Fifteen years ago, the Institute of Medicine (IOM) issued a report entitled To Err Is Human: Building a Safer Health System.1 The major finding of this report is that errors in the care of patients results in tens of thousands of deaths annually in the United States. This report focused primarily on surgical errors, medication errors, and other treatment errors, with little attention to errors in diagnosis. Very recently, the IOM, part of the National Academies of Sciences, Engineering, and Medicine, issued a new report entitled Improving Diagnosis in Health Care2 which focuses on diagnostic error. The committee creating the report, of which we were both members, noted that diagnostic error is a major problem in the United States. A key finding of the report was that “It is likely that most of us will experience at least one diagnostic error in our lifetime, sometimes with devastating consequences.” In addition, the committee also provided a clear definition of diagnostic error: “the failure to (1) establish an accurate and timely explanation of the patient's health problem(s) or (2) communicate that explanation to the patient.”
The individual goals (“recommendations”) made by the committee are listed below, and a paragraph with implications for anatomic pathology and laboratory medicine follows each one. Importantly, we are responsible for the content of this article, and our comments do not necessarily represent the views of the National Academies of Sciences, Engineering, and Medicine.
GOAL 1: FACILITATE MORE EFFECTIVE TEAMWORK IN THE DIAGNOSTIC PROCESS AMONG HEALTH CARE PROFESSIONALS, PATIENTS, AND THEIR FAMILIES
Implications for Pathology
This is the open door that pathologists have requested for years. The committee states that the diagnostic process is a team activity and, importantly, focuses on the patient. Further, the complexity of the diagnostic test menu, particularly with the advent of so-called molecular diagnostics, makes it too easy to commit a diagnostic error without the input of laboratory-based experts. The message to treating physicians of all specialties is that rather than just guess at test selection and result interpretation, they need to ask questions of pathologists—such as the evaluation of a highly positive antinuclear antibody test result; the prognostic implications of a newly described genetic test for a patient with cancer; the evaluation of a prolonged partial thromboplastin time in a patient not receiving heparin; and, the significance of a positive troponin test result, using the latest generation of the troponin test. Up until now, pathologists have not been paid for this activity. Similarly, in anatomic pathology, surgical pathologists, for example, should be actively involved, that is, consulted, in report interpretation.
GOAL 2: ENHANCE HEALTH CARE PROFESSIONAL EDUCATION AND TRAINING IN THE DIAGNOSTIC PROCESS
Implications for Pathology
The committee recommended that health care professional education address performance in the diagnostic process, including a focus on diagnostic testing, teamwork, and communication with patients, their families, and other health care professionals. More specifically, the committee cited a study involving a survey of approximately 75% of medical schools in the United States about the teaching of both anatomic and clinical pathology.3 The survey showed that the hours spent teaching anatomic pathology in US medical schools ranges from 61 to 302 hours. On the other hand, the median time spent in lecture teaching the practical aspects of laboratory medicine—that is, the selection of the appropriate tests and the correct interpretation of the test results—is only 8 hours. Generally speaking, anatomic pathology has dominated the medical school curriculum, whether taught as a “pathology” course or a curriculum in which pathology is integrated with the other “basic sciences.” Although some medical schools have a course focused on laboratory medicine, with a final examination to assess the students, this is rare. In addition, the diagnostic process is a process that often evolves over time and involves many health care providers. Thus, team-based health care delivery needs to be optimized and correspondingly, medical students and house staff need to be educated in working as part of an interdisciplinary team.
GOAL 3: ENSURE THAT HEALTH INFORMATION TECHNOLOGY SUPPORTS PATIENTS AND HEALTH CARE PROFESSIONALS IN THE DIAGNOSTIC PROCESS
Implications for Pathology
Although there is tremendous dependence on electronic communication of diagnostic data, many of these communications are not effective. In addition, many of the needed technologies, such as those that connect treating physicians in one location with expert physicians elsewhere, are much more difficult to obtain and use. Hospital information systems and laboratory information systems have been so ineffective in some settings that they have had to be removed after being placed into use. The committee recommended that all of the various health information technologies used in the diagnostic process be assessed for performance so that these technologies support individuals in the diagnostic process and to ensure that diagnostic errors are not introduced by ineffective health information technologies. A specific concern is the difficulty that all too often arises in transmitting information from the Laboratory Information System to the electronic medical record. Pathologists should be proactive in ensuring that patient care, including diagnosis, is not impeded.
GOAL 4: DEVELOP AND DEPLOY APPROACHES TO IDENTIFY, LEARN FROM, AND REDUCE DIAGNOSTIC ERRORS AND NEAR MISSES IN CLINICAL PRACTICE
Implications for Pathology
The committee described several opportunities to improve collaboration among pathologists and treating clinicians, such as the diagnostic management team model. Pathologists could also improve their diagnostic performance by receiving feedback. Current professional taboos to providing feedback on diagnostic performance and a lack of mechanisms to provide this information are challenges that need to be overcome.
Most treating physicians are reluctant to admit diagnostic error. The admission of an error in the selection of laboratory tests or the interpretation of a test result is often presented to the patient as a problem that originated in the laboratory rather than with the physician ordering the test. Diagnostic errors can be embarrassing to the physician, and many physicians will indicate that such errors, if made known to the patient, jeopardize the confidence that the patient has in a treating physician. In addition, admission of errors in test selection and result interpretation is likely to catch the attention of colleagues and administrators, and have negative consequences for the physician who orders too many or too few laboratory tests or misinterprets test results. The pathologist is often the person who sees the errors in test selection and result interpretation firsthand. Most pathologists are reluctant to provide feedback to physicians about their mistakes involving anatomic pathology and laboratory medicine. To further cloud the issue about providing feedback, there is significant variability on what might be acceptable in the evaluation of the patient with regard to test selection. However, there are still many definitive mistakes. The committee indicated the need for physicians to reveal errors and near misses to patients. There was no indication from the committee about the role of pathologists regarding this issue. However, it is clear that providing no feedback to a physician who makes errors in test selection and result interpretation is not an option. In addition, pathologists are not immune from diagnostic errors. Therefore, many of the issues pertaining to physicians and other health care providers must be acknowledged and addressed. Lastly, the evaluation of doctors by patients and others is all over the Internet. In this difficult context, there is much to learn with regard to changing a culture to allow physicians to freely report their mistakes.
In short, the committee recommended that health care organizations implement procedures and practices to provide systematic feedback on diagnostic performance to individual health care professionals, care teams, and clinical and organizational leaders. Pathologists play an important role in providing feedback to other clinicians about test selection choices, results' interpretation, and subsequent decision making.
GOAL 5: ESTABLISH A WORK SYSTEM AND CULTURE THAT SUPPORTS THE DIAGNOSTIC PROCESS AND IMPROVEMENTS IN DIAGNOSTIC PERFORMANCE
Implications for Pathology
Develop and implement processes to ensure effective and timely communication between diagnostic testing health care professionals and treating health care professionals across all health care delivery settings. For several decades, much attention has been paid to the generation of revenue, at the expense of attention directed to the timeliness, accuracy, and precision of the test result that is produced. The report on diagnostic error indicates that this culture needs to change. The cost of diagnostic errors is enormous but difficult to quantitate, and for that reason has received limited attention in the published literature. Another crucial point, which is brought out in the committee's definition of diagnostic error, is that the results be communicated to the patient. Pathologists must play a role in the timely reporting of results and help ensure that the ordering health care provider has received such information.
GOAL 6: DEVELOP A REPORTING ENVIRONMENT AND MEDICAL LIABILITY SYSTEM THAT FACILITATES IMPROVED DIAGNOSIS THROUGH LEARNING FROM DIAGNOSTIC ERRORS AND NEAR MISSES
Implications for Pathology
In a manner yet to be determined, in a health care system today where most physicians make definitive errors in the selection of diagnostic tests and interpretation of test results, there must be a feedback loop to permit physicians ordering diagnostic tests to improve their performance. The solution must not jeopardize the bond between a patient and a physician trying to do the best for a patient. And this too applies to anatomic pathologists; for example, a diagnostic error in evaluating a fine-needle aspiration or a diagnostic error in evaluating flow cytometric data.
GOAL 7: DESIGN A PAYMENT AND CARE DELIVERY ENVIRONMENT THAT SUPPORTS THE DIAGNOSTIC PROCESS
Implications for Pathology
The payment system operative in the United States for 3 decades has made it possible to earn a living only if a pathologist predominantly practices anatomic pathology. For more than 30 years, it has been incorrectly assumed by payers that most treating physicians are highly capable of ordering the right tests and just the right tests and that they are fully aware of the significance of the test results. This has resulted in an imbalance of expertise among pathologists toward anatomic pathology and away from laboratory medicine. This recommendation is an attempt to remove that imbalance and financially recognize the contributions of pathologists for both anatomic pathology and laboratory medicine. That said, anatomic pathologists give ample consultative advice that is also not reimbursed.
GOAL 8: PROVIDE DEDICATED FUNDING FOR RESEARCH ON THE DIAGNOSTIC PROCESS AND DIAGNOSTIC ERRORS
Implications for Pathology
In their deliberations, members of the committee found limited information about the extent and severity of diagnostic errors in the published literature. Currently, it is extremely challenging to obtain funding for studies involving diagnostic error because this topic is not a priority for the funding agencies. As pathologists confronting diagnostic errors made on a daily basis by talented physicians, we are well positioned to perform these important studies.
CONCLUSIONS
The committee's key themes are that diagnostic errors are a significant and underappreciated challenge, that patients are central to the solution, and that diagnosis is a collaborative effort. Rather than focusing on diagnostic errors, the health care community needs to focus on improving diagnosis.
Anatomic pathology, laboratory medicine, and radiology are the major disciplines that generate diagnostic information. The committee made a major recommendation for inclusion of pathologists as diagnostic experts in establishing a timely and accurate diagnosis that is effectively communicated. This is the opportunity for which many people in all areas of pathology and laboratory medicine have been waiting for. We must now step forward and make a major change in the way we practice both anatomic pathology and laboratory medicine. We must go beyond providing numbers or short verbal reports delivered behind the scenes to becoming fully integrated members of the diagnostic team.
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Author notes
The authors have no relevant financial interest in the products or companies described in this article.