Diagnostic errors in medicine are a patient safety and quality of care challenge. At the end of September 2015, the National Academies of Sciences, Engineering, and Medicine released an Institute of Medicine (IOM) report, Improving Diagnosis in Health Care. This month’s Patient Safety Focus interviews Mark Graber, MD, founder and president of the Society to Improve Diagnosis in Medicine (SIDM), a member of the report committee, and a pioneer in the field of diagnostic errors.

Nikola Baumann, PhD, of the Mayo Clinic department of pathology and laboratory medicine conducted this interview.

Can you explain how Improving Diagnosis in Health Care came to be?

SIDM asked the IOM to undertake this report in 2013. We were convinced that diagnostic errors were a common and important safety problem that had been overlooked in the original IOM report on patient safety, To Err is Human. We assisted the IOM in raising funds to undertake the report, which commenced in 2014 and was finally released to the public in September 2015. The Centers for Disease Control and Prevention (CDC) was a key sponsor of the report.

How do you expect the report to influence current practices?

One of the central axioms in the field of safety is that every system is perfectly designed for the results that it achieves. This applies to diagnostic safety, too. Reducing the chances of harm from diagnostic error will require changes in practice, changes in attitudes and behaviors, and changes in culture. By spelling out exactly what each stakeholder can do, the IOM report recommendations provide a blueprint for achieving the changes that are needed. But these are only recommendations; that is as far as the IOM can go. It will be up to each of the stakeholders to actually adopt the IOM recommendations and make this blueprint a reality.

Since its release, tell us about reactions to the report. What has surprised you the most?

The IOM report as of November 1 has already been downloaded more than 8,000 times, and there were 356 stories in the media about the report (in 37 of the 50 states) with 125 million media impressions. This was certainly a successful outreach, especially given that the report was released in competition with Pope Francis’ visit to the United States, which saturated the news that week. The response to the report has been overwhelmingly positive. The general sense is that the report got it right: it touched on all of the main themes and made important recommendations in many different areas.

What is the role of the clinical laboratory in improving diagnosis in health care? Are there specific actions for laboratories?

The clinical lab is a superb role model for improving quality and safety through performance improvement. There is no better example in all of medicine for the success that the lab has realized, reducing the error rate in the analytical phase of testing to 5 sigma levels of reliability in some cases. Major advances in automation and repeated cycles of monitoring and improving the analytical process led to this achievement.

One of the most important aspects of the IOM report is to point out that diagnosis is a process too, with discrete steps, each of which is error prone. This opens the door to the same type of performance improvement initiatives that have been so successful in the clinical laboratory.

At the same time, many facets of analytical testing remain problematic, including send-out tests, point-of-care testing, and every test that requires visual interpretation. Moreover, it is now very clear that the vast majority of errors involving the clinical laboratory occur in the pre- and post-analytical phases of testing, including many steps and processes that take place outside the confines of the lab. Physicians don’t know the right test to order—there are more than 4,000—or that a test was already done, or how to interpret the result, or the test results get lost.

Diagnostic errors involve both system-related and cognitive breakdowns, whether in the clinical laboratory or front-line practice. Although laboratories excel at detecting errors in analytical testing, they are less adept at detecting and managing the many lab testing-related errors that occur outside the confines of labs. Indeed, a substantial fraction of the harm related to diagnostic errors derives from issues outside the lab, and it is not clear that laboratories appreciate the magnitude of the problem.

To begin tackling these issues, the IOM report calls for much greater interaction and partnership between clinicians and clinical labs. The authors also appeal for payment reform to provide reimbursement for consultative services, with the goal of restoring the clinical pathology position that has essentially disappeared from many, even most, laboratory departments. In addition, the document recommends restoring autopsies at a limited number of centers as a way to learn about diagnostic errors. Autopsies provide invaluable lessons in the limits of diagnostic accuracy, with one in 10 disclosing major discrepancies that could have changed patient management and outcomes. But autopsies have essentially disappeared in American medicine, and nothing has replaced them.

Beyond these steps, the largest challenge for clinical labs will be the remaining problems in analytical testing, taking on the “pre-pre” and “post-post” problems that right now very few institutions are addressing. This will be a big job, but the need is clear, the time to start is now, and hopefully laboratory departments will find willing partners on the clinical side of the house to work with.

What role could professional societies play?

Professional societies need to take a leadership role in promoting awareness about diagnostic error, and considering what specific actions they and their members can take to improve diagnostic reliability. SIDM has recently launched a new group, the Coalition to Improve Diagnosis in Medicine, a voluntary alliance of professional societies which have agreed to take both individual and collective action to improve diagnostic quality and safety. This group includes the National Patient Safety Foundation, the American Society of Healthcare Risk Managers, the American Boards of Medical Specialties, and many others. The Agency for Healthcare Research and Quality and CDC are prominent advisory members of this group. Laboratory associations and societies would be welcome members, and could play a vital role in coordinating how departments of laboratory medicine and laboratory professionals can most effectively begin reducing lab-related diagnostic errors.

Mark L. Graber, MD, FACP is president of the Society to Improve Diagnosis in Medicine, a senior fellow at RTI International and professor emeritus at the State University of New York, Stony Brook, New York.

CLN's Patient Safety Focus is sponsored by ARUP Laboratories

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