Applying the Paris system for reporting urine cytology to challenging cytology cases.

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.

Precancerous cervical lesions and HPV genotypes identified in previously unsatisfactory cervical smear tests after inexpensive glacial acetic acid processing.

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.

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.

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.

Accuracy and risk of malignancy for diagnostic categories in urine cytology at a large tertiary institution.

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.

Laboratory medicine handoff gaps experienced by primary care practices: A report from the shared networks of collaborative ambulatory practices and partners (SNOCAP).

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.

The current and ideal state of anatomic pathology patient safety.

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.

A prospective assessment defining the limitations of thyroid nodule pathologic evaluation.

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.

Quality and patient safety in the diagnosis of breast cancer.

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.

Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results.

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.

Cost-effectiveness of gene-expression profiling for tumor-site origin.

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.

Evaluating the connections between primary care practice and clinical laboratory testing: a review of the literature and call for laboratory involvement in the solutions.

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.

The effect of a Lean quality improvement implementation program on surgical pathology specimen accessioning and gross preparation error frequency.

Few reports have documented the effectiveness of Lean quality improvement in changing anatomic pathology patient safety. We used Lean methods of education; hoshin kanri goal setting and culture change; kaizen events; observation of work activities, hand-offs, and pathways; A3-problem solving, metric development, and measurement; and frontline work redesign in the accessioning and gross examination areas of an anatomic pathology laboratory. We compared the pre- and post-Lean implementation proportion of near-miss events and changes made in specific work processes.

Discrepancies in dermatopathology diagnoses: the role of second review policies and dermatopathology fellowship training.

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.

Directed peer review in surgical pathology.

Second pathologist peer review is used in many surgical laboratory quality-assurance programs to detect error. Directed peer review is 1 method of second review and involves the selection of specific case types, such as cases from a particular site of anatomic origin. The benefits of using the directed peer review method are unique and directed peer review detects both errors in diagnostic accuracy and precision and this detection may be used to improve practice.

Effectiveness of barcoding for reducing patient specimen and laboratory testing identification errors: a Laboratory Medicine Best Practices systematic review and meta-analysis.

Objectives: This is the first systematic review of the effectiveness of barcoding practices for reducing patient specimen and laboratory testing identification errors.

Design And Methods: The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used.

Results: A total of 17 observational studies reporting on barcoding systems are included in the body of evidence; 10 for patient specimens and 7 for point-of-care testing.

Preoperative diagnosis of benign thyroid nodules with indeterminate cytology.

Background: Approximately 15 to 30% of thyroid nodules evaluated by means of fine-needle aspiration are not clearly benign or malignant. Patients with cytologically indeterminate nodules are often referred for diagnostic surgery, though most of these nodules prove to be benign. A novel diagnostic test that measures the expression of 167 genes has shown promise in improving preoperative risk assessment.