Do No Harm: Diagnostic Errors and the Lab

By Jennifer (McMahon) Dawson, MHA, DLM (ASCP)  bio

“Do no harm” is the mantra that health care providers live by. Doctors, nurses and laboratory professionals alike enter into the business of health care because they are motivated to help people.

Why then do 5% of adults in the United States experience diagnostic error annually in outpatient settings at the hands of these well-meaning providers?¹ Humans work in health care. Where humans are involved, there will be mistakes.

There is also a certain level of trial-and-error that is acceptable in the diagnosis of patients. Laboratory professionals often feel removed from the actual diagnosis of the patients that they serve.

Laboratories play a critical role as lab testing is often used to confirm initial impressions or rule out differential diagnoses. It is estimated that 70% of all health care decisions affecting diagnosis or treatment involve lab testing² and at least 10% of all diagnoses are not considered final until lab testing is complete.^3,4

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We can all agree that the identification of diagnostic errors in medicine is critical to improving patient safety; however, it is easier said than done. Historically, the laboratory industry has focused its quality improvement efforts within boundaries of the laboratory. We have been lab-centric in this respect and have not focused on collaboration with other members of the care team or patient outcomes. The laboratory has been very good at detecting and eliminating errors in the analytical phase. Less focus has been placed on identifying and remedying errors outside of the analytical phase, particularly those that occur outside the boundaries of the lab (pre-pre and post-post-analytical).

In order for the laboratory to have a positive impact on diagnostic errors, it is necessary to become part of the interdisciplinary patient-centered care team. Laboratory professionals need to view their services as contributing to patient outcomes, not just generating results.

Research on diagnostic errors and the laboratory’s role has found that failure to order appropriate diagnostic tests, including lab tests, makes up 55% of missed and delayed diagnoses in the ambulatory setting and 58% of errors in emergency departments.⁵ We know that health care providers don’t understand our tests as well as we do. This statistic underscores the need for Clinical Lab Scientists to interact with and provide education to ordering providers on the proper use of the testing we provide.

One way that clinical laboratory professionals can affect positive change is by collaborating with other health care providers to establish evidence-based decision-making guidance for ordering tests. Providing feedback to providers detailing improper test utilization patterns, both over- and under-utilization, is another way that laboratory professionals can help to reduce diagnostic errors. Other ways the laboratory can help reduce diagnostic errors include reflexive testing, consultative services and improved test reporting.

Unfortunately, standardized feedback systems and reliable evidence-based decision support mechanisms do not yet exist on a large scale. In the meantime, we are reliant largely on our non-conforming event management systems to capture diagnostic errors. The success of these systems, whether you choose a manual or electronic option, is contingent on the establishment of a reporting culture.

A reporting culture is a culture of trust where employees feel safe, supported and comfortable pointing out errors, which may include their own, in the interest of patient safety and continuous improvement. The types of errors captured will include laboratory errors, errors generated outside the confines of the laboratory, and near misses. A near miss is “any event that could have had an adverse patient consequence, but did not, and was indistinguishable from a full-fledged adverse event in all but outcome.”⁶ A near miss is the perfect quality improvement opportunity, as we have the opportunity to eliminate the root cause before a patient is harmed. It is only after we are made aware of an event or near miss that a root cause analysis and corrective action can be formulated to prevent the event’s recurrence.

The identification of diagnostic errors to which the laboratory has contributed is a crucial piece of the puzzle in our effort to improve patient safety and outcomes. The lack of comprehensive information on the incidence of diagnostic errors should not prompt us to conclude that these errors are uncommon or unavoidable.⁷

In addition to the patient safety benefits, the shift from fee-for-service to value-based purchasing is already requiring us to become more patient-centric and outcomes-focused. This way of thinking is in line with the way we will be reimbursed in the future. The lab can help to reduce diagnostic errors by focusing on becoming more patient-centered, educating providers on lab testing, providing consultative services, initiating feedback loops that extend beyond the walls of the lab and ensuring that we have an effective non-conformity management system.

• Singh, H., Meyer, A. N. D., & Thomas, E. J. (2014). The frequency of diagnostic errors in outpatient care:estimations from three large observational studies involving US adult populations. BMJ Quality & Safety, 1–5.
• Badrick T. (2013) Evidence-Based Laboratory Medicine. Clin Biochem Rev. 2013 Aug; 34(2): 43–46
• Peterson MC, Holbrook JH, Von Hales D, et al. Contributions of the history, physical examination, and laboratory investigation in making medical diagnoses. The Western Journal of Medicine. BMJ 1992;156:163–5.
• Wahner-Roedler DL, Chaliki SS, Bauer BA, et al. Who makes the diagnosis? The role of clinical skills and diagnostic test results. J Eval Clin Pract 2007;13:321–5.
• Plebani M. Diagnostic errors and laboratory medicine – causes and strategies. EJIFCC. 2015 Jan; 26(1): 7–14
• Barach P, Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting. BMJ 2000;320:759-63
• Committee on Diagnostic Error in Health Care; Board on Health Care Services; Institute of Medicine; The National Academies of Sciences, Engineering, and Medicine; Balogh EP, Miller BT, Ball JR, editors. Improving Diagnosis in Health Care. Washington (DC): National Academies Press (US); 2015 Dec 29. 9, The Path to Improve Diagnosis and Reduce Diagnostic Error. Available from: https://www.ncbi.nlm.nih.gov/books/NBK338589/

Jennifer Dawson, MHA, LSSBB, CPHQ, DLM(ASCP)SLS, QLC, QIHC is a Lab Quality Management Leader and advocate for lab quality and patient safety. She is Senior Director, Quality, for Human Longevity, Inc.; Affiliate Faculty, Health Services Administration at Regis University; and a Lab Quality Consultant.

Ms. Dawson sits on the CLMA Board of Directors, the CLSI Quality Management Systems & General Practices Expert Panel, and the AACC Management Sciences & Patient Safety Division. She also serves on the National Malcolm Baldrige Quality Award Board of Examiners and serves on the ASCLS Patient Safety Committee and the AACC Management Sciences and Patient Safety Executive Committee.