News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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SIDM estimates approximately one in 10 patients with serious medical conditions are initially misdiagnosed, a problem that can be addressed if the right medical laboratory test is ordered at the right time for individual patients

Clinical laboratory leaders know that lab tests are essential to a large proportion of medical diagnoses. Therefore, any formal effort to reduce diagnostic errors that affects how doctors order and use lab tests also will impact medical laboratories that perform those tests.

One such formal effort is underway, led by the Society to Improve Diagnosis in Medicine (SIDM). Dubbed the Coalition to Improve Diagnostics (CID), the collaboration comprises more than 50 leading healthcare and patient advocacy organizations, all joined to end diagnostic errors, one of the most common causes of preventable medical errors.

“Diagnostic error is one of the most important safety problems in healthcare today and causes the most patient harm,” said Paul L. Epner, CEO and co-founder of the SIDM, in a news release. “While many organizations have diagnostic quality on their radar, it generally is not seen as a top priority. Those who’ve joined the coalition acknowledge that diagnostic quality and safety are vital to improving healthcare.”

To participate in the coalition, organizations must promise to pursue ways to circumvent troublesome diagnostic errors and submit action plans to the SIDM outlining proposals to diminish such errors. There are no fees associated with being part of the coalition.

12-Million Patients Each Year Affected by Diagnostic Errors

Epner told Modern Healthcare that this coalition is the only one that exists that focuses solely on diagnostic errors and ways to eradicate them. “There are a lot of systematic things that we understand are problems, but we aren’t very good at implementing solutions,” he said. “In terms of having standard solutions, we are early.”

The National Academy of Medicine (NAM) defines diagnostic error as “the failure to establish an accurate and timely explanation of the patient’s health problem(s) or to communicate that explanation to the patient. Simply put, these are diagnoses that are missed altogether, wrong, or should have been made much earlier.”

The SIDM website lists the following key sources for acquiring data on diagnostic errors:

  • Autopsy data;
  • Physician self-reports of experiencing diagnostic error;
  • Patient self-reports of experiencing diagnostic error;
  • Hospital incident reporting systems;
  • Statistical analysis of unexpected hospitalizations;
  • Research studies designed to measure diagnostic error; and
  • Medical malpractice claims data.
“Providing an accurate medical diagnosis is complex and involves uncertainty, but it’s obviously essential to effective and timely treatment,” Paul L. Epner, CEO and co-founder of the SIDM, said in a news release announcing the formation of the coalition. “Nearly everyone will receive an inaccurate diagnosis at some point in their life and for some, the consequences will be grave. Major improvement is needed to systematically identify how to improve diagnostic quality and reduce harm to patients.” (Photo copyright: Society to Improve Diagnosis in Medicine.)

The SIDM states that diagnostic errors affect an estimated 12-million patients in the US each year, and that approximately one in 10 patients with a serious medical condition are initially misdiagnosed. In addition, an estimated 40,000 to 80,000 people die each year from diagnostic errors in US hospitals, and it is probable that at least that many patients suffer from permanent disability annually due to improper diagnosis. It is also likely that diagnostic errors cause more harm to patients than all other medical errors combined and are responsible for an increasing number of malpractice cases, the SIDM notes.

John’s Hopkins Finds Most Misdiagnoses in Three Categories of Medicine

A study published in the peer-reviewed journal Diagnosis, reported that one in three malpractice cases that resulted in death or serious harm to patients are due to misdiagnosis. The research for this study was carried out by a team from the Johns Hopkins University School of Medicine and was funded by the SIDM.

After analyzing more than 55,000 malpractice claims, the researchers found that 34% of those cases which resulted in death or permanent disability could be attributed to inaccurate or delayed diagnosis, an SIDM analysis of the John’s Hopkins study noted.

The research team also examined underlying disease states to search for misdiagnosis patterns and discovered that three quarters or 74.1% of the misdiagnosed cases occurred in just three categories of medical conditions:

  • Cancer (37.8%);
  • Vascular events (22.8%); and
  • Infection (13.5%).

These serious cases resulted in $1.8 billion in malpractice payouts over the course of 10 years, according to the SIDM. 

“It is not just inconvenient to have a wrong or delayed diagnosis. For many patients, misdiagnosis causes severe harm and expense, and in the worst cases, death,” said David Newman-Toker, MD, PhD, Director, Armstrong Institute Center for Diagnostic Excellence at Johns Hopkins University School of Medicine, in an SIDM news post. “If we’re going to reduce serious harms from medical errors, major strides must be made to improve diagnostic accuracy and timeliness. This study shows us where to focus to start making a difference for patients. It tells us that tackling diagnosis in these three specific disease areas could have a major impact on reducing misdiagnosis-related harms.”

The John’s Hopkins research confirms that misdiagnosis is a common and costly form of medical errors that can have catastrophic results. The team concluded that it will take a system-wide effort involving physicians, patients, and their families to improve the accuracy of diagnosis.

The SIDM’s Coalition to Improve Diagnostics is one such effort and is primarily supported by a $2.45 million grant awarded by the Gordon and Betty Moore Foundation. The main purpose for this grant was to help increase awareness about diagnostic errors and develop ways to prevent such errors in the future. 

“We think this is a new frontier of safety and quality we want to be part of,” Daniel Yang, MD, Program Officer for Diagnostic Excellence Initiative at the Moore Foundation, told Modern Healthcare.

Clinical laboratory tests are essential to the diagnostic process. Therefore, lab managers and staff should constantly review their procedures to ensure accuracy in testing and reporting of results to ordering physicians. If preventable medical errors are to be significantly reduced, labs will be a big part of the team effort that will make it happen.

—JP Schlingman

Related Information:

Coalition Tackling Diagnostic Errors Gains Some Traction

Four New Organizations Commit to Improve Diagnostic Quality and Safety

Improving Diagnosis in Health Care

The Frequency of Diagnostic Errors in Outpatient Care: Estimations from Three Large Observational Studies Involving US Adult Populations

40+ Healthcare Organizations Launch Unprecedented Effort to Improve Accuracy and Timeliness of Diagnosis

Analysis: One in Three Malpractice Cases with Serious Patient Harms Are Due to Misdiagnosis

Serious Misdiagnosis-Related Harms in Malpractice Claims: The “Big Three” – Vascular Events, Infections, and Cancers