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.

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.

Cytologic-histologic correlation.

The process of cytologic-histologic correlation is highly valuable to the fields of both cytopathology and surgical pathology, because correlation provides a wealth of data that may be used to improve diagnostic testing and screening processes. In this study, overall improvement appeared to be driven largely by improvement in preanalytic Papanicolaou (Pap) test sampling, because longer institutional participation also was associated with improved sampling sensitivity. The authors hypothesized that Pap test sampling may have improved secondary to the introduction of liquid-based technology, which was implemented in many laboratories during the study time frame.

Resident education and quality of gross tissue examination practices of benign uteri.

Introduction: In the USA, most anatomical pathology residency training is based on an apprenticeship model in which residents learn directly by watching more senior personnel and then performing the examination. The level and the effect of the standardisation of resident trainee gross tissue examination practices have not been extensively evaluated.

Methods: In this apprenticeship-based training programme, a retrospective report review was performed to measure the level of standardisation of gross description (for 11 mandatory descriptors) and tissue submission (for four mandatory sections) practices for uterine specimens removed for benign conditions (n=78).

Quality in cancer diagnosis.

Improving the quality of oncologic pathology diagnosis is immensely important as the overwhelming majority of the approximately 1.6 million patients who will be diagnosed with cancer in 2010 have their diagnoses established through the pathologic interpretation of a tissue sample. Millions more patients have tissue samples obtained to rule out cancer and do not have cancer.

A summary of deliberations on strategic planning for continuous quality improvement in laboratory medicine.

On September 24-26, 2007, the Centers for Disease Control and Prevention convened the 2007 Institute on Critical Issues in Health Laboratory Practice: Managing for Better Health to develop an action plan for change for the immediate and long-term future. A wide variety of stakeholders, including pathologists, pathologist extenders, clinicians, and researchers, examined means to improve laboratory service communication, quality parameters, and potential future laboratory contributions to health care. In this summary document, we present the identified gaps, barriers, and proposed action plans for improvement for laboratory medicine in the 6 quality domains identified by the Institute of Medicine: safety, effectiveness, patient centeredness, timeliness, efficiency, and equity.

Effectiveness of random and focused review in detecting surgical pathology error.

Different error detection methods yield different error proportions and have variable benefits for surgical pathology divisions with limited resources. We performed a nonconcurrent cohort study at a large institution that practices subspecialty surgical pathology sign-out to compare the effectiveness and usefulness of error detection using a targeted 5% random review process and a focused review process. Pathologists reviewed 7,444 cases using a targeted 5% random review process and 380 cases using a focused review process.

Amended reports: development and validation of a taxonomy of defects.

Amended pathology reports produce rework, confusion, and distrust. To develop a reproducible amendment taxonomy we derived a classification from 141 amended reports, then validated it with 130 new cases before 4 observers independently reviewed 430 cases measuring agreement (k). Next, agreement in classifying 30 other amended reports in 7 institutions was measured.

Measuring quality in anatomic pathology.

This article focuses mainly on diagnostic accuracy in measuring quality in anatomic pathology, noting that measuring any quality metric is complex and demanding. The authors discuss standardization and its variability within and across areas of care delivery and efforts involving defining and measuring error to achieve pathology quality and patient safety. They propose that data linking error to patient outcome are critical for developing quality improvement initiatives targeting errors that cause patient harm in addition to using methods of root cause analysis, beyond those traditionally used in cytologic-histologic correlation, to assist in the development of error reduction and quality improvement plans.

Dissemination of Lean methods to improve Pap testing quality and patient safety.

Objective: To determine if the implementation of Lean methods resulted in improved Pap test quality and diagnostic accuracy in 5 clinician practices.

Materials And Methods: We performed a 1-year case-control study that included 5,384 control (preintervention) and 5,442 case (postintervention) women who had a Pap test procured by 1 of 5 clinicians. Using Lean methods, the clinicians increased their focus of Pap test procurement by creating a "one-by-one" workflow and recorded process completion using a Lean checklist.

Evaluation of whole slide image immunohistochemistry interpretation in challenging prostate needle biopsies.

Whole slide images (WSIs), also known as virtual slides, can support electronic distribution of immunohistochemistry (IHC) stains to pathologists that rely on remote sites for these services. This may lead to improvement in turnaround times, reduction of courier costs, fewer errors in slide distribution, and automated image analyses. Although this approach is practiced de facto today in some large laboratories, there are no clinical validation studies on this approach.

Interobserver variability in human papillomavirus test results in cervicovaginal cytologic specimens interpreted as atypical squamous cells.

We studied interobserver variability in the proportions of human papillomavirus (HPV)-positive results for atypical squamous cells of undetermined significance (ASCUS) and atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion (ASC-H) diagnoses among 5 pathologists from the me laboratory during a 2-year period. These proportions were compared with individual pathologist's ASCUS/squamous intraepithelial lesion (SIL) ratios. Of 1,299 ASCUS diagnoses, 32.

Frequency and outcome of cervical cancer prevention failures in the United States.

We measured the frequency and outcome of cervical cancer prevention failures that occurred in the Papanicolaou (Pap) and colposcopy testing phases involving 1,646,580 Pap tests in 4 American hospital systems between January 1, 1998, and December 31, 2004. We defined a screening failure as a 2-step or greater discordant Pap test result and follow-up biopsy diagnosis. A total of 5,278 failures were detected (0.

Urine cytology discrepancies: frequency, causes, and outcomes.

Although urine cytology is used for the early detection and surveillance of urothelial carcinoma, there has been little study of the frequency, causes, and outcomes of cytologic-histologic discrepancies. We obtained histologic follow-up in 361 (6.2%) of 5,785 voided, 124 (19.

Use of a new method in reaching consensus on the cause of cytologic-histologic correlation discrepancy.

Pathologists exhibit very poor agreement in adjudicating the cause of cytologic-histologic correlation discrepancies, which contributes to problems in designing interventions to reduce discrepancy frequency. In this observational study, we developed a visual method of adjudicating discrepancy cause, termed the No-Blame Box method, which consisted of initially assessing specimen interpretability by separately evaluating specimen quality and the presence of tumor. Five pathologists blindly adjudicated the cause of discrepancy in pulmonary specimens from 40 patients.

Effectiveness of Toyota process redesign in reducing thyroid gland fine-needle aspiration error.

Our objective was to determine whether the Toyota Production System process redesign resulted in diagnostic error reduction for patients who underwent cytologic evaluation of thyroid nodules. In this longitudinal, nonconcurrent cohort study, we compared the diagnostic error frequency of a thyroid aspiration service before and after implementation of error reduction initiatives consisting of adoption of a standardized diagnostic terminology scheme and an immediate interpretation service. A total of 2,424 patients underwent aspiration.

The "Big Dog" effect: variability assessing the causes of error in diagnoses of patients with lung cancer.

Purpose: The frequency of diagnostic error in patients who have a lung mass and a pathology specimen is as high as 15%. This study examined the role of inter-pathologist agreement in identifying the cause of error in these patients.

Methods: Pathologists from six institutions reviewed the slides of 40 patients who had a pulmonary specimen false-negative diagnosis.

Errors in thyroid gland fine-needle aspiration.

Scant published data exist on redesigning pathology practice based on error data. In this first step of an Agency for Healthcare Research and Quality patient safety project, we measured the performance metrics of thyroid gland fine-needle aspiration, performed root cause analysis to determine the causes of error, and proposed error-reduction initiatives to address specific errors. Eleven cytologists signed out 1,543 thyroid gland aspirates in 2 years, and surgical pathology follow-up was obtained in 364 patients.

Double slide viewing as a cytology quality improvement initiative.

Few studies have measured the effect of pre-sign out double viewing of cytology cases as a means to decrease error. Three Agency for Healthcare Research and Quality-funded project sites performed pre-sign out double viewing of 431 pulmonary cytology cases. Two-step or more differences in diagnosis were arbitrated as interpretive errors, and the effect of double viewing was measured by comparing the frequency of cytologic-histologic correlation-detected errors in the previous 2 years with the double-viewing period.

Clinical impact and frequency of anatomic pathology errors in cancer diagnoses.

Background: To the authors' knowledge, the frequency and clinical impact of errors in the anatomic pathology diagnosis of cancer have been poorly characterized to date.

Methods: The authors examined errors in patients who underwent anatomic pathology tests to determine the presence or absence of cancer or precancerous lesions in four hospitals. They analyzed 1 year of retrospective errors detected through a standardized cytologic-histologic correlation process (in which patient same-site cytologic and histologic specimens were compared).