Diagnostic errors: Reducing healthcare’s blind spot

Re-envisioning the diagnostic process is essential to improving healthcare, says report

JHC-March16-iStock_000053050534_LargeEver since the Institute of Medicine published its landmark report, To Err Is Human: Building a Safer Health System, in 1999, the public, clinicians and suppliers have focused on one of healthcare’s greatest secrets: Healthcare providers make mistakes, and patients – as many as 100,000 a year – die because of them. Largely because of that report, “patient safety” has become a well-recognized term among the healthcare community and the public at large.

One aspect of error has been relatively underreported, however, and it is one of the most basic: diagnostic error. That is no longer the case, given the National Academy of Sciences’ newest report, Improving Diagnosis in Health Care, published in September 2015.

“The data on diagnostic error are sparse, few reliable measures exist, and often the error is identified only in retrospect,” says the NAS committee that wrote the report. “Yet the best estimates indicate that all of us will likely experience a meaningful diagnostic error in our lifetime.”

The committee defines diagnostic error as 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. Either way, such errors constitute a “blind spot” within the healthcare system, one that has persisted for decades.

“Improving the diagnostic process is not only possible, but also represents a moral, professional, and public health imperative,” says the NAS. “Achieving that goal will require a significant re-envisioning of the diagnostic process and a widespread commitment to change among healthcare professionals, healthcare organizations, patients and their families, researchers, and policy makers.”

The committee’s recommendations address eight goals to improve diagnosis and reduce diagnostic error.

Goal 1: Teamwork
Healthcare organizations should ensure that healthcare professionals have the appropriate knowledge, skills, resources, and support to engage in teamwork in the diagnostic process, says NAS. To accomplish this, they should facilitate and support collaboration among pathologists, radiologists, other diagnosticians, and treating healthcare professionals.

What’s more, patients and their families contribute valuable input that can facilitate the diagnostic process and ensure shared decision-making about the path of care, according to NAS. Accordingly, the committee recommends that providers.

  • Provide patients with opportunities to learn about the diagnostic process.
  • Create environments in which patients and their families are comfortable engaging in the diagnostic process and sharing feedback and concerns about diagnostic errors and near misses.
  • Ensure patient access to electronic health records (EHRs), including clinical notes and diagnostic testing results, to facilitate patient engagement in the diagnostic process and patient review of health records for accuracy.
  • Identify opportunities to include patients and their families in efforts to improve the diagnostic process by learning from diagnostic errors and near misses.

Goal 2: Education and training
Getting the right diagnosis depends on all healthcare professionals getting involved in the process, and receiving appropriate education and training, according to the NAS committee. Feedback – or information about the accuracy of a clinician’s diagnosis – is essential for improved diagnostic performance.

The committee made two recommendations:

  • Educators should ensure that curricula and training programs address performance in the diagnostic process, including areas such as clinical reasoning; teamwork; communication with patients, their families, and other healthcare professionals; appropriate use of diagnostic tests and the application of these results on subsequent decision-making; and use of health information technology.
  • Healthcare professional certification and accreditation organizations should ensure that healthcare professionals have and maintain the competencies needed for effective performance in the diagnostic process.

Goal 3: Health IT
Health IT has the potential to improve diagnoses and reduce diagnostic errors by facilitating access to information; communication among healthcare professionals, patients, and their families; clinical reasoning; and feedback and follow-up, says the NAS committee. However, many experts are concerned that health IT is failing to effectively facilitate the diagnostic process and may even be contributing to errors. The committee made three recommendations:

  • Health IT vendors and the Office of the National Coordinator for Health Information Technology (ONC) should work with users to ensure that health IT used in the diagnostic process demonstrates usability, incorporates human factors knowledge, integrates measurement capability, fits well within clinical workflow, provides clinical decision support, and facilitates the timely flow of information among patients and healthcare professionals.
  • ONC should require health IT vendors to meet standards for interoperability among different health IT systems to support effective, efficient, and structured flow of patient information across care settings by 2018.
  • The Secretary of Health and Human Services should require health IT vendors to routinely submit their products for independent evaluation and notify users about potential adverse effects on the diagnostic process related to the use of their products.

Goal 4: Identifying, learning from, and reducing errors
Due to the difficulty in identifying diagnostic errors and competing demands from existing quality and safety improvement priorities, very few healthcare organizations have processes in place to identify diagnostic errors and near misses (i.e., failures in the diagnostic process that do not lead to diagnostic errors), says the committee. The committee recommends:

  • Accreditation organizations and the Medicare conditions of participation should require that healthcare organizations have programs in place to monitor the diagnostic process and identify, learn from, and reduce diagnostic errors and near misses in a timely fashion.
  • Healthcare organizations should monitor the diagnostic process and identify, learn from and reduce diagnostic errors and near misses as a component of their research, quality improvement, and patient safety programs; and implement procedures and practices to provide systematic feedback on diagnostic performance to healthcare professionals, care teams, and clinical and organizational leaders.
  • The Department of Health and Human Services should provide funding for a subset of healthcare systems to conduct routine postmortem examinations on a representative sample of patient deaths.
  • Healthcare professional societies should identify opportunities to improve accurate and timely diagnoses and reduce diagnostic errors in their specialties.

Goal 5: Work system and culture
The culture and leadership of healthcare organizations are key factors in ensuring continuous learning in the diagnostic process. The committee recommends that healthcare organizations:

  • Adopt policies and practices that promote a non-punitive culture, which values open discussion and feedback on diagnostic performance.
  • Design the work system in which the diagnostic process occurs to support the work and activities of patients, their families, and healthcare professionals, and to facilitate accurate and timely diagnoses.
  • Develop and implement processes to ensure effective and timely communication between diagnostic testing healthcare professionals and treating healthcare professionals.

Goal 6: Reporting environment
Conducting analyses of diagnostic errors, near misses, and adverse events presents the best opportunity to learn from such experiences and implement changes, according to the NAS committee. But the environment must be safe – without the threat of legal discovery or disciplinary action. The NAS recommends:

  • The Agency for Healthcare Research and Quality (AHRQ) or other appropriate agencies or independent entities should facilitate the voluntary reporting of diagnostic errors and near misses.
  • AHRQ should evaluate the effectiveness of patient safety organizations (PSOs) as a major mechanism for voluntary reporting and learning from these events.
  • States, in collaboration with other stakeholders (healthcare organizations, professional liability insurance carriers, state and federal policy makers, patient advocacy groups, and medical malpractice plaintiff and defense attorneys), should promote a legal environment that facilitates the timely identification, disclosure and learning from diagnostic errors. Specifically, they should encourage the adoption of communication and resolution programs with legal protections for disclosures and apologies under state laws; and conduct demonstration projects of alternative approaches to the resolution of medical injuries, including administrative health courts and safe harbors for adherence to evidence-based clinical practice guidelines.
  • Professional liability insurance carriers and captive insurers should collaborate with healthcare professionals on opportunities to improve diagnostic performance through education, training, and practice improvement approaches.

Goal 7: Fee-for-service payment
Fee-for-service reimbursement lacks financial incentives to coordinate care among clinicians. However, as long as fee-for-service remains the predominant payment mechanism, the NAS recommends that the Centers for Medicare & Medicaid Services and other payers:

  • Create current procedural terminology (CPT) codes and provide coverage for additional evaluation and management activities not currently coded or covered, including time spent by pathologists, radiologists, and other clinicians in advising ordering clinicians on the selection, use, and interpretation of diagnostic testing for specific patients.
  • Reorient relative value fees to more appropriately value the time spent with patients in evaluation and management (E&M) activities.
  • Modify documentation guidelines for evaluation and management services to improve the accuracy of information in the electronic health record and to support decision-making in the diagnostic process.
  • Assess the impact of payment and care delivery models on the diagnostic process, the occurrence of diagnostic errors, and learning from these errors.

Goal 8: Dedicated funding
The NAS recommends that the federal government pursue and encourage opportunities for public–private partnerships among a broad range of stakeholders, such as the Patient-Centered Outcomes Research Institute, foundations, the diagnostic testing and health information technology industries, health care organizations, and professional liability insurers to support research on the diagnostic process and diagnostic errors.


Facts about diagnostic errors

  • A conservative estimate found that 5 percent of U.S. adults who seek outpatient care each year experience a diagnostic error.
  • Postmortem examination research spanning decades has shown that diagnostic errors contribute to approximately 10 percent of patient deaths.
  • Medical record reviews suggest that diagnostic errors account for 6 to 17 percent of hospital adverse events.
  • Diagnostic errors are the leading type of paid medical malpractice claims, are almost twice as likely to have resulted in the patient’s death compared to other claims, and represent the highest proportion of total payments.

Source: Improving Diagnosis in Health Care, Sept. National Academies of Sciences, Engineering and Medicine


The good news about new payment models

JHC-March16-iStock_000027623338_LargeNew payment models probably will have an impact – a positive one, at that – on diagnostic processes, says the National Academies of Science, Engineering and Medicine in its report, Improving Diagnosis in Health Care.

Global payment, capitation, per-member-per-month.
Definition: A single per-member-per-month payment is made for all services delivered to a patient, with payment adjustments based on measured performance and patient risk.
Potential impact on diagnosis: Broader adoption could enhance provider activities that improve diagnostic accuracy and reduce diagnostic errors, because the capitated, at-risk organization bears the cost of diagnostic error if there are immediate costs associated with the error.

Accountable care organizations (ACOs)
Definition: Groups of providers that voluntarily assume responsibility for the care of a population of patients.
Potential impact on diagnosis
: The quality of care in accountable care organizations (ACOs) is assessed through a set of quality measures, though none of them involve accuracy or timeliness of diagnosis. Even so, ACOs have the potential infrastructure to provide a base of activity to improve diagnostic accuracy for their constituent or affiliated clinicians.

Bundled payment or episode-based payment
Definition: A single “bundled” payment, which may include multiple providers in multiple care settings, is made for services delivered during an episode of care related to a medical condition or procedure.
Potential impact on diagnosis: By definition, bundled payment would seem to apply mostly to well-established, “correct” diagnoses, for which efficiencies of care can be further gained. However, bundled payment remains volume-based, that is, the financial incentive is to produce more, efficiently provided episodes. This raises the importance of addressing appropriateness of the bundled episode procedure being performed. Appropriateness is relevant to the topic of diagnostic error in the sense of needing to determine acuity of the condition as part of the diagnostic process.

Pay-for-performance, or value-based purchasing
Definition: Physicians receive differential payments for meeting or missing performance benchmarks
Potential impact on diagnosis: The effects of pay-for-performance on outcomes remain unsettled, with concerns about the effects on important elements of care that are not being measured. Current pushes for accountability neglect performance measures for diagnosis, and that is a major limitation of these approaches.

Patient-centered medical homes
Definition: A physician practice or other provider is eligible to receive additional payments if medical home criteria are met.
Potential impact on diagnosis: A well-functioning medical home – with teamwork, longstanding relationships with patients as the center for care and care coordination, and improved electronic health records and interoperability of patient information – has the potential to improve diagnostic performance. There are concerns, however, that medical home performance will be assessed using measures that do not include those related to diagnostic performance, although it is known that diagnostic error is a significant problem in primary care.

Shared savings
Definition: A payment strategy that offers incentives for providers to reduce healthcare spending for a defined patient population by offering them a percentage of net savings realized as a result of their efforts.
Potential impact on diagnosis: There are no direct incentives to focus on improving diagnostic accuracy. The impact depends largely on the objectives of the underlying organization to which the payment is being applied. For example, shared savings has become the primary method for rewarding ACOs for spending less than a target spending amount. Theoretically, at least, the ACO should be interested in diagnostic accuracy if by getting the diagnosis correct, the ACO can reduce spending. So the focus would be on efforts to make correct diagnoses of acute, urgent presentations of illness in emergency departments and primary care practices and for commonly misdiagnosed conditions, such as stroke and congestive heart failure. Conversely, based on incentives alone, the organization might be less interested in efforts to make accurate and timely diagnoses of conditions whose costs would not be borne for many months or years. To date, little attention paid seems to be paid to diagnostic accuracy as a mechanism for achieving savings.

Source: Improving Diagnosis in Health Care, National Academies of Sciences, Engineering and Medicine