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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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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?

Barriers Restricting Access to EHR Data in Support of Patient Safety and Privacy Laws Can Lead to Diagnostic Errors, Some Involving Clinical Laboratory Tests

What causes diagnostic errors? This was the question asked by researchers at the Michael E. DeBakey VA Medical Center (EDVA) in Houston. It is also a question of great interest to pathologists and clinical laboratory scientists, since the failure of physicians to properly order and interpret medical laboratory tests can be a cause of diagnostic errors.

Researchers were investigating how access to patient data embedded in hospital electronic health records (EHRs) affects patient safety. The results of their study—and the challenges they encountered accessing the data during the research—led to some startling conclusions about accessibility to patient data, and the nature of the data itself.

The researchers published their findings online in “Challenges in Patient Safety Improvement Research in the Era of Electronic Health Records.” Their paper examines ways in which EHRs can assist healthcare professionals in improving patient safety and guaranteeing proper follow-up care. (more…)

Recent Study Estimates that 5% of Patients in Outpatient Settings Are Misdiagnosed, Offering Pathologists an Opportunity to Provide More Consultations to Doctors

This spring, researchers at the VA Hospital in Houston published a study revealing that one in 20 patients in outpatient settings are misdiagnosed

Publication of new peer-reviewed clinical studies indicates that, within the United States, more than 5% of outpatients—or 12 million people—are misdiagnosed annually. Few pathologists and clinical laboratory scientists would dispute this number because every day they see the best and the worst of how physicians use medical laboratory tests.

These findings were reported in a study published in the April edition of the British Medical Journal, BMJ Quality & Safety. (more…)

In Recent Months, Health Officials in Alberta Disclose Diagnostic Errors by Two Pathologists and a Radiologist

Public awaits findings from board of inquiry empaneled by the Alberta Health System

Once more, a province in Canada is dealing with public disclosure of unacceptable rates of errors in anatomic pathology testing services. This time it is the healthcare system of Alberta. Since November, the public has learned about two separate cases of individual pathologists who were determined to have misdiagnosed cancer cases.

But pathology errors turned out to be only part of this story. Public concern in Alberta about the quality of diagnostics services was further heightened by another round of newspaper stories later in December. This time, the news was about the discovery of imaging errors made by a radiologist working in one of Alberta’s hospitals.

(more…)

Hospitals Take Steps to Drive Down Medical Errors in Their Emergency Departments

Clinical laboratory managers are often part of the ER’s process improvement team

Hospital emergency rooms (ER) across the country are intensifying their focus on improving patient safety  and reducing errors. The cost of malpractice lawsuits filed after errors in emergency rooms is a major reason why growing numbers of hospitals are initiating formal programs to identify and eliminate the source of errors and wrong care provided to patients.

It probably won’t surprise most pathologists and clinical laboratory managers to learn that diagnostic errors are one significant source of malpractice claims that result from care provided by hospital emergency rooms, which can often be chaotic and overcrowded. Recently, The Wall Street Journal reported that a large percentage of medical errors in hospitals—and the resulting malpractice suits—occur because of mistakes in the emergency room. Studies of closed claims show that 37% to 55% of the malpractice suits are attributable to diagnostic errors. (more…)

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