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Artroplastia , Biopsia , Cuidados Intraoperatorios , Artropatías/cirugía , Articulaciones/cirugía , Evaluación de Procesos y Resultados en Atención de Salud , Artroplastia/economía , Biopsia/economía , Análisis Costo-Beneficio , Costos de la Atención en Salud , Humanos , Cuidados Intraoperatorios/economía , Artropatías/diagnóstico por imagen , Artropatías/patología , Articulaciones/diagnóstico por imagen , Articulaciones/patología , Evaluación de Procesos y Resultados en Atención de Salud/economía , Pautas de la Práctica en Medicina , Valor Predictivo de las Pruebas , Resultado del Tratamiento , Procedimientos InnecesariosRESUMEN
BACKGROUND: Implementing the Paris system for reporting urine cytology (TPS) can substantiate atypical diagnosis while improving standardization and risk stratification. This study evaluates its performance and reproducibility in challenging cases and examines whether focused education of morphological features can improve outcomes. METHODS: In our prior study, urine cytology cases diagnosed as "atypical" with surgical follow-up were used. Cases showing poor agreement in that study were collected for this one. Representative photographs of each case were taken and distributed via online questionnaires. Participants were asked to render an initial diagnosis and evaluate the presence of several morphological features. Educational material was distributed, followed by additional questionnaires. RESULTS: Three participants evaluated 40 cases before and after educational materials. TPS diagnoses were significantly more specific (0.23 vs 0.59, P = 0.004) and more accurate (0.43 vs 0.66, P = 0.0125) than diagnoses made with our institutional system. Fewer overall cases were diagnosed as "atypical" with TPS. TPS education resulted in slightly, though not significantly, more specific diagnoses (0.25 vs 0.59, P = 0.083). Interobserver agreement decreased for nuclear-to-cytoplasmic (N/C) ratio, TPS diagnoses and initial diagnoses, and increased for all other features. TPS resulted in downgrading of cases with biopsy-proven low grade urothelial neoplasm (LGUN) from "atypical" to negative for high grade urothelial carcinoma (NHGUC) (P = 0.018). CONCLUSIONS: Use of TPS in challenging urine cytology cases can improve specificity, risk stratification, and diagnostic accuracy while decreasing the number of "atypical" diagnoses. Though training can help cytopathologists better apply these criteria, it is unclear how to effectively improve evaluation of N/C ratio.
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Carcinoma/patología , Citodiagnóstico/normas , Orina/citología , Neoplasias Urológicas/patología , Urotelio/patología , Carcinoma/orina , Citodiagnóstico/métodos , Diagnóstico Diferencial , Humanos , Reproducibilidad de los Resultados , Proyectos de Investigación/normas , Sensibilidad y Especificidad , Neoplasias Urológicas/orinaRESUMEN
OBJECTIVE: To determine the effectiveness of using glacial acetic acid (GAA) to convert unsatisfactory bloody ThinPrep (TP) cervical smear test to satisfactory, and identify associated missed diagnoses and high-risk HPV (hrHPV) genotypes. METHODS: In a retrospective descriptive cross-sectional analysis, all TP tests performed in Mississippi, USA, 2012-2016, were evaluated for unsatisfactory results owing to blood. Tests that were converted to satisfactory by GAA treatment, and corresponding anomalies and HPV genotypes were identified. RESULTS: Among 106 384 TP tests, there were 1460 (1.37%) unsatisfactory results, of which 1442 (98.77%) were converted to satisfactory after GAA treatment. Laboratory preprocessing with GAA increased costs minimally. Precancerous lesions were detected in 166 (11.51%) of 1442 GAA-treated samples, of which 12 (7.2%) were high-grade lesions, 110 (66.3%) were atypical squamous cells of undetermined significance, and 63 (57.3%) tested positive for hrHPV. Of 60 genotyped samples, 39 (65%) had non-HPV16 and non-HPV18. Including mixed infections, 48 (80%) contained less-common hrHPV types, reflecting an unexpected distribution in bloody specimens. CONCLUSIONS: GAA pretreatment of bloody TP tests would reduce the incidence of unsatisfactory results and missed high-grade lesions, and prevent the cost of repeat tests and delayed treatment. Clinicians without access to GAA should consider HPV testing.
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Ácido Acético , Pruebas de ADN del Papillomavirus Humano/métodos , Indicadores y Reactivos , Displasia del Cuello del Útero/virología , Neoplasias del Cuello Uterino/virología , Adulto , Estudios Transversales , Femenino , Genotipo , Pruebas de ADN del Papillomavirus Humano/economía , Humanos , Persona de Mediana Edad , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/diagnóstico , Estudios Retrospectivos , Sensibilidad y Especificidad , Neoplasias del Cuello Uterino/diagnóstico , Neoplasias del Cuello Uterino/patología , Frotis Vaginal/métodos , Displasia del Cuello del Útero/diagnóstico , Displasia del Cuello del Útero/patologíaRESUMEN
BACKGROUND: This study investigates the use of The Paris System (TPS) for Reporting Urinary Cytopathology and examines the performance of individual and combined morphological features in atypical urine cytologies. METHODS: We reviewed 118 atypical cytologies with subsequent bladder biopsies for the presence of several morphological features and reclassified them into Paris System categories. The sensitivity and specificity of individual and combined features were calculated along with the risk of malignancy. RESULTS: An elevated nuclear-to-cytoplasmic ratio was only predictive of malignancy if seen in single cells, while irregular nuclear borders, hyperchromasia, and coarse granular chromatin were predictive in single cells and in groups. Identification of coarse chromatin alone yielded a malignancy risk comparable to 2-feature combinations. The use of TPS criteria identified the specimens at a higher risk of malignancy. CONCLUSION: Our findings support the use of TPS criteria, suggesting that the presence of coarse chromatin is more specific than other individual features, and confirming that cytologic atypia is more worrisome in single cells than in groups.
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Carcinoma/patología , Neoplasias de la Vejiga Urinaria/patología , Vejiga Urinaria/patología , Urotelio/patología , Carcinoma/orina , Carcinoma in Situ/patología , Carcinoma in Situ/orina , Núcleo Celular/patología , Forma de la Célula , Cromatina/patología , Citodiagnóstico , Humanos , Clasificación del Tumor , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Factores de Riesgo , Urinálisis/métodos , Neoplasias de la Vejiga Urinaria/orina , Orina/citologíaRESUMEN
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 evidence-based 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.
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Citodiagnóstico , Errores Diagnósticos , Patología Quirúrgica , Humanos , Citodiagnóstico/normas , Errores Diagnósticos/prevención & control , Laboratorios/normas , Patología Quirúrgica/normas , Revisiones Sistemáticas como AsuntoRESUMEN
BACKGROUND: At a high-volume center, it became necessary to provide benchmarks for the accuracy and risk of malignancy per urine cytology diagnostic category. The additive sensitivity for the determination of the residual risk of disease was calculated with the goal of determining the performance of cytology and optimal triage, including the number of urine samples, before the detection of malignancy in surveillance patients. METHODS: A 2-year laboratory information system-based search was conducted, and it yielded 587 subjects (695 biopsy and cytology pairs) with histological follow-up. The sensitivity and specificity of cytology for urothelial malignancy, the risk of malignancy per diagnostic category, the additive sensitivity, and the time for conversion from a negative initial cytology result to a positive cytology result were examined. RESULTS: The overall average sensitivity and specificity of cytology were 48.9% and 83.0%, respectively. The additive sensitivity increased with each subsequent cytology and peaked with the third cytology. A median conversion time of 22.2 months from a negative initial cytology result to a positive cytology result and a decline in predictive positive cytology after the fourth cytology were noted. Subcategorization of the atypical category failed to show statistical significance in predicting outcomes of biopsy. Surveillance subjects, as compared to primary subjects, showed a higher sensitivity for the detection of high and low grade cancers. CONCLUSIONS: The findings suggest that atypia favoring malignancy is being appropriately flagged. However, further definition of the atypical category is needed to increase specificity with a better qualitative or quantitative morphological algorithm. This study provides a risk of malignancy for each category for benchmarking and clinical triage. The data suggest that follow-up should include at least 4 consecutive urine specimens over a period of 22.2 months.
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Neoplasias de la Vejiga Urinaria/diagnóstico , Orina/citología , Área Bajo la Curva , Benchmarking , Citodiagnóstico , Humanos , Modelos Logísticos , Riesgo , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: The majority of errors in laboratory medicine testing are thought to occur in the pre- and postanalytic testing phases, and a large proportion of these errors are secondary to failed handoffs. Because most laboratory tests originate in ambulatory primary care, understanding the gaps in handoff processes within and between laboratories and practices is imperative for patient safety. Therefore, the purpose of this study was to understand, based on information from primary care practice personnel, the perceived gaps in laboratory processes as a precursor to initiating process improvement activities. DESIGN: A survey was used to assess perceptions of clinicians, staff, and management personnel of gaps in handoffs between primary care practices and laboratories working in 21 Colorado primary care practices. Data were analyzed to determine statistically significant associations between categorical variables. In addition, qualitative analysis of responses to open-ended survey questions was conducted. RESULTS: Primary care practices consistently reported challenges and a desire/need to improve their efforts to systematically track laboratory test status, confirm receipt of laboratory results, and report results to patients. Automated tracking systems existed in roughly 61% of practices, and all but one of those had electronic health record-based tracking systems in place. One fourth of these electronic health record-enabled practices expressed sufficient mistrust in these systems to warrant the concurrent operation of an article-based tracking system as backup. Practices also reported 12 different procedures used to notify patients of test results, varying by test result type. CONCLUSION: The results highlight the lack of standardization and definition of roles in handoffs in primary care laboratory practices for test ordering, monitoring, and receiving and reporting test results. Results also identify high-priority gaps in processes and the perceptions by practice personnel that practice improvement in these areas is needed. Commonalities in these areas warrant the development and support of tools for use in primary care settings.
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Servicios de Laboratorio Clínico , Pase de Guardia , Atención Ambulatoria , Estudios de Cohortes , Laboratorios , Sistemas RecordatoriosAsunto(s)
Competencia Clínica , Cognición/fisiología , Técnicas de Preparación Histocitológica/métodos , Patología Quirúrgica/métodos , Patología Quirúrgica/normas , Seguridad del Paciente , Garantía de la Calidad de Atención de Salud , Diagnóstico Diferencial , Errores Diagnósticos/prevención & control , Técnicas de Preparación Histocitológica/normas , Humanos , FenotipoRESUMEN
An anatomic pathology diagnostic error may be secondary to a number of active and latent technical and/or cognitive components, which may occur anywhere along the total testing process in clinical and/or laboratory domains. For the pathologist interpretive steps of diagnosis, we examine Kahneman's framework of slow and fast thinking to explain different causes of error in precision (agreement) and in accuracy (truth). The pathologist cognitive diagnostic process involves image pattern recognition and a slow thinking error may be caused by the application of different rationally-constructed mental maps of image criteria/patterns by different pathologists. This type of error is partly related to a system failure in standardizing the application of these maps. A fast thinking error involves the flawed leap from image pattern to incorrect diagnosis. In the ideal state, anatomic pathology systems would target these cognitive error causes as well as the technical latent factors that lead to error.
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BACKGROUND: Clinical management of thyroid neoplasms is based on light microscopic diagnosis, but its accuracy and precision are poorly defined. OBJECTIVE: To assess inter- and intraobserver variability of preoperative cytopathologic and postoperative histopathologic thyroid diagnoses. DESIGN: Samples were collected in a prospective, multicenter trial validating a gene expression classifier between June 2009 and December 2010. SETTING: 14 academic and 35 community clinical sites. PATIENTS: 653 patients with 776 surgically resected thyroid nodules of 1 cm or greater. MEASUREMENTS: Intraobserver concordance among 2 or more central histopathologists who independently read histopathology slides was calculated. Interobserver concordance between the diagnoses made by the central histopathologists and those made by local pathologists were calculated. Intra- and interobserver concordance for cytopathology was similarly calculated by comparing diagnoses made by local pathologists with those made by a central panel of 3 cytopathologists. RESULTS: Concordance on the histopathologic distinction between benign and malignant diagnoses was 91% comparing local with central histopathologists and 90% comparing 2 central histopathologists. Using the 6-category Bethesda System, 64.0% of diagnoses made by local and central cytopathologists and 74.7% of intraobserver diagnoses were concordant. Central cytopathologists made fewer indeterminate diagnoses than local pathologists (41.2% vs. 55.0%). LIMITATIONS: Many local pathologists did not use the Bethesda System, so their reports were translated to allow comparison. The study required histopathology, and the study population and specimens did not encompass all newly evaluated patients with a thyroid nodule. CONCLUSION: Substantial inter- and intraobserver variability exists in the cytopathologic and histopathologic evaluation of thyroid nodules, confirming an inherent limitation of visual microscopic diagnosis. PRIMARY FUNDING SOURCE: Veracyte.
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Variaciones Dependientes del Observador , Nódulo Tiroideo/patología , Adulto , Anciano , Anciano de 80 o más Años , Biopsia con Aguja Fina , Femenino , Humanos , Masculino , Persona de Mediana Edad , Periodo Posoperatorio , Periodo Preoperatorio , Estudios Prospectivos , Glándula Tiroides/patología , Nódulo Tiroideo/cirugía , Adulto JovenRESUMEN
The media, medical legal, and safety science perspectives of a laboratory medical error differ and assign variable levels of responsibility on individuals and systems. We examine how the media identifies, communicates, and interprets information related to anatomic pathology breast diagnostic errors compared to groups using a safety science Lean-based quality improvement perspective. The media approach focuses on the outcome of error from the patient perspective and some errors have catastrophic consequences. The medical safety science perspective does not ignore the importance of patient outcome, but focuses on causes including the active events and latent factors that contribute to the error. Lean improvement methods deconstruct work into individual steps consisting of tasks, communications, and flow in order to understand the affect of system design on current state levels of quality. In the Lean model, system redesign to reduce errors depends on front-line staff knowledge and engagement to change the components of active work to develop best practices. In addition, Lean improvement methods require organizational and environmental alignment with the front-line change in order to improve the latent conditions affecting components such as regulation, education, and safety culture. Although we examine instances of laboratory error for a specific test in surgical pathology, the same model of change applies to all areas of the laboratory.
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Neoplasias de la Mama/diagnóstico , Errores Diagnósticos , Seguridad del Paciente , Femenino , Humanos , Laboratorios/normas , Garantía de la Calidad de Atención de SaludRESUMEN
OBJECTIVE: To prospectively evaluate a new non invasive device that combines fluorescence and reflectance spectroscopy in a population in women at risk for cervical dysplasia. METHODS: A total of 1607 women were evaluated with multimodal hyperspectroscopy (MHS), a painless test with extremely high spectral resolution. Subjects who were referred to colposcopy based on abnormal screening tests or other referral criteria underwent the MHS test and also had a sample taken for additional cytology and presence of high risk human papilloma virus (HPV) prior to undergoing biopsy. RESULTS: Sensitivity of MHS for cervical intraepithelial neoplasia (CIN) 2+ was 91.3% (252/276). Specificity, or the potential reduction in referrals to colposcopy and biopsy, was 38.9% (222/570) for women with normal or benign histology and 30.3% (182/601) for women with CIN1 histology. Two year follow-up data, collected for a subgroup of 804 women, revealed 67 interval CIN2+ that originally were diagnosed at enrollment as normal or CIN1. MHS identified 60 of these (89.6%) as positive for CIN2+ prior to their discovery during the two year follow-up period. CONCLUSIONS: MHS provides an immediate result at the point of care. Recently, the limitations of cytology have become more obvious and as a consequence greater emphasis is being placed on HPV testing for cervical cancer screening, creating a need for an inexpensive, convenient and accurate test to reduce false positive referrals to colposcopy and increase the yield of CIN2+ at biopsy. MHS appears to have many of the attributes necessary for such an application.
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Espectrometría de Fluorescencia/métodos , Neoplasias del Cuello Uterino/diagnóstico , Adolescente , Adulto , Detección Precoz del Cáncer/métodos , Femenino , Humanos , Óptica y Fotónica/métodos , Papillomaviridae/aislamiento & purificación , Infecciones por Papillomavirus/diagnóstico , Infecciones por Papillomavirus/patología , Estudios Prospectivos , Análisis Espectral/métodos , Displasia del Cuello del Útero/diagnóstico , Displasia del Cuello del Útero/patología , Displasia del Cuello del Útero/virología , Neoplasias del Cuello Uterino/patología , Neoplasias del Cuello Uterino/virología , Adulto JovenRESUMEN
CONTEXT: Growing evidence has demonstrated a high frequency of quality gaps in laboratory medicine, with recent studies estimating that 15% to 54% of primary care medical errors reported by primary care physicians and staff are related to the testing process. However, there is lack of evidence-based performance metrics in the preanalytic and postanalytic phases of the testing pathway for primary care practices. OBJECTIVE: To use results of the literature review to assist in the development of quality indicators that could improve preanalytic and postanalytic processes in primary care-based laboratory medicine. DATA SOURCES: Literature in Ovid/MEDLINE from 2001 through 2011 was searched as a primary source of information. Ninety-five peer-reviewed and non-peer-reviewed publications were retrieved following title and abstract review and 10 articles were reviewed in their entirety by the authors. A systematic review of the literature was conducted regarding the connections between clinical laboratories and primary care offices and the resulting errors. Root causes of errors were categorized into 7 major themes: process failures, delays, communication gaps, errors in judgment and cognition, influence of minorities/language, practice culture, and lack of patient centeredness. Selected articles were evaluated for evidence quality using the Systematic Evidence Review and Evaluation Methods for Quality Improvement grading scale developed by the Centers for Disease Control and Prevention. CONCLUSIONS: The focused literature review documented 7 key error themes in the laboratory medicine/primary care testing process. Performance metrics related to these themes are proposed that deserve future study for evidence-based improvement.
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Técnicas de Laboratorio Clínico , Atención Primaria de Salud , Técnicas de Laboratorio Clínico/normas , Diagnóstico Tardío , Práctica Clínica Basada en la Evidencia/normas , Humanos , Errores Médicos , Participación del Paciente , Atención Primaria de Salud/normas , Mejoramiento de la Calidad , Indicadores de Calidad de la Atención de SaludRESUMEN
OBJECTIVES: Gene-expression profiling (GEP) reliably supplements traditional clinicopathological information on the tissue of origin (TOO) in metastatic or poorly differentiated cancer. A cost-effectiveness analysis of GEP TOO testing versus usual care was conducted from a US third-party payer perspective. METHODS: Data on recommendation changes for chemotherapy, surgery, radiation therapy, blood tests, imaging investigations, and hospice care were obtained from a retrospective, observational study of patients whose physicians received GEP TOO test results. The effects of chemotherapy recommendation changes on survival were based on the results of trials cited in National Comprehensive Cancer Network and UpToDate guidelines. Drug and administration costs were based on average doses reported in National Comprehensive Cancer Network guidelines. Other unit costs came from Centers for Medicare & Medicaid Services fee schedules. Quality-of-life weights were obtained from literature. Bootstrap analysis estimated sample variability; probabilistic sensitivity analysis addressed parameter uncertainty. RESULTS: Chemotherapy regimen recommendations consistent with guidelines for final tumor-site diagnoses increased significantly from 42% to 65% (net difference 23%; P<0.001). Projected overall survival increased from 15.9 to 19.5 months (mean difference 3.6 months; two-sided 95% confidence interval [CI] 3.2-3.9). The average increase in quality-adjusted life-months was 2.7 months (95% CI 1.5-4.3), and average third-party payer costs per patient increased by $10,360 (95% CI $2,982-$19,192). The cost per quality-adjusted life-year gained was $46,858 (95% CI $13,351-$104,269). CONCLUSIONS: GEP TOO testing significantly altered clinical practice patterns and is projected to increase overall survival, quality-adjusted life-years, and costs, resulting in an expected cost per quality-adjusted life-year of less than $50,000.
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Antineoplásicos/uso terapéutico , Perfilación de la Expresión Génica/métodos , Neoplasias/terapia , Guías de Práctica Clínica como Asunto , Anciano , Antineoplásicos/economía , Análisis Costo-Beneficio , Femenino , Perfilación de la Expresión Génica/economía , Costos de la Atención en Salud , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/economía , Neoplasias/genética , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Estudios Retrospectivos , Tasa de Supervivencia , Factores de Tiempo , Estados UnidosRESUMEN
BACKGROUND: Expert consultation and institutional policies mandating second review of pathologic diagnoses in the course of referral have been advocated to optimize patient care. OBJECTIVE: We sought to investigate the rate of diagnostic discrepancies between pathologists with and without dermatopathology fellowship training. METHODS: All available outside pathology reports were reviewed for material sent to the University of Pittsburgh Medical Center Dermatopathology Unit during 1 year. The outside diagnosis was compared with the diagnosis rendered by the referral dermatopathology service. Cases were assigned into 1 of 4 categories: melanocytic neoplasm, nonmelanocytic neoplasm, inflammatory, and other. For each case, the outside pathologist's level of dermatopathology training was noted. Any change in diagnosis resulting in significant alteration in therapy or prognosis, as dictated by the accepted standard of care, was considered a major discrepancy. RESULTS: A total of 405 cases were reviewed. In 51 cases (13%), no preliminary diagnosis was rendered at the outside facility. The referral diagnosis differed from the outside diagnosis in 226 cases (56%), and major discrepancies were identified in 91 cases (22%). Of these 91 cases, 84 were received from outside pathologists who were not dermatopathology trained and 7 were received from pathologists with dermatopathology training. The 91 cases with major discrepancies were categorized as: 36 nonmelanocytic neoplasms (40%), 30 inflammatory (33%), 23 melanocytic neoplasms (25%), and 2 other (2%). LIMITATIONS: This was a retrospective study limited to 2 consultant dermatopathologists at an academic referral center, which typically receives and reviews select cases. CONCLUSION: Dermatopathology fellowship training is associated with a substantial decrease in major diagnostic discrepancies. Pathologists without dermatopathology fellowship training tend to successfully identify those cases for which expert consultation is most useful.