ensure high quality testing, and they must report test results to the state, officials said.
“While reports of potentially unlicensed facilities are concerning, these reports represent a small fraction of COVID testing operations in San Francisco,” a representative with the City Attorney’s Office said in a news release Tuesday.
The letter says that the CLIA license that was provided was issued to Crestview Clinical Laboratories and had expired in November 2021.
Justin Nguyen, a representative from Crestview Clinical Laboratories, said in an email that he was unaware that testing sites in San Francisco were using a CLIA license under the company’s name. He said Crestview does not receive swap samples from Community Wellness-operated testing sites in San Francisco.
“They should be shut down immediately,” he added. “They must have used our license without our approval.”
City officials said that Community Wellness does not have a permit to operate on city property.
Community Wellness came under fire last year when Marin County health officials shut down one of the company’s testing sites after it conducted tests at a private residence without authorization.
As a result, the California Department of Public Health said it was investigating the company.
Representatives with the state’s public health department did not immediately respond to emails from The Chronicle about the status of the investigation.
The company has also raised concerns in Washington state and San Diego, where health officials in San Diego are warning residents of unlicensed operations. But the California Department of Public Health told the San Diego Union-Tribune last week that Community Wellness was in fact working with a licensed lab and “found no evidence of non-compliance with clinical lab laws.”
The San Francisco City Attorney’s Office asked Community Wellness to provide copies of a valid CLIA license, a permit to operate on public property and information that shows the company is using FDA-approved COVID-19 tests by Jan. 17.
“If Community Wellness America is not authorized to administer COVID-19 tests in San Francisco, it must immediately cease providing tests in San Francisco and is prohibited from conducting testing until it is appropriately authorized to do so,” the letter said.
Residents were encouraged to go to their health care provider for a COVID-19 test or visit sf.gov/gettested to find a testing site.