One morning in early January, Jordan Zandi felt terrible. So he went to the only COVID-19 testing site he could find that didn’t require an appointment.
He stood in a line that folded in on itself because it was so long. People approached a shed and a plastic folding table planted in the parking lot of Johnson Creek Market, a convenience store in southeast Portland.
The site did not inspire confidence. He gave his personal details to the testing company and was told to dab his nose in his car. Then he put his sample in a plastic bin.
“There’s a little plastic bin that you put this in. There were a bunch of other bags in there,” Zandi says. “There is no disposable area for your swab. I ended up taking it home and putting it in the trash.
Zandi tested negative. But he was sure he had COVID. He had night sweats and severe body aches. He returned a week later and again tested negative.
The installation, says Zandi, was clearly improvised and its workers seemed to know little. But Zandi didn’t give it much thought: “Everything was so messy around the pandemic anyway.”
Last week, WW reported that the Oregon Department of Justice had launched an investigation into the Center for Covid Control, the company that operated the testing site visited by Zandi.
Justice officials launched the investigation three months after receiving two complaints from Oregonians against the Illinois-based company. The beleaguered company, which coordinates 300 sites across the country, is under investigation in nearly a dozen other states.
In some cases, according to reports across the country, patients said they waited weeks for results. In other cases, they said they received the results by email before taking the test.
WW found no pending legal action against the company.
Additionally, the Oregon Health Authority said WW as of last week, it had not received any test results from the company or its partner lab since it began operating as early as October, a violation of state and federal laws.
If true, it means thousands of Portlanders have taken tests for COVID-19 whose results are now in question. And that means state officials never saw a significant number of COVID test results at the start of the Omicron wave.
Federal, state and local officials have said little about their investigations, even after the federal government gave the Center for Covid Control partner lab — which appears to be run by the company — more than $100 million.
Although the company decided to close its sites for a week citing staff shortages, it is unclear whether it will resume operations in Oregon.
Over the past week, WW looked at how a company could slip through the cracks of regulators for months while thousands of Portlanders took tests, convinced their results were accurate.
What emerges is evidence of a country in desperation: The scarcity of testing in the United States has created a system in which overnight startups can make large sums of money by charging the federal government for services over which regulators have little control.
ARE THESE LABORATORIES REGULATED?
Normally, any diagnostic testing site or laboratory must be federally certified. This certification is governed by the Clinical Laboratory Improvement Amendments of 1988 of the Public Health Services Act, or CLIA for short.
But in 2020, amid the public health emergency of the pandemic, the federal government made an exception allowing companies to operate multiple temporary mobile sites for COVID-19 testing under a single certificate. Federal guidelines do not limit the number of mobile sites that can operate with a single certificate.
The tracking databases for these certificates show only one for the company.
CLIA certification experts believe the Center for Covid Control has broadened the intent of the exemption. Dr. David Ku, an internal medicine physician who runs multiple labs, says that shouldn’t apply to a single company with 300 different sites, especially if not all of them are mobile. (One of the Portland sites is a storefront in the Hollywood district.)
“You can’t pretend these are temporary labs, because these places have display cases,” Ku says. “It is absolutely a violation.”
The Centers for Medicare & Medicaid Services oversees CLIA certificates, but the federal agency’s office in Seattle has refused to provide WW with even basic facts about certification.
USA today reported over the weekend that CMS inspected the Doctors Clinical Laboratory late last year – the lab that CCC claims to partner with to process its PCR tests but which it says USA today, is actually managed by CCC and found the lab to be non-compliant. He also visited several test sites. This investigation is ongoing.
SO WHO CHECKS IF THE RULES ARE FOLLOWED?
There is little oversight of testing sites such as those operated by the Center for Covid Control.
Reporting of test results to local health authorities is required by state and federal laws. But it appears the OHA was aware of the company’s existence: spokesman Rudy Owens said last week that “we have received complaints about this company and referred them to the US Department of Justice. ‘Oregon for investigation’. He added that sites must notify the state if they are operating as a test site, but did not say whether the company had done so.
Owens said Doctors Clinical Laboratory “is on the OHA list on board for [electronic reporting], and we are awaiting additional information from this lab to begin the integration process.
It’s impossible to know how many tests have gone unreported to the state in the past three months. But the company said last week it was performing 80,000 tests a day nationwide during the Omicron push.
State health officials and the Centers for Medicare & Medicaid Services have pointed fingers when asked who is supposed to keep records at testing sites. What is clear is that the more basic the testing sites perform, the less oversight government agencies provide.
The Center for Covid Control has an “exempt” certificate, intended for sites performing low complexity testing – even though the company was performing moderate complexity rapid antigen tests and PCR tests (this is another exception the government federal made for COVID-19 testing sites due to the pandemic.)
The federal government has also accelerated the process for certifying COVID-19 sites. “They gave out CLIA certificates like water,” says Ku.
Exempt sites are not subject to any regular checks, while establishments with a higher certificate undergo normal checks and assessments.
“I think public health agencies need to go to each of these pop-ups,” Ku says. “My opinion is that those could be shut down immediately, but many public health agencies just don’t have the teeth.”
The Oregon Department of Justice received its first complaint about a Center for Covid Control site on October 3. He opened his investigation three months later, just as news broke nationwide that the company was under surveillance.
“Often we don’t open an official case until we are able to gather more information or we receive a series of complaints. Additional information leading to the opening of a formal case…was not received until this week,” said ODOJ spokeswoman Kristina Edmunson, who told WW that another company test had been added to the CCC’s investigation. “We registered the information we had – which was not sufficient to open a separate investigation at the time – with the other related case.”
HOW DOES THE COMPANY MAKE MONEY?
Last week, experts including Ku said WW that the company was likely billing the federal government for testing services.
This was confirmed by freelance journalist Michael Figueroa, who reported that the lab received $124 million from a federal program that pays companies that provide testing to uninsured people. The story was picked up by USA today.
WW asked United Healthcare, the company that cut checks for the federal program, last week if CCC or the lab had been paid for the tests. United never responded.
(Last week, a page on the company’s website advertised a guaranteed PCR result within 24 hours if you paid $100. That page is now password protected.)
Portlanders who took a test at one of the three Portland-area sites say they were asked to fill out insurance information if they had any.
Opal Brockschmidt did. They filled in their Oregon health plan policy number online. “They said they were going to charge insurance for the test,” says Brockschmidt.
Oregon Health Plan declined to say whether it was billed by the Center for Covid Control or its lab, citing member confidentiality.
WHO IS BEHIND PORTLAND POP-UPS?
Until last week, the Center for Covid Control operated three sites locally.
The Southeast Portland location is in the Johnson Creek Market parking lot. WW spoke to a market employee, who said the site operator was a friend of the store manager and denied any wrongdoing.
“It’s a complete lie,” he said when told the state had received no results. Like WW was leaving, he said, “That’s bullshit, shit. Use your brain.”
A webpage run by Center for Covid Control, which is now password protected, says it is looking for “test site owners” and encourages interested parties to contact its franchise service.
On that same page was a list of all the sites the company said would be opening soon. Two new sites in the Portland area have been listed: an empty storefront at 1541 W Burnside St. and an address in Tigard.
WW visited the Tigard address, which was a light blue house in the suburbs. Two men answered the door, both in their thirties or forties.
One of the men spoke with WW for 10 minutes, but declined to give his name. He said he had been the manager of Tigard’s site and allowed the company to temporarily list his home address as a site. He said his house was not a site, nor would it be.
He said he told the company to remove his address. (Later, this same page became password protected.)
We asked him how he found the work: “I just looked around,” he replied. “I don’t know. I just got it.
He offered to make a bet with this journalist to find out if his company would have regulatory problems. We refused. He said the offer was valid: “You know where I live.”