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Coronavirus Testing Efforts in Iowa got off to Chaotic Start

Testing company's lack of on-site support almost halted testing until the key players ironed out issues plaguing the system, including delayed results and struggles Iowans encountered trying to schedule tests.

(TNS) - On the April morning Gov. Kim Reynolds unveiled a $26 million Test Iowa Initiative she envisioned running 3,000 COVID-19 tests a day with support from the State Hygienic Lab, officials at the University of Iowa-based laboratory expressed confusion.
“Paul,” State Hygienic Lab Director Mike Pentella wrote to Paul Trombino III, Reynolds’ chief operations officer, at 3:39 p.m. April 21 — about four hours after the announcement. “I’m getting many questions from laboratorians around the state about Test Iowa.”
Pentella wanted to know “any information about the test that we are getting” as well as “when is (the State Hygienic Lab) going to start testing?” and “are samples being forwarded to another lab until we have the test in place here?
“It would help me a great deal to have the total picture about this test,” Pentella wrote.
Previously undisclosed emails provided to The Gazette in response to a public records request shed more light on the rush to roll out the huge and complicated Test Iowa program in an emergency and the confusion it sparked at the state’s largest processing lab, which was to be a linchpin in making the initiative come true but that appears to have known little about it beforehand.
Reynolds signed the no-bid contract with Utah-based Nomi Health after actor and Iowa native Ashton Kutcher called the company to her attention.
Later in his emails, Pentella came to question the company’s lack of on-site support and at one point suggested halting Test Iowa until the key players ironed out issues plaguing the system — which later became the target of criticism over test inaccuracies, delayed results and struggles Iowans encountered trying to schedule tests.
On that April 21 when Reynolds unveiled Test Iowa to the public, Trombino responded to Pentella’s questions by passing him to founders of the company behind the initiative.
“As you know, we are getting unbelievable demand today and it is critical for us to get all the laboratory issues resolved quickly,” Trombino wrote to the representatives of Nomi Health, which serves as general contractor for Test Iowa and, on its website, boasts “ensuring that every step of the testing process functions seamlessly — from tents to tests to tech.”
In arranging a Zoom call with the founders and Pentella, Trombino attached a 30-second video of equipment the state lab would receive.
But state lab officials weren’t alone with their questions, as health care providers statewide — including MercyOne in Des Moines and UnityPoint Health in Cedar Rapids — heaped query after query onto an already-slammed hygienic lab, the epicenter of Iowa’s pandemic response.
One laboratory manager from a 25-bed hospital in Albia the morning after Test Iowa was announced asked if her facility could start sending samples from patients who met the Test Iowa criteria but “not necessarily SHL guidelines?”
“It is confusing,” Pentella replied, “because there are two different test streams.”
When UI State Relations Officer Keith Saunders sent Pentella a copy of the contract with Nomi Health, which had taken effect one week before and outlined expectations and parameters, the lab director responded as if he hadn’t seen it before.
“Thanks Keith, I appreciate knowing what to expect,” Pentella wrote.
He further expressed frustration over the dearth of information about a program his lab was supposed to play a crucial role in when he was asked to keep the U.S. Centers for Medicare & Medicaid Services informed on Test Iowa.
“We have so little information at this point,” he wrote April 22.
“This is coming from the governor’s office and we were only recently informed,” he wrote.
Late that night, though, the governor’s office emailed Pentella with a promise that more information — plus automated testing equipment, supplies, kits and trainers — was on its way.
“A private jet will be bringing the needed test kits and supplies,” Trombino wrote. “We want to provide all the support you need to get this testing process ready by early next week.”
In comments to The Gazette this week, Pentella said that “the governor’s office was always responsive when we had questions and issues.”
He said the emails underscore how “any undertaking as large as Test Iowa is going to come with challenges” and lauded staff who “worked as a team to work through them as quickly as possible.”
‘A nightmare’
Although Reynolds announced the program April 21, she was not able to announce the state lab had validated the Test Iowa equipment and process until May 14 — more than three weeks later.
At that time, in her push to reopen the state’s economy, Reynolds said the now-validated Test Iowa machines enabled the capacity to ramp up to processing as many as 5,000 samples a day.
An analysis by The Gazette found Iowa didn’t exceed 5,000 tests on a single day until 20 days after May 14 — on June 3. Even then, the public wouldn’t know how many of those tests came under the Test Iowa program because the state doesn’t break out its testing data in its public reports.
In response to questions from The Gazette, governor’s spokesman Pat Garrett said the key metrics are positive and negative results and the total of individuals tested. “The name of the laboratory or where the sample was taken is not relevant to communicating critical public health messages,” he said.
He did say Test Iowa has processed more than 148,000 tests, or about 3,000 a day for a five-day week, and processed 3,201 Monday.
In announcing the validation in May, Reynolds acknowledged there had been some problems getting such a large initiative launched under emergency conditions, but said the program had turned a corner.
In response to questions from the public and those raised by its own reporting, The Gazette submitted a public records request May 7 for Pentella’s emails.
After agreeing to split a $300 charge with two other news outlets seeking the same records and waiting nearly three months for them, The Gazette on Friday afternoon received 444 emails from the university.
Many of the records show not only confusion over how the program was to work, but also show a sense of urgency and teamwork amid a backdrop of questions about cost, staffing and Nomi Health’s capacity to support the program it sold to Iowa.
As interest in the testing initiative swirled, more people at the state lab signed on to help than the lab had the capacity to handle, Pentella wrote April 23. Yet he worried about the lab’s ability to pay its staff for the extra work.
“The number of people needed for Test Iowa has climbed to about 12-18 per shift. I have about 20 people starting,” Pentella told the governor’s office. “How do I cover their salary costs? It is going to be way over my budget.”
Trombino promised that the state would handle salary expenses, which he noted were reimbursable under the Coronavirus Aid, Relief, and Economic Security — or CARES — Act.
In response to The Gazette’s questions about whether the state reimbursed it for Test Iowa-related costs, Pentella said, “The governor’s office, state legislature, and University of Iowa have been incredibly supportive and ensured we have sufficient resources to conduct testing.”
Legislators this year approved a supplemental appropriation of $525,578 for the lab in the budget year that just ended. But they did not increase the lab’s appropriations for the current budget year.
Days after Pentella in late April raised concerns about his lab’s staffing resources, he emailed Trombino and state epidemiologist Dr. Caitlin Pedati to raise more red flags — this time about the test itself.
“Yesterday, we started our first run of controls. The results were not adequate,” he wrote, noting, “This testing is very labor intensive … and therefore, there is more potential for error.”
The following day, he ticked off a list of frustrations to Pedati and Trombino including software and equipment issues.
“Who else is there for support?” he asked. “Typically a company sends a technical expert who spends the time you need to get up and running.”
At that point, he suggested halting the collection of samples for Test Iowa — at least for the time being.
“Continuing to collect samples for the Test Iowa program is very unwise at this time because this is not going forward at the lab as is needed, despite a tremendous effort,” Pentella said. “The company is not supporting this as they should.”
He further heightened his alarm after requesting a Test Iowa collection schedule as the equipment it had provided was still not validated.
“This schedule greatly concerns me until we get this test running,” he said in an email April 28. “If this test validation is not completed by Thursday, it could turn into a nightmare. We will do everything possible from the lab, but I am worried.”
Ship to Utah?
Responding to the lab concerns, Trombino promised a list of actions, including sending “all Test Iowa Swabs this week to Utah for testing” — even as Reynolds said publicly that Test Iowa swabs were being sent to the State Hygienic Lab.
Meanwhile, providers of other tests in Iowa were starting to wonder whether they, too, should send their samples out of state — with state lab wait times growing, affecting patient lives and potentially promulgating the disease.
A lab director with the Cass County Health System directed his concerns to Pentella, after inpatient samples sent to his lab four days earlier were “still not even showing as being received.”
“We are burning through (personal protective equipment) awaiting these results,” Mitch Whiley, director of laboratory services with Cass County, told Pentella. “When I called SHL, all they would tell me was they are busy with over 5,000 samples per day and they were processing as quickly as they could.”
Acknowledging the “increased turnaround time” was unacceptable, Whiley asked whether his county should start designating samples “as inpatients so that they get priority processing?”
“We are trying to determine if we need to completely change our process and start sending more samples to Mayo,” he said.
Although the governor’s office the next day offered a promising report showing progress and Nomi Health on-site support, lab officials sustained their demand for better preparation before continuing with Test Iowa as planned.
“We need all of our test equipment installed and calibrated before we even think about starting Test Iowa,” UI epidemiologist Ryan Jepson wrote in an email April 29, noting the lab received another “big cooler full of Test Iowa samples this morning.”
“I thought these were being shipped to Utah until we have all of our equipment on-site and the validation completed?” Jepson asked, getting this response from Pentella: “They will have to be.”
Pentella this week confirmed to The Gazette that samples never were sent to Utah.
The lab encountered other problems as well, including reporting errors and leaky specimens. The latter prompted Pentella to ask Trombino to remind those working at Test Iowa collection sites to “make sure that the tops are tightly secured.”
“Do you want us to create some instructions with pictures? Sometimes that helps,” Pentella asked, prompting Trombino’s response: “That would be great.”
©2020 The Gazette (Cedar Rapids, Iowa)
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