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Stephen S Raab

Publications and source records attributed to Stephen S Raab.

At least 37 records · Page 2Linked to original sources

Error detection in anatomic pathology.

OBJECTIVES: To define the magnitude of error occurring in anatomic pathology, to propose a scheme to classify such errors so their influence on clinical outcomes can be evaluated, and to identify quality assurance procedures able to reduce the frequency of errors. DESIGN: (a) Peer-reviewed literature search via PubMed for studies from single institutions and multi-institutional College of American Pathologists Q-Probes studies of anatomic pathology error detection and prevention practices; (b) structured evaluation of defects in surgical pathology reports uncovered in the Department of Pathology and Laboratory Medicine of the Henry Ford Health System in 2001-2003, using a newly validated error taxonomy scheme; and (c) comparative review of anatomic pathology quality assurance procedures proposed to reduce error. RESULTS: Marked differences in both definitions of error and pathology practice make comparison of error detection and prevention procedures among publications from individual institutions impossible. Q-Probes studies further suggest that observer redundancy reduces diagnostic variation and interpretive error, which ranges from 1.2 to 50 errors per 1000 cases; however, it is unclear which forms of such redundancy are the most efficient in uncovering diagnostic error. The proposed error taxonomy tested has shown a very good interobserver agreement of 91.4% (kappa = 0.8780; 95% confidence limit, 0.8416-0.9144), when applied to amended reports, and suggests a distribution of errors among identification, specimen, interpretation, and reporting variables. CONCLUSIONS: Presently, there are no standardized tools for defining error in anatomic pathology, so it cannot be reliably measured nor can its clinical impact be assessed. The authors propose a standardized error classification that would permit measurement of error frequencies, clinical impact of errors, and the effect of error reduction and prevention efforts. In particular, the value of double-reading, case conferences, and consultations (the traditional triad of error control in anatomic pathology) awaits objective assessment.

Diagnostic Errors↗

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.

Benchmarking↗

Patient safety in anatomic pathology: measuring discrepancy frequencies and causes.

CONTEXT: Anatomic pathology discrepancy frequencies have not been rigorously studied. OBJECTIVE: To determine the frequency of anatomic pathology discrepancies and the causes of these discrepancies. DESIGN: Participants in the College of American Pathologists Q-Probes program self-reported the number of anatomic pathology discrepancies in their laboratories by prospectively performing secondary review (post-sign-out) of 100 surgical pathology or cytology specimens. Reasons for the secondary review included conferences, external review, internal quality assurance policy, and physician request. PARTICIPANTS: Seventy-four laboratories self-reported data. MAIN OUTCOME MEASURES: Frequency of anatomic pathology discrepancy; type of discrepancy (ie, change in margin status, change in diagnosis, change in patient information, or typographic error); effect of discrepancy on patient outcome (ie, no harm, near miss, or harm); and clarity of report. RESULTS: The mean and median laboratory discrepancy frequencies were 6.7% and 5.1%, respectively. Forty-eight percent of all discrepancies were due to a change within the same category of interpretation (eg, 1 tumor type was changed to another tumor type). Twenty-one percent of all discrepancies were due to a change across categories of interpretation (eg, a benign diagnosis was changed to a malignant diagnosis). Although the majority of discrepancies had no effect on patient care, 5.3% had a moderate or marked effect on patient care.Conclusions.-This study establishes a mean multi-institutional discrepancy frequency (related to secondary review) of 6.7%.

Humans↗

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.

Accreditation↗

Improving the quality of cytology diagnosis: root cause analysis for errors in bronchial washing and brushing specimens.

Detailed root cause analysis to determine causes of pulmonary cytology errors has not been used to design specific practice changes. We performed root cause analysis of all false-negative bronchial brushing and washing specimen errors (n = 32) detected by the cytologic-histologic correlation process in 2002. Medical records and all slides were reviewed. Based on the correlation process, 10 errors were interpretive, 16 sampling, and 6 combined interpretive/sampling. Root cause analysis showed that the lesion was not accessible in 8 cases and tumor was readily identified on the slides in only 1 case. In 11 cases, the malignant cells were few and not recognized, and in 13 cases, obscuring artifacts (eg, cellular crushing and air drying) limited interpretation. Sampling issues had a major role in the misdiagnosis in 31 cases (97%), and recommendations for error reduction include immediate interpretation and the use of transmucosal fine-needle aspiration.

Bronchoalveolar Lavage Fluid↗

Association between war and cervical cancer among Vietnamese women.

Decades ago, cervical cancer was the leading form of cancer among women in both North Vietnam and South Vietnam. Currently, cervical cancer rates are considerably lower in the northern region of the country. We performed a case-control study to measure factors associated with the development of cervical cancer among Vietnamese women. Questionnaire-based interviews were conducted with 202 women in southern Vietnam and 97 women in northern Vietnam. Case subjects were women hospitalized with cervical cancer. Control subjects were women hospitalized with extrauterine neoplasms. Data were analyzed using logistic regression, and odds ratios for the development of invasive cervical cancer were measured. The development of invasive cervical cancer was significantly associated with military service by husbands during the Second Indochinese War and with parity status. Odds ratio for the development of cervical cancer among southern Vietnamese women whose husbands had served in the armed forces was 2.6 (95% CI = 1.2-5.5). Odds ratio for the development of cervical cancer among northern women whose husbands had served in the armed forces was 3.9 (95% CI = 1.5-10.4) if their husbands had been stationed in South Vietnam during the war years. Northern women whose husbands had served in the military experienced no significant increase in cervical cancer risk if their husbands had been stationed in North Vietnam during the war years. Geographic and temporal variation in cervical cancer rates among Vietnamese women was associated with the movement of soldiers. These findings may be useful for cervical cancer prevention efforts in Vietnam and in other countries.

Case-Control Studies↗

Improving patient safety by examining pathology errors.

A considerable void exists in the information available regarding anatomic pathology diagnostic errors and their impact on clinical outcomes. To fill this void and improve patient safety, four institutional pathology departments (University of Pittsburgh, Western Pennsylvania Hospital, University of Iowa Hospitals and Clinics, and Henry Ford Hospital System) have proposed the development of a voluntary, Web-based, multi-institutional database for the collection and analysis of diagnostic errors. These institutions intend to use these data proactively to implement internal changes in pathology practice and to measure the effect of such changes on errors and clinical outcomes. They believe that the successful implementation of this project will result in the study of other types of diagnostic pathology error and the expansion to national participation. The project will involve the collection of multi-institutional anatomic pathology diagnostic errors in a large database that will facilitate a more detailed analysis of these errors, including their effect on patient outcomes. Participating institutions will perform root cause analysis for diagnostic errors and plan and execute appropriate process changes aimed at error reduction. The success of these interventions will be tracked through analysis of postintervention error data collected in the database. Based on their preliminary studies, these institutions proposed the following specific aims: Specific aim #1: To use a Web-based database to collect diagnostic errors detected by cytologic histologic correlation and by second-pathologist review of conference cases. Specific aim #2: To analyze the collected error data quantitatively and generate quality performance reports that are useful for institutional quality improvement programs. Specific aim #3: To plan and implement interventions to reduce errors and improve clinical outcomes, based on information derived from root cause analysis of diagnostic errors. Specific aim #4: To assess the success of implemented interventions by quantitative measure of postinterventional errors and clinical outcomes and by qualitative assessment by project participants. Funding for this project was approved by the Agency for Health Care Research and Quality in September 2002, and data collection and analysis are ongoing. Over 5000 errors have been collected in the database, and the clinical outcomes of these errors have been tracked. At a national meeting in November 2003, root cause analysis was performed to determine causes of errors. The findings of these root cause analyses have been presented at national pathology meetings and are currently being published.

Diagnostic Errors↗

Pathology and patient safety: the critical role of pathology informatics in error reduction and quality initiatives.

Understanding the role of pathology informatics in patient safety entails an introduction to terminology and projects that have represented efforts to date in this area. The authors provide a short alphabetized introduction to several "buzzwords" and terms related to tools and processes that are used by health care research experts and workers involved in patient safety initiatives. The authors also include short descriptions of key health care research and patient safety projects that are relevant to pathology. They aim to highlight the areas where pathology informatics in all of its flavors (production systems provided by vendors as well as research and development efforts) can play a role in promoting patient safety.

Diagnostic Errors↗

Error-free pathology: applying lean production methods to anatomic pathology.

The current state of our health care system calls for dramatic changes. In their pathology department, the authors believe these changes may be accomplished by accepting the long-term commitment of applying a lean production system. The ideal state of zero pathology errors is one that should be pursued by consistently asking, "Why can't we?" The philosophy of lean production systems began in the manufacturing industry: "All we are doing is looking at the time from the moment the customer gives us an order to the point when we collect the cash. And we are reducing that time line by removing non-value added wastes". The ultimate goals in pathology and overall health care are not so different. The authors' intention is to provide the patient (customer) with the most accurate diagnostic information in a timely and efficient manner. Their lead histotechnologist recently summarized this philosophy: she indicated that she felt she could sleep better at night knowing she truly did the best job she could. Her chances of making an error (in cutting or labeling) were dramatically decreased in the one-by-one continuous flow work process compared with previous practices. By designing a system that enables employees to be successful in meeting customer demand, and by empowering the frontline staff in the development and problem solving processes, one can meet the challenges of eliminating waste and build an improved, efficient system.

Diagnostic Errors↗

Expression of cytokeratin by malignant meningiomas: diagnostic pitfall of cytokeratin to separate malignant meningiomas from metastatic carcinoma.

Based on clinical and histologic features, differentiating metastatic carcinomas from benign or malignant meningiomas usually is not difficult. Occasionally, however, in some patients without a clinical history of carcinoma, malignant meningiomas can morphologically simulate metastatic carcinoma, necessitating an immunohistochemical study for cytokeratin to make a correct diagnosis. However, the utility of immunohistochemical markers to separate malignant meningioma from metastatic carcinoma has not been investigated. The immunoperoxidase method with antigen retrieval was used to characterize the expression of three cytokeratins (AE1/AE3, CAM 5.2, and Pan cytokeratin), EMA, CEA, Ber-EP4, CD 15, and B72.3 in 12 previously diagnosed malignant meningiomas, 20 benign meningiomas, and 20 metastatic carcinomas. Cytokeratin expression was detected in 75% of malignant meningiomas, 0% of benign meningiomas, and 100% of metastatic carcinomas. While epithelial markers of Ber-EP4, CEA, B72.3 and CD-15 were positive in 90, 80, 70 and 65% of the metastatic carcinoma, respectively, they were negative in all 12 malignant meningioma examined. Vimentin immunoreactivity was seen in all benign and malignant meningiomas, and in 20% of metastatic carcinomas. Our results indicated that cytokeratin is not a reliable immunohistochemical marker to separate a malignant meningioma from metastatic carcinoma. A panel of epithelial markers including Ber-EP4, CEA, B72.3 and CD-15, and vimentin may be needed to separate malignant meningioma from metastatic carcinoma. Cytokeratin expression can be a potential pitfall for confusing a malignant meningioma with a metastatic carcinoma.

Antibodies, Neoplasm↗

Papanicolaou screening in developing countries: an idea whose time has come.

Cervical cancer is the leading cause of cancer-related death among women in developing countries. Although progress is optional in all settings, Papanicolaou screening is feasible anywhere that cervical screening is appropriate and should be implemented without further delay in high-risk communities with access to curative treatment services. Successful prophylactic cervical cancer vaccines, prospects for which remain uncertain, will not eliminate requirements for cervical screening. The feasibility of human papillomavirus test analysis has not been demonstrated in low-resource developing country settings. Because past failures of cervical screening in developing countries are attributable to failures in programmatic quality rather than to technological limitations of the screening test, a shift in paradigmatic focus from technology toward quality is mandatory. Because visual screening techniques coupled with immediate ablative treatment are rendered obsolete by an embedded quality-control paradox, a moratorium should be placed on all such programs. Considerable opportunity costs, borne by the underserved, are associated with prioritizing research of novel interventions in developing countries when satisfactory interventions already exist.

Developing Countries↗

Use of physician extenders in surgical pathology practice.

CONTEXT: Use of a variety of nonphysician personnel for surgical pathology gross examination is generally known to be increasing, although detailed information regarding nonphysician use is currently unavailable. OBJECTIVE: To measure and describe the use of nonphysician personnel for surgical pathology gross examination in order to gain a better understanding of the current surgical pathology workforce. DESIGN: A voluntary, mailed questionnaire containing items related to the use of multiple nonphysician personnel types in surgical pathology was distributed to (1) a cross-sectional sample (n = 968) of US pathologists and (2) a purposive sample of pathologist directors of surgical and/or anatomic pathology (n = 77) located at teaching institutions. Responses were analyzed using descriptive statistics, correlation analyses, the chi2 test, and 1-way analysis of variance. Staffing ratios were calculated for multiple nonphysician personnel types. RESULTS: The overall response rate was 22% (n = 225). Of the US sample, 56% of respondents reported using nonphysician laboratory personnel to perform gross examinations, compared with 91% of the directors' sample. The most frequently reported personnel type for both samples was pathologists' assistants, but multiple other personnel types were used as well. Significant associations existed between certain practice types and personnel types used, as well as differences in the scope of responsibilities between personnel types. Calculated staffing ratios were variable across personnel types and were highest for pathologists' assistants. CONCLUSIONS: The use of a variety of nonphysician laboratory personnel for surgical pathology gross examination is common, particularly in academic pathology practice. Further studies are needed to examine the impact of physician extenders on laboratory efficiency and quality of care.

Pathology, Surgical↗

Low-grade urothelial carcinoma: reappraisal of the cytologic criteria on ThinPrep.

The diagnostic criteria for low-grade urothelial lesions that have been described in the past were based on urinary specimens prepared by the cytospin method. Recognizing the recent popularity of the ThinPrep methodology and the cytologic alterations it introduces to the cellular features, we sought to evaluate the reproducibility of these criteria in ThinPrep urinary samples. One hundred twenty-six ThinPrep urinary specimens with a tissue diagnosis of low-grade urothelial carcinoma (LGUC) and 45 negative controls were evaluated. Three pathologists blindly reviewed the slides separately and the consensus on each feature was used in the study. Logistic regression analysis was used to determine which criteria in combination were most predictive of low-grade urothelial carcinoma. All specimens were evaluated for the following 18 features: nucleus/cytoplasm ratio, irregular nuclear border, cytoplasm homogeneity, cell clusters, high cellularity, prominent nucleoli, granular nuclear chromatin, hyperchromasia, acute inflammation, vesicular chromatin, nuclear molding, nuclear eccentricity, elongated nuclei, necrosis, anisonucleosis, irregular bordered fragments, absent cytoplasmic collar, and peripheral palisading. High nucleus-to-cytoplasm ratio, irregular nuclear borders, and homogeneous cytoplasm (combination sensitivity of 59% and specificity of 100%) were the best predictive features for LGUC. Minor predictive criteria were eccentric nuclei and nuclear molding. ThinPrep provides well preserved, cleaner specimens without significantly altering the morphology. The three key criteria applied in cytospin specimens to diagnose LGUC were reproducible in ThinPrep specimens.

Adult↗

Role of cytology in the diagnosis of Barrett's esophagus and associated neoplasia.

We studied 327 consecutive paired esophageal biopsies and brushing specimens obtained during the same endoscopic session to evaluate the role of cytology for the diagnosis of Barrett's esophagus (BE) and/or surveillance for associated dysplasia. A diagnosis of BE was based on the cytologic presence of goblet cells. Cases were reviewed and categorized into: 1) benign esophageal lesions (125 cases), with 48 cases of Candida (32 cases diagnosed by both techniques and 16 diagnosed only by cytology), 3 cases of herpes simplex with only 1 case diagnosed by cytology, and 74 cases of inflammation and/or repair; 2) benign BE (141 cases), with 74 cases (52%) diagnosed by both techniques, 11 cases by cytology only (8%), and 56 cases (40%) by histology only; 3) low-grade dysplasia (LGD, 30 cases), with 5 cases (17%) diagnosed with both specimens, one case (3%) by cytology only, and 24 cases (80%) by histology only; 4) high-grade dysplasia (HGD, 10 cases), with 8 cases (80%) diagnosed with both specimens, 1 case (10%) by cytology, and 1 case (10%) by histology; and 5) carcinomas (23 cases), with 20 cases (87%) diagnosed with both specimens, 2 cases (9%) by cytology only, and 1 case (4%) by histology only. Our results support the high degree of diagnostic accuracy of cytology for the diagnosis of Barrett's-associated HGD and/or carcinoma, and moderate sensitivity for BE.

Adenocarcinoma↗

Human papillomavirus reporting: impact on Bethesda cytology reports.

In 2001, the Bethesda Committee revised the terminology for reporting Papanicolaou tests. One of the 2001 Bethesda forum groups addressed the use of ancillary tests, and the most commonly used ancillary test is for human papillomavirus (HPV). The Bethesda Ancillary Testing Forum presented terminology related to HPV testing. The Ancillary Testing Forum recommended that the specific HPV test method be presented and the results reported as positive or negative for HPV of a certain type or class. The Papanicolaou test and the HPV test should be reported together or should refer to each other if possible. A number of reporting schema currently are used to report HPV results; these schema include probabilistic reporting, integrated reporting, reporting as a result, and reporting with clinical management recommendations. Few data currently are available to support an optimal reporting method.

Cytodiagnosis↗