State Didn’t Help, But OSU Lab Found A Way Into COVID-19 Testing Anyway
Specialists at Oregon State University’s veterinary laboratory figured they could help the state ramp up testing for coronavirus. They run a sophisticated facility with state-of-the-art testing equipment, and they’re experts at diagnostics and tracking viruses.
But they couldn’t just start running COVID-19 tests. They faced a tangle of red tape.
So they approached the Oregon Health Authority, and a lawmaker contacted Gov. Kate Brown’s office for help. That led nowhere. The authority did not give them any support, and Brown’s office did not follow up with them, according to interviews and documents obtained by The Lund Report.
The lab’s managers did not give up. They forged ahead, dismantling obstacles without the state’s help. They joined forces with a commercial medical lab in Corvallis. In a joint effort, the two labs plan to launch their first COVID-19 tests on Wednesday. The project expects to run nearly 1,000 COVID-19 a day, giving Oregon a much-needed boost in its efforts to track the virus. Right now, Oregon tests between 7,000 and 8,000 people a week, Brown said.
Oregon’s lack of adequate testing infrastructure has dogged the state’s efforts to contain the virus. State public health officials repeatedly have said the state needs more tests to halt the spread, something that Brown repeated at a news conference on Tuesday. "We need to ramp up testing in every region of the state," she said.
Yet state officials did not pursue a homegrown opportunity that taps the expertise of an Oregon university research laboratory.
From the start, testing has lagged in Oregon. Initial kits from the Centers for Disease Control and Prevention were faulty, and there was a lack of supplies. The state expected all tests to be conducted at the public health lab in Hillsboro but has since allowed testing by five hospital systems, two private labs and the University of Washington. Still, the state only has results for about 30,000 people, according to an Oregon Health Authority report on Monday.
The OSU project shines a light on the difficulties faced by entities outside the public health system to help Oregon track and quell the epidemic. The Oregon Health Authority apparently failed to recognize the contribution a veterinary lab could make despite examples in other states.
University veterinary labs in at least two other states -- Colorado and Oklahoma -- have been conducting COVID-19 testing for weeks. Each can process hundreds of tests a day. Their veterinary labs -- unlike OSU’s -- had help from public authorities.
Physicians lack drugs to fight the virus, and it will be a year or more before a vaccine is on the market. The only tool public health officials have right now are tests.
"Testing is an essential pillar of any public health response to a disease outbreak,” Dr. Sharon Meieran, a Multnomah County commissioner and emergency room doctor, told The Lund Report in an email. “It allows for case identification, contact tracing and importantly, especially in congregate settings, the ability to isolate individuals who are infected so that they do not risk infecting others. Any increase in our capacity to test for COVID-19 will aid in our ability to respond to this disease at both an individual and community level."
Experts say that the more entities that test and the quicker the results, the sooner people will isolate themselves and stop spreading the highly contagious virus.
“The lack of testing from the beginning has been one of the leading causes for where we are now," said Chunhuei Chi, director of OSU’s Center for Global Health.
Lab Has Diagnostic Track Record
In Oregon, the idea to get the veterinary lab involved came from the medical community in Corvallis, including Good Samaritan Regional Medical Center. Frustrated over long waits for testing results, physicians approached the Oregon Veterinary Diagnostic Laboratory at OSU last month to see if officials there could use their equipment to run COVID-19 tests. The lab was a prime candidate to help.
“Any additional testing capacity that they can provide would be welcomed by the region and the state of Oregon,” said Dr. Adam Brady, an infectious disease specialist and chairman of the hospital’s coronavirus task force, in an email.
The lab, part of the university’s Carlson College of Veterinary Medicine, has a long history of tracking illness, like viruses in sheep and hoof and mouth disease in cattle. It works with state epidemiologists and is part of a U.S. Food and Drug Administration network of about 45 facilities nationwide that specialize in investigating animal diseases. They analyze animal blood, urine, stool and tissue samples for signs of illnesses to help the federal agency investigate complaints about tainted food and drugs.
One of the lab’s machines extracts genetic material from samples, usually collected via nasal swabs. The other machine analyzes the genetic material and provides the results.
This is just the sort of technology needed to conduct COVID-19 tests.
Mark Ackermann, director of the veterinary lab, wanted to help out but to run human analyses, a lab needs to be certified by the Centers for Medicare & Medicaid Services. His lab lacked that certification.
To obtain it, a lab has to meet federal standards. That process is complicated and takes time, even for a research lab that already meets other federal standards to track diseases in animals.
So Ackermann asked the Oregon Health Authority for help in smoothing the way for the veterinary lab to conduct tests on its own or work with another facility.
Agency officials visited the lab and discussed federal certification requirements, said Jonathan Modie, a spokesman for the agency. But they didn’t help. They suggested that Ackermann contact clinical laboratories instead.
Early on, Ackermann received support from Sen. Sara Gelser, D-Corvallis, who saw the potential in the idea. On March 26, Gelser tried to enlist the support of Gov. Kate Brown by emailing Brown’s chief of staff, Nik Blosser, and copying other lawmakers. That email, obtained by The Lund Report, encouraged the governor’s office to consider an executive order allowing COVID-19 tests at research universities. Gelser pointed out that Oklahoma’s governor had issued such an order enabling a university veterinary lab there to participate in testing.
“Would the governor consider a similar executive order so that OSU could make the same application and hopefully come online immediately,” Gelser wrote, calling it a “game-changer” for containment efforts.
Charles Boyle, a spokesman for Brown, said the office passed along the request to the health authority. He referred a reporter to the health authority for further comment.
Ackermann said he never heard from the governor’s office.
Partnership Is Formed
But the lab found a way forward on its own.
At the same time that Ackermann was crashing into a regulatory wall, another lab in Corvallis was trying to conduct testing. Willamette Valley Toxicology Laboratory, a commercial lab that normally analyzes toxins in urine and runs drug tests, contacted Benton County’s emergency operations center to see what it needed to do to conduct COVID-19 testing. That contact led to WVT hooking up with OSU through Dr. Bruce Thomson, a retired family physician in Corvallis who does consulting work for the county.
The two labs complemented each other.
WVT Laboratory has the necessary certification from CMS to conduct COVID-19 testing. It also has an approved records system that meets federal privacy regulations for patients. And the veterinary lab has the equipment that WVT needed to run the tests.
Less than a week after they met on April 1, the heads of the two labs decided that OSU would contribute its equipment. The university lab will extract the genetic material from tests and WVT will run the tests. After contacting the county, the pact came together quickly, said Manny Cruz, chief executive officer of WVT, which has a staff of eight people.
In an interview, Thomson gave the Oregon Health Authority credit for visiting Corvallis even though that didn’t lead to anything.
“I know they were pretty darn busy juggling a lot of things and felt that they just couldn’t be of any help to us,” Thomson said.
But in an April 4 email to Ackermann and Sen. Brian Boquist, R-Dallas, Thomson criticized the agency.
“Our pursuit was not supported in any way by OHA,” Thomson wrote. “In spite of all the obstacles that OHA enumerated several times during an hour-long pitch by us, it now appears that the lab instrument will be up and running.”
The two labs trained together for the first time Friday, with a plan to ramp up testing this week. The lab will not collect samples directly from patients. Instead, local doctors will determine who needs testing, collect samples from patients and send them to the lab for testing.
Similar Efforts Elsewhere
The public-private collaboration between OSU and WVT may be unique in the U.S. Other veterinary labs involved in COVID-19 testing have official support. Those states found ways to either obtain the federal certification for the veterinary lab or they hooked the lab up with a partner with federal approval.
Last month, the diagnostic veterinary lab at Colorado State University in Fort Collins forged the path by gaining federal certification through a collaboration with the university’s student health center lab. Kristy Pabilonia, director of the veterinary lab at Colorado State, said the student health center’s lab director had the right qualifications, enabling the veterinary lab to apply for the certification, which requires audits and inspections. Usually, the federal government completes a background check and vets the director. The Colorado lab didn’t need that step because the student lab director was already qualified.
The veterinary lab equipment can handle 200 tests a day.
Oklahoma State University is also running COVID-19 tests. It has five machines processing 1,000 tests a day at its diagnostic laboratory, which usually investigates animal diseases and outbreaks. The university could expand to around-the-clock testing if necessary, said Kenneth Sewell, the university’s vice president of research.
Like OSU, the veterinary lab at Oklahoma State lacked CMS certification. But it teamed up with its medical school, which is run by a certified director. The medical school’s certification allows the lab to run tests.
The state’s governor, Kevin Stitt, also helped by signing an executive order that allowed the university to do the tests.
“We became an extension or arm of the public health process so the hospitals and health care providers and pop-up specimen collection centers could send specimens to us,” Sewell said. “It allowed us to relieve the pressure on the department of health.”
The Oregon solution came together differently. Ackermann, who avoided criticizing the health authority, said he was grateful that WVT was eager to collaborate.
“They were willing to help, so let’s go down that road and see where it takes us.”