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

Abstract

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-

Quality Assurance in Breast Pathology: Lessons Learned From a Review of Amended Reports

“…Although focused double review was an effective pre-signout intervention for interpretative error reduction, the authors also emphasized the importance of conference review as a post-sign-out mechanism of detection of interpretative errors (80%) and detection of all types of error (10%-20%). 8 In comparison to these 2 prior studies, we found a higher amendment rate, which likely reflects exclusive focus on breast specimens, an academic practice setting, and frequent second review of cases at the time of ancillary studies. A recent evidence-based guideline by the College of American Pathologists Pathology and Laboratory Quality Center and the Association of Directors of Anatomic and Surgical Pathology emphasized the value of double review in surgical pathology and cytology.…”

“…As previously mentioned, breast was one of the most common organ sites with total amendments, misinterpretations, and misidentifications, second only to skin. 7 Meier et al 1,8 reported a single institution experience in the development and validation of amended report taxonomy and implementation of a real-time amended reportmonitoring system and lean process-improvement program. Amendment rates increased from 2.6 to 4.8 per 1000 during the validation period to 10.1 per 1000 during the initial phases of monitoring and subsequently decreased to 5.6 per 1000 once lean processes took hold.…”

“…Interestingly, in this study, an analysis of defects by organ site confirmed our impressions from the medicolegal and quality literature: breast specimens are among the most prone to error in surgical pathology. [1][2][3][4][5][6][7][8][9] Breast was the second most common organ site for misinterpretations (16.2%) and misidentifications (12.6%) and the most common organ site for specimen defects (41.6%). of detection to identify strategies to reduce these types of errors and their associated clinical consequences.…”

Error Disclosure in Pathology and Laboratory Medicine: A Review of the Literature

“…The CAP's and the ADASP's recently released results of the novel Interpretive Diagnostics Error Reduction Project offer practicing anatomic pathologists the following insightful recommendations to minimize errors [22]: timely mandatory and routine case review tailored to each anatomic pathology lab, followed by investigation of "problematic" cases wrought by significant pathologist disagreements and meaningful steps to investigate and rectify the discordance. While work is underway to prevent medical errors and to design procedures for handling them when they occur, managing communication about errors awaits further exploration in the pathology professionalism literature.…”

Targeting errors in microbiology: the case of the Gram stain

“…Recently, Nakhleh and colleagues suggested that "the test cycle in surgical pathology and cytology is similar to the test cycle of other laboratory tests" [4]. In fact, the testing process is always composed of the pre-analytic, analytic and post-analytic phases and although the brainto-brain loop model was developed specifically for laboratory medicine, it is useful for describing the general process of diagnostic testing [5].…”