The “Big Dog” Effect: Variability Assessing the Causes of Error in Diagnoses of Patients With Lung Cancer

Raab, Stephen S.; Meier, Frederick A.; Zarbo, Richard J.; Jensen, Chris S.; Geisinger, Kim R.; Booth, Christine N.; Krishnamurti, Uma; Stone, Chad H.; Janosky, Janine E.; Grzybicki, Dana M.

doi:10.1200/jco.2005.04.3661

Cited by 32 publications

(26 citation statements)

References 22 publications

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“…If 60 to 70% of medical decisions are based on laboratory results, it stands to reason that erroneous laboratory results play some role in avoidable patient mortality (24). Anatomic pathologists have made significant efforts to track, categorize, and determine the impacts of errors in slide review in multicenter studies, but they have had difficulties in developing consensus on interpretation of results and root causes (15,18,19). Clinical microbiologists face similar obstacles in attempts to characterize the incidence and nature of errors in their laboratories.…”

Section: Discussionmentioning

confidence: 99%

“…The frequency of errors in cancer diagnosis was found to be 11.8% in cytologic-histologic specimen comparisons (13). Attempts to assess root causes of these errors have been hampered by significant interobserver variability and lack of consensus (19). In spite of these challenges, these efforts have led to interventions that reduced the incidence of errors in surgical pathology (15).…”

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confidence: 99%

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Multicenter Assessment of Gram Stain Error Rates

et al. 2016

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Gram stains remain the cornerstone of diagnostic testing in the microbiology laboratory for the guidance of empirical treatment prior to availability of culture results. Incorrectly interpreted Gram stains may adversely impact patient care, and yet there are no comprehensive studies that have evaluated the reliability of the technique and there are no established standards for performance. In this study, clinical microbiology laboratories at four major tertiary medical care centers evaluated Gram stain error rates across all nonblood specimen types by using standardized criteria. The study focused on several factors that primarily contribute to errors in the process, including poor specimen quality, smear preparation, and interpretation of the smears. The number of specimens during the evaluation period ranged from 976 to 1,864 specimens per site, and there were a total of 6,115 specimens. Gram stain results were discrepant from culture for 5% of all specimens. Fifty-eight percent of discrepant results were specimens with no organisms reported on Gram stain but significant growth on culture, while 42% of discrepant results had reported organisms on Gram stain that were not recovered in culture. Upon review of available slides, 24% (63/263) of discrepant results were due to reader error, which varied significantly based on site (9% to 45%). The Gram stain error rate also varied between sites, ranging from 0.4% to 2.7%. The data demonstrate a significant variability between laboratories in Gram stain performance and affirm the need for ongoing quality assessment by laboratories. Standardized monitoring of Gram stains is an essential quality control tool for laboratories and is necessary for the establishment of a quality benchmark across laboratories. C linical microbiology laboratories have undergone dramatic changes with the implementation of novel technologies, yet traditional techniques, such as the Gram stain, still play key roles throughout the diagnostic process (1-3). Gram stains are initially used as a preanalytical indicator of specimen quality and acceptability for culture. They also give the clinician preliminary information regarding the nature of potential pathogens present in the patient specimen and thus serve to guide empirical therapy. Although the Gram stain has been the staple of clinical microbiology laboratories for over a century, it is still considered a high-complexity procedure by the Clinical Laboratory Improvement Amendments (CLIA) program. The manual nature of the staining process and the subjectivity of Gram stain interpretation contribute to the incidence of errors (4-7). Inappropriate specimen sampling, specimen processing, smear preparation, and prior antibiotic therapy are all factors that can have an adverse impact on Gram stain result. The inherent nature of some organisms may also produce misleading results; for example, Acinetobacter spp. may stain Gram positive, while Bacillus spp. species may appear Gram negative. In addition, staining practices, such as use of cytospin and ...

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Multicenter Assessment of Gram Stain Error Rates

et al. 2016

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“…[5][6][7][8][9] It is therefore more subjective than clinical laboratory tests. There are many factors that contribute to an accurate interpretive diagnosis, including: (1) the patholo-gist's knowledge and experience, (2) clinical correlation, (3) standardized diagnostic criteria and taxonomy, (4) confirmatory ancillary studies when available, and (5) secondary review of cases.…”

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Interpretive Diagnostic Error Reduction in Surgical Pathology and Cytology: Guideline From the College of American Pathologists Pathology and Laboratory Quality Center and the Association of Directors of Anatomic and Surgical Pathology

Nakhleh

Nosé²,

Colasacco³

et al. 2015

Archives of Pathology &Amp; Laboratory Medicine

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Context.-Additional reviews of diagnostic surgical and cytology cases have been shown to detect diagnostic discrepancies.Objective.-To develop, through a systematic review of the literature, recommendations for the review of pathology cases to detect or prevent interpretive diagnostic errors.Design.-The College of American Pathologists Pathology and Laboratory Quality Center in association with the Association of Directors of Anatomic and Surgical Pathology convened an expert panel to develop an evidencebased guideline to help define the role of case reviews in surgical pathology and cytology. A literature search was conducted to gather data on the review of cases in surgical pathology and cytology.Results.-The panel drafted 5 recommendations, with strong agreement from open comment period participants ranging from 87% to 93%. The recommendations are: (1) anatomic pathologists should develop procedures for the review of selected pathology cases to detect disagreements and potential interpretive errors; (2) anatomic pathologists should perform case reviews in a timely manner to avoid having a negative impact on patient care; (3) anatomic pathologists should have documented case review procedures that are relevant to their practice setting; (4) anatomic pathologists should continuously monitor and document the results of case reviews; and (5) if pathology case reviews show poor agreement within a defined case type, anatomic pathologists should take steps to improve agreement.Conclusions.-Evidence exists that case reviews detect errors; therefore, the expert panel recommends that anatomic pathologists develop procedures for the review of pathology cases to detect disagreements and potential interpretive errors, in order to improve the quality of patient care. (Arch Pathol Lab Med. 2016;140:29-40; doi: 10.5858/ arpa.2014-0511-SA) T he test cycle in surgical pathology and cytology is similar to the test cycle of other laboratory tests. [1][2][3][4] It is composed of the preanalytic, analytic, and postanalytic phases. The preanalytic and postanalytic phases are very similar to tests in the clinical laboratory. The preanalytic phase is composed of specimen acquisition, specimen labeling, and delivery to the laboratory, where the specimen is prepared for the analytic phase. The postanalytic phase begins with report generation and ends with delivery of the report to the clinician.Unlike the other phases of the test cycle, the analytic phase is substantially different in surgical pathology and cytology (versus clinical pathology) in that it involves the inherent judgment of the pathologist at the time of slide interpretation. [5][6][7][8][9] It is therefore more subjective than clinical laboratory tests. There are many factors that contribute to an accurate interpretive diagnosis, including: (1) the patholo-

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“…Небольшое ко-личество клеточного материала опухоли затрудняет рас-познавание злокачественности процесса в целом, что при-водит к ложноотрицательным и ложноположительным интерпретациям. Согласно литературным данным, такие ошибки отмечаются у 15 % пациентов [6]. Ложноотри-цательные заключения цитологической диагностики не-редко обусловлены некачественным забором материала: наличием единичных опухолевых клеток в препарате, присутствием примеси крови, слизи, бесструктурных масс детрита, воспалительных элементов.…”

Section: Introductionunclassified