The San Francisco City Attorney’s Office is investigating a Covid-19 testing site at 18th and Dolores streets, which began to offer free, self-swab PCR testing last week.
In a letter the office sent to the site’s proprietor, Community Wellness America, late Monday, Deputy City Attorney John H. George told the organization to provide “information establishing Community Wellness America’s ability to lawfully administer COVID-19 tests in San Francisco.” This must be done by Jan. 17.
The site had failed to produce a valid lab license and permit to operate on public property near Dolores Park upon Mission Local’s requests last week. According to a statement released by the City Attorney’s Office on Tuesday, “reports began of individuals operating on behalf of Community Wellness America, Inc. offering COVID tests on public property” near Dolores Park, Golden Gate Park, and other areas as early as Jan. 5.
In addition to a valid laboratory license and a permit to operate on public property in San Francisco, the City Attorney’s Office also asked Community Wellness America to demonstrate that the tests used at the site are approved by the U.S. Food and Drug Administration, which is required to obtain the Clinical Laboratory Improvement Amendments [CLIA] laboratory license from the Centers for Medicare & Medicaid Services (CMC).
“They do need a valid CLIA license from CMS and must be able to present their license when asked,” a San Francisco Department of Public Health representative wrote in an email Monday, referring to the program and governing body which regulate lab testing on human specimens.
“We do know they did not have a permit to set up on City property or to occupy the right of way of a sidewalk,” continued the Health Department.
Read or download the letter from the Office of the City Attorney to Community Wellness America above.
Jennifer Horan, who spoke with Mission Local over the weekend, said she is an independent contractor in the role of regional manager for Community Wellness America testing sites, including the one at 18th and Dolores streets. She said the appropriate documents would be posted at the site on Monday.
As of Monday at noon, however, the site did not have any permits on hand and had displayed what appeared to be a Crestview Clinical Laboratory license that expired in November, 2021.
Crestview is the Irvine-based lab used to process the tests. Horan additionally sent a PDF of what appeared to be Crestview’s current license to Mission Local, via text, with an accompanying message: “Slander is against the law and one can sue in a court of law.”
The laboratory license, however, only certifies Crestview Clinical Laboratory, and not Community Wellness America. Both the San Francisco Department of Public Health and Office of the City Attorney said that testing site operators must have a valid CLIA license, which staff at the site had failed to provide at each of Mission Local’s four in-person visits to the site, beginning Jan. 7.
Additionally, Justin Nguyen, chief operating officer and president of Crestview Clinical Laboratory, said that vendors they contract with, like Community Wellness America, are not authorized to use Crestview’s lab license.
“All vendors are independently owned and operated,” Nguyen wrote in an email on Monday. “None of them are authorized to use Crestview credentials, representing Crestview Lab or claiming that they work for Crestview as an employee or a contractor.”
Nguyen also differed with Horan on alleged delays in his lab’s turnaround times, which test-takers at the 18th and Dolores site were told would result in slower results.
Horan was adamant that Crestview was experiencing delays in processing tests due to ill employees. “I don’t know the exact number, but it was a big chunk of the lab techs got COVID,” she said, adding that individuals who took tests at 18th and Dolores should actually return for retesting, since specimens may not be “valid” for more than two weeks. Staff at the 18th and Dolores site advised Saturday that test results were typically available within two to five days.
Nguyen from Crestview, however, said there were no significant delays due to staff illness but, rather, a high volume of tests; about 10,000 a day, coming from across the country. Some of his staffers indeed tested positive for Covid-19 after the holidays, but they are working from home to enter results, he said. At present, he added, Crestview is only a day or two behind.
He said they have received complaints about Community Wellness America before, but clarified that Crestview contracts with organizations, not individual sites. He compared suspect sites to a “bad apple.”
Community Wellness America could not be reached for comment.
“I understand the concern of thinking that we are some fake COVID testing sites, “ Horan said. “But just because we don’t have a permit doesn’t mean we aren’t real.”
In an article published Tuesday, the California Department of Public Health told The San Diego Union-Tribune that the “CDPH inspected Community Wellness America (CWA), and it appears to be operating collection sites and sending the specimens to a licensed California lab for testing.”
They did not specify the lab, adding that “CDPH also inspected the lab that was contracted to do the testing for specimens collected by CWA, and found no evidence of non-compliance with clinical lab laws.”
But in August, 2021, a Community Wellness America site was shut down in Marin County for operating an “unauthorized” testing center. Earlier, public health officials in the states of Washington and Oregon advised residents to avoid or use caution regarding sites operated by the same organization. Just last week, authorities were sharing a similar message about multiple sites run by Community Wellness America in the St. Louis, Missouri, area.
Speaking before the City Attorney’s letter was sent, Horan said she would continue to offer testing, regardless of permitting.
In addition to the Dolores site and a previous site at the Whole Foods on Stanyan Street near Golden Gate Park, Horan said they have a testing site in Santa Cruz with plans for another at Legion of Honor and more in the East Bay. She said they hope to be carrying rapid tests by the end of this week.
The Office of the City Attorney encouraged residents seeking tests to first contact their healthcare provider and then seek options affiliated with the San Francisco Department of Public Health, which can be found here. To submit a tip about testing sites operating without authorization, call 311.