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Johns Hopkins Researchers Determine 795,000 Americans Harmed from Diagnostic Errors Annually

Clinical laboratories can play a critical role in helping doctors to order correct tests and interpret the results

Nearly 800,000 Americans die or are permanently disabled each year due to diagnostic errors. That’s according to research conducted at Johns Hopkins School of Medicine that found most misdiagnoses are due to cognitive errors on the part of the treating physicians. Many diagnoses typically begin with–and are often achieved through—clinical laboratory testing. For that reason, the range of diagnostic errors identified in this study will interest pathologists and lab managers.

Of course, many types of diagnostic errors have nothing to do with lab tests. That said, the research team noted that some diagnostic errors take place when physicians do not pay attention to test results that indicate a patient is not doing well, or do not understand the significance of the test results. There are also examples where doctors order the wrong lab tests for patients’ symptoms.

The Johns Hopkins study findings were published in the journal BMJ Quality and Safety titled, “Burden of Serious Harms from Diagnostic Error in the USA.” The research team determined that only 15 diseases “accounted for 50.7% of total serious harms” and nearly 40% of those harms involved just five medical conditions:

These can be narrowed down even further to just three categories, the researchers noted in BMJ Quality and Safety. They are:

  • Major vascular events,
  • Infections, and
  • Cancers.

In an interview with CNN Health, lead author of the study David Newman-Toker, MD, PhD, a neurology professor at Johns Hopkins and Director of the Division of Neuro-Visual and Vestibular Disorders, said “These are relatively common diseases that are missed relatively commonly and are associated with significant amounts of harm.”

David Newman-Toker, MD, PhD

“We focused here on the serious harms, but the number of diagnostic errors that happen out there in the US each year is probably somewhere on the order of magnitude of 50 to 100 million,” neurologist David Newman-Toker, MD, PhD (above), professor and Director of the Division of Neuro-Visual and Vestibular Disorders at Johns Hopkins, who led the study, told STAT. “If you actually look, you see it’s happening all the time.” Clinical laboratories play a key role in ensuring correct understanding of the tests they perform. (Photo copyright: Johns Hopkins University.)

Changes to Healthcare Risk Management

According to Newman-Toker, the Johns Hopkins study is “the first population health estimate of the number of patients seriously harmed. It also provides more information about the distribution of the diseases that are involved,” Relias Media reported.

The sheer volume of this issue is not lost on the researchers. Newman-Toker likens it to measuring an iceberg.

“You dive below the surface, and you measure the circumference of the iceberg, and [you] will say, ‘Oh my gosh, it’s really big down here.’ And then you go five more feet, and you measure the circumference, and it keeps getting bigger. By the time you’re 20 feet below the surface, you realize this is huge,” he told Relias Media.  

Newman-Toker believes his team’s research offers an opportunity for physicians and healthcare risk managers to better understand how exactly to prioritize their resources and focus their efforts. “In terms of how it informs their day-to-day decision-making, it really is rebalancing some of the efforts a little bit in the direction of conditions that are more common and more commonly misdiagnosed than perhaps indicated by simply looking at claims data,” he noted.

Vascular events can present in symptoms typical of much less serious conditions. Strokes, for example, can present with vague symptoms such as a headache or dizziness. This is similar to heart attacks, which can just present as chest pains. However, heart attacks are far less misdiagnosed than strokes because of a decades-long effort to eradicate those diagnostic errors.

“Diagnostic errors are errors of omission,” Daniel Yang, MD, an internist and Program Director for the Diagnostic Excellence Initiative at the Gordon and Betty Moore Foundation, told CNN Health. “The question is: Could [the outcome] be prevented if we had done something differently earlier on? Oftentimes, that’s a judgment call that two doctors might disagree on.”

Physicians and risk managers can work together to determine the best course of action to identify vague symptoms and prevent the deaths and serious injuries that can come from diagnostic errors.

Economic Cost of Misdiagnosis

Misdiagnosis also comes with a huge economic burden. William Padula, PhD, Assistant Professor of Pharmaceutical and Health Economics at USC Mann School of Pharmacy and Pharmaceutical Sciences, laid out the cost burden for STAT News.

“A patient comes into the ED with a headache or dizziness, and they get told it’ll go away, and then they go home. And then a week later, you find out that they [had] a stroke,” he explained. “By then, the stroke has compounded so much that what could have been addressed in the moment … for $10,000 now becomes a $100,000 issue. … So, there’s a margin of $90,000 that has been added to the US health system burden because of the misdiagnosis.”

Padula estimates that the total cost for these misdiagnoses could come to as much as $100 billion on the healthcare system.

What’s the Solution?

How can physicians avoid misdiagnoses and keep their patients safe? Newman-Toker suggests that physicians consult with other doctors. “I believe that the quickest way to solve the diagnostic error problem in the real world would be to construct approaches that basically rely on the ‘phone a friend’ model,” he told STAT News.

“This doesn’t mean that the patient should have to seek a second opinion, but rather that providers should make it standard practice to consult with a colleague before providing a diagnosis or dismissing a patient,” STAT News added.

Clinical laboratory professionals should note that while these misdiagnoses do not take place in the lab, doctor may order incorrect tests for patients by misreading their symptoms. Thus, clinical pathologists and lab scientists can play a critical role in helping doctors to order the correct tests for their patients and accurately interpret the results.

—Ashley Croce

Related Information:

Burden of Serious Harms from Diagnostic Error in the USA

Burden of Harm from Diagnostic Error Still High

Diagnostic Errors Linked to Nearly 800,000 Deaths or Cases of Permanent Disability in US Each Year, Study Estimates

Misdiagnoses Cost the US 800,000 Deaths and Serious Disabilities Every Year, Study Finds

Cognitive Errors in Clinical Decision Making

What is Diagnostic Error?

Supply Chain Shortages Threaten Medical Imaging Testing While Clinical Laboratories Face Scarcity of Blood Collection Specimen Tubes

From infant formula to contrast dye for CT scans, ongoing healthcare product shortages highlight continuing US supply chain and manufacturing issues

Medical laboratory directors and pathologists have firsthand knowledge of COVID-19 pandemic-driven supply chain issues, having faced backlogs for everything from pipettes and transport media to personal protective equipment (PPE). But the latest shortage impacting blood collection tubes is another example of why it is important to manufacture key products—including clinical laboratory tests, analyzers, and consumables—domestically.

On January 19, 2022, the federal Food and Drug Administration (FDA) issued a Letter to Healthcare Providers and Laboratory Personnel recommending “conservation strategies” to minimize blood collection tube use because of  “significant disruptions” in supplies due to COVID-19-increased demand and “recent vendor supply challenges.”

“The FDA updated the device shortage list to include all blood specimen collection tubes (product codes GIM and JKA),” the letter noted.

This announcement followed a similar June 10, 2021, Letter to Healthcare Providers and Laboratory Personnel that stated the FDA was aware “that the US is experiencing significant interruptions in the supply of sodium citrate blood specimen collection (light blue top) tubes because of an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges.”

A spokesperson for Becton-Dickinson (BD), a manufacturer of blood specimen collection products, told Forbes that the COVID-19 pandemic caused “the most unpredictable demand that BD has experienced in our company’s history.” The spokesperson added, “Worldwide, BD produced nearly a half a billion additional blood tubes in 2021 versus 2020 … Like every business across every industry around the world, BD is experiencing limited availability of and access to raw materials, shipping and transportation delays, and labor shortages, which hinders our ability to ramp production.”

Christine Nielsen, CEO of the Canadian Society for Medical Laboratory Science, explained that the supply-chain problem includes many routine items, such as Phosphate-buffered saline, and cannot be solved by stockpiling certain supplies.

“It’s also a challenge because we’ve moved to just-in-time (JIT) inventory across all sectors, including labs … They outdate just like food [and] are no longer fresh. [The product] is no longer reliable and you can’t use it. So, we can’t stockpile either,” Nielsen told Forbes.

Shortages Hit Other Critical Healthcare Sectors

But shortages of supplies and equipment have spread beyond the clinical laboratory. Intravenous contrast—which contains iodine and is used to improve the accuracy of CT scans and exclude life-threatening conditions such as cancer—has been in short supply since GE Healthcare shut down its manufacturing facility in Shanghai, China, during the city’s two-month pandemic lockdown that began in early April.

“I can’t overstate the importance of iodinated contrast for really critical diagnostic tests,” said radiologist Geoffrey Rubin, MD, a specialist in cardiovascular and pulmonary imaging, and professor and Chair of Radiology at University of Arizona, Tucson, in a Radiological Society of North America (RSNA) news release covering the contrast shortage.

“This isn’t an ancillary tool. This is something that’s used many, many times every day for both lifesaving decisions in the setting of trauma and for managing cancer patients and determining the appropriate care for them,” he added.

Rosa DeLauro, US Representative
 US Rep. Rosa DeLauro (above), lamented the fact these vital products are not being made in sufficient quantities in the US. “In the wealthiest nation on Earth, there should be no reason doctors are forced to ration lifesaving medical scans to compensate for a shortage of material,” DeLauro told The New York Times. “We are seeing supply chains break down because of consolidated industries experiencing manufacturing shortages and offshoring American jobs to China.” Clinical laboratory managers have first-hand knowledge of the severity of supply shortages. (Photo copyright: CNN.)

GE Healthcare is one of four companies that supply iodine-containing contrast to the United States, but the other three manufacturers have been unable to scale-up and offset the shortage.

By June 14, 2022, the Shanghai facility had returned to 100% production capacity following the easing of local COVID restrictions, according to a GE Healthcare statement. But shortages remain.

“There is still the challenge of bringing the contrast media across the ocean and distributing it to healthcare facilities across the nation,” Nancy Foster, the American Hospital Association’s (AHA) Vice President of Quality and Patient Safety Policy, told CNN.

“The hospital association estimates that about half of all hospitals in the United States rely on GE for contrast dye to perform about 20 million scans a year, or about 385,000 scans each week,” CNN reported.

Critical Medical Products Must be Manufactured Domestically

Oncologist Shikha Jain, MD, Assistant Professor of Medicine at the University of Illinois Cancer Center in Chicago, told CNN that contrast shortages are “not an isolated incident.”

“We’ve been having shortages throughout the pandemic. At the very beginning of the pandemic, it was PPE shortages,” Jain said. “Now, we have contrast shortages and formula shortages for babies.”

The infant formula crisis is the other headline grabbing news in recent weeks. Three companies—Abbott, Reckitt, and Gerber—manufacture 95% of the baby formula sold in the US, with Abbott controlling roughly 42% of the nation’s supply, CNN reported.

“Initially, this problem affected those who are on more specialized formulas or had nutritional issues,” Stephanie Seger, Director of Government Relations at Children’s Mercy Hospital in Kansas City, Mo., told CNN. ‘Then the gap, or the emptiness on the shelves, increased to the point where it’s now any formula. It’s now any parent of any baby.”

The Biden administration took steps in May to increase the supply of imported formula, but like the Intravenous contrast shortage, the problem has not been solved.

The COVID-19 pandemic has served to underscore the serious issues affecting supply chains for hospital, medical laboratory, and other critical supplies. While no quick fix has appeared on the horizon, the clinical laboratory industry should take steps now to work toward long-term solutions.

—Andrea Downing Peck

Related Information:

GE Healthcare Update on Iodinated Contrast Media

Update: Blood Specimen Collection Tube Conservation Strategies—Letter to Health Care and Laboratory Personnel

Blood Specimen Collection Tube Shortage: Frequently Asked Questions

Patients Face Long Delays for Imaging of Cancers and Other Diseases

Memorandum: Hearing on ‘Formula Safety and Supply: Protecting the Health of America’s Babies’

President Biden Announces Additional Steps to Address Infant Formula Shortage

Despite Moves to Increase Supply, Families Are Still Feeling the Pain of the Baby Formula Shortage

Blood Collection Tube Shortages Continue, ‘Routine’ Labs Should Be Limited

Hospitals Grapple with Shortage of Crucial Component for Medical Imaging Testing

Iodinated Contrast Shortage Challenges Radiologists

Australia’s HPV Vaccination Program Could Eliminate Cervical Cancer If Its National HPV Vaccination and Screening Programs Remain on Current Pace

CDC estimates that 92% of cancers caused by HPV could be eliminated in the US if HPV vaccination recommendations in this country are followed

Medical laboratories in the United States once processed as many as 55-million Pap tests each year. However, the need for cervical cancer screening tests is diminishing. That’s primarily because the human papilloma virus (HPV) vaccination effectively eliminates new cases of cervical cancer. At least, that’s what’s happening in Australia.

When it was introduced in 2007, Australia’s nationwide publicly-funded HPV vaccination program only included girls, but was extended to boys in 2013. Today, it is being credited with helping slash the country’s cervical cancer rates.

Research published in The Lancet Public Health (Lancet) predicts cervical cancer could be eliminated in Australia by 2028 if current vaccination rates and screening programs continue. Cervical cancer would be classified as effectively eliminated once there are four or fewer new cases per 100,000 women each year. These developments will be of interests to pathologists and cytotechnologists in the United States.

“From the beginning, I think the [Australian] government successfully positioned the advent of HPV vaccination as a wonderful package that had a beneficial effect for the population,” Karen Canfell, PhD, Director, Cancer Research Division at Cancer Council New South Wales, Australia, and Adjunct Professor, University of Sydney, told the Texas Tribune. “It was celebrated for that reason, and it was a great public health success.”

In addition to high vaccination rates, the Lancet study notes that last year Australia transitioned from cytology-based cervical screening every two years for women aged 18 to 69 years, to primary HPV testing every five years for women aged 25 to 69 and exit testing for women aged 70 to 74 years.

“Large-scale clinical trials and detailed modelling suggest that primary HPV screening is more effective at detecting cervical abnormalities and preventing cervical cancer than screening with cytology at shorter intervals,” the Lancet study states.

The incidence of cervical cancer in Australia now stands at seven cases per 100,000. That’s about half the global average. The country is on pace to see cervical cancer officially considered a “rare” cancer by 2020, when rates are projected to drop to fewer than six new cases per 100,000 women.

US Cervical Cancer Rates

In Texas, meanwhile, the state’s failure to embrace HPV vaccination is being blamed for slowing potential improvements in cervical cancer rates. In 2007, Texas lawmakers rejected legislation that would have mandated girls entering sixth grade be vaccinated for HPV. The Texas Tribune reports that, in the decade that followed, vaccination rates remained stagnant with only about 40% of Texans between 13 and 17 years old having been vaccinated for HPV by 2017.

Though Texas has a similar size population as Australia, the state’s low vaccination rates have meant cervical cancer rates have shown little improvement. Statistics compiled by the federal Centers for Disease Control and Prevention (CDC) show that Texas’ age-adjusted rate of new cervical cancer cases sits at 9.2 per 100,000 women—unchanged since 2006.

Texas has the fifth highest rate of cervical cancer in the nation, according to the CDC.

Texas State Rep. Jessica Farrar, a Democrat from Houston, maintains Texas should have followed the example of Australia, which in 2007 began a publicly funded HPV vaccination program that has the country on the verge of eliminating cervical cancer by 2028. Texas rejected mandatory HPV vaccinations and now has one of the highest cervical cancer rates in the US. “This is a preventable disease, and we should and can be doing more,” she told the Texas Tribune. “Here we are 12 years later, and look where we could’ve been, but because of certain beliefs, we’re suffering from cancers that could have been avoided.” (Photo copyright: The Texas Tribune.)

Lois Ramondetta, MD, Professor of Gynecologic Oncology at MD Anderson Cancer Center in Houston, told the Texas Tribune the state ignored an opportunity that Australia seized. “[Australia] embraced the vaccine at that time, and our fear kind of began around then,” Ramondetta said. “Really, vaccination in general has just gone down the tube since then.”

CDC Study Pushes HPV Vaccination Recommendations in US

Texas is not the only state failing to capitalize on the HPV vaccine’s cancer-curing promise. The CDC recently stated in a news release announcing a recent study that 92% of cancers caused by HPV could be eliminated if HPV vaccine recommendations were followed. CDC published the study in its Morbidity and Mortality Weekly Report.

HPV is a common virus that is linked to not only cervical cancer but also cancers of the penis, head, and neck, as well as conditions like genital warts. Though the CDC recommends children get the two-dose vaccine at ages 11-12, the study findings indicate that only 51% of teens ages 11 to 17 have received the recommended doses of HPV vaccine, a 2% increase from 2017 to 2018.

“A future without HPV cancers is within reach, but urgent action is needed to improve vaccine coverage rates,” Brett Giroir, MD, Assistant Secretary for Health, US Department of Health and Human Services (HHS), stated in the CDC news release. “Increasing HPV vaccination overage to 80% has been and will continue to be a priority initiative for HHS, and we will continue to work with our governmental and private sector partners to make this a reality.”

Can Australia Eliminate Cervical Cancer?

University of Queensland Professor Ian Frazer, MD, who co-authored the Lancet Public Health study, believes Australia is on the verge not only of eliminating cervical cancer, but also eradicating the HPV virus itself.

“Because this human papillomavirus only infects humans, and the vaccine program prevents the spread of the virus, eventually we’ll get rid of it, like we did with smallpox,” Frazer told The Age.

“It’s not going to happen in my lifetime,” he added. “But it could happen in the lifetime of my kids if they go about it the right way.”

If Australia’s combination of high HPV vaccination rates and new HPV screening program succeeds in effectively eliminating cervical cancer, clinical laboratories in this country should expect stepped-up efforts to increase HPV vaccination rates in the United States. A renewed focus on reducing—and ultimately eliminating—cervical cancer, could lead to fewer or less-frequently performed Pap tests as part of cervical cancer screening protocols.

—Andrea Downing Peck

Related Information:

The Projected Timeframe Until Cervical Cancer Elimination in Australia: A Modelling Study

Years after Texas Backed Off HPV Vaccine Mandate, Cervical Cancer Rate Soars

Cervical Cancer Set to Be Eliminated from Australia in Global First

An Estimated 92% of Cancers Caused by HPV Could be Prevented by Vaccine

Morbidity and Mortality Weekly Report