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When It Comes to Monkeypox Testing, Clinical Laboratories Should Be Aware of Five Significant Developments

There are reports of phlebotomists refusing to draw monkeypox blood samples and social stigma surrounding the disease can affect who gets a medical laboratory test

Cases of monkeypox are increasing in the US—14,115 as of Aug. 19, up 1,400 from the prior week—and clinical laboratories around the country are bracing for a potential increase in monkeypox testing orders.

Several factors, however, are affecting the testing. Chief among them:

  • Lab workers refusing to take blood draws from potential monkeypox patients, and
  • Community clinics in some cities having to delay other care to deal with an onslaught of monkeypox test orders.

Here are five trends clinical laboratory leaders should be aware of that are influencing the state of monkeypox testing in the country.

Trend 1: Some Phlebotomists Refuse to Draw Possible Monkeypox Specimens

CNN reported that phlebotomists at two of the largest commercial laboratories—Labcorp and Quest Diagnostics—were either refusing or being told not to draw blood samples from suspected monkeypox patients.

“Labcorp and Quest don’t dispute that, in many cases, their phlebotomists are not taking blood from possible monkeypox patients,” according to CNN. “What remains unclear, after company statements and follow-ups from CNN, is whether the phlebotomists are refusing on their own to take blood or if it is the company policy that prevents them. The two testing giants say they’re reviewing their safety policies and procedures for their employees.”

In “Medical Laboratories Respond to Monkeypox Outbreak Using CDC-Developed Diagnostic Test,” Dark Daily noted that skin lesion swabbing, such as that necessary to perform the Orthopoxvirus PCR test, is the preferred method to check for monkeypox because of higher viral counts in the lesions. However, physicians may order follow-up blood tests for confirmed monkeypox patients, and suspected patients may need bloodwork as part of other routine care.

In an update posted on its website, Quest noted it has been testing swab specimens of skin lesions for monkeypox, but those swabs are performed by providers and not Quest. However, the company was also preparing to take blood draws of possible monkeypox patients in its patient service centers.

“Given that monkeypox has been declared a national public health emergency and the most recent CDC guidance, we are now implementing procedures to safely enable patients with suspected or confirmed monkeypox infection into our patient service sites for phlebotomy blood draws and other non-swab specimen collections,” Quest stated. “This approach will enable patients with suspected or confirmed monkeypox infections to receive additional testing they may need.”

Trend 2: Guidance Is Available to Help Lab Workers Avoid Monkeypox Infection

The CDC has posted guidance to maintain infection control around suspected monkeypox specimens. Among the steps noted by the agency:

  • Lesion specimens from patients suspected of having monkeypox will carry the highest quantity of the virus. When possible, lab workers that have a smallpox vaccination from within the last three years should handle these specimens. Smallpox vaccination also protects from monkeypox in many cases. Unvaccinated workers who test suspected monkeypox specimens need to take extra precautions, such as wearing a buttoned lab coat, gloves, and face protection, and avoiding splashes, the CDC stated.
  • Blood specimens draw from suspected monkeypox patients will have a low quantity of the virus. Lab workers testing these specimens do not need to be vaccinated for monkeypox, but standard precautions should be followed.
  • Before using automated testing platforms with suspected monkeypox specimens, labs should conduct a risk assessment to identify potential hazards.

Trend 3: Monkeypox Testing Gains an Early Social Stigma

Some people who need to be tested for monkeypox may be hesitant to seek out a medical laboratory or patient service center because of a stigma being attached to the disease.

Although it does not match the early hysteria associated with HIV infections in the 1980s—in a 1987 poll, 60% of respondents said AIDS patients should carry a card identifying them as such, Gallup noted—there have been clear instances where people and agencies have associated monkeypox infection with men having sex with other men.

“The focus for all countries must be engaging and empowering communities of men who have sex with men to reduce the risk of infection and onward transmission, to provide care for those infected, and to safeguard human rights and dignity,” Tedros Adhanom Ghebreyesus, PhD, the Director-General at the World Health Organization, said in a July 27 media briefing.

Ghebreyesus added that while 98% of monkeypox infections have been among men who have sex with men, anyone can get the disease, including children.

Tedros Adhanom Ghebreyesus, PhD

“Stigma and discrimination can be as dangerous as any virus, and can fuel the outbreak,” said Tedros Adhanom Ghebreyesus, PhD (above), Director-General at the World Health Organization (WHO), in a media briefing. Clinical laboratories would be wise to prepare for a marked increase in demand for monkeypox testing. (Photo Copyright: WHO/Christopher Black.)

“Men who have sex with men have been hit the hardest by monkeypox to date, but LGBTQ+ health advocates say improper messaging risks branding monkeypox as a ‘gay disease,’ eroding effective preventive measures and allowing the virus to spread,” Bloomberg Law reported.

Further, while many Americans are aware of monkeypox, a significant number don’t know enough about the disease, according to survey results from the Annenberg Public Policy Center of the University of Pennsylvania.

For example, 66% of respondents either were not sure or did not believe there is a vaccine for monkeypox.

Trend 4: Workers Who Refuse to Test Patients for Monkeypox Face Possible Backlash

Some medical professionals have raised concerns about healthcare workers being unwilling to test monkeypox patients.

“This is absolutely inexcusable. It’s a grave dereliction of duty,” David Harvey, Executive Director of the National Coalition of STD Directors, told CNN. The group represents sexually transmitted disease (STD) directors at public health departments in the US.

“For every single patient that walks [through] your door, you use universal precautions because every disease doesn’t have a phenotype or outward appearance, so you have to treat everyone exactly the same,” Garfield Clunie, MD, president of the National Medical Association and Assistant Professor of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai, told Bloomberg Law. “You can’t treat someone differently because of their sexual orientation, or race, or gender, or for any other reason.”

Trend 5: Public Clinics Show Early Signs of Monkeypox Testing Pressure

A survey of 80 public health departments conducted by the National Coalition of STD Directors indicated that some sites may already be getting overwhelmed by demand for monkeypox testing.

According to the survey results, 79% of public health clinics saw an increased demand for monkeypox testing over the past four weeks. In a troubling aspect, 28% of clinics said they could not meet testing demand if it increases.

Further, 22% of clinics have reduced screenings for other STDs to prioritize monkeypox testing. Such moves likely delay patients from receiving other care they need.

Clinical laboratories may want to take note of the survey findings. The pressure public health clinics currently face could be a precursor to similar problems at labs if demand for monkeypox testing grows.

Scott Wallask

Related Information:

Some Lab Techs Refuse to Take Blood from Possible Monkeypox Patients, Raising Concerns about Stigma and Testing Delays

NCSD Releases Second Survey of Clinic Capacity in Monkeypox Response

AIDS Echoes in Monkeypox Messages Worry LGBTQ Health Advocates

WHO Director-General’s Opening Remarks at the COVID-19 Media Briefing—27 July 2022

CDC: Laboratory Procedures and Biosafety Guidelines

CDC: Monkeypox and Smallpox Vaccine Guidance

Gallup Vault: Fear and Anxiety During the 1980s AIDS Crisis

Quest Diagnostics Media Statement about COVID-19 and Monkeypox Testing

Medical Laboratories Respond to Monkeypox Outbreak Using CDC-Developed Diagnostic Test

Labcorp monkeypox testing information

WHO fact sheet on monkeypox

Medical Laboratories Respond to Monkeypox Outbreak Using CDC-Developed Diagnostic Test

The federal agency shipped tests to five commercial clinical laboratory companies, augmenting efforts by public health labs

Medical laboratories in the US are ramping up their efforts to respond to an outbreak of monkeypox that has been spreading around the globe. Microbiologists and clinical laboratory scientists will be interested to learn that this infectious agent—which is new to the US—may be establishing itself in the wild rodent population in this country. If proved to be true, it means Americans would be at risk of infection from contact with rodents as well as other people.

The Centers for Disease Control and Prevention (CDC) announced on May 18 that it had identified the infection in a Massachusetts resident who had recently traveled to Canada. As of August 3, the federal agency was reporting 6,617 confirmed cases in the US.

Soon after the CDC’s initial announcement, public health labs belonging to the CDC’s Laboratory Response Network (LRN) were testing for the infection, according to an Association of Public Health Laboratories (APHL) press release. The LRN uses a CDC-developed test designed to detect Orthopoxviruses, the family that includes the monkeypox virus.

“Because there are no other non-variola orthopoxviruses circulating in the US, a positive test result is presumed to be monkeypox,” states the APHL press release.

Chris Mangal
“As we focus on the US response, we keep a close watch on the global outbreak. Infectious diseases don’t respect borders, as we know,” said Chris Mangal (above), director of public health preparedness and response, APHL, in a press release. “I am proud of how LRN member laboratories have rapidly and effectively responded to this emergency. This is precisely what the LRN was intended to do. Should this outbreak continue to grow, preparing for expanded testing and increasing capacity beyond LRN laboratories is important to ensuring we are ready for a surge in testing.” (Photo copyright: Association of Public Health Laboratories.)
 

 

Commercial Labs Get Involved

Seeking to bolster testing capacity, the federal Department of Health and Human Services (HHS) announced on June 22 that the CDC had begun shipping Orthopoxvirus PCR tests to five commercial lab companies. They include:

“By dramatically expanding the number of testing locations throughout the country, we are making it possible for anyone who needs to be tested to do so,” said HHS Secretary Xavier Becerra in an HHS press release.

Labcorp was first out of the gate, announcing on July 6 that it was offering the CDC-developed test for its customers, as well as accepting overflow from public labs. “We will initially perform all monkeypox testing in our main North Carolina lab and have the capacity to expand to other locations nationwide should the need arise,” said Labcorp chief medical officer and president Brian Caveney, MD, in a press release.

Mayo Clinic Laboratories followed suit on July 11, announcing that the clinic’s Department of Laboratory Medicine and Pathology would perform the testing at its main facility in Rochester, Minnesota.

“Patients can access testing through Mayo Clinic healthcare professionals and will soon be able to access testing through healthcare professionals who use Mayo Clinic Laboratories as their reference laboratory,” Mayo stated in a press release.

Then, Quest Diagnostics announced on July 13 that it was testing for the virus with an internally developed PCR test, with plans to offer the CDC test in the first half of August.

The lab-developed test “was validated under CLIA federal regulations and is now performed at the company’s advanced laboratory in San Juan Capistrano, Calif.,” Quest stated in a press release.

Public Health Emergency?

Meanwhile, the CDC announced on June 28 that it had established an Emergency Operations Center to respond to the outbreak. A few weeks later, on July 23, World Health Organization (WHO) Secretary-General Tedros Adhanom Ghebreyesus, PhD, declared that the outbreak represented “a public health emergency of international concern.”

He noted that international health regulations required him to consider five elements to make such a declaration.

“WHO’s assessment is that the risk of monkeypox is moderate globally and in all regions, except in the European region where we assess the risk as high,” he said in a WHO news release. “There is also a clear risk of further international spread, although the risk of interference with international traffic remains low for the moment. So, in short, we have an outbreak that has spread around the world rapidly, through new modes of transmission, about which we understand too little, and which meets the criteria in the International Health Regulations.”

Still, public health authorities have made it clear that this is not a repeat of the COVID-19 outbreak.

“Monkeypox virus is a completely different virus than the viruses that cause COVID-19 or measles,” the CDC stated in a June 9 advisory. “It is not known to linger in the air and is not transmitted during short periods of shared airspace. Monkeypox spreads through direct contact with body fluids or sores on the body of someone who has monkeypox, or with direct contact with materials that have touched body fluids or sores, such as clothing or linens. It may also spread through respiratory secretions when people have close, face-to-face contact.”

The New York Times reported that some experts disagreed with the CDC’s assessment that the virus “is not known to linger in the air.” But Professor of Environmental Health Donald Milton, MD, DrPH, of the University of Maryland, told The Times it is still “not nearly as contagious as the coronavirus.”

The Massachusetts resident who tested positive in May was not the first known case of monkeypox in the US, however, previous cases involved travel from countries where the disease is more common. Two cases in 2021—one in Texas and one in Maryland—involved US residents who had recently returned from Nigeria, the CDC reported. And a 2003 outbreak in the Midwest was linked to rodents and other small mammals imported to Texas from Ghana in West Africa.

Testing Procedures

The CDC has issued information for healthcare professionals, including guidelines for specimen collection, along with information for laboratory personnel who may be testing the specimens.

CNN reported on Aug. 4 that phlebotomists who work for Quest and Labcorp have refused to draw blood from suspected monkeypox patients.

“Labcorp and Quest don’t dispute that in many cases, their phlebotomists are not taking blood from possible monkeypox patients,” according to CNN. “What remains unclear, after company statements and follow-ups from CNN, is whether the phlebotomists are refusing on their own to take blood or if it is the company policy that prevents them. The two testing giants say they’re reviewing their safety policies and procedures for their employees.”

One symptom of monkeypox, the CDC states, is a rash resembling pimples or blisters. Clinicians are advised that two swabs should be collected from each skin lesion, though “procedures and materials used for collecting specimens may vary depending on the phase of the rash.”

“Effective communication and precautionary measures between specimen collection teams and laboratory staff are essential to maximizing safety when manipulating specimens suspected to contain monkeypox virus,” the CDC notes. “This is especially relevant in hospital settings, where laboratories routinely process specimens from patients with a variety of infectious and/or noninfectious conditions.” 

Perhaps the negative reaction to the CDC’s initial response to the COVID-19 outbreak in the US is driving the federal agency’s swift response to this new viral threat. Regardless, clinical laboratories and pathology groups will play a key role in the government’s plan to combat monkeypox in America.

Stephen Beale

Related Information:

CDC: Monkeypox

CDC and Health Partners Responding to Monkeypox Case in the US

CDC Activates Emergency Operations Center for Monkeypox Response

HHS Expanding Monkeypox Testing Capacity to Five Commercial Laboratory Companies

Labcorp to Begin Monkeypox Testing Today, Doubling Nationwide Testing Capacity

Labcorp First National Laboratory to Offer Monkeypox Test

Monkeypox (Orthopoxvirus), DNA, PCR Test

Mayo Clinic Laboratories to Begin Monkeypox Testing Today, Increasing Nationwide Testing Capacity

Mayo Clinic Laboratories Launches Monkeypox Test to Increase Access, Availability

Quest Now Offers a Test to Detect Monkeypox Virus DNA, Delivering Faster Answers for You and Your Patients

Quest Diagnostics to Begin Monkeypox Testing Today, Increasing Nationwide Testing Capacity

Quest Diagnostics Launches Monkeypox Virus Testing

APHL Supports Public Health Response to Monkeypox, Phased Expansion of Testing

World Health Organization: Monkeypox

Second Meeting of the International Health Regulations (2005) (IHR) Emergency Committee regarding the Multi-Country Outbreak of Monkeypox

WHO Director-General’s Statement at the Press Conference Following IHR Emergency Committee Regarding the Multi-Country Outbreak of Monkeypox

CDC Dismisses Airborne Transmission of Monkeypox. Some Experts Disagree.

We Let Monkeypox Spread for Too Long. If It Infects Our Pets, There’s No Getting Rid of It

Ireland’s ‘CervicalCheck’ Cancer Screening Program Remains Plagued by Controversy Despite Reform Efforts

Two US clinical laboratories providing testing for the problem-laden program have been targets of lawsuits from women who allege their smear test results were misread

In Ireland, the nation’s health service continues to deal with the consequences from problems with its “CervicalCheck” service that is designed to provide timely screening for the early detection of cervical cancer. It became a national scandal when the news media learned that a number of women had received diagnoses of terminal cervical cancer due to failings in the screening program.

Throughout 2021, news reports have called attention to the efforts of the publicly-funded Health Service Executive (HSE) to regain the trust of women in that country. Earlier this year, TheJournal.ie wrote “the CervicalCheck controversy has been a complex and emotional series of tragedies and mistakes that damaged what is an important, free public health measure for women that could, along with the HPV vaccine, eradicate cervical cancer.” 

This ongoing controversy provides cytopathologists and medical laboratory leaders in the US with yet another example of how easily trust in clinical laboratories can be lost when patients lose confidence in the accuracy of test results.

Missed Cancer Results in Nearly $3 Million Settlement

First launched in 2008, Ireland’s CervicalCheck program aimed to screen all Irish women between the ages 25 to 60 for cervical cancer. However, due to a claimed lack of in-house gynecological cytology testing capacity, Ireland’s HSE outsourced the nation’s entire caseload to two lab companies: New Jersey-based Quest Diagnostics and Sonic Healthcare’s Texas-based Clinical Pathology Laboratories (CPL), which received the majority of Irish Pap smear screenings for review.

A decade later, the public became aware of serious misdiagnoses involving the CervicalCheck program. In “Pap Test Errors in Ireland Attributed to Quest, CPL,” Dark Daily’s sister publication, The Dark Report (TDR), noted that 209 women in Ireland had been misdiagnosed in the nation’s cervical cancer screening program.

Concerns about the CervicalCheck program came to light in April 2018 when Vicky Phelan settled a €2.5 (US$2.9) million lawsuit with Ireland’s HSE and with US-based CPL. Phelan had been told that her 2011 Pap smear test result indicated no abnormalities. But a second test three years later revealed she had cervical cancer.

And though CervicalCheck discovered the 2011 false negative result during an internal review, neither the service nor her physician informed Phelan about the error until 2017.

During the Irish High Court proceedings, RTE, Ireland’s national public service media, reported that Phelan’s lawyers argued their client would have had a 90% chance of survival if she had received treatment in 2011.

HSE and CPL settled the lawsuit without admission of liability.

Additional Screenings Identify Hundreds of ‘Suboptimal Colposcopy’ Test Results

Following the Phelan settlement, Ireland’s CervicalCheck released a statement announcing its review of screening tests for 1,482 women diagnosed with cervical cancer between 2008 and 2018. That review identified 208 women whose “screening test could have provided a different result or a warning of increased risk or evidence of developing cancer.”

Of those 208 women, 162 had not been alerted about earlier audits revealing errors affecting their results.

Since then, 308 of the 1,034 women who participated in the program have been identified by a 2019 government-mandated review conducted by the Royal College of Obstetricians and Gynaecologists (RCOG) as having “a different cytology result from the original CervicalCheck result,” an Irish government press release noted.

The RCOG made recommendations for improvements but concluded “the small minority of cases in which suboptimal colposcopy contributed to a missed opportunity to prevent or diagnose a cancer at an earlier stage is probably inevitable when cases that end in cancer are reviewed, but this should not be taken to conclude that colposcopic practice in the CervicalCheck program is substandard.”

Women’s Trust in Ireland’s Cancer-Screening Program Is Broken

The Irish government established the CervicalCheck Tribunal in 2019 to provide the women with an alternate system for adjudicating claims.

However, in “The CervicalCheck Controversy: How a Vital Cancer Screening Service Is Fighting to Regain the Trust of Women,” online Irish news site TheJournal.ie reported that women’s trust in the screening program remains broken due to simmering CervicalCheck controversies.

“Though a 2019 review of Ireland’s cervical screening program found that it was in line with international standards, questions remain about how the service communicates with women who use it, the State’s method of procuring laboratories, and how to regain trust after waves of scandals,” TheJournal.ie wrote.

According to TheJournal.ie, the “issue at the heart of the CervicalCheck controversy” is HSE’s advice to doctors to not routinely provide smear test audit results to affected patients, but instead to “use their judgement in selected cases where it is clear that discussion of the outcomes of the review could do more harm than good.”

In “Cervical Cancer Controversy: ‘Why Are They Fighting These Women So Badly?’,” The Irish Times pointed out that justice has been elusive for the women whose lives have been lost or damaged by the CervicalCheck debacle. Women who die before their cases are concluded, the paper reported, lose any entitlement to general damages (approximately $587,000), though their families can seek damages for loss of a parent or spouse.

Lorraine Walsh and Vicky Phelan

“Why are they fighting these women so badly and making them spend the last few months of their lives fighting for justice for themselves and their children?” asked Lorraine Walsh (on left, with Vicky Phelan on right), a CervicalCheck survivor whose successful, but invasive, treatments for cervical cancer have left her unable to have children. “We have seen how [the late] Ruth [Morrissey] and Vicky [Phelan] and [the late Emma Mhic Mhathúna], and lots of others, have really been put through the mill in the High Court, and we are all wondering if we have to go through that torture just to get justice out of this,” Walsh told The Irish Times. (Photo copyright: The Irish Times.)

Are Women in the US in Danger?

Cian O’Carroll, a solicitor specializing in medical negligence and personal injury law who represents more than 60 CervicalCheck plaintiffs, maintains that women in the US should be concerned about the quality of their laboratory test results as well.

“In quite a number of cases we’re looking at, there are multiple errors,” he told CBS News, adding, “Not only did they get the tests wrong, but they got them very, very wrong.”

The CervicalCheck controversy highlights how quickly a health system and clinical laboratories can lose the trust of the patients they serve. Both Quest Diagnostics and Sonic’s Clinical Pathology Laboratories found themselves in an unwelcome news spotlight in Ireland, given their participation in a cervical cancer screening system that failed in multiple ways the women it was designed to serve.

These events are a reminder to other medical laboratories and pathology groups that accuracy of results is paramount to keeping the trust of patients and healthcare consumers. When a patient’s trust is lost, it is difficult if not nearly impossible to regain.

Andrea Downing Peck

Related Information

The CervicalCheck Controversy: How a Cancer Screening Service Is Fighting to Regain the Trust of Women

CervicalCheck Statement—1st May 2018

CervicalCheck Tribunal Act 2019

Minister for Health Publishes Report of the Independent Expert Panel Review of Cervical Screening

Cervical Cancer Controversy: Why Are They Fighting These Women So Badly

€2.5m Settlement for Terminally Ill Woman Whose Cancer Was Missed

Irish Smear Scandal: Woman Who Highlighted Failures Dies

State Did Not Apologize to Ruth Morrissey ‘Now It Is Too Late,’ Says Husband After Her Death

Patient Representative Lorraine Walsh Resigns from CervicalCheck Steering Committee

Expert Panel Review of Cervical Screenings

CervicalCheck: Leo Varadkar Offers State Apology to 1,000 Women

Lab Companies Quest and CPL at Center of Lawsuits in Ireland Over Missed Cervical Cancer Diagnoses

Pap Test Errors in Ireland Attributed to Quest, CPL

What It Means to Be a Clinical Laboratory Whistleblower Outlined in Newly Released ‘Tell-All’ Book by Lab Executive Chris Riedel

Book provides detailed road map for clinical laboratory professionals who believe they have a valid case to file under the federal qui tam statute, as well as lab owners who want to understand what motivates whistleblowers and what practices to avoid

Several high-profile whistleblower cases uncovering massive fraud have shocked the clinical laboratory industry over the past decade. Media coverage nearly always focuses on the court battle and subsequent renderings of justice. But little is written about what it is like to be a whistleblower who wants to hold a medical laboratory accountable for alleged violations of federal and state laws.

Now, a new “tell-all” book penned by Chris Riedel, a whistleblower who owned a clinical laboratory company in California, details the exploits of clinical laboratory whistleblowers over the past 15 years. The intriguing white-collar crime thriller, titled, “Blood Money: One Man’s Bare-Knuckle Fight to Protect Taxpayers from Medical Fraud,” outlines Riedel’s battle with major clinical laboratory players—including the so-called “Blood Brothers” Labcorp (NYSE:LH) and Quest Diagnostics (NYSE:DGX)—to expose medical laboratory fraud.

‘Most Whistleblowers Get Absolutely Destroyed’

The book takes the reader on a gripping journey into extortion, money laundering, attempted murder, buried gold in a CEO’s backyard, fraudsters hiding money in the Cayman Islands, and, according to the author, an Assistant Attorney General sabotaging her own state’s case and a corrupt state Governor who undermined litigation by his own Attorney General.

“I wrote it to be a true crime thriller, so I’m hoping people who love thrillers will enjoy it as a true crime story,” Riedel said in an exclusive interview with Dark Daily. “For anyone who’s considering filing a whistleblower lawsuit, this is an absolute must read.

“Most whistleblowers get absolutely destroyed,” he explained. “When companies find out who’s trying to attack their business model, they do everything they can to destroy the whistleblower’s life. Many end up bankrupt, unemployable, and divorced.

“There are things you can do to protect yourself and I list those in my rules for whistleblowers. I hope enough people will read it—particularly in Congress and maybe the Department of Justice (DOJ)—to put pressure on the DOJ to change their behavior. They are far too willing to accept what they call ‘affordable civil settlements’ as opposed to punishing companies and people for their theft,” Riedel said.

Chris Riedel


Chris Riedel (above) has worked in the healthcare industry as an executive and an entrepreneur for more than 40 years. He founded five companies, including two medical laboratories and a cardiovascular disease management company. For the past 15 years, he has been tirelessly working to fight against medical companies that are defrauding US taxpayers. His actions have resulted in a court verdict and settlements totaling more than $550 million. (Photo copyright: Leadership Books.)

Riedel became a whistleblower in 2005 when he filed a case under California law that was sealed until 2009. Jerry Brown, California Attorney General at that time, joined the case and unsealed it.

Riedel had acted after his sales representatives informed him that his company, Hunter Laboratories, needed to come up with a way to compete against larger labs’ pricing to survive. Knowing the test-price-discounting practices transpiring within the lab industry in California, Riedel determined he had three choices:

  • Violate federal and state laws to compete,
  • Close his business, which would cause him to lay off more than 150 employees and lose most of his life’s savings, or
  • Try to stop the other companies from participating in fraudulent practices.

“It is very frustrating for honest CEOs of clinical labs to see that they cannot compete well against those lab companies employing fraudulent schemes. Rather than compete on the quality of service of their products as honest companies do, fraudsters compete based on the value of their illegal inducements,” he states on his website. “I felt the pain that many other honest CEO’s and lab owners have had to endure as they try to compete with fraud and watch their life’s work destroyed.”

He chose to try leveling the playing field for all labs and stop taxpayers from being fleeced. After filing that first whistleblower lawsuit in California in 2005, he later filed similar whistleblower lawsuits in other states that had statutes defining how labs were to price lab tests for their Medicaid programs.

Riedel encountered many roadblocks and frustrations during the initial lawsuit, including some genuinely frightening moments. He described one such experience for Dark Daily.

“Quest and Labcorp together went to Blue Shield of California, a major insurance company, and they got our clinical lab kicked out of network. They offered Blue Shield a 10% discount on all their laboratory testing if they would kick Hunter Laboratories out of network,” Riedel explained. “Since [Quest and Labcorp] represented about 70% to 80% of the total outpatient laboratory testing for Blue Shield, it was too good for this insurer to pass up.

“When your lab loses a major insurance carrier like that, you can’t survive. What doctor is going to want to start with a clinical lab that doesn’t have Blue Shield? And existing clients don’t want to subject their patients to having much higher out-of-pocket expenses.

“From that point on, it was like a dagger in our heart,” he added. “We were literally two weeks away from both corporate and personal bankruptcy when we reached our historic settlement with Quest. Had it not been for that settlement, our 150 employees would have lost their jobs, we would have lost our house, and we would have been completely bankrupt. That was very scary, and I had a very hard time dealing with it.”

Uncovering Medical Laboratory Fraud

While performing his research for the whistleblower case, Riedel was astonished by the information and fraud he discovered.

“There was one point where we had to prove that Quest and Labcorp were passing out discounts to some clients that were at or below cost, without giving those same prices to the Medi-Cal program, as required by state law at that time,” Riedel explained. “I personally reviewed over a million documents. It took more than five years, but it was worth it.

“I eventually found three documents that exposed the complete fraud by Quest. These documents showed what Quest had billed Medi-Cal, how much money the company lost client billing and capitation contracts, and how much business they ‘pulled through’ from the government and insurance payers that made up for the staggering losses on deeply discounted client and capitated billing. That was like the silver bullet.”

In the process, Riedel also discovered what it was like to work with the federal Department of Justice.

“The DOJ hates people who file more than one whistleblower lawsuit,” he added. “They don’t like the statute to begin with, and they barely tolerate whistleblowers, so when they find someone who does it time and again, they really don’t like it.”

"Blood Money"

“Blood Money” (above) contains practical advice and suggestions that are useful for both clinical laboratory executives and pathologists who want to keep their lab operations compliant with federal law, thus not giving whistleblowers any issues to pursue a qui tam lawsuit, as well as lab whistleblowers who observe violations within their clinical labs—or at competing labs—and who want to do something that may rectify the situation. (Photo copyright: Chris Riedel.)

Riedel is considering writing a second book and is trying to decide which qui tam lawsuits will provide the best subject matter.

“I am currently investigating what would be a multi-billion-dollar lawsuit against an insurance company and that is going to be, by far, the biggest of the cases I have ever been involved in. That might make a good book all by itself,” he said.

Riedel finds his work fighting fraud against the government rewarding and plans to continue his efforts in the future.

“Even though it’s risky—and the book details how my life was almost destroyed when the Blood Brothers counter attacked—I enjoy the investigative work and legal challenges. For me, it is very fulfilling, and I am proud to carry the torch for taxpayers,” he says in a statement on his website.

The 368-page book should be of interest to clinical laboratory personnel, healthcare professionals, those considering becoming a whistleblower, and basically anyone involved in medical laboratory testing.

—JP Schlingman

Related Information

An Interview with Whistleblower and Author, Chris Riedel

Chris Riedel Massive Health Care Fraud and the Importance of Whistleblowing

Health Diagnostic Laboratory Files for Bankruptcy after Settlement with Government

National Group Names Riedel “Whistleblower of the Year”

Senators Baucus and Grassley Want Documents from Quest Diagnostics and Labcorp Relating to Discounted Medical Lab Test Pricing Practices

Bio-Reference Laboratories Acquires Hunter Laboratories as a Way to Enter California’s Competitive Clinical Laboratory Marketplace

Walmart, Quest Diagnostics, and DroneUp Collaborate on Pilot Project to Deliver COVID-19 Laboratory Tests to Consumers in Select Cities

Coronavirus pandemic expected to spur wider acceptance of drone delivery services for clinical laboratory specimens and medical supplies

Routine delivery of clinical laboratory specimens and medical supplies by drone moved one step closer to reality with news that Walmart (NYSE:WMT), Quest Diagnostics (NYSE:DGX), and DroneUp of Virginia Beach, Va., are partnering to bring at-home self-collection COVID-19 test kits to residents of several areas hard hit by the COVID-19 pandemic.

In its race to keep pace with online retailer Amazon (NASDAQ:AMZN), Walmart last September implemented two drone-delivery trials. One, according to Progressive Grocer, is with Tel Aviv, Israel-based drone company Flytrex, to deliver select grocery and household essentials in and around Fayetteville, N.C. The other trial program is with drone company Zipline of San Francisco, to test delivery of certain health and wellness products to areas around Walmart’s headquarters in Bentonville, Ark., Progressive Grocer also reported.

Then, Walmart announced a third pilot project for home delivery—one that could potentially affect clinical laboratories. This time, in collaboration with Quest and DroneUp, Walmart is piloting delivery of at-home COVID-19 collection kits in North Las Vegas, and Cheektowaga, New York, a Walmart news release stated.

Is this yet another example of how the COVID-19 pandemic will continue to drive shifts in delivery of key healthcare services? Probably.

According to Walmart’s news release, “Patients who qualify for drone delivery of the COVID-19 self-collection kits must live in a single-family residence within a 1-mile radius of the designated [Walmart] Supercenters in North Las Vegas and Cheektowaga. The kits will land on the driveway, front sidewalk, or backyard of the customer’s home, depending on where there are cars and trees. There is no delivery or kit cost for customers electing to receive an at-home [COVID-19] kit delivered via drone. Once the kits are delivered, the person will perform a self-administered nasal swab in the privacy of their home and send their sample back to Quest Diagnostics for testing using the included prepaid shipping label.”

Walmart’s home delivery service of at-home COVID-19 test kits video screenshot
Click the image to watch the short video that demonstrates Walmart’s home delivery service of at-home COVID-19 test kits. Clinical laboratories in these areas may wonder how Walmart’s new drone-delivery service will impact their own specimen delivery programs. (Photo/video copyright: Walmart.)

The giant retailer’s expanding use of drone delivery systems will likely lead to greater acceptance among consumers of unmanned aerial vehicles for delivering all sorts of personal items, as well as various types of clinical laboratory specimens. If consumers embrace drone delivery systems, clinical laboratories with existing courier and logistics networks may experience another disruption in how they do business.

In a news release following the announcement of a yet another drone-delivery service of COVID-19 at-home test kits—this time in El Paso, Texas,—Amanda Jenkins, Vice President of Operation Support and Implementation, Walmart US Health and Wellness, said, “Walmart has been serving the El Paso community throughout the pandemic with drive-thru testing sites and extended testing hours, and we wanted to provide another way to access testing that provides convenience and leverages technology, while learning how drones could impact the delivery of healthcare in the future,” KTSM-9 TV reported.

Drone Delivery Systems Worldwide for Healthcare

The United States is not the only country turning to drone technology to speed deliveries and reduce person-to-person contact during the pandemic. A World Economic Forum blog post outlined the critical role drones are playing in China, the world’s most populated country, as it responds to the health crisis.

“At the moment of life and death, the air transport network can significantly confine the flow of people, avoid unnecessary physical contact, and prevent secondary transmission,” Lv Yinxiang, Secretary of the Party Committee of the County People’s Hospital, said in the blog post. “Medical samples delivered through air can shrink the delivery time … while saving precious field resources.”

Amazon also is predicting a bright future for drone delivery of all types of goods. In August, Amazon’s Prime Air drone delivery service received approval from the Federal Aviation Administration (FAA) to operate its fleet of drones, CNBC reported. Amazon launched its drone project in 2013 and began the process of seeking FAA approval in 2019.

In “UPS Expands Drone Delivery Service for Transporting Clinical Laboratory Specimens Across Healthcare Systems to Include Delivering Prescriptions from CVS Pharmacy to Customers’ Homes,” Dark Daily reported on UPS’ plans to become a major player in healthcare’s use of drones by partnering with CVS Health to not only transport clinical laboratory specimens, but also make pharmacy deliveries to customers’ homes.

And in “WakeMed Uses Drone to Deliver Patient Specimens,” Dark Daily’s sister publication, The Dark Report (TDR), reported on UPS’ launch of a drone delivery service on the WakeMed Health and Hospitals medical campus in Raleigh, N.C. The implementation followed a two-year test period during which UPS used drones manufactured by Matternet of Menlo Park, Calif., to fly clinical laboratory specimens from a medical complex of physicians’ offices to the health system’s clinical laboratory.

COVID-19 Pandemic Drives Drone Delivery System Development

Tom Ward, Walmart’s Senior Vice President for Customer Product, predicts the drone delivery systems being rolled out during the COVID-19 pandemic will increase the use of contactless delivery for all types of deliveries, not just healthcare.

“There’s a lot we can learn from our drone delivery pilots to help determine what roles drones can play in pandemic response, healthcare delivery, and retail,” he said in the Walmart news release. “We hope drone delivery of self-collection kits will shape contactless testing capabilities on a larger scale and continue to bolster the innovative ways Walmart plans to use drone delivery in the future.”

The widespread use of drone technology appears to be soaring to new heights as the COVID-19 pandemic moves forward into the new year. Clinical laboratory managers will want to keep their eyes on the skies as this new delivery system becomes more commonplace and potentially disrupts the way laboratory specimens traditionally have traveled to and from medical laboratories.

—Andrea Downing Peck

Related Information:

Walmart, Quest Diagnostics and DroneUp Pilot COVID-19 At-Home Self-Collection Kit Delivery in Cheektowaga, New York

Walmart Adds Even More Fuel to Drone Delivery

Walmart, Quest Diagnostics and DroneUp Pilot Drone COVID-19 At-Home Self-Collection Kit Delivery in North Las Vegas

Walmart Now Piloting Drone Delivery of COVID-19 At-Home Self-Collection Kits

3 Ways China Is Using Drones to Fight Coronavirus

Amazon Wins FAA Approval for Prime Air Drone Delivery

UPS Expands Drone Delivery Service for Transporting Clinical Laboratory Specimens Across Healthcare Systems to Include Delivering Prescriptions from CVS Pharmacy to Customers’ Homes

WakeMed Uses Drone to Deliver Patient Specimens

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