Diagnostic Error: Common Causes, Effective Countermeasures

“Diagnostic error” refers to the failure to establish an accurate and timely explanation of the patient’s health problem, and/or communicate that explanation to the patient.1 These errors typically involve failure to diagnose, misdiagnosis or delayed diagnosis. The most common patient safety occurrence in outpatient settings, diagnostic errors affect, by conservative estimate, approximately 5 percent of adult outpatients every year. According to the Data Sharing Project of the Medical Professional Liability Association, associated claims resulted in an average indemnity payment of $407,000.²

Due to the multifaceted nature of the patient assessment and diagnostic process, errors rarely occur at a single point in time. Lapses are more often attributed to the cumulative impact of a wide range of risk factors, including the episodic and sometimes fragmented nature of ambulatory care, breakdowns in provider- patient communication, overlapping workflow processes and cognitive biases on the part of providers.

To help facilities and providers prevent incidents related to diagnostic inaccuracies and minimize consequent liability, this issue of inBrief ^® examines common sources of error and presents strat- egies designed to enhance diagnostic accuracy. Suggestions range from the use of diagnostic teams and provider timeouts to improved documentation of clinical reasoning and automated test ordering and reporting systems.
 

Diagnostic Error

Error Types

• Failure to diagnose, i.e., when an underlying condition – such as colon cancer in a patient who presents with rectal bleeding, bowel irritability and  a positive family history – is not  detected or thoroughly assessed.
• Wrong diagnosis, i.e., when a diagnosis is rendered incorrectly, such as prema-turely diagnosing acid indigestion in a patient who later suffers a myocardial infarction.
• Delayed diagnosis, i.e., when the  initial workup is timely, but subsequent intervention is not, as with a patient whose test results suggest a chronic and degenerative condition, but who is  not notified of the findings and does not receive necessary treatment.

Commonly Misdiagnosed Conditions

• Cancer, including breast, colon and lung, as well as lymphoma.
• Infection, including sepsis, meningitis, encephalitis, epidural abscess, appendicitis and urinary tract infection.
• Cardiovascular events, including myocardial infarction, aortic dissection and hemorrhage.
• Neural conditions, including multiple sclerosis, epilepsy, stroke and dementia.

Major Causal Factors

• Facility- or practice-related:
  • Improper framing of the diag- nostic process as an individual, rather than team activity.
  • Lack of provider education and training on the diagnostic process and clinical reasoning.
  • Flawed protocols, leading to outdated problem lists and medication reconcilia-tion lapses.
  • Loss of test results, inaccessible health records and other information transfer problems.
  • Poor transitions of care due to fragmented workflow and handoff procedures.
  • No consistent auditing of post-mortem examinations and patient records for diagnostic accuracy.
  • Failure to monitor provider  performance regarding diagnostic accuracy and establish ongoing  
    peer review activities.
• Provider-related:
  • Cognitive bias, leading to errors in clinical judgment. 
  • Insufficient time allocated for patient history and fact-finding.
  • Inadequate physical exam and description of morbidity factors, poten- tially concealing high risk conditions.
  • Incomplete ordering of diagnostic tests following initial patient assessment.
  • Misinterpretation or limited  interpretation of tests, including failure to note reported incidental findings.
  • Reluctance to consult with relevant specialists.
  • Rushed diagnostic process, including failure to employ “diagnostic timeouts.”
  • Fatigue and lack of focus due to overwork or clinical burnout.
  • Insufficient documentation, especially with respect to historical data.
  • Not utilizing “teach-back” methods when discussing diagnosis and treatment with the patient.
  • Lack of follow-up, including ongoing monitoring of patient’s clinical status.
• Patient-related:
  • Noncompliance with treatment instructions, including return visits.
  • Failure to follow up on referrals and consultations.
  • Linguistic, cognitive or health literacy obstacles hindering communication and comprehension.
  • Lack of support network and/or stable living arrangements.

 

Provider Strategies 
The following suggestions are intended to help providers improve their diagnosis-related practices and minimize errors:

Be aware of potential bias and erroneous logic. Misdiagnosis is often due to errors in judgment, which, in turn, are frequently associated with various types of cognitive bias.³ Common biases affecting clinical decision-making include the following:

• Confirmation bias, i.e., absorbing only information that confirms one's assumptions and ignoring contradictory facts.
• Anchoring bias, i.e., over-focusing on findings that support an initial impression or hypothesis and discounting others.
• Affect heuristic, i.e., allowing an emotional response to a person or situation override reasoned judgment.
• Outcomes bias, i.e., making present decisions based entirely on what has worked in the past.

(For more suggestions concerning diagnostic decision-making and documentation, see “Sound Clinical Reasoning: Five Documentation ‘Must-haves’”)

Engage with patients and families. To the extent possible, include patients and their significant others in the diagnostic process, soliciting their cooperation and input. Through the use of online portals, offer patients prompt access to test results, clinical notes and ongoing workup. And when informing patients of diagnoses and related follow-up, employ the teach-back method and provide written post-visit summaries delineating necessary future actions.

Utilize diagnostic timeouts. Periodic pauses in the diagnostic process encourage wider consultation and more comprehensive analysis of findings, thereby reducing the likelihood of error. Timeouts also may be used to ensure that remote diagnoses have been considered, and that the reasons for ruling them out are included on the patient healthcare information record.

Comprehensively document tests and results. The patient healthcare information record should include answers to the follow- ing test-related questions, among others:

• What is the rationale for the ordered test?
• What are the results of the test, and are they conclusive?
• If inconclusive, what additional steps have been taken, such as requesting a second review or an alternative test?
• Do the results raise questions about the working diagnosis or suggest an alternative hypothesis?
• Have test findings been shared with the patient and treatment team?
• What are the next steps regarding treatment?

System/Process Improvement Strategies 
The following suggestions are intended to aid administrators in giving providers the tools they need to enhance diagnostic methods and outcomes:

Educate providers about understanding and preventing cognitive bias. Because bias is a major cause of diagnostic error, the problem should be addressed in orientation and educational programs. The following anti-bias teaching strategies, among others, can help providers enhance diagnostic accuracy:

• Focus on the most meaningful clinical data, rather than every aspect of a patient assessment.
• Repeat diagnostic tests when clinical findings diverge.
• Avoid making diagnostic assumptions based upon past situations.
• Look at cases from different perspectives, and consult colleagues when deciding among educated guesses.

Treat diagnosis as a team activity. Encourage treatment team members – including physicians, nurse practitioners and registered nurses, as well as radiologists, pathologists and other ancillary service diagnosticians – to collaborate on such key tasks as compil- ing data, scrutinizing test results and integrating information. Stress the need to share incidental findings and critical test results from imaging reports, as well as significant pathology results that may result in misdiagnosis if not communicated personally, using a structured reporting/categorization system.

Enhance referrals and other patient transitions. Sound selection of IT systems and related tools can help clarify expectations and timelines related to diagnostic consultation. For optimal results, develop a standard digital referral form that conveys, at a minimum, why the referral is necessary, when reports are due, how additional test results will be reported and who is responsible for delivering medical advice to the patient.

Reduce paperwork demands. By deploying medical assistants and scribes to relieve providers of time-consuming administrative tasks, providers can focus more intently on performing the diag- nostic workup and interpreting test results and other findings.

Digitize the diagnostic process. Up-to-date healthcare IT systems can streamline the flow of information across care settings, while helping to ensure that clinical data are presented in user-friendly formats. When selecting or upgrading IT systems, check that the new or updated system includes decision-support tools, diagnostic testing order sets, embedded checklists, preset alerts for critical test values, a tracking function for tests and referrals, and other useful diagnosis-related features.

Monitor diagnostic performance. Peer review and other forms of professional feedback – offered in a constructive, collaborative spirit – have been demonstrated to influence the accuracy of diagnosis. In addition, as part of the organization’s quality improve- ment program, monitor diagnostic practices by tracking these performance indicators, among others: rates of misdiagnosis, extent of consultation with treatment team members, timeliness of response to test result reports, promptness of referral to specialists when indicated and comprehensiveness of documentation.

Accurate, timely diagnosis is fundamental to safe and effective healthcare. The strategies described in this resource are designed to help organizational administrators and providers review their diagnostic practices, strengthen relevant systems and processes, and foster team-based, patient-focused care.
  

 

Editorial Board Members
Kelly J. Taylor, RN, JD, Chair Janna Bennett, CPHRM
Laura Benton
Brian Boe 
Elisa Brown, FCAS 
Patricia Harmon, RN, MM, CPHRM Hilary Lewis, JD, LLM
Lynn Pierce, MSN, FNP-C, CPHRM Katie Roberts
Adam Sekunda

Publisher
Lauran Cutler, RN, BSN, CPHRM 

Editor
Hugh Iglarsh, MA

¹ In 2015, the National Academies of Science, Engineering, and Medicine proposed this patient-centered, communication-focused definition of diagnostic error in the landmark report, “Improving Diagnosis in Healthcare.” The definition has been endorsed by the Patient Safety Network of the Agency for Healthcare Research and Quality, as well as other patient safety organizations.
² Reprinted with permission from Inside Medical Liability Magazine. Data Sharing Project Highlight – Diagnostic Error. Third Quarter. Copyright, 2021. MPL Association. The information provided may be used for personal use only. Any other use requires prior permission of the MPL Association.
³ The Johns Hopkins Armstrong Institute for Patient Safety and Quality examined 55,377 medical malpractice claims in which misdiagnosis led to death or disability and found that 86 percent of these claims involved judgment errors on the part of the provider, primarily attributable to gaps or problems of knowledge, attention and interpretation, as well as implicit bias.

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