If FEMA Wanted COVID-19 Tests To Be 'Sterile' or 'Usable' It Should Have Said So!
Photo: Christiano Betta, Creative Commons License 2.0

As part of the Trump administration's Very Be Best response to the coronavirus pandemic, a whole bunch of government agencies are shoveling money at contractors that have never provided medical supplies before. And as a jaw-dropping ProPublica story explains, the government is in some cases getting far less than it paid millions of dollars for. Like for instance COVID-19 "test tubes" that turned out not to be test tubes at all, but plastic tubes used in making soda bottles — not only are they the wrong size to be used in labs, they're also not sterile. FEMA has so far paid $7.3 million for three million of the tubes, which have been sent on to all 50 states, even though they're unusable. And if the company supplying them, "Fillakit LLC," fulfills its full contract for four million (unusable) tubes, the full payment will come to $10.16 million.

And that, kids, is why America is the best at everything.

The ProPublica story is a follow-up to an earlier investigation in which ProPublica found that, in the rush to get caught up on the nation's medical supply shortage, the government handed out a whole bunch of multimillion-dollar no-bid contracts to companies that have never had federal contracts before, including

A firm set up by a former telemarketer who once settled federal fraud charges for $2.7 million. A vodka distributor accused in a pending lawsuit of overstating its projected sales. An aspiring weapons dealer operating out of a single-family home.

Fillakit LLC was in that story too; it's the one founded by the former telemarketer, one Paul Wexler, who settled a Federal Trade Commission lawsuit in 2013 after his company was accused of "illegal robocalling, making unauthorized charges to consumers' bank accounts and falsely claiming to be a nonprofit organization" that did "credit counseling." Wexler was assessed a $2.7 million judgment and enjoined from ever representing his company as a credit counseling service. But nothing in the suit prevented him from becoming a federal contractor, whee! So in May, six days after Fillakit was incorporated, the new venture was awarded that $10.5 million FEMA contract for test kit swabs and containers to hold the samples obtained from swabs.

Usually, those containers would be sealable vials made of glass or sterile plastic that also contain a sterile "viral transport medium" that preserves the sample's coronavirus RNA (if any) long enough for the sample to be tested in a lab. Such materials are typically manufactured in sterile facilities to prevent contamination of the vials.

Or maybe, if the containers are from Fillakit, none of the above, according to former employees and a sneak peek at the Fillakit site — a "makeshift warehouse outside of Houston" — by a ProPublica reporter.

The tubes Wexler's company delivered aren't medical supplies at all. They're plastic tubes called "preforms" that are designed to be expanded by heat and a burst of compressed air into 2-liter soda bottles. And whoo boy, how's this for the very best in Clean Room manufacturing technology? The preforms arrive at Fillakit in big shipping containers, and then workers, who may or may not be wearing masks, use snow shovels to sort 'em into plastic bins. After that, since "viral transport medium" is in short supply, the workers squirt some saline solution into the bottles before capping them. The FDA did approve the form of saline being used as an emergency alternative, as long as it can keep viral samples alive for a minimum of three days. BUT:

Three former Fillakit employees said that its process was unsterile. Workers shoveled up the tubes from unsanitary surfaces. The liquid that they added to each tube to preserve samples for lab analysis was kept in trays exposed to the air, which was whipped around by large fans.

We first heard about "clean rooms" when we read The Andromeda Strain, in high school, a decade after it was published in 1969. Michael Crichton would surely be impressed with Fillakit's modern improvements.

This is one of those stories where virtually every new paragraph left us saying "Oh, for fuck's sake." One former employee said that in the first week of manufacturing, none of the workers wore masks. After that, "supervisors did hand out masks but did not require employees to wear them."

And then there's the horrifying low comedy of ProPublica's own sort-of site visit:

On June 10, a ProPublica reporter observed workers, some not wearing masks, standing over snow shovels and bins of tiny soda bottles.

Wexler and workers loaded a shipment of tubes into an Enterprise rental truck, which lacked the refrigeration that the Centers for Disease Control and Prevention say is needed to safely transport legitimate testing supplies.

Wexler denied a request to tour the warehouse. Asked about the lack of sterile conditions and the use of soda preforms, Wexler screamed, "What's your problem, man?"

A former nurse who worked at Fillakit said she had brought concerns about the warehouse's conditions to her manager, Stephen Wachtler, who dismissed them, and also got his basic sanitation facts wrong:

"I kind of said to Stephen, 'Is this supposed to be, like, clean technique, or sterile technique or what?'" Hardy said. "He's like: 'No, it's fine. It's fine what you're doing because they're just testing for COVID, and so if there's any other bacteria or viruses in there then it's not going to show up.'"

That's not true, according to Vjollca Konjufca, an associate professor of microbiology at Southern Illinois University. If Fillakit employees were infected, they might have contaminated the tubes with their own virus, potentially causing false test results, she said.

But apparently there's little chance of that happening, since the tubes Fillakit delivered to FEMA mostly end up in storage, because they're utterly unsuited to lab use. Talk about a safety protocol! One state official said the Fillakit tubes set back their state's testing program:

"They're the most unusable tubes I've ever seen," said a top public health scientist in that state, who asked to remain anonymous to protect his job. "They're going to sit in a warehouse and no one can use them. We won't be able to do our full plan."

Because there's just SO MUCH in this piece, we'll leave aside the other quotes from distressed state health agency workers who can't believe FEMA would send them such crap. You deserve your own "Oh for fucksake" moments, but in response to state officials' complaints, FEMA "has asked health officials in several states to find an alternative use for the unfinished soda bottles." Nobody has found any such alternative uses. Maybe health officials could send the bottles to state tourism agencies to sell novelty "Fresh [state name here] Air" in souvenir shops. Or sell 'em to the Trump campaign to make into really shitty vuvuzelas.

But hold on a minute — we thought one of the reasons the feds went with so many no-bid contracts was that, if the contractors failed to deliver, the agencies wouldn't have to pay, and they'd just find a new contractor that could do the job. Why did FEMA pay for stuff that doesn't meet basic standards? ProPublica went looking for answers, and got a ... response, of sorts.

In a written response to questions, FEMA said it inspects testing products "to ensure packaging is intact to maintain sterility; that the packing slip matches the requested product ordered, and that the vials are not leaking." It said that "product validation" that medical supplies are effective "is reinforced at the state laboratories."

The agency did not answer questions about the size and lack of sterilization of Fillakit's tubes or about why it sought an alternative use for them.

So now making sure the federal government doesn't provide unusable crap is a state responsibility, too!

A contract law expert at the University of Baltimore, Richard Loeb, told ProPublica that FEMA does have the ability to "claw back" payments for crappy supplies, and said it was "outrageous" that the purchases went through at all. "I still am a little bit troubled as to why FEMA accepted them. ... They may have stupidly accepted something that was nonconforming."

That seems a bit harsh of him, however, since stupid, ineffective, and grifty are top Republican governing priorities.

Rest-of-the Story Update: In late June, Fillakit LLC went belly-up as investigations into how it got a contract at all went forward.

[ProPublica / Update: Law360 / Photo: Christiano Betta, Creative Commons License 2.0]

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Doktor Zoom's real name is Marty Kelley, and he lives in the wilds of Boise, Idaho. He is not a medical doctor, but does have a real PhD in Rhetoric. You should definitely donate some money to this little mommyblog where he has finally found acceptance and cat pictures. He is on maternity leave until 2033. Here is his Twitter, also. His quest to avoid prolixity is not going so great.


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