Errors within the total laboratory testing process, from test selection to medical decision-making – A review of causes, consequences, surveillance and solutions

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Abstract

Laboratory analyses are crucial for diagnosis, follow-up and treatment decisions. Since mistakes in every step of the total testing process may potentially affect patient safety, a broad knowledge and systematic assessment of laboratory errors is essential for future improvement. In this review, we aim to discuss the types and frequencies of potential errors in the total testing process, quality management options, as well as tentative solutions for improvement. Unlike most currently available reviews on this topic, we also include errors in test-selection, reporting and interpretation/action of test results. We believe that laboratory specialists will need to refocus on many process steps belonging to the extra-analytical phases, intensifying collaborations with clinicians and supporting test selection and interpretation. This would hopefully lead to substantial improvements in these activities, but may also bring more value to the role of laboratory specialists within the health care setting.

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Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claims.

Tejal Gandhi, Allen Kachalia, Eric Thomas … (2006)

Although missed and delayed diagnoses have become an important patient safety concern, they remain largely unstudied, especially in the outpatient setting. To develop a framework for investigating missed and delayed diagnoses, advance understanding of their causes, and identify opportunities for prevention. Retrospective review of 307 closed malpractice claims in which patients alleged a missed or delayed diagnosis in the ambulatory setting. 4 malpractice insurance companies. Diagnostic errors associated with adverse outcomes for patients, process breakdowns, and contributing factors. A total of 181 claims (59%) involved diagnostic errors that harmed patients. Fifty-nine percent (106 of 181) of these errors were associated with serious harm, and 30% (55 of 181) resulted in death. For 59% (106 of 181) of the errors, cancer was the diagnosis involved, chiefly breast (44 claims [24%]) and colorectal (13 claims [7%]) cancer. The most common breakdowns in the diagnostic process were failure to order an appropriate diagnostic test (100 of 181 [55%]), failure to create a proper follow-up plan (81 of 181 [45%]), failure to obtain an adequate history or perform an adequate physical examination (76 of 181 [42%]), and incorrect interpretation of diagnostic tests (67 of 181 [37%]). The leading factors that contributed to the errors were failures in judgment (143 of 181 [79%]), vigilance or memory (106 of 181 [59%]), knowledge (86 of 181 [48%]), patient-related factors (84 of 181 [46%]), and handoffs (36 of 181 [20%]). The median number of process breakdowns and contributing factors per error was 3 for both (interquartile range, 2 to 4). Reviewers were not blinded to the litigation outcomes, and the reliability of the error determination was moderate. Diagnostic errors that harm patients are typically the result of multiple breakdowns and individual and system factors. Awareness of the most common types of breakdowns and factors could help efforts to identify and prioritize strategies to prevent diagnostic errors.

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The Landscape of Inappropriate Laboratory Testing: A 15-Year Meta-Analysis

Qiao-Ming Zhi, Eric Ding, Jesse Theisen-Toupal … (2013)

Background Laboratory testing is the single highest-volume medical activity and drives clinical decision-making across medicine. However, the overall landscape of inappropriate testing, which is thought to be dominated by repeat testing, is unclear. Systematic differences in initial vs. repeat testing, measurement criteria, and other factors would suggest new priorities for improving laboratory testing. Methods A multi-database systematic review was performed on published studies from 1997–2012 using strict inclusion and exclusion criteria. Over- vs. underutilization, initial vs. repeat testing, low- vs. high-volume testing, subjective vs. objective appropriateness criteria, and restrictive vs. permissive appropriateness criteria, among other factors, were assessed. Results Overall mean rates of over- and underutilization were 20.6% (95% CI 16.2–24.9%) and 44.8% (95% CI 33.8–55.8%). Overutilization during initial testing (43.9%; 95% CI 35.4–52.5%) was six times higher than during repeat testing (7.4%; 95% CI 2.5–12.3%; P for stratum difference <0.001). Overutilization of low-volume tests (32.2%; 95% CI 25.0–39.4%) was three times that of high-volume tests (10.2%; 95% CI 2.6–17.7%; P<0.001). Overutilization measured according to restrictive criteria (44.2%; 95% CI 36.8–51.6%) was three times higher than for permissive criteria (12.0%; 95% CI 8.0–16.0%; P<0.001). Overutilization measured using subjective criteria (29.0%; 95% CI 21.9–36.1%) was nearly twice as high as for objective criteria (16.1%; 95% CI 11.0–21.2%; P = 0.004). Together, these factors explained over half (54%) of the overall variability in overutilization. There were no statistically significant differences between studies from the United States vs. elsewhere (P = 0.38) or among chemistry, hematology, microbiology, and molecular tests (P = 0.05–0.65) and no robust statistically significant trends over time. Conclusions The landscape of overutilization varies systematically by clinical setting (initial vs. repeat), test volume, and measurement criteria. Underutilization is also widespread, but understudied. Expanding the current focus on reducing repeat testing to include ordering the right test during initial evaluation may lead to fewer errors and better care.

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Errors in a stat laboratory: types and frequencies 10 years later.

Mario Plebani, Paolo Carraro (2007)

In view of increasing attention focused on patient safety and the need to reduce laboratory errors, it is important that clinical laboratories collect statistics on error occurrence rates over the whole testing cycle, including pre-, intra-, and postanalytical phases. The present study was conducted in 2006 according to the design we previously used in 1996 to monitor the error rates for laboratory testing in 4 different departments (internal medicine, nephrology, surgery, and intensive care). For 3 months, physicians and nurses were asked to pay careful attention to all test results. Any suspected laboratory error was recorded with associated pertinent clinical information. Every day, a laboratory physician visited the 4 departments and a critical appraisal was made of any suspect results. Among a total of 51 746 analyses, clinicians notified us of 393 questionable findings, 160 of which were confirmed as laboratory errors. The overall frequency of errors, 3092 ppm, was significantly lower (P <0.05) than in 1996 (4700 ppm). Of the 160 confirmed errors, 61.9% were preanalytical errors, 15% were analytical, and 23.1% were postanalytical. During the last decade the error rates in our stat laboratory have been reduced significantly. As demonstrated by the distribution pattern, the pre- and postanalytical steps still have the highest error prevalences, but changes have occurred in the types and frequencies of errors in these phases of testing.

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Author and article information

Journal

Journal ID (nlm-ta): Biochem Med (Zagreb)

Journal ID (iso-abbrev): Biochem Med (Zagreb)

Journal ID (publisher-id): BM

Title: Biochemia Medica

Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine

ISSN (Print): 1330-0962

ISSN (Electronic): 1846-7482

Publication date (Print and electronic): 15 June 2020

Publication date (Electronic): 15 June 2020

Publication date (Print): 15 June 2020

Volume: 30

Issue: 2

Electronic Location Identifier: 020502

Affiliations

[1 ]Department of Laboratory Medicine, Paracelsus Medical University , Salzburg, Austria

[2 ]Section of Clinical Chemistry, University of Verona , Verona, Italy

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[* ]Corresponding author: c.mrazek@ 123456salk.at

Article

Publisher ID: bm-30-2-020502

DOI: 10.11613/BM.2020.020502

PMC ID: 7271754

PubMed ID: 32550813

SO-VID: 138976df-6ebb-4025-a43a-1efb4b838ea5

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution ( http://creativecommons.org/licenses/by/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Errors within the total laboratory testing process, from test selection to medical decision-making – A review of causes, consequences, surveillance and solutions

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Most cited references 93

Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claims.

The Landscape of Inappropriate Laboratory Testing: A 15-Year Meta-Analysis

Errors in a stat laboratory: types and frequencies 10 years later.

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