PubMed Health⌕ Search

Biomedical subjects

Stephen S Raab

Publications and source records attributed to Stephen S Raab.

At least 19 recordsLinked to original sources
PubMed2006

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.

Bronchi↗
PubMed2006

Systems analysis of real-world obstacles to successful cervical cancer prevention in developing countries.

Papanicolaou screening is feasible anywhere that screening for cervical cancer, the leading cause of cancer-related death among women in developing countries, is appropriate. After documenting that the Vietnam War had contributed to the problem of cervical cancer in Vietnam, we participated in a grass roots effort to establish a nationwide cervical cancer prevention program in that country and performed root cause analyses of program deficiencies. We found that real-world obstacles to successful cervical cancer prevention in developing countries involve people far more than technology and that such obstacles can be appropriately managed through a systems approach focused on programmatic quality rather than through ideological commitments to technology. A focus on quality satisfies public health goals, whereas a focus on technology is compatible with market forces.

Developing Countries↗
PubMed2006

Discrepancy analysis, communication, and feedback for cytotechnologist quality improvement of nongynecologic cytopathology.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) detail the requirements for the cytotechnologist (CT) who evaluates gynecologic cytopathology specimens. However, the role of the CT in nongynecologic cytopathology is not clearly defined. Furthermore, non gynecologic cytopathology cases are diverse and the screening, interpretative, and diagnostic issues may be quite different from the gynecologic cases. At our institution, the CT and pathologist review nongynecologic cytopathology cases. Since CLIA '88 does not require the CT to screen nongynecologic cytopathology cases, there are few guidelines for quality assessment or quality improvement for the CT regarding nongynecologic cytopathology cases. To provide better understanding of the expectations of the CT and the needs of the pathologist, we developed a system comparing the CT's interpretation to the pathologist's interpretation as a means for enhanced communication and feedback. Using our Laboratory Information System (LIS), we generate a daily report that lists all cases with discrepancy in diagnoses between the CT and pathologist. The general supervisor reviews this report for diagnostic discrepancy in each case. To determine the degree of discrepancy, numerical values are assigned to each primary interpretation. Minor discrepancies are defined as differences less than +/-2.0. Major discrepancies are defined as differences greater than or equal to +/-2.0. For the entire laboratory, the overall percentage of concordant cases was consistently above 80% for each of the 6 mo analysis. Regarding the monthly discrepancies, the proportion of minor discrepancies ranged from 11.09% to 15.44% and the proportion of major discrepancies ranged from 1.40% to 3.56%. The frequency distribution of discrepancies by degree approximates a normal (Gaussian) curve and serves as baseline information that may be used for comparison when there are changes in practice or personnel. The CTs attend slide review sessions conducted by the general supervisor for discussion of cases with major discrepancies. The discrepancy data from individual CTs are useful in counseling and recommending areas for improvement. As the CT and pathologist work cooperatively and in tandem, our system allows for a mechanism by which the expectations and needs of pathologist are communicated to the CT more effectively. We believe our process is a fundamental step in improving CT performance in Nongynecologic cytopathology and keeps the CT informed of complexities of nongynecologic cytopathology.

Clinical Laboratory Information Systems↗
PubMed2006

Improving Papanicolaou test quality and reducing medical errors by using Toyota production system methods.

OBJECTIVE: The objective of the study was to determine whether the Toyota production system process improves Papanicolaou test quality and patient safety. STUDY DESIGN: An 8-month nonconcurrent cohort study that included 464 case and 639 control women who had a Papanicolaou test was performed. Office workflow was redesigned using Toyota production system methods by introducing a 1-by-1 continuous flow process. We measured the frequency of Papanicolaou tests without a transformation zone component, follow-up and Bethesda System diagnostic frequency of atypical squamous cells of undetermined significance, and diagnostic error frequency. RESULTS: After the intervention, the percentage of Papanicolaou tests lacking a transformation zone component decreased from 9.9% to 4.7% (P = .001). The percentage of Papanicolaou tests with a diagnosis of atypical squamous cells of undetermined significance decreased from 7.8% to 3.9% (P = .007). The frequency of error per correlating cytologic-histologic specimen pair decreased from 9.52% to 7.84%. CONCLUSIONS: The introduction of the Toyota production system process resulted in improved Papanicolaou test quality.

Case-Control Studies↗
PubMed2006

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. The kappa statistic of all pathologist pairs in adjudicating discrepancy cause using the No-Blame Box method ranged from 0.400 to 0.796, indicating acceptable to excellent agreement. Pathologists ranged in their assessment of specimen interpretability from 13% to 20%, and in no case did all 5 pathologists concur that a specimen was interpretable. Most discrepancies resulted from pathologists diagnosing noninterpretable samples. Pathologists who used the No-Blame Box showed significant agreement in the adjudication of discrepancy cause.

Consensus↗
PubMed2006

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. Of the 364 patients, 91 (25.0%) had a false-negative diagnosis and 36 (9.9%) a false-positive diagnosis. Root cause analysis showed that major sources of error were pre-analytic (poor specimen quality) and analytic (interpretation of unsatisfactory specimens as nonneoplastic and lack of diagnostic category standardization). We currently are evaluating the effectiveness of error reduction initiatives that target pre-analytic and analytic portions of the diagnostic pathway.

Biopsy, Fine-Needle↗
PubMed2006

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. Following terminology standardization, the false-negative rate decreased from 41.8% to 19.1% (P = .006), the specimen nondiagnostic rate increased from 5.8% to 19.8% (P < .001), and the sensitivity increased from 70.2% to 90.6% (P < .001). Cases with an immediate interpretation had a lower noninterpretable specimen rate than those without immediate interpretation (P < .001). Toyota process change led to significantly fewer diagnostic errors for patients who underwent thyroid fine-needle aspiration.

Biopsy, Fine-Needle↗
PubMed2006

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.

Carcinoma, Small Cell↗
PubMed2006

Identification errors involving clinical laboratories: a College of American Pathologists Q-Probes study of patient and specimen identification errors at 120 institutions.

CONTEXT: Misidentified laboratory specimens may cause patient injury, but their frequency in general laboratory practice is unknown. OBJECTIVES: To determine (1) the frequency of identification errors detected before and after result verification, (2) the frequency of adverse patient events due to specimen misidentification, and (3) factors associated with lower error rates and better detection of errors. DESIGN: One hundred twenty clinical laboratories provided information about identification errors during 5 weeks. RESULTS: In aggregate, 85% of errors were detected before results were released; one quarter of laboratories identified more than 95% of errors before result verification. The overall rate of patient identification errors involving released results was 55 errors per 1,000,000 billable tests. A total of 345 adverse events were reported. Most of the adverse events caused material inconvenience to the patients but did not result in any permanent harm. On average, adverse events resulted from 1 of every 18 identification errors. Extrapolating the adverse event rate observed in this study to all United States hospital-based laboratories suggests that more than 160,000 adverse events per year result from misidentification of patients' laboratory specimens. CONCLUSIONS: Identification errors are common in laboratory medicine, but most are detected before results are released, and only a fraction are associated with adverse patient events. Even when taking into consideration the design of this study, which used imperfect case finding, institutions that did a better job of detecting errors within the laboratory released a smaller proportion of results that involved specimen misidentification.

Diagnostic Errors↗
PubMed2006

The value of monitoring frozen section-permanent section correlation data over time.

CONTEXT: The effectiveness of the long-term monitoring of errors detected by frozen section-permanent section correlation is unknown. OBJECTIVE: To determine factors important in laboratory improvement in frozen section-permanent section discordant and deferral rates by participation in a multi-institutional continuous quality improvement program. DESIGN: Participants in the College of American Pathologists Q-Tracks program self-reported the number of anatomic pathology frozen-permanent section discordant and deferred cases in their laboratories by prospectively performing secondary review of intraoperative consultations. Laboratories participated in the program for 1 to 5 years and reported their data every quarter. We calculated mean and median discordant and deferred case frequencies and used mixed linear modeling to determine if length of participation in the program was associated with improved performance. PARTICIPANTS: One hundred seventy-four laboratories self-reported data. MAIN OUTCOME MEASURES: Mean frozen-permanent section discordant and deferred diagnostic frequencies and changes in these frequencies over time were measured. RESULTS: The mean and median frozen-permanent section discordant frequencies were 1.36% and 0.70%, respectively. The mean and median deferred diagnostic frequencies were 2.35% and 1.20%, respectively. Longer participation in the Q-Tracks program was significantly associated (P = .04) with lower discordant frequencies; 4- or 5-year participation showed a decrease in discordant frequency of 0.99%, whereas 1-year participation showed a decrease in discordant frequency of 0.84%. Longer participation in the Q-Tracks monitor was associated with lower microscopic sampling frequencies for discordant diagnoses (P = .04). Increased length of participation in the Q-Tracks program was significantly associated (P = .04) with lower deferred diagnostic frequencies. CONCLUSIONS: Long-term monitoring of frozen-permanent section correlation is associated with sustained improvement in performance.

Diagnostic Errors↗
PubMed2006

Improving patient safety through quality assurance.

CONTEXT: Anatomic pathology laboratories use several quality assurance tools to detect errors and to improve patient safety. OBJECTIVE: To review some of the anatomic pathology laboratory patient safety quality assurance practices. DESIGN: Different standards and measures in anatomic pathology quality assurance and patient safety were reviewed. MAIN OUTCOME MEASURES: Frequency of anatomic pathology laboratory error, variability in the use of specific quality assurance practices, and use of data for error reduction initiatives. RESULTS: Anatomic pathology error frequencies vary according to the detection method used. Based on secondary review, a College of American Pathologists Q-Probes study showed that the mean laboratory error frequency was 6.7%. A College of American Pathologists Q-Tracks study measuring frozen section discrepancy found that laboratories improved the longer they monitored and shared data. There is a lack of standardization across laboratories even for governmentally mandated quality assurance practices, such as cytologic-histologic correlation. The National Institutes of Health funded a consortium of laboratories to benchmark laboratory error frequencies, perform root cause analysis, and design error reduction initiatives, using quality assurance data. Based on the cytologic-histologic correlation process, these laboratories found an aggregate nongynecologic error frequency of 10.8%. Based on gynecologic error data, the laboratory at my institution used Toyota production system processes to lower gynecologic error frequencies and to improve Papanicolaou test metrics. CONCLUSION: Laboratory quality assurance practices have been used to track error rates, and laboratories are starting to use these data for error reduction initiatives.

Humans↗
PubMed2005

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). Medical record reviews were performed to determine patient outcomes. The authors also measured the institutional frequency, cause (i.e., pathologist interpretation or sampling), and clinical impact of diagnostic cancer errors. RESULTS: The frequency of errors in cancer diagnosis was found to be dependent on the institution (P < 0.001) and ranged from 1.79-9.42% and from 4.87-11.8% of all correlated gynecologic and nongynecologic cases, respectively. A statistically significant association was found between institution and error cause (P < 0.001); the cause of errors resulting from pathologic misinterpretation ranged from 5.0-50.7% (the remainder were due to clinical sampling). A statistically significant association was found between institution and assignment of the clinical impact of error (P < 0.001); the aggregated data demonstrated that for gynecologic and nongynecologic errors, 45% and 39%, respectively, were associated with harm. The pairwise kappa statistic for interobserver agreement on cause of error ranged from 0.118-0.737. CONCLUSIONS: Errors in cancer diagnosis are reported to occur in up to 11.8% of all reviewed cytologic-histologic specimen pairs. To the authors' knowledge, little agreement exists regarding whether pathology errors are secondary to misinterpretation or poor clinical sampling of tissues and whether pathology errors result in serious harm.

Diagnostic Errors↗
PubMed2005

Coming to terms with Vietnam: the Viet/American Cervical Cancer Prevention Project.

The Viet/American Cervical Cancer Prevention Project embraces a dual mission. We seek to develop sustainable, cost-effective cervical cancer prevention services for women in Vietnam. Because the problem of cervical cancer in Vietnam is in part a legacy of the Second Indochinese War, we also seek to examine obstacles to reconciliation by presenting what most acknowledge to be a remedy in advance of what some will perceive to be an accusation. Certain research and commercial interests have produced obstacles to our dual mission in Vietnam. The Alliance for Cervical Cancer Prevention, supported by the Bill and Melinda Gates Foundation, has failed to endorse Pap screening for developing countries and is conducting clinical trials which may further disaffect medically underserved groups. Visual screening techniques combined with immediate ablative treatment methods are incompatible with the requirements of "first do no harm." Because the Pap smear will probably be a component of any future human papillomavirus (HPV)-based or visual- based screening programs, it serves the interests of those promoting noncytologic screening methods to also support the development of Pap screening services. Research on HPV screening in developing countries raises concerns of commercial exploitation. Because Pap screening is feasible wherever cervical screening is appropriate, it is inappropriate to delay the development of Pap screening services pending research into HPV vaccines or alternative screening technologies. Quality management is the point at which public health and diagnostic pathology intersect and will remain an indispensable element of cervical screening programs irrespective of the screening test(s) eventually used. Pap screening in developing countries is an ethical imperative without a substantial political constituency and will benefit from the engagement of organized cytology.

Female↗
PubMed2005

Variability of practice in anatomic pathology and its effect on patient outcomes.

Variability in the delivery of medical care negatively affects patient outcomes and contributes to escalating health care costs. Such heterogeneity exists on geographic, provider-related, institutional, and financial levels. Efforts to reduce it have resulted in the development of evidence-based clinical practice guidelines that have been only inconsistently adopted. Testing patterns in anatomic pathology (AP) also manifest considerable inconsistency, further contributing to suboptimal health outcomes and increased costs. Test variability in AP can be identified in its clinician-dependent preanalytic aspect and in the analytic phase as well, including the gross prosection of specimens, their processing, and reporting formats. To address selected facets of these issues, pathologists have developed practice guidelines that generally are based on "expert" opinion, representing the weakest form of evidence. Interpretative variability in AP has been investigated in numerous published studies that have measuring the "kappa statistic." Few of those analyses have addressed the impact of diagnostic disagreement on patient care; in addition, proposed and effective methods to reduce interpretative variability have only rarely been included.

Diagnostic Errors↗
PubMed2005

Database construction for improving patient safety by examining pathology errors.

A critical component of improving patient safety is reducing medical errors. "Improving Patient Safety by Examining Pathology Errors" is a project designed to collect data about and analyze diagnostic errors voluntarily reported by 4 academic anatomic pathology laboratories and to develop and implement interventions to reduce errors and improve patient outcomes. The study database is Web-mediated and Oracle-based, and it houses de-identified error data detected by cytologic-histologic correlation and interdepartmental conference review. We describe the basic design of the database with a focus on challenges faced as a consequence of the absence of standardized and detailed laboratory workload and quality assurance data sets in widely used laboratory information systems and the lack of efficient and comprehensive electronic de-identification of unlinked institutional laboratory information systems and clinical data. Development of these electronic data abstraction capabilities is critical for efforts to improve patient safety through the examination of pathology diagnostic errors.

Databases, Factual↗