SF investigates COVID testing company that could have operated illegally

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 on Monday asking for the company’s cooperation in an investigation into its legitimacy to administer tests after city employees raised concerns about a site. test at Golden Gate Park and other places in the city.

“We have reason to believe that Community Wellness America is associated with an illegal COVID-19 testing site in San Francisco,” City Attorney David Chiu said in the letter.

The company has previously violated COVID testing regulations in the Bay Area as well as other parts of California.

According to the letter, a person offering the tests last week had an expired Clinical Laboratory Improvement Amendment (CLIA) license.

Private COVID-19 testing operations are required to obtain a valid CLIA license from the United States Centers for Medicare and Medicaid Services and must be able to provide it upon request, a spokesperson for the Department of Health said. public of San Francisco.

CLIA licenses are needed to help officials ensure high-quality laboratory tests.

“While reports of potentially unauthorized facilities are concerning, these reports represent a small fraction of COVID testing operations in San Francisco,” a representative of the city’s attorney’s office said in a press release on Tuesday.

The letter states that the CLIA license that was provided was issued to Crestview Clinical Laboratories and expired in November 2021. Community Wellness America operates collection sites and sends tests to Crestview Clinical Laboratories. Crestview did not immediately respond to a request for comment.

City officials said Community Wellness does not have a license to operate on city property.

Dr Steve Sterling, a San Diego doctor and CEO of Community Wellness America, did not respond to The Chronicle’s multiple requests for comment.

Community well-being was criticized last year when Marin County health officials shut down one of the company’s testing sites after performing tests at a private residence without permission.

As a result, the California Department of Public Health said it was investigating the company.

Representatives of the state’s public health department did not immediately respond to emails from The Chronicle about the status of the investigation.

The company also raised concerns in Washington state and San Diego, where San Diego health officials are warning residents of unauthorized operations. But the California Department of Public Health told the San Diego Union-Tribune last week that Community Wellness was in fact working with an accredited lab and “found no evidence of non-compliance with clinical lab laws. “.

San Francisco City Attorney’s Office has asked Community Wellness to provide copies of a valid CLIA license, a license to operate on public property, and information showing the company is using approved COVID-19 tests by the FDA by January 17.

“If Community Wellness America is not allowed to administer COVID-19 tests in San Francisco, it must immediately stop providing tests in San Francisco and be prohibited from performing tests until it is duly authorized to do so, ”the letter reads.

Residents were encouraged to visit their health care provider for a COVID-19 test or visit sf.gov/gettested to find a testing site.

Jessica Flores is a writer for the San Francisco Chronicle. Email: [email protected] Twitter: @jesssmflores

Comments are closed.