Patient safety/original research
Missed and Delayed Diagnoses in the Emergency Department: A Study of Closed Malpractice Claims From 4 Liability Insurers

https://doi.org/10.1016/j.annemergmed.2006.06.035Get rights and content

Study objectives

Diagnostic errors in the emergency department (ED) are an important patient safety concern, but little is known about their cause. We identify types and causes of missed or delayed diagnoses in the ED.

Methods

This is a review of 122 closed malpractice claims from 4 liability insurers in which patients had alleged a missed or delayed diagnosis in the ED. Trained physician reviewers examined the litigation files and the associated medical records to determine whether an adverse outcome because of a missed diagnosis had occurred, what breakdowns were involved in the missed diagnosis, and what factors contributed to it. Main outcome measures were missed diagnoses, process breakdowns, and contributing factors.

Results

A total of 79 claims (65%) involved missed ED diagnoses that harmed patients. Forty-eight percent of these missed diagnoses were associated with serious harm, and 39% resulted in death. The leading breakdowns in the diagnostic process were failure to order an appropriate diagnostic test (58% of errors), failure to perform an adequate medical history or physical examination (42%), incorrect interpretation of a diagnostic test (37%), and failure to order an appropriate consultation (33%). The leading contributing factors to the missed diagnoses were cognitive factors (96%), patient-related factors (34%), lack of appropriate supervision (30%), inadequate handoffs (24%), and excessive workload (23%). The median numbers of process breakdowns and contributing factors per missed diagnosis were 2 and 3, respectively.

Conclusion

Missed diagnoses in the ED have a complex cause. They are typically the result of multiple breakdowns in the diagnostic process and several contributing factors.

Introduction

Medical error continues to capture the attention of the medical profession, policymakers, and the public.1 Inpatient care has been the major focus of attention, but there is increasing recognition of the risks of iatrogenic harm in the outpatient setting, including the emergency department (ED).2, 3, 4, 5 Diagnostic errors are of particular concern and throughout the last decade have become the most prevalent type of malpractice claim in the United States.2, 6, 7

The ED is an especially challenging environment in which to consistently make accurate and timely diagnoses. Patients often present with high-acuity illness, elevating the stakes from the outset.8 Triage, consultations, admissions, discharge, and other steps in emergency care are operationally complex and must usually be executed under tight time constraints. Emergency physicians seldom have a continuous relationship with the patients they treat, and the continuous nature of an ED necessitates a perpetual cycle of shift changes and handoffs.8, 9 Supervision needs are high because trainees with widely varying clinical backgrounds and skills participate in care delivery. These intrinsic pressures of emergency care are amplified by crowding10, 11, 12 and increasing utilization by uninsured patients.13

Previous studies of missed diagnoses in the ED have focused on specific diagnoses or used epidemiologic methods to identify clinical risk factors.8, 14, 15, 16, 17, 18, 19, 20 However, little is known about the system-of-care factors that lead to diagnostic errors. Medical malpractice claims files present a potentially valuable source of information. They often involve severe injuries; they represent a powerful catchment point for information on errors; and by drawing together documentation from both formal legal inquiries and confidential internal investigations, they present a substantially richer body of information about the antecedents of medical injury than the medical record alone. Several clinical areas,2, 21, 22, 23, 24, 25 most notably anesthesiology,26 have made impressive use of malpractice claims file analysis.

We analyzed a sample of medical malpractice claims involving allegations of misdiagnosis in the ED. The study goal was to determine specifically where breakdowns in the diagnostic process occurred and what contributing factors (systems, cognitive, and patient-related) played a role in their occurrence. Such descriptive information may help to identify priority areas for interventions to enhance safety in the ED.

Section snippets

Materials and methods

Four malpractice insurance companies based in 3 regions in the United States (northeast, southwest, and west) participated in the study. Collectively, the insurers covered approximately 21,000 physicians, 46 acute care hospitals (20 academic and 26 nonacademic), and 390 outpatient facilities. Institutional review boards at the investigators’ institutions and at each review site approved the study.

Data were extracted from random samples of closed malpractice claims files at each insurer. The

Results

One hundred twenty-two of the claims alleged diagnostic error in the ED. The claims alleged injuries sustained between 1979 and 2001. All the claims were closed between 1984 and 2003. In 80% of the claims, the alleged diagnostic error occurred in 1990 or later, and in 46%, it occurred in 1994 or later.

In 3% (4/122) of the claims, no adverse outcome or change in the patient’s clinical course was evident. Thirty-two percent (39/122) of the claims contained an adverse outcome but no error. The

Limitations

The use of malpractice claims for addressing patient safety has limitations. First, severe injuries are probably overrepresented because they are more likely to trigger litigation. Second, certain breakdowns or contributing factors may not have been discernible in claims file review, even though they played a role; to the extent that this occurred, the prevalence findings for such estimates will be lower bounds, and the multifactorial causality we observed probably understates the true

Discussion

By reviewing malpractice claims files related to care in the ED, this study identified 79 missed diagnoses that varied widely in type, often involved acute illnesses, and frequently resulted in severe injury. The cause of these events was complex, with the majority involving multiple breakdowns in the diagnostic process, several contributing factors, and more than 1 provider. The most common breakdown points were test ordering and interpretation, performance of the medical history and physical

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    Supervising editor: Robert L. Wears, MD, MS

    Authors contributions: TAB and DMS conceived the study and obtained funding. AK, TKG, and DMS designed this analysis. TKG, ALP, EJT, and DMS designed the data collection instruments. AK, TKG, ALP, EJT, and DMS trained physician reviewers. TAB and DMS undertook recruitment of participating sites. ALP, CY, and DMS managed the data collection, including quality control. RG contributed to quality control efforts after the data had been collected. AK, TKG, CY, and DMS analyzed the data. AK, TKG, and DMS drafted the article, and all authors contributed substantially to revision of its intellectual content. AK, TKG, and DMS take responsibility for the paper as a whole.

    Funding and support: This study was supported by grants from the Agency for Healthcare Research and Quality (HS011886-03) and the Harvard Risk Management Foundation. Dr. Studdert was also supported by grant KO2HS11285 from the Agency for Healthcare Research and Quality.

    Reprints not available from the authors.

    Publication dates: Available online December 1, 2006.

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