By The Washington Post · Steve Thompson · NATIONAL, HEALTH, POLITICS, HEALTH-NEWS
As it became clear that the much-touted tests could not help detect which Maryland residents had contracted the novel coronavirus, the Hogan administration quietly paid the same South Korean company $2.5 million for 500,000 replacement tests.
The state offered the tests free to two private labs, one of which declined because the tests took much longer to process than U.S. versions, records and interviews show.
The University of Maryland, which had spent months equipping its lab in Baltimore to process coronavirus tests, abandoned the replacement South Korean tests this fall after a spate of suspected false positives. But the other private lab continues to use them; a state official said Wednesday that 370,000 of the replacement tests have been used.
Hogan heralded the initial purchase as "an exponential, game-changing step forward" and featured it as the climax of his political memoir, published this summer.
"No one knew how many lives those 500,000 tests might save, but it would be a lot," he wrote of their arrival in April at Baltimore-Washington International Marshall Airport. "The successful mission got tons of attention in the national media."
Local officials in Maryland hoped that the purchase would make screening in the state more widely available. When the tests were not quickly deployed, they - and state lawmakers - began asking what was going on.
But Hogan and his top health and procurement officials withheld the tests' flaws from the legislature, state spending authorities and the public, according to a review of public testimony and hundreds of pages of emails and other records.
In response to queries from lawmakers, Hogan's top officials repeatedly said they did not know how many tests had been used.
Hogan declined requests to discuss the tests for this article. Responding to written questions, spokesman Mike Ricci said the governor and his aides have kept Marylanders "updated often on the progress we are making in our long-term testing strategy."
Ricci said the original tests "could have been used through a custom lab process, but this would have taken longer than purchasing the upgraded kits."
Told of The Washington Post's findings, state lawmakers said they felt misled by the Hogan administration.
"It's incredibly frustrating that the administration seems to have taken very obvious measures to avoid accountability and oversight of these tests," said Sen. Clarence Lam, D-Howard, the Senate's lone physician. "We spent a lot of money on these tests, and to not be able to have forthcoming answers as to how they were used while people were dying is just unconscionable."
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As the coronavirus made its initial dash across the United States, scientists and health specialists recognized the need to massively expand testing capacity.
The most widely used type of screening - called a polymerase chain reaction (PCR) test - diagnoses infections by looking for specific genes within small bits of genetic material collected from nasal swabs. Those specimens are processed in laboratories, using PCR test kits and chemical compounds called reagents.
By mid-March, U.S. manufacturers were able to ship PCR tests by the millions to domestic labs. But testing remained scarce because of limitations in how many kits labs could process, as well as shortages of swabs and reagents.
Hogan, at the time the chairman of the National Governors Association, urged President Donald Trump to help expand testing. But the federal government left it to the states to lead the effort, and they were forced to scramble for supplies amid the crisis. Meanwhile, South Korea was drawing worldwide attention for its effective handling of the virus through large-scale testing.
Hogan began considering whether his Korean-born wife, Yumi, could help acquire tests from her native country. Emails obtained by The Post through the Maryland Public Information Act show that he directed procurement and health officials to vet various South Korean test makers, focusing on them rather than U.S. suppliers.
On March 28, Hogan asked Yumi to join him on a call with Lee Soo-hyuck, the South Korean ambassador to the United States. The conversation, Hogan said, set in motion negotiations with the South Korean company LabGenomics.
The state soon sent a letter of intent to buy 500,000 LabGenomics PCR tests - branded LabGun - and scheduled the first of several wire transfers that would total $9 million for the tests and $464,389 in shipping costs.
That amounted to almost $19 per test, more expensive than some tests that had become available domestically. At the same time, emails show, some U.S. companies were starting to contact state officials with their own offers.
An executive at Thermo Fisher Scientific, one of the nation's leading PCR test providers, contacted Hogan's office the same week that the state sent its letter of intent to South Korea. Noting inefficiencies in other states' approaches to testing, the company offered to help Maryland, saying it had relationships with private labs across the state and would expedite sending testing supplies to whichever labs state officials chose to process their coronavirus tests.
Matthew Clark, Hogan's chief of staff at the time, said he would contact some of the labs, but made clear that acquiring test kits was not his first concern.
"The key question will be availability of reagent and swabs," he said in an email to Thermo Fisher executives on April 5. "Obviously test cartridges/kits are needed but we don't have the same shortages there." Clark, who left Hogan's administration at the end of May, referred questions to current administration officials.
Over the next two weeks, state officials moved forward with importing the South Korean tests - an effort that Hogan repeatedly described as immensely complicated.
"It took dozens and dozens of phone calls, night after night, sometimes it seemed like all night, working through language barriers and the 13-hour time difference," the governor would write in his book.
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On Saturday, April 18, the first of two chartered Korean Air flights arrived at BWI airport, its belly loaded with 350,000 LabGun tests packed in dry ice. A second shipment of 150,000 tests would arrive a few days later.
At a news conference that Monday, Hogan announced his test purchase to the world, boasting that what "we have just acquired is equal to the total amount of testing that has been completed by four of the top five states in America combined."
But the tests required labs to process them. From a list supplied by Thermo Fisher, Hogan administration officials selected two: Integrated Cellular and Molecular Diagnostics (ICMD), based in Greenbelt, and CIAN Diagnostics, based in Frederick. The private labs would test specimens from nursing homes and community sites on behalf of the state, records show.
According to a copy of CIAN's contract and an interview with an ICMD executive, the state agreed to pay the companies $98 per test, regardless of whether the labs used the Korean test kits, which the state would provide free, or purchased Thermo Fisher tests, called TaqPaths.
Asked why Hogan's administration agreed to pay the labs the same fee when the state also had to provide the test kit, Ricci referred The Post to health officials. Dennis Schrader, the health department's chief operating officer, told The Post he didn't know.
ICMD discovered problems with the LabGun kits, just as University of Maryland scientists would. "We couldn't reproduce what the literature was saying," said Richard Puritz, a company vice president, referring to documentation that came with the tests.
Fran Phillips, who retired in July as deputy health secretary, said the problems reported by ICMD prompted her to ask Robert Myers, director of the state's public health lab, to look at the test kits. He realized that materials in the kits didn't match those the test maker had submitted to the Food and Drug Administration for authorization weeks earlier.
"He said, 'There's no point in going through with the validation study. We just don't have the right stuff here,' " Phillips said in an interview Wednesday.
State officials alerted CIAN to the problems. "The state said do not use them, so we didn't use them," CIAN principal Sam Mullapudi said.
Emails exchanged later between a scientist at the University of Maryland at Baltimore and the school's president also detail problems with the LabGuns.
The test kit's instructions on how to interpret results were, in some ways, the opposite of what LabGenomics had submitted to the FDA, according to a May 19 email from professor Jacques Ravel to the university's president, Bruce Jarrell. The email, obtained this month through a Public Information Act request, said required steps were given in a different order.
LabGenomics officials did not respond to multiple requests for comment about the test kits.
"Because this is a sensitive issue, we would like to discuss the matter with you first and strategize on how to proceed with bringing this up to the State," Ravel wrote in an email to Jarrell.
During a phone call with state officials, Jarrell learned they already were arranging to replace all the tests with new shipments of LabGun tests from South Korea. The first shipment arrived May 21, records show. University scientists confirmed the replacement tests matched what the FDA had authorized, according to an email from Ravel to Jarrell.
Still, the LabGun test, by design, took longer than Thermo Fisher's TaqPath tests to process in large batches.
"The LabGun basically takes twice as long," said Puritz of ICMD. Rather than continuing to try to use the free LabGuns, the company kept buying TaqPaths, which Puritz said had not been in short supply.
CIAN and the University of Maryland lab, however, began "bridging studies" that FDA regulations required to ensure the LabGun tests could be used with those labs' instruments.
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The hype around Hogan's test purchase had raised expectations among nursing homes, county governments and others that their arrival would quickly expand the state's testing capacity. But as the weeks passed with no sign of them, lawmakers - both Republicans and Democrats - grew impatient.
Sen. Paul Pinsky, D-Prince George's, who chairs the Education, Health and Environmental Affairs Committee, asked Hogan to send someone from his office to the panel's meeting on May 27, noting that the test purchase was made "outside of normal procurement channels."
At that meeting, Pinsky and Lam pressed General Services Secretary Ellington Churchill Jr. about reports that the tests were not being used. They repeatedly asked whether the state had all the supplies it needed and, if not, what was missing.
"For two weeks, we saw on national TV that Santa Claus had landed in Maryland, and you had procured 500,000 tests with the administration to save our lives," Pinsky said.
Churchill, whom Hogan had thanked when announcing the initial test purchase and whose name appeared on the invoice for the replacement tests, disclosed nothing about the problems with the tests, repeatedly referring lawmakers' questions to the state health department.
"I'm going to try not to sound like a broken record," he told the lawmakers.
Asked by The Post about his responses to lawmakers, Churchill said in a statement that he was proud of the state's procurement officers for their "unprecedented effort to secure large quantities of medical commodities."
A week later, Phillips and Health Secretary Robert Neall attended a meeting of the Covid-19 Response Legislative Work Group. Again, Lam and other lawmakers pressed for answers.
Lam grew frustrated as Phillips, who gave the presentation, spoke at length but did not respond to inquiries about how many of the tests from South Korea had been used or whether there were any problems.
"It's a very simple question," Lam said, interrupting her. "How many of those tests have been used to date?"
Phillips avoided answering, saying the LabGun tests were part of a long-term strategy as the state planned for the fall.
In a briefing memo to the governor, Hogan adviser Keiffer Mitchell Jr. said the health officials "stuck to their talking points and the hearing went well."
Phillips said Wednesday that she didn't think the work group session was the right place to detail the state's testing challenges.
"As I remember, I didn't feel like it was the situation to get into all of the problems that go into the fact that we couldn't get to the testing goals that we were aiming toward," she said. "I thought that the information we did convey was complete, and it was thorough, and it was truthful."
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Unlike with the initial purchase of tests from South Korea, Hogan and his top officials kept the arrival of the replacement tests quiet.
"There shall be no media, no publicity, and no pictures for this flight," Ricky Smith, the Hogan-appointed executive director of BWI, told subordinates in an email before the shipment.
The governor first mentioned them publicly nearly two months later, while being interviewed on Washington Post Live about his memoir, "Still Standing." The pandemic delayed publication of the book, which details Hogan's tenure as the highly popular Republican leader of a blue state. Hogan added several chapters about his actions in the coronavirus crisis, culminating in his purchase of the first South Korean tests.
"We're actually getting, you know, upgraded and new and improved testing from South Korea," the governor told Post interviewer Frances Stead Sellers on July 16.
Asked about the new tests later that day by Jayne Miller, an investigative reporter for WBAL-TV in Baltimore, he again described the purchase as an upgrade.
"They were swapped out, like you trade in your iPhone, for faster, better tests . . . at a couple dollars more per kit," Hogan said, according to the news report. Miller reported that Hogan said no one had raised concerns about the original batch of tests.
Hogan administration officials also referred to the tests as "upgrades" when submitting information on Aug. 28 to the Board of Public Works, which authorizes state expenditures. Paperwork provided to the board said the new tests cost the state $2,514,265.
Hogan officials did not respond to questions about why the state had to pay to replace the flawed tests.
The state also spent $2.5 million to create a robotic lab at the University of Maryland at Baltimore, which a news release said would become "the backbone of the state's testing strategy."
Deborah Kotz, a spokeswoman for the University of Maryland School of Medicine, said university labs began to process LabGun tests on June 10. By late summer, the university was processing a few thousand tests a day, far short of the 20,000 officials had hoped for.
In mid-July, state officials told nursing homes that they would have to begin arranging their own weekly testing for employees, after the state had provided testing for months. Officials said the university lab would provide the tests for $40 per specimen, about half the going rate.
The university entered arrangements with 23 nursing homes on Aug. 14, but turned away dozens more. As capacity expanded in later weeks, Kotz said, the university added 49 more nursing facilities.
At a meeting of the House health committee in late August, lawmakers again grilled Neall and Schrader, who accompanied him. This time, the impatience was evident on both sides of the aisle.
"I hate to belabor this point, but I know I share the frustration with many of the delegates that I talk to on the question of the Korean tests," said Brian Chisholm, R-Anne Arundel. "Did we really use the original Korean tests that we showed all over the media?"
Schrader said he didn't know.
Committee Chair Shane Pendergrass, D-Howard, asked for an accounting of how many of the original and replacement South Korean tests had been used.
"I don't know whether we have that information, Madam Chair. I will inquire," replied Neall, a former state senator.
"How could you not know what tests you're giving to the lab?" Pendergrass said. "Don't you know whether the tests were swapped out or they weren't swapped out?"
"I do not know," Neall said.
"Well who would know?" Pendergrass asked.
"Well, I'll try to get the answer for you," Neall replied. "The only thing that I'm saying is that those tests came at a time when the world didn't have any tests, and we were damn glad to get them. And the fact that we got them saved a lot of lives, because we were able to test when other people were not able to test."
Schrader told The Post on Thursday that he only became involved in testing issues in June, after the replacements had arrived.
Neall, who plans to retire Dec. 1, did not respond to a request for comment about his statements.
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Days after the August meeting, in early September, health officials in Howard County received word of an apparent coronavirus outbreak at Lorien Columbia nursing home, a 205-bed facility that had about 90 cases among patients and staff members during the first months of the pandemic.
About 30 Lorien employees had just tested positive, according to the University of Maryland lab. They were ordered to isolate, meaning they could not go to work.
"That was just mouth-dropping," recalled Lisa de Hernandez, a spokeswoman for the Howard County Health Department.
But several of the workers soon were tested again, and this time the results were negative, according to county health officials. When the others were retested, those results, too, were negative.
Health officials soon learned that between Sept. 2 and Sept. 8, the university lab had also given dozens of people at several other facilities suspected false positive results.
The lab's director, Jeffrey Parker, sent an email to nursing homes, saying it was investigating test results. He added that the lab had stopped using the LabGun tests and was moving to a test that could check for both the coronavirus and influenza.
Soon afterward, Jarrell, the university's president, released a statement saying the lab had been "planning for some time" to make the switch.
Ricci, the governor's spokesman, declined to say whether those plans were a reversal of assertions by Hogan and Phillips that the LabGun tests were a key part of the state's strategy for the fall.
The state's Office of Health Care Quality inspected the university lab in response to the suspected false positives and found shortcomings in how the lab ensured specimens were properly transported and stored. The report did not identify a cause of the suspected false positives, and LabGenomics officials did not return requests for information.
Kotz, the university spokeswoman, said scientists and inspectors found no evidence showing the results were false positives. She declined to say whether the LabGun tests were involved. Although "a few nursing homes" had an increase in positive results, she said in an email, the university reported results during that time to "several other nursing homes where no increase in positivity was observed."
Kotz said the university has used 129,000 of the LabGun tests. But she declined to say how many results from those tests were reported to patients. She said the figure "includes tests used in our validation and tests used for repeat testing when [the] first test is undetermined."
CIAN, the private lab located in Frederick, is still using the LabGun tests, Mullapudi said. State records indicate that the lab was using about 1,300 per day in mid-September. On Wednesday, Schrader told the state Board of Public Works that, so far, 370,000 of the LabGun tests had been used, a figure that includes the tests processed at the university lab as well.
The board - which is chaired by Hogan and includes Democrats Comptroller Peter Franchot and Treasurer Nancy Kopp - accepted increasing the state's testing contract with CIAN to $45 million, which includes tests given at the governor's mansion and State House complex for state employees.
Hogan said he expects to have used all of the LabGun tests by the end of the year.
Franchot replied that he was glad to hear it, noting that the purchase had prompted some criticism.
"That was a bunch of nonsense," Hogan said. He described the tests as the "backbone of our testing strategy," adding that he bought them "at a time where there were no tests available in America."