Taking COVID-19 funds, Cole was ‘reckless’ with lab operations, records and former staff say

Three former employees and public records paint a chaotic picture of Dr. Ryan Cole and his laboratory

By: - May 6, 2022 4:30 am
Photo of Dr. Ryan Cole in Washington, D.C., speaking at a "Defeat the Mandates" rally on Jan. 23, 2022.

Dr. Ryan Cole speaks at a “Defeat the Mandates” rally in Washington, D.C., on Jan. 23, 2022. “Let doctors be doctors, and let us treat patients and save their lives. Don’t shackle our hands. We will not comply with your silliness,” he said. (Screenshot from livestream video)

Dr. Ryan Cole made his ascent in the past two years from pathologist at a small laboratory in Garden City, to board member for a Treasure Valley public health department, to national figure in a movement that eroded trust in medical institutions and public health advice.

According to interviews and records gathered by the Idaho Capital Sun over the past six months, Cole’s ascent came at the expense of patients, taxpayers and public health.

“In my view, it was reckless,” said Mark Carter, former molecular diagnostics supervisor at Cole Diagnostics.

During the pandemic, Idaho Medicaid and potentially other health insurers paid Cole Diagnostics a premium rate for COVID-19 tests, because the lab claimed it was using fully automated, high-volume systems. It wasn’t, according to former employees and public records.

The Idaho Department of Health and Welfare gave Cole Diagnostics nearly a half million dollars to bolster the lab’s COVID-19 test production. But, a large share of the funds instead paid for equipment Cole Diagnostics didn’t use for COVID-19 tests, former lab employees told the Sun in interviews.

Former employees say Cole, the lab’s CEO and medical director, also made concerning changes to how Cole Diagnostics operated. Those changes were out of line with accepted laboratory protocols and would have caused people with COVID-19 to receive negative test results, the former employees said.

“It was volume over safety and accuracy,” Carter said. Carter holds a doctorate in molecular biology and immunology and previously worked in laboratories at cancer research centers and universities. He quit his job at the laboratory in spring 2021.

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“Cole Diagnostics was a small lab at the beginning of 2020 and took on more than what Dr. Cole promised and said it could do that summer,” Carter said.

The Idaho Capital Sun reached out to Cole by email and certified mail with a summary of findings in this story. The Sun sought comment and any additional information that might correct or clarify the findings.

Cole responded by email, directing the Sun to email attorney Steven Biss. Biss, a Virginia-based lawyer, represented former U.S. Congressman Devin Nunes and people associated with Nunes in a number of unsuccessful lawsuits against CNN, the McClatchy Co., journalist Ryan Lizza and others.

Biss has not responded to three emails and a voicemail from the Sun.

He put himself in a cocoon. He just wouldn’t allow himself to be challenged.

– Mark Carter, former molecular diagnostics supervisor at Cole Diagnostics

Cole Diagnostics took more than $1 million in COVID-related government spending

Throughout the pandemic, while Dr. Ryan Cole downplayed the risks of COVID-19, Cole Diagnostics received:

  • $508,251 in federal pandemic aid, according to data from the Department of Health and Human Services and the Small Business Administration. This included a forgiven Paycheck Protection Program loan, and direct aid for health care providers in need of financial relief due to COVID-19.
  • $504,479 from the Idaho Department of Health and Welfare, in a subgrant to expand COVID-19 testing, according to invoices paid by the state.
  • $391,071 for COVID-19 tests administered to Idaho Medicaid patients, according to Medicaid billing records.
  • $97,151 in federal reimbursements for COVID-19 tests to uninsured patients, and $400 in federal reimbursements for COVID-19 treatment to uninsured patients, according to HHS data.
  • $3,220 for COVID-19 testing for State Hospital North; and $8,015 for COVID-19 testing for the Ada County Sheriff’s Office, which runs the county jail, according to Idaho Rebounds payment data.
  • Payments from private health insurance companies, Medicare and individual patients for COVID-19 tests. Cole said he performed “over 100,000” COVID-19 tests between early 2020 and mid-2021. How much Cole Diagnostics made from those tests is unclear. Idaho Medicaid — traditionally one of the lowest paying health insurers — paid Cole Diagnostics about $90 per COVID-19 test. Cole Diagnostics currently charges $99 for PCR tests, $50 for rapid antigen tests and $30 to $50 for antibody tests.

Cole has become a regular public speaker at events across the country, such as the Global Covid Summit and Take Action for Freedom series. Tickets for those events range from $30 to $340.

He also offered treatment to people who contracted COVID-19. Cole has worked in Idaho since the early 2000s as a pathologist — conducting lab tests and diagnosing medical conditions through a microscope.

Pathologists do not typically see patients or prescribe them medications.

But, according to his public statements and comments to the Sun and other media outlets, Cole saw patients through telemedicine platforms and prescribed ivermectin and other unproven drugs to COVID-19 patients, including his brother.

Photo of Dr. Ryan Cole speaking on a panel that U.S. Sen. Ron Johnson, R-Wisconsin, convened on Jan. 24 "to provide a different perspective" on the pandemic, early treatment, hospital treatment and vaccines.
Dr. Ryan Cole speaks on a panel that U.S. Sen. Ron Johnson, R-Wisconsin, convened on Jan. 24 “to provide a different perspective” on the pandemic, early treatment, hospital treatment and vaccines. Johnson’s office issued a press release on Jan. 25, saying the video had 800,000 views in the first 24 hours. (Screenshot from video)

“Our primary concern is that he says he has treated patients ‘from Florida to California’ by refusing to use accepted and documented medical practices and vaccination and instead prescribing ivermectin,” the Idaho Medical Association said in a complaint last October to the Idaho Board of Medicine.

“We understand that as a dermatopathologist Dr. Cole has a laboratory, but we do not believe he has a clinic in which he sees and treats patients,” the complaint said. “We are concerned that he may not have followed proper clinical procedures for the diagnosis and treatment of patients and may not have kept appropriate patient medical records.”

Statement from Dr. Ryan Cole dated Oct. 11, 2021: I invite members of the IMA, particularly the governing board behind this complaint, to sit down with me to discuss the nature of their concerns about my practice of medicine. Filing a complaint and threatening my license is unprofessional and sows distrust within the medical community and with patients in our state. My mission as a physician is to care for patients. I take my oath to “do no harm” very seriously. There are many ways to care for patients, and in times of crisis, as we have experienced in the last year, our profession must come together to examine all ways we can provide optimal medical care. I am an experienced and educated physician with authority to analyze data and share medical science. Medicine advances when we examine what is and is not working, when we notice patterns, and when we continually strive to improve and find answers to perplexing challenges. We can do better as a profession than to silence those who have a different perspective. My attorneys and I will be working with other physicians and attorneys around the country who have been wrongfully attacked in the media and by those within the medical profession as we fight back against these unfounded complaints and actions. I will continue to put the health and well-being of patients in our community, our state, and our nation first and foremost.
Statement from Dr. Ryan Cole provided by email to the Sun on Oct. 11, 2021, in response to the Idaho Medical Association complaint.

As Cole gained prominence and furthered the distrust of public health advice, groups he once cited to bolster his authority — the Mayo Clinic, the College of American Pathologists and the American Board of Pathology — have distanced themselves from him.

Complaint raises questions about Cole’s cancer claims

As Cole’s laboratory took in federal and state funds — and he was appointed to serve as the sole physician on the Central District Health public health agency board — he misdiagnosed at least two patients, according to interviews and records.

Idaho doctor who falsely links COVID-19 vaccine to cancer has misdiagnosed two patients

Cole misdiagnosed them during the past year — while claiming to see a spike in cancers at his laboratory.

“I’ve seen a 20 times increase of endometrial cancers over what I see on an annual basis — a 20 times increase, not exaggerating at all,” Cole said in a video produced by anti-vaccination group Health Freedom Idaho in August 2021.

“I just talked to a nurse right now who has a young patient, got their shot, got COVID, and is dying of stage four cancer now,” he said in an April 21 video produced by The Epoch Times that has been viewed more than 67,000 times.

Cole makes similar claims in videos shared widely on Facebook and other platforms.

Such claims have been refuted and debunked repeatedly by health care providers, news outlets such as USA Today and The Associated Press, and even by cancer centers.

“The vaccines have been examined in millions upon millions of people at this point and there is zero evidence that there is any link to any kind of cancer,” Dr. Gigi Gronvall, immunologist and senior scholar at the Johns Hopkins Center for Health Security, told Reuters, in direct response to Cole’s claims.

Photo of Dr. Ryan Cole starting a presentation at a "Global COVID Summit" in Gilbert, Arizona, in mid-February with an homage to Fred Rogers' character in the children's television series "Mister Rogers' Neighborhood."
Dr. Ryan Cole begins a presentation at a “Global COVID Summit” in Gilbert, Arizona, in mid-February with an homage to Fred Rogers’ character in the children’s television series “Mister Rogers’ Neighborhood,” whistling the show’s theme song and putting on his shoes. Cole quickly pivoted into talking about emergency powers used by some government officials to slow the spread of the coronavirus. “I think we need to keep things friendly. I think we need to remember who we are as a people. But also, I think we need to remember to keep centered on a lot of things that our society has allowed us to get away from,” he said. “So here we go: Deus ex vaccina … Have we created a new false god?” (Screenshot from video)

A complaint to the Washington Medical Commission suggested that the licensing board investigate whether Cole has intentionally or subconsciously misread cancer tests, while making those false claims about COVID-19 vaccines and cancer.

Cole also claims to have autopsy evidence that the COVID-19 vaccine is harmful. But he has yet to publicly produce research to support that claim. In his presentations, he does not acknowledge the need to rule out death from other causes, such as organ damage and other health problems that are known to be caused by the COVID-19 disease itself.

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Exiled by his peers, Cole loses customers but gains a national platform

Cole’s resume shows very few publications or speaking engagements before the pandemic.

But in the past two years, he gained prominence.

Cole’s curriculum vitae lists eight research papers and presentations in the 20 years before the pandemic. Then, in March 2021, Cole gave a speech at the Idaho State Capitol that downplayed the individual and public-health risks of COVID-19. It went viral on social media.

Photo of Ryan Cole and Richard Urso in a Tennessee subcommittee
Dr. Ryan Cole, left, and Dr. Richard Urso testified recently before a Tennessee health subcommittee. (Screen capture from Tennessee General Assembly livestream)

Cole gave at least 14 interviews and presentations — an average of more than one per week — in the three months following that speech, according to his C.V.

Those appearances included testimony to legislators in Tennessee and in New Hampshire, where he called the vaccine rollout “the largest experiment on humanity” and a “violation of the Nuremberg Code,” which is untrue.

Cole is now a regular speaker at events around the U.S. that promote disinformation about the COVID-19 vaccine, the coronavirus and “early treatment” for the disease.

One such event brought 1,200 people into a room last fall in Anchorage, Alaska. Tickets were $20 each, the Anchorage Daily News reported. At the time, Alaska was battling through a surge of the delta variant and the state was reporting dozens of COVID-19 hospitalizations and deaths each week.

Cole also was a headliner for the “Global COVID Summit” in mid-February at the Foothills Christian Church in Garden City. Tickets cost $30 to $90, with a “green room pass” available for an additional $250.

Photo of Reps. Tammy Nichols of Middleton, Greg Ferch of Boise, Dorothy Moon of Stanley and Tony Wisniewski of Post Falls at Global COVID Summit
Republican politicians from Idaho attended the “Global COVID Summit” event in Garden City in February. Here, Reps. Tammy Nichols of Middleton, Greg Ferch of Boise, Dorothy Moon of Stanley and Tony Wisniewski of Post Falls make a brief appearance onstage. (Screenshot from video)

He was a featured speaker at “Global COVID Summit” events in other cities, and has spoken at ticketed events across the U.S., from Washington to Florida.

Recordings of his remarks include comments accusing the World Health Organization, the U.S. Centers for Disease Control and Prevention and public health agencies in general of corruption — while sitting on the board of a public health agency in Boise.

“Why they would lie just exposes what we were talking about earlier. There are layers and levels of money and corruption and pure evil at these levels of power and government that are inexplicable,” Cole said in the April 21 video.

“Pure money, power, control, corruption, pure evil,” he said — referring to public health efforts to vaccinate people, instead of advocating for widespread infection.

Cole says he is under attack.

Late one night in September 2021, Cole sent a two-page letter to clients, saying, “I have nothing to gain personally by speaking out on COVID. In fact, I have risked a great deal personally and professionally in order to do what I see as the right thing for patients.”

He repeated that message five months later at the Garden City event. By then, Cole Diagnostics had been paid more than $390,000 by Idaho Medicaid alone for COVID-19 tests.

“I’m doing what I’m doing on behalf of humanity. I have no financial interest in this whatsoever,” Cole told the audience. “But I do care about my fellow human being, and I’m going to continue to do so until they have stripped me of everything …”

How we reported this story

The Idaho Capital Sun has covered the rise of Dr. Ryan Cole since mid-2021, when Cole was appointed to the board of the Central District Health department, Idaho’s largest regional public health agency. Since then, the Sun has followed Cole’s speaking engagements and presentations as he became one of the leading voices of COVID-19 disinformation.

Some of the information in this story comes directly from Cole’s comments in those public forums. In addition, this story draws on multiple interviews the Sun conducted since fall 2021 with former employees of Cole Diagnostics and a patient diagnosed by Cole.

This story also relies on documents obtained through requests to the Idaho State Controller’s Office, the Idaho Department of Health and Welfare and the Washington Medical Commission.

Finally, much of the information in this story comes from: the U.S. Centers for Disease Control and Prevention’s Provider Relief Fund and uninsured claims reimbursements databases; Idaho Division of Medicaid billing data; the Idaho Rebounds database of pandemic assistance; usaspending.gov records of federal contracts; and Small Business Administration PPP loan data.

Cole’s views ‘do not represent’ Mayo Clinic

A year ago, as he began to ride a wave of COVID-19 distrust, Cole named several prestigious medical institutions to demonstrate his credibility as a speaker on COVID-19.

For example, he cites his training at the Mayo Clinic, where he completed a residency in clinical and anatomic pathology and a fellowship in surgical pathology.

Most of the institutions he names have since distanced themselves from Cole.

The Boise VA Medical Center:

Cole Diagnostics has been a contractor for the Boise VA Medical Center since 2010, under multi-year contracts.

But as his claims spread online — and he began to pitch ivermectin and other unproven medications as COVID-19 treatments — doctors at the VA hospital saw patients who took his medical advice.

VA officials “were flabbergasted” by Cole’s public statements, VAMC spokesperson Josh Callihan said in an interview earlier this year.

The hospital removed Cole as a consultant last year. Cole had yet to remove the hospital from a list of current positions on his website as of May 5.

Cole’s VA contract is set to expire at the end of July. It is worth more than $60,000 per year.

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St. Luke’s health insurance network:

St. Luke’s Health Partners also removed Cole from its network, which covers nearly 200,000 patients in Idaho.

St. Luke’s Health System told the Sun in December 2021 that a state statute on physician peer review confidentiality barred St. Luke’s from providing details about Cole’s removal.

That removal affected business for Cole Diagnostics.

One of the laboratory’s major clients was Women’s Health Associates, one of the Treasure Valley’s largest women’s health practices. The practice stopped using Cole Diagnostics for its testing earlier this year.

Scott Tucker, administrator for Women’s Health Associates, told the Sun the practice dropped Cole Diagnostics because so many of its patients were on health insurance plans using the Luke’s Health Partners network.

“We like Dr. Cole, liked his practice. Had no issues with Dr. Cole,” Tucker said. “We had a good relationship.”

Tucker said the group also had no experience with Cole misdiagnosing patients.

Professional organizations and Mayo Clinic:

Cole routinely describes himself as a Mayo Clinic-trained, board-certified clinical and anatomic pathologist.

Last year, the American Board of Pathology that certifies Cole weighed in on his public comments.

Dr. Rebecca L. Johnson, the CEO of the American Board of Pathology, sent the Washington Medical Commission a letter to raise concerns about Cole.

Board certification records show that Cole is certified in anatomic and clinical pathology. The records do not show any action against his board certification. Physicians like Cole who were certified before 2006 hold “non-time limited (or lifetime) certificates,” the board’s website says.

In its letter to the commission, the board said: “We have received multiple complaints about Dr. Cole and have been alerted to social media content relating to those complaints. The complaints accuse Dr. Cole of promulgating disinformation, advising against vaccines and masks, and giving advice that promotes the transmission of COVID-19. … He has advised patients to take hydroxychloroquine and ivermectin without scientific data to support their use in the treatment of patients with COVID-19. We also received an allegation that Dr. Cole may have provided prescriptions to patients in the absence of a physician-patient relationship and without sufficient medical record keeping.”

The American Board of Pathologists said it supports the Federation of State Medical Boards position that doctors who spread false information about COVID-19 vaccines may be subject to disciplinary action.

“Patients must be able to trust physicians with their lives and health. Thank you for your consideration and for protecting the health and safety of patients,” it said.

Cole also has cited the College of American Pathologists among his credentials. But in mid-April, the college told the Sun it took action against Cole.

Dr. Ryan Cole has been sanctioned by the (College of American Pathologists) and his membership revoked for three years. This … decision provides an opportunity to reassess professional behavior over the intervening years.

– Dr. Emily E. Volk, president of the College of American Pathologists

“The CAP fosters robust exchanges of varying professional opinions in the practice of medicine and individual pathologists are free to express their own personal views. However, the CAP does not condone Fellows of the organization disseminating COVID-19 information that is not firmly grounded in science,” Dr. Emily E. Volk, president of the College of American Pathologists, said in an emailed statement to the Sun. “Beginning with the initial distribution of COVID-19 vaccines, the CAP has steadfastly encouraged vaccinations for all who are eligible. We are committed to maintaining public trust in vaccination, just as we are committed to accurate COVID-19 testing.”

The Idaho Capital Sun last fall reached out to the Mayo Clinic, which provided a statement to the Sun.

“Mayo Clinic is aware of claims made by Dr. Ryan Cole regarding vaccines. Dr. Cole was trained at Mayo Clinic but is not a Mayo Clinic employee. His views do not represent Mayo Clinic,” it said.

Inside the laboratory as Cole pushed for more COVID-19 tests

Cole Diagnostics was among the first and most aggressive providers of coronavirus testing in Idaho. Cole spoke at length with the Idaho Statesman in March 2020 about his efforts to provide antibody testing — an attempt to help fill a global void in diagnostic testing for COVID-19.

Cole also told the Statesman his laboratory could run COVID-19 diagnostic tests in the Treasure Valley, but the Trump administration’s COVID-19 response favored the larger out-of-state labs. Idahoans were waiting days or even weeks for results to come back from those labs.

A few months later, Cole expanded the lab’s coronavirus testing capacity.

Photo of Dr. Ryan Cole speaking at the "Faith, Health and Hope Global COVID Summit" at a church in Grandview, Missouri, a suburb of Kansas City, on Nov. 13, 2021.
Dr. Ryan Cole speaks at the “Faith, Health and Hope Global COVID Summit” at a church in Grandview, Missouri, a suburb of Kansas City, on Nov. 13, 2021. “Here’s how much I’m making on COVID,” he said, making a ‘zero’ with his hand. “Here’s how much I’m getting paid to be here today.” The event sold tickets for $30 and advertised up to 50 tickets for a $90 VIP dinner. (Screenshot from video)

The number of people working in the lab increased “more than 5-fold and the number of molecular tests increased on almost a daily basis at a rate that put a lot of unnecessary pressure on the staff,” Carter said in an email to the Sun.

The Centers for Medicare and Medicaid Services on April 14, 2020, issued a ruling that said Medicare would pay a premium for COVID-19 tests processed by laboratories with “high throughput technologies,” using “a platform that employs automated processing” of more than 200 test samples per day.

The CMS ruling listed some examples of machinery that would qualify: Roche Cobas 6800 or 8800, Abbott m2000, Hologic Panther Fusion, GeneXpert Infinity and NeuMoDx 288 Molecular — all systems that make COVID-19 testing fully automated from start to finish.

Those technologies are more expensive to buy and operate. For example, the Roche Cobas 6800 is priced at $300,000 and the 8800 is $600,000, according to The Global Fund.

The CMS administrator said Medicare would pay $100 per test for laboratories using this kind of system. Laboratories that didn’t use those expensive systems would receive $51.31 per test.

Former employees say the laboratory did not qualify for the higher payments until late 2021, at the earliest.

Andrea Winn, former molecular technician at Cole Diagnostics, said that when she left in mid-August 2020, there were just a few people with the education and training required to run high-volume, fully automated COVID-19 testing.

Many of the people Cole hired to ramp up COVID-19 testing had little or no previous laboratory experience, she said.

Carter confirmed that.

“Most of the new hires were either recent college graduates or still in college working on a science degree,” he said. “They all had the basic understanding of molecular biology, but most had limited or no laboratory experience in a clinical setting.”

Winn said that “preventable mistakes (mislabeling, discrepancies between information on specimens and patient records) became more frequent with the addition of untrained staff to a pressurized situation,” but those mistakes “were made by everyone” as the staff worked to keep up with testing.

Winn and two other employees said the lab also didn’t have the fully automated equipment until late 2021.

The Cole Diagnostics Facebook page on Dec. 17, 2021, shared a photo of a large machine. “Our newest upgrade is now ready to provide excellent science and service to our community! Say hello to the Roche Cobas 6800!” the post said.

“What is its purpose?” someone asked in a comment on the post.

An employee of Cole Diagnostics responded that its purpose “is to continue some of our molecular testing and also automate Covid19 testing.”

Pure money, power, control, corruption, pure evil.

– Dr. Ryan Cole, in an April 21 video interview by The Epoch Times — remarking on public health vaccination efforts

The state in December 2020, a year earlier, had given Cole Diagnostics a subgrant for a total of $504,479. The Coronavirus Financial Advisory Committee had approved $3 million to increase COVID-19 testing. The grants to Cole amounted to about 17% of the available funds.

According to former employees and state records, Cole used some of that money to pay for machines that weren’t used for COVID-19 testing.

One machine — the PerkinElmer JANUS, for which the state paid Cole Diagnostics $125,000 — can automatically prepare test samples for analysis. But in practice at Cole Diagnostics, it didn’t work to prepare samples from nasal mucus, said one former lab technician. The technician declined to be named because he still works in local health care and is concerned about retribution.

“We never used it for COVID testing once,” he said, calling it “a giant, glorified … paperweight.”

The technician said he watched the lab manager “give a little presentation to the guy from the state with his clipboard, and I was like, ‘Are they really gonna take money for that? It … doesn’t work for COVID testing.’”

The subgrant agreement between Cole Diagnostics and the Idaho Department of Health and Welfare said the lab must follow a testing protocol using “the purchased Perkin-Elmer Chemagic RNA extractor, the Perkin-Elmer Janis (sic) liquid handler, and the Quiagen Quiagility PCR plater. This process has been internally validated and allows for increased throughput.”

The lab did not use that protocol, according to three former employees.

Payment data from Idaho Medicaid shows that Cole Diagnostics began charging the higher rate — for tests run on fully automated systems — in mid-July 2020.

The laboratory went from making $46.18 for each test it billed to Medicaid, to making $90 per test. (Idaho Medicaid pays a lower rate than Medicare.)

Lab staff raised concerns about the integrity of COVID-19 tests

Three of Cole’s former employees described a pattern of Cole taking shortcuts in the laboratory.

Andrea Winn noted that many of the patients for whom Cole Diagnostics processed COVID-19 tests were at high risk: nursing home residents, caregivers and health care workers.

“Given Dr. Cole’s public statements downplaying the severity of the virus, it makes sense that he was permissive of a lowered standard for testing,” Winn said. “He either did not believe, or refused to acknowledge, that bad results were of potentially high consequence to his patients and the public.”

Over time, employees said, Cole changed the threshold for what he considered a positive test result — moving that threshold below what the test manufacturer’s instructions required.

The test and machine Cole Diagnostics used — according to its application for state funding — has a “cycle threshold” set by the manufacturer and authorized by the FDA. It is 40 cycles. That means a test is positive if the machine has to run 40 or fewer cycles to identify COVID-19 genetic material.

Cole decided the laboratory would use a different threshold, former employees said.

“Now, all of those (test results) that would have been a positive were now called a negative,” Carter said. “That goes against the FDA (authorization for the test). We’re just not allowed to mess with that.”

At the “Global COVID Summit” in Garden City in February, Cole confirmed that.

Photo of speakers at an event in Garden City, Idaho.
Speakers gather for photos during the “Global COVID Summit” at a church in Garden City, Idaho. The speakers included Dr. Ryan Cole (third from left) and Dr. Robert Malone (third from right). (Screenshot from video)

The gold-standard test for COVID-19 — the polymerase chain reaction, or PCR — “is a phenomenal test if you use it correctly,” he told the audience. “Now, if you want to create a ‘casedemic,’ you set the cycles too high. … So, PCR, if you do cycle it above 35 cycles, then you start to get 80-, 90-plus percent false positive rates. So, in our lab, do we cycle it above 35? We don’t. It’s most accurate if you’re below 30 and symptomatic.”

The PCR test is considered the most accurate COVID-19 test because it can detect the coronavirus even at low levels, such as when the virus is just starting to invade cells and isn’t yet causing symptoms.

“I could stick a swab and anybody’s nose and detect tons of different viruses and bacteria. Doesn’t mean you’re a case of that disease; it means you’re carrying the organism …” Cole said at the summit.

Cole Diagnostics also would occasionally receive leaky COVID-19 test vials that no longer contained the liquid to preserve coronavirus RNA on a swab, according to all three former employees.

When a laboratory has reason to think a test might be flawed — for example, if the viral RNA wasn’t preserved — the “standard procedure” is for the lab to reject the sample and ask the health care provider to retest the patient and submit a new sample.

Photo of Ada County Commissioners interviewing Dr. Ryan Cole for an appointment to the Central District Health public health board, in summer 2021.
Ada County Commissioners interview Dr. Ryan Cole for an appointment to the Central District Health public health board, in summer 2021. (Screenshot from livestream)

Winn said procedures were lax when it came to maintaining the “integrity” of the tests — such as taking time to double check the patient’s name on a record, or ensuring that specimens were stored properly before they were processed.

But, according to the former employees, Cole wanted to run as many tests as possible, as fast as possible. He took shortcuts, they said.

“We were told to run specimens where we knew the integrity had been compromised, certainly,” Winn said.

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Two employees, in separate interviews, described being told the same words: “We’re not in the business of rejecting samples.”

For example, they noticed Cole pouring liquid into dried-out vials and running the tests with that “reconstituted” sample. Diluting an already compromised sample could have caused people with the virus to get false-negative test results, the former employees said.

The employees said Cole initially wrote on the lab test worksheets that the sample had been reconstituted with new liquid — then, later, he stopped doing that and instructed staff to stop documenting it as well.

Those records would be a red flag if a laboratory inspector saw them, employees said.

Cole Diagnostics passed its most recent inspection in February, according to federal and state records.

Carter said laboratories like Cole Diagnostics must follow certain protocols, because they have federal Clinical Laboratory Improvement Amendments, or CLIA, certification.

Deviating from the COVID-19 test instructions authorized by the Food and Drug Administration “requires extensive testing to show that the modified procedure does not affect the test results,” Carter said.

“Dr. Cole did not validate his alternative method” for trying to salvage dried-out test samples, nor did he go through the standard procedures for “redefining of a positive COVID test result by lowering the … threshold cutoff number,” Carter said. “… And to change the definition of (what defines a) positive test result without proper validation study violates CLIA accepted lab procedures. Every lab director knows this.”

Dr. Christopher Ball, bureau chief and laboratory director for the Idaho Bureau of Laboratories, confirmed in an interview with the Sun that tests must follow a manufacturer’s instructions.

“If a laboratory is using a system that has been authorized (by the FDA), then in general they need to” follow the manufacturer’s instructions, Ball said.

“If they wanted to change the manufacturer’s design parameters, then it would require a full revalidation of that manufacturer’s assay, and they would be producing a … laboratory-developed test,” which requires its own FDA authorization, he said, speaking in general and not about Cole Diagnostics.

Ball also confirmed that if there’s a question about “the integrity of the sample,” then a laboratory can’t confirm the accuracy of the results. The lab would normally reject that sample.

All three of Cole’s former employees in separate interviews described him working in the laboratory late into the night and appearing to work while very sleep-deprived. They would arrive at the lab in the morning and find mistakes Cole left behind that they had to correct, they said.

In the first few months of the pandemic, as Cole ramped up the laboratory’s COVID-19 test volume, the technicians got pressure from the company’s sales and accounting managers.

“There was a shift from everything being done meticulously and being an emphasis on patient care to, ‘We just need to hit these numbers,’” Winn said. “Even when concerns were presented to them … we were told, ‘Just push it through.’”

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Audrey Dutton
Audrey Dutton

Audrey Dutton, senior investigative reporter, joined the Idaho Capital Sun after 10 years at the Idaho Statesman. Her favorite topics to cover include health care, business, consumer protection issues and white collar crime. Dutton hails from Twin Falls. She attended college at Hamline University in St. Paul, Minnesota, and received a master's degree in journalism from Columbia University in New York City. Before coming home to Idaho, Dutton worked as a journalist in Minnesota, New York, Maryland and Washington, D.C. Dutton's work has earned dozens of state, regional and national awards for investigative reporting, health care and business reporting, data visualization and more.

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