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. 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.

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. 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.

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. In the implementation phase, we documented 29 individual A3-root cause analyses. The pre- and postimplementation proportions of process- and operator-dependent near-miss events were 5.5 and 1.8 (P < .002) and 0.6 and 0.6, respectively. We conclude that through culture change and implementation of specific work process changes, Lean implementation may improve pathology patient safety.

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. Through the performance of continuous data tracking and retrospective root cause analysis to identify factors that may have influenced any observed changes in performance indicators, institutions may learn which initiatives are successful or unsuccessful. The future of correlation lies in the standardization of methods, the development of more formal and rigorous root cause analysis processes to determine system components underlying correlation discrepancies, and the active use of correlation data to redesign testing and screening processes for quality and patient safety improvement.

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). Practices were examined for significant relationships with error, turnaround time (TAT), resource utilisation and postgraduate year of resident (n=25) training. RESULTS: Residents provided mandatory descriptors from 23.1% to 93.6% of the time and submitted mandatory sections from 82.1% to 96.2% of the time. Cases submitted by less experienced residents had a longer TAT and were associated with more errors, measured by the necessity to submit additional tissues. Less experienced residents used greater resources (submitting 9.5 tissue cassettes per case) compared with more experienced residents (7.3 cassettes per case), and a statistically significant correlation was found between the number of cassettes submitted and TAT. CONCLUSIONS: In this training programme, the model of apprenticeship training leads to less than optimal standardisation of gross examination practices, inefficiency, active errors and a high frequency of latent conditions leading to error.

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. The majority of studies on the quality of oncologic pathology diagnoses have focused on patient safety and have documented a variety of causes of error that occur in the clinical and pathology laboratory testing phases of diagnostic testing. The reported frequency of a diagnostic error made by oncologic pathology depends on several factors, such as definitions and detection methods, and ranges from 1% to 15%. The large majority of diagnostic errors do not result in severe harm, although mild to moderate harm in the form of additional testing or diagnostic delays occurs in up to 50% of errors. Clinical practitioners play an essential role in error reduction through several avenues such as effective test ordering, providing accurate and pertinent clinical information, procuring high-quality specimens, providing timely follow-up on test results, effectively communicating on potentially discrepant diagnoses, and advocating second opinions on the pathology diagnosis in specific situations.

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. The numbers of errors detected by the targeted 5% random and focused review processes were 195 (2.6% of reviewed cases) and 50 (13.2%), respectively (P < .001). The numbers of major errors for the targeted 5% random and focused review processes was 27 (0.36%) and 12 (3.2%), respectively (P < .001). Focused review detects a higher proportion of errors and may be more effectively used for design of error reduction initiatives.

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. We further tracked amendment rates, defect categories, defect discoverers, and discovery mechanisms. In the 430-case validation set agreement was excellent (k = 0.8780 [range, 0.8416-0.9144]). Among the 7 institutions, agreement was good (k = 0.6235 [range, 0.3105-0.8975]). Amendment rates ranged from 2.6 to 4.8 per 1,000 reports. Misinterpretation fractions varied least (23%-29%). Misidentification fractions ranged more widely (20%-38%). Specimen defects were least frequent (4%-10%) and report defects most frequent (29%-48%). Misidentifications and report defects inversely correlated. Pathologists discovered most misinterpretations, and clinicians found most misidentifications. Conference review revealed 40% to 80% of misinterpretations. This taxonomy produced excellent reproducibility and good agreement across institutions.

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. We compared the case and control Pap test quality and accuracy measures using the proportion of Pap tests lacking a transformation zone component, proportion of unsatisfactory Pap tests, frequency of newly detected cervical intraepithelial neoplasia following a previous benign Pap test, and proportion of Pap tests with a diagnosis of atypical squamous cells of unknown significance. RESULTS: After the intervention, there was a statistically significant decrease in the mean proportion of Pap tests lacking a transformation zone component, p =.011. Two of 5 clinicians showed a statistically significant decrease in their unsatisfactory Pap test frequency, although the overall Pap test unsatisfactory frequency for the case group was not statistically significant lower, p =.087. The case group showed a 114% increase in newly detected cervical intraepithelial neoplasia following a previous benign Pap test, p =.004. There was no statistically significant difference for the proportion of Pap tests with a diagnosis of atypical squamous cells of unknown significance, p =.908. CONCLUSIONS: Disseminating Lean methods across a group of clinicians resulted in improved Pap test quality and diagnostic accuracy.

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. Our retrospective study evaluated the interpretation of IHC stains performed in difficult prostate biopsies using WSIs. The study included 30 foci with IHC stains identified by the original pathologist as both difficult and pivotal to the final diagnosis. WSIs were created from the glass slides using a scanning robot (T2, Aperio Technologies, Vista, CA). An evaluation form was designed to capture data in 2 phases: (1) interpretation of WSIs and (2) interpretation of glass slides. Data included stain interpretations, diagnoses, and other parameters such as time required to diagnose and image/slide quality. Data were also collected from an expert prostate pathologist, consensus meetings, and a poststudy focus group. WSI diagnostic validity (intraobserver pairwise kappa statistics) was "almost perfect" for 1 pathologist, "substantial" for 3 pathologists, and "moderate" for 1 pathologist. Diagnostic agreement between the final/consensus diagnoses of the group and those of the domain expert was "almost perfect" (kappa = 0.817). Except for one instance, WSI technology was not felt to be the cause of disagreements. These results are encouraging and compare favorably with other efforts to quantify diagnostic variability in surgical pathology. With thorough training, careful validation of specific applications, and regular postsignout review of glass IHC slides (eg, quality assurance review), WSI technology can be used for IHC stain interpretation.

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, 32.3% had HPV testing; 49.4% were HPV+. Positive findings by individual pathologists ranged from 38% to 67% (P = .057). There was a difference in the proportions of high risk HPV results for individual pathologists (P < .001). For the pathologist who diagnosed 38% (23/61) of samples as HPV+, the ASCUS/SIL was 0.58; the pathologist who diagnosed 67% (28/42) as HPV+ had a ratio of 1.02. Of the ASC-H diagnoses, 32.9% were tested for HPV; 63% (46/73) were positive. Although the HPV+ proportion by pathologist ranged from 54% to 83%, no significant differences were identified. Within the me laboratory, interobserver variability exists in the proportions of HPV positivity for ASCUS and ASC-H interpretations.

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. The initial assessment of error cause arose from cytologic-histologic correlation slide review of discrepant diagnostic samples in patients who had both a bronchial brushing cytologic and surgical specimen. The cause of error was attributed either to clinical sampling (diagnostic material obtained in one but not the other sample) or interpretation (pathologist failed to identify the salient diagnostic features). The pairwise kappa (kappa) statistic was used to calculate interobserver agreement between the review and original diagnoses and between the separate review diagnoses. RESULTS: The pairwise kappa statistic ranged widely from -0.154 to 1.0, and the pairwise kappa statistic of the slides from one institution was undetermined because that institutional pathologist never made the assessment that error was secondary to interpretation. Agreement for observers within the same institution was better than agreement between observers from different institutions. CONCLUSION: Pathologists exhibit poor agreement in determining the cause of error for pulmonary specimens sent for cancer diagnosis. We developed a psychosocial hypothesis (the "Big Dog" Effect) that partially explains biases in error assessment. This lack of agreement precludes confident targeting of these errors for quality improvement interventions with prospects of success across a variety of institutions.

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. The number of interpretive errors detected by double viewing for the 3 institutions was 2.7%, 0% and 1.9%, respectively. Double viewing did not lower the frequency of cytologic-histologic correlation false-negative errors. We conclude that double viewing detects errors in up to 1 of every 37 cases and that biases in the double-viewing process limit error detection.

Anatomic pathology databases and patient safety.

CONTEXT: The utility of anatomic pathology discrepancies has not been rigorously studied. OBJECTIVE: To outline how databases may be used to study anatomic pathology patient safety. DESIGN: The Agency for Healthcare Research and Quality funded the creation of a national anatomic pathology errors database to establish benchmarks for error frequency. The database is used to track more frequent errors and errors that result in more serious harm, in order to design quality improvement interventions intended to reduce these types of errors. In the first year of funding, 4 institutions (University of Pittsburgh, Henry Ford Hospital, University of Iowa, and Western Pennsylvania Hospital) reported cytologic-histologic correlation error data after standardizing correlation methods. Root cause analysis was performed to determine sources of error, and error reduction plans were implemented. PARTICIPANTS: Four institutions self-reported anatomic pathology error data. MAIN OUTCOME MEASURES: Frequency of cytologic-histologic correlation error, case type, cause of error (sampling or interpretation), and effect of error on patient outcome (ie, no harm, near miss, and harm). RESULTS: The institutional gynecologic cytologic-histologic correlation error frequency ranged from 0.17% to 0.63%, using the denominator of all Papanicolaou tests. Based on the nongynecologic cytologic-histologic correlation data, the specimen sites with the highest discrepancy frequency (by project site) were lung (ranging from 16.5% to 62.3% of all errors) and urinary bladder (ranging from 4.4% to 25.0%). Most errors detected by the gynecologic cytologic-histologic correlation process were no-harm events (ranging from 10.7% to 43.2% by project site). Root cause analysis identified sources of error on both the clinical and pathology sides of the process, and error intervention programs are currently being implemented to improve patient safety. CONCLUSIONS: A multi-institutional anatomic pathology error database may be used to benchmark practices and target specific high-frequency errors or errors with high clinical impact. These error reduction programs have national import.

Interobserver variability in the fine needle aspiration biopsy diagnosis of follicular lesions of the thyroid gland.

OBJECTIVE: To study the degree of interobserver variability in the interpretation of fine needle aspiration (FNA) biopsies of the thyroid, specifically in the categorization of follicular lesions (FLs), and to examine the accuracy of FNA diagnosis of FLs with surgical follow-up. STUDY DESIGN: Fifty cases were chosen with surgical follow-up and a cytologic diagnosis of either FL (21) or follicular neoplasms (29). Representative slides were selected for each case and circulated to 4 pathologists for review. Interobserver variability was assessed using pairwise K statistics. Accuracy of the cytologic diagnoses in predicting a nonneoplastic or neoplastic outcome was determined by measuring sensitivity and specificity. Likelihood ratios and receiver operator characteristic curves were calculated for each reviewer. RESULTS: Interobserver agreement between the 4 pathologists was fair to substantial (K scores, 0.199-0.617). The accuracy of the 4 pathologists' cytologic diagnoses in predicting the surgical outcome was 77-90% for follicular neoplasms and 53-74% for nonneoplastic diagnoses. CONCLUSION: FLs present diagnostic difficulties as to cytologic categorization. A wide range of interobserver agreement was found in this study of 4 pathologists from the same institution. Some pathologists make greater use of intermediate categories, such as FL, favor nonneoplastic, or FL, favor neoplastic, whereas others show more definitive categorization into benign and neoplastic groups.

Variability in cytologic-histologic correlation practices and implications for patient safety.

CONTEXT: The Clinical Laboratory Improvement Amendments of 1988 require that laboratories perform cytologic-histologic correlation, although the optimal methods and the value of performing correlation have not been determined. OBJECTIVE: To determine the similarities and differences in how laboratories perform cytologic-histologic correlation. DESIGN: One hundred sixty-two American laboratories were sent a letter requesting copies of the materials they used in the cytologic-histologic correlation process. The returned materials were classified into the categories of forms, logs, and tally sheets. A checklist (derived from the College of American Pathologists Laboratory Accreditation Cytopathology Checklist) was developed to classify the "minimum expected" (15) and "additional" data points that laboratories collected when they performed a correlation. PARTICIPANTS: American pathology laboratories. MAIN OUTCOME MEASURES: Measures were percentage of laboratories that recorded minimum expected and additional data points and the frequency with which specific minimum expected data points were recorded. RESULTS: The response frequency was 32.1%, and a total of 84 cytologic-histologic correlation materials were obtained. The only minimum expected variables recorded on forms or logs by more than 50% of laboratories were cytology case number, sign-out cytology diagnosis, surgical pathology case number, and sign-out surgical pathology diagnosis. Nine (17.3%) laboratories did not record data on forms, logs, or tally sheets. The mean number of minimum expected and additional variables recorded on forms was 6.5 and 8.7, respectively. CONCLUSIONS: Laboratories record data from the cytologic-histologic correlation process in a number of ways, indicating the lack of standardization of the data collection process.

Chronic abdominal complaints and Helicobacter pylori in a Haitian population.

The objective of this study was to examine demographic, clinical, and pathologic variables, including Helicobacter pylori infection and malignancy, associated with chronic abdominal pain in a rural Haitian population. One hundred four patients underwent esophagogastroduodenoscopy, with biopsy only in those with gross findings. Associations between demographic, clinical, and pathologic variables were examined using the chi-square test. P values less than or equal to 0.05 were considered statistically significant. The majority (n = 66; 63%) required biopsy. Of these, 62% were positive for H. pylori. The associations between (1) chest complaints and esophageal disease, (2) female gender and benign esophageal disease, and (3) chronic active gastritis and presence of H. pylori were significant. There was one malignancy. H. pylori gastritis was common; malignancy was rare. Demographic and clinical variables poorly predicted pathologic diagnosis, which is consistent with previous studies. Further study is needed to assess the influence of other variables, including the African enigma, on disease progression in this population.

The economic benefit for family/general medicine practices employing physician assistants.

OBJECTIVE: To measure the economic benefit of a family/general medicine physician assistant (PA) practice. STUDY DESIGN: Qualitative description of a model PA practice in a family/general medicine practice office setting, and comparison of the financial productivity of a PA practice with that of a non-PA (physician-only) practice. METHODS: The study site was a family/general medicine practice office in southwestern Pennsylvania. The description of PA practice was obtained through direct observation and semistructured interviews during site visits in 1998. Comparison of site practice characteristics with published national statistics was performed to confirm the site's usefulness as a model practice. Data used for PA productivity analyses were obtained from site visits, interviews, office billing records, office appointment logs, and national organizations. RESULTS: The PA in the model practice had a same-task substitution ratio of 0.86 compared with the supervising physician. The PA was economically beneficial for the practice, with a compensation-to-production ratio of 0.36. Compared with a practice employing a full-time physician, the annual financial differential of a practice employing a full-time PA was $52,592. Sensitivity analyses illustrated the economic benefit of a PA practice in a variety of theoretical family/general medicine practice office settings. CONCLUSIONS: Family/general medicine PAs are of significant economic benefit to practices that employ them.