Better collaboration among physicians, nurses, patients, and laboratory medicine professionals can go a long way toward reducing diagnostic errors and preventing unnecessary deaths, concludes the Institute of Medicine (IOM) in the latest report in its Quality Chasm Series, Improving Diagnosis in Health Care. IOM is a part of the National Academy of Medicine (NAM). The report is a follow up to two previous reports, including the landmark report on patient safety released 15 years ago—To Err Is Human: Building a Safer Health System. That report, which highlighted the rarely discussed fact that those in healthcare make mistakes, served as a wake-up call for healthcare organizations.

According to an expert committee convened by IOM, the occurrence of diagnostic errors has largely been unappreciated due in part to the fact that data on diagnostic errors are sparse and few reliable measures exist. The best estimates are that most people will experience at least one diagnostic error in their lifetime, says the report, noting that diagnostic errors contribute to about 10% of patient deaths.

Hardeep Singh, MD, a patient safety researcher with the Michael E. DeBakey VA Medical Center in Houston, estimates that outpatient diagnostic errors affect about 12 million (or 5%) of American adults each year, with about half of these errors potentially causing harm. “The report sets the foundation for reducing diagnostic errors, but ultimately these recommendations require action from all stakeholders—health systems, physicians, laboratories, and other healthcare providers,” said Singh, whose recommendations on a framework for measuring and reducing diagnostic errors helped inform the approach adopted by the report. Singh is also an associate professor at Baylor College of Medicine in Houston and has done extensive work on diagnostic errors.

Singh applauded the report, calling it comprehensive with recommendations that are multi-faceted. “Operationalizing the key constructs laid out by the report will be hard, but it is a good starting point,” he said. “The challenge will be getting everyone on the same page for action, including support for the ton of research needed to inform policymakers on concrete next steps for change and improvement.”

Defining Diagnostic Error

NAM defines diagnostic error from the patient’s viewpoint as “the failure to (a) establish an accurate and timely explanation of the patient’s health problem(s) or (b) communicate that explanation to the patient.” The definition uses the patient’s perspective because a patient bears the ultimate risk of harm from diagnostic errors, according to NAM.

Diagnostic errors stem from many causes, according to the report, including inadequate collaboration and communication among clinicians, patients, and their families; a healthcare work system that is not well designed to support the diagnostic process; limited feedback to clinicians about diagnostic performance; and a culture that discourages transparency and disclosure of diagnostic errors.

The committee recognized that concentrating only on reducing errors is not enough. Instead, the authors emphasized that a broader emphasis on improving diagnosis is warranted. To provide a framework for this dual focus, the committee developed a conceptual model to articulate the diagnostic process, describe work system factors that influence this process, and identify opportunities to improve it.

Teamwork and Collaboration

Perhaps the most significant goal for laboratories is the one focused on improving teamwork and collaboration. “Despite the important roles that laboratory medicine, anatomic pathology, and medical imaging play in a diagnosis, pathologists and radiologists have sometimes been treated as ancillary or support services,” says the report. “Expert testimony to the committee found that many pathologists and radiologists have not been adequately engaged in the diagnostic process and that better collaboration among all diagnostic team members is necessary.”

The committee recommends that healthcare organizations promote collaboration throughout the testing process, including the ordering of appropriate tests or images, analysis and interpretation, the reporting and communication of results, and subsequent decision-making. This recommendation dovetails with value-based healthcare reimbursement, which pays based on patient outcomes, not on the volume of procedures or tests.

Now is the time for laboratorians and pathologists to “step up to the plate” and become more active participants in helping treating physicians choose tests and interpret results, according to Michael Laposata, MD, PhD, chairman of the department of pathology at the University of Texas Medical Branch in Galveston and a member of the committee who has long advocated a team-based approach to diagnostics. “Here is our opportunity to be welcomed as participants in the diagnostic process,” Laposata said. “The committee is saying, it’s time for you to suit up. The score is tied 3-3 in the bottom of the ninth, and we’re sending the pathologist to the plate. Don’t strike out. You’re going to have to swing the bat.”

Paul Epner, MBA, MEd, executive vice president, co-founder, and director of the Society to Improve Diagnosis in Medicine (SIDM), says the NAM report identifies “a significant gap in our knowledge” and notes that SIDM intends to drive action on the NAM recommendations through a coalition of more than a dozen major medical societies and healthcare organizations. Coalition members have committed to taking measurable action to improve diagnosis, with each organization driving a specific initiative.

“It is the responsibility of everyone involved in the diagnostic process to consider the steps they can take to improve outcomes,” Epner said. The concept of diagnosis as a team endeavor is a very powerful one, allowing the patient to be an active party, along with nursing staff and the diagnostic professionals in the clinical laboratory and radiology, Epner stressed.

“Education reform is another key element so that trainees learn mechanisms to reduce diagnostic errors in practice,” he added. “Finally—for a problem that may be as lethal as traffic accidents, diabetes, or AIDS—research funding on the causes and potential solutions is urgently needed.”

Improving Diagnostic Information Technology

The report also calls for health information technologies to support patients and healthcare professionals in the diagnostic process. The committee notes that so far there is little evidence that health IT actually improves diagnosis in clinical practice. “Indeed, many experts are concerned that current health IT tools are not effectively facilitating the diagnostic process and may be contributing to diagnostic errors,” the report says.

Electronic medical records (EMRs) often still fail to provide useful information about laboratory tests, said Brian Jackson, MD, MS, vice president and chief medical informatics officer for ARUP Laboratories in Salt Lake City. For example, most EMRs refer to lab tests by name, but do not provide additional information about what individual tests are used for or how results should be interpreted. “We need lab experts to have the opportunity to deliver a much richer set of information that could actually be of use to ordering physicians,” Jackson said.

In a 2011 survey of primary care physicians sponsored by the Centers for Disease Control and Prevention, physicians reported uncertainty about ordering tests in about 15% of encounters and uncertainty in interpreting test results in more than 8% of encounters. The findings suggested that many physicians were open to electronic clinical decision support tools.

Standards are currently in development to allow plug-ins to existing EMR systems to provide additional information on lab tests, Jackson noted. Meanwhile, laboratories can try “low-tech” ways to assist ordering physicians, such as building robust webpages with detailed information about tests on the lab’s menu and providing easy access to the lab when physicians want more help.

Labs should also partner with their IT departments to improve the lab information in the EMR system, such as reviewing and approving physicians’ ordering sets and enhancing the presentation of test results. “These are things labs can do right now to make it more likely that docs order the right tests and that they can communicate easily with the lab when a question arises,” stressed Jackson. “Labs can and should play a role in improving the diagnostic process.”


An Opportunity for Labs to Engage With Providers and Patients

AACC responded with strong support for the National Academy of Medicine report that cohesive communication between all members of the healthcare team will reduce diagnostic errors. AACC’s 2015 President David Koch, PhD, emphasized AACC members have long been committed to reducing error and improving diagnosis. “We fully agree with the National Academies that taking a team approach to the diagnostic process is central to accomplishing this goal, and laboratory medicine professionals will be a key player on any successful team,” Koch said in a statement on the day of the report’s release. “Laboratory medicine professionals hold a wealth of knowledge on clinical tests and, if involved more in day-to-day clinical consulting, can provide vital insight to help physicians find better, faster, and more precise answers to challenging patient health problems.”

The report also urges healthcare professionals to make it easier for patients to participate in the diagnostic process. To learn more about diagnostic tests, patients can visit AACC’s website Lab Tests Online (www.labtestsonline.org), an award-winning patient resource that explains hundreds of diagnostic tests and conditions, written by laboratory professionals.

Learn more about AACC’s response to the report and ongoing advocacy and policy work.