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Publicly Available Published by De Gruyter December 2, 2015

Building a bridge to safe diagnosis in health care. The role of the clinical laboratory

Giuseppe Lippi ORCID logo, Mario Plebani ORCID logo and Mark L. Graber

In the United States, during the year 2014, 8124 firearms homicides were reported to the Federal Bureau of Investigation (FBI) [1], and 761 people died in commercial airline accidents worldwide [2]. In the United States, it has also been estimated that preventable medical harm accounts for approximately 98,000 deaths each year [3]. These alarming figures highlight that the chance of death or significant injury because of medical care may be substantially higher than either or both of these major and well-known threats.

Laboratory medicine is a hidden and sometimes neglected treasure in health care, inasmuch as up to 70% of health care decisions affecting diagnosis or treatment and approximately 40% of practice guidelines involve biomedical testing [4]. Laboratory diagnostics is a multifaceted enterprise, characterized by a high degree of complexity, and involving a variety of health care technologies and personnel. As any other complex human activity, it is predictable that things may go wrong at various points in the total testing process, which spans all of the steps from test ordering to result interpretation and action [5, 6]. Reliable data suggests that the frequency of diagnostic errors pertaining to in vitro diagnostics can be as high as one every 330 tests [7], with 25% of such errors producing a major impact on the clinical decision making due to test(s) repetition, further inappropriate investigations or even unjustified clinical and therapeutic management [8]. According to autopsy data, an estimated 40,000–80,000 deaths annually in the United States are attributable to diagnostic error [9, 10], and laboratory testing is a factor in a substantial fraction of these cases [11, 12].

Formal recognition of safety as a concern in health care was first suggested in the landmark report from the US Institute of Medicine (IOM) in 1999: “To Err is Human” [3]. Although this report mentioned diagnostic error only in passing, the report is regarded as a milestone in the field of patient safety by emphasizing the need to improve safety and reduce error-related harm. The IOM released a follow-up report in 2001 entitled “Crossing the Quality Chasm: A New Health Care System for the 21st Century” [13], that reiterated the urgent call for fundamental change to close the quality gap. Major emphasis was placed on viewing medical error as a property of how healthcare systems are designed, and calling for efforts to focus on system-based improvements and the use of evidence-based practices as the most appropriate solutions to improve the safety of health care. Most recently, the IOM has released the latest report in the Quality Chasm series, “Improving Diagnosis in Health Care”, which focuses specifically on the problem of diagnostic error. This report emphasizes that diagnostic errors constitute an important and underestimated safety concern, and that addressing this issue represents a professional and moral imperative. Similarly, the World Health Organization’s (WHO) World Alliance for Patient Safety has identified misdiagnosis as a priority area of research for developed countries [14].

The concepts of “diagnostic errors” and “patient safety” are hardly new ones in the field of laboratory medicine. Our professionals have been early and effective leaders in efforts to improve the quality and safety of diagnostic testing, as evidenced by the large volume of articles published on this topic in laboratory medicine journals. More importantly, our field has an impressive and long record of progressive improvements in the quality of laboratory testing, an achievement recognized by the “Outstanding Contributions to Management Sciences and Patient Safety Award” bestowed by the American Association of Clinical Chemistry [15]. Since its birth in the year 1963, under the original name of “Zeitschrift für Klinische Chemie”, Clinical Chemistry and Laboratory Medicine(CCLM) has published 475 and 124 documents containing the keywords “error” or “safety” in the title, abstract or keywords. Although many publications preceded the original report from the IOM, it is clear that the growing interest in safety is reflected by a comparable growth in the number of safety- and quality-related publications since the original IOM report (Figure 1). It is also noteworthy that the most cited articles published in CCLM over the past decade were directly related to errors in laboratory diagnostics [7, 16, 17]. The ever-expanding number of publications focused on safety reflects both the broad interest of the laboratory community in addressing safety and quality, and an expanding appreciation of the many vulnerabilities that exist in the complex world of modern laboratory-based testing. The contribution of this journal to improving the awareness of patient safety issues related to laboratory testing and the evidence of a link between laboratory-associated and diagnostic errors, and adverse events for patients has been recognized [18].

Figure 1: Documents containing the keywords “error” or “safety” in title, abstract or keywords published by Clinical Chemistry and Laboratory Medicine under current and previous titles since the year 1973.

Figure 1:

Documents containing the keywords “error” or “safety” in title, abstract or keywords published by Clinical Chemistry and Laboratory Medicine under current and previous titles since the year 1973.

The timely publication of “Improving Diagnosis in Health Care” by the IOM reminds us that, regardless of the substantial progress that has been realized to date in improving the safety of laboratory testing, additional challenges remain. The report concludes that each of us is likely to experience one or more diagnostic errors in our lifetime, and that some of these will have serious or life-threatening consequences. Diagnostic error may involve any of various types of overlapping missed opportunities to make a correct and timely diagnosis, including mistakes in laboratory testing [19]. The IOM report offers eight goals for improving diagnosis, and recommendations related to each of these (Table 1). The report concludes that each of the stakeholders in the diagnostic process can play a role in improving safety, starting with the patient who is at the center of the process. The report envisions patients as becoming an active member on the diagnostic team, both to help ensure that the correct diagnosis is made on a timely basis, and to help catch at an ameliorable stage, any errors that might occur. The report provides a useful “Checklist For Getting The Right Diagnosis”, a comprehensive and user-friendly tool for patients to facilitate their engagement.

Table 1

List of US Institute of Medicine (IOM) recommendations (goals) for improving diagnosis in health care.

1. Facilitate more effective teamwork in the diagnostic process among health care professionals, patients, and their families
2. Enhance health care professional education and training in the diagnostic process
3. Ensure that health information technologies support patients and health care professionals in the diagnostic process
4. Develop and deploy approaches to identify, learn from, and reduce diagnostic errors and near misses in clinical practice
5. Establish a work system and culture that supports the diagnostic process and improvements in diagnostic performance
6. Develop a reporting environment and medical liability system that facilitates improved diagnosis by learning from diagnostic errors and near misses
7. Design a payment and care delivery environment that supports the diagnostic process
8. Provide dedicated funding for research on the diagnostic process and diagnostic errors

The report also conveys a clear message to laboratory professionals in regard to improving the safety of diagnosis. This is largely based on the framework of the total testing process, and the realization that so many diagnostic errors reflect problems in the pre- and post-analytical phases of testing [20, 21]. Now that laboratories have achieved such an impressive record of quality in the analytical phase of testing, it is time for the laboratory to help address these other problems, many of which occur outside of the laboratory walls [22]. Thus the report calls for laboratory professionals to be actively involved as a partner on the diagnostic team [23], and for payment reform that would reward the time spent on clinical advice and consultation. The report calls for more autopsies as a vital tool to identify mistakes in diagnosis and learn from these mistakes. Another important focus area involves communication. The report urges that each of the stakeholders helps ensure that diagnostic information, as well as the ultimate diagnosis, is reliably communicated to the interested parties. This may be the ‘low hanging fruit’ that could jumpstart improvement, given how often failed communication of laboratory tests is cited as a contributing factor in diagnostic error [24, 25]. Finally, the analytical phase of testing also has residual areas that demand attention in regard to timeliness and reliability, for example anatomic pathology [26] and all tests that depend on visual interpretation, point-of-care tests, and tests sent to reference laboratories [27]. Each of these represents vulnerabilities that can ultimately lead to harm.

The IOM reports have emphasized that large gaps, chasms, separate the current state from the goal of providing safe health care. The newest volume in this series, Improving Diagnosis in Health Care, makes an effective case that this also applies to the goal of providing safe, effective, and timely diagnosis. Fortunately, the report also represents a unique resource that provides both a framework and a wealth of ideas for how to construct the bridge that spans this quality chasm, and the laboratory has a major role to play in both building and crossing this bridge.


Corresponding author: Prof. Giuseppe Lippi, Section of Clinical Biochemistry, University Hospital of Verona, P.le LA Scuro 10, 37134 – Verona, Italy, E-mail: .

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Published Online: 2015-12-2
Published in Print: 2016-1-1

©2016 by De Gruyter

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