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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. Five major recommendations emerged from concluding discussions and included focusing on preanalytic and postanalytic processes as areas of potential quality improvement and recruiting a multidisciplinary group of nonlaboratory stakeholders to work with laboratory personnel to achieve improvement goals.

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.

Background: In the USA, the lack of processes standardisation in histopathology laboratories leads to less than optimal quality, errors, inefficiency and increased costs. The effectiveness of large-scale quality improvement initiatives has been evaluated rarely., Aim: To measure the effect of implementation of a Lean quality improvement process on the efficiency and quality of a histopathology laboratory section., Methods: A non-concurrent interventional cohort study from 1 January 2003 to 31 December 2006 was performed, and the Lean process was implemented on 1 January 2004. Also compared was the productivity of the Lean histopathology section to a sister histopathology section that did not implement Lean processes. Pre- and post-Lean specimen turnaround time and productivity ratios (work units/full time equivalents) were measured. For 200 Lean interventions, a 5-part Likert scale was used to assess the impact on error, success and complexity., Results: In the Lean laboratory, the mean monthly productivity ratio increased from 3439 to 4074 work units/full time equivalents (p<0.001) as the mean daily histopathology section specimen turnaround time decreased from 9.7 to 9.0 h (p = 0.01). The Lean histopathology section had a higher productivity ratio compared with a sister histopathology section (1598 work units/full time equivalents, p<0.001) that did not implement Lean processes. The mean impact, success and complexity of interventions were 2.4, 2.7 and 2.5, respectively. The mean number of specific error causes affected by individual interventions was 2.6., Conclusion: It is concluded that Lean process implementation improved efficiency and quality in the histopathology section.

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.

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.

The National Cancer Institute (NCI) sponsored the NCI Thyroid Fine-Needle Aspiration (FNA) State of the Science Conference on October 22-23, 2007 in Bethesda, MD. The 2-day meeting was accompanied by a permanent informational website and several on-line discussions between May 1 and December 15, 2007 (http://thyroidfna.cancer.gov). This document summarizes the indications for performing an FNA of a nodule discovered by physical examination or an imaging study; the indications for using ultrasound versus palpation for guidance when performing a thyroid FNA; the issues surrounding informed consent for thyroid FNA; and the information required on a requisition form that accompanies a thyroid FNA specimen. (http://thyroidfna.cancer.gov/pages/info/agenda/)

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.

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 (0.321% of all Pap tests); 48% and 52% of failures occurred in the Pap test and colposcopy phases, respectively. Missed squamous cancers (1 in 187,786 Pap tests), glandular cancers (1 in 19,426 Pap tests), and high-grade lesions (1 in 6,870 Pap tests) constituted 4.1% of all failures. Unnecessary repeated tests or diagnostic delays occurred in 70.8% and 63.9% of failures involving high- and low-grade lesions, respectively. We conclude that cervical cancer prevention practices are remarkably successful in preventing squamous cancers, although a high frequency of failures results in low-impact negative outcomes.

Purpose: Patient identification errors in surgical pathology often involve switches of prostate or breast needle core biopsy specimens among patients. We assessed strategies for decreasing the occurrence of these uncommon and yet potentially catastrophic events., Materials and Methods: Root cause analyses were performed following 3 cases of patient identification error involving prostate needle core biopsy specimens., Results: Patient identification errors in surgical pathology result from slips and lapses of automatic human action that may occur at numerous steps during pre-laboratory, laboratory and post-laboratory work flow processes., Conclusions: Patient identification errors among prostate needle biopsies may be difficult to entirely prevent through the optimization of work flow processes. A DNA time-out, whereby DNA polymorphic microsatellite analysis is used to confirm patient identification before radiation therapy or radical surgery, may eliminate patient identification errors among needle biopsies.

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 (19.5%) of 636 lower tract instrumented, and 23 (33%) of 69 upper tract urinary cytologic specimens from 1 institution during a 2-year timeframe to determine diagnostic discrepancy frequency and outcomes. Cytologic-histologic discrepancies were observed in 208 (40.9%) cases with histologic followup, and the cause of discrepancy was interpretation and sampling in 35.1% and 63.0%, respectively. Of all discrepancies, 101 (48.6%) resulted in minimal or mild harm, consisting mainly of repeated testing and/or diagnostic delays. Severe harm never was observed. We conclude that current screening and surveillance methods that incorporate urine cytology are accurate in diagnosing urothelial cancer. However, the current protocols result in potentially reducible errors that lead to unnecessary testing and diagnostic delays.

The debate over the best route for cervical cancer prevention in developing countries may be considered part of a larger debate over whether the global health community has become enamored with the promise of new approaches at the expense of delivering available preventives today. Pap screening, which is feasible anywhere cervical screening is appropriate, is the only intervention currently available for the prevention of cervical cancer in developing countries, and the Pap test will be an essential component of future novel preventive approaches. Cervical cancer vaccination, the long-term effectiveness of which is uncertain, will not eliminate screening requirements and is currently not affordable in developing countries. Root cause analyses, which may appropriately inform the best routes for improving health in developing countries, document that failures of cervical cancer prevention efforts are not attributable to factors specific to the Pap test but to lapses in programmatic quality management to which all screening tests are vulnerable. The genuine promise of cervical cancer prevention for all the world's women therefore resides in skilled quality management rather than novel screening approaches. We propose a global consensus policy by which Pap screening services will be provided in any setting where cervical screening is appropriate but unavailable, with consideration given to novel preventive approaches as they mature. Opportunity costs, borne by the underserved, are associated with prioritizing research on new approaches in any setting where established preventives are feasible but unavailable.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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., (Copyright 2005 American Cancer Society)

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.

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.

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 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.

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.

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.

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.

The Association of Directors of Anatomic and Surgical Pathology (ADASP) has developed recommendations for the surgical pathology report for primary and metastatic epithelial tumors in the liver. These recommendations are reported herein.

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.

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., (Copyright 2004 Wiley-Liss, Inc.)

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.

Objective: To evaluate the accuracy of fine needle aspiration biopsy (FNAB) in the diagnosis of vertebral lesions., Study Design: Eighty-nine FNAB cases of vertebral lesions from January 1996 to December 2001 were retrieved from the Allegheny General Hospital laboratory information system. The cases were reviewed and correlated with clinical findings, including previous clinical history, primary site of malignancy and final pathologic diagnosis., Results: ENAB diagnoses were malignant in 43 cases, benign in 35, suspicious in 1, unsatisfactory in 7 and false negative in 3. Previous clinical history included malignancy (37 patients), osteomyelitis and systemic disease (11), and nonspecific or no history (41). In 34 cases (38.2%) both aspirates and core biopsies were available, and the diagnoses correlated in 29/34 cases (85%). Surgical or core biopsies in the unsatisfactory/suspicious group showed malignancy in 4 cases (50%). The sensitivity of FNAB of vertebral lesions was 96%, specificity 100%, positive predictive value 100% and negative predictive value 92%, with no false positive cases., Conclusion: FNAB of vertebral lesions is an effective, sensitive and specific procedure in the diagnostic workup of a patient with or without a prior history of malignancy. Surgical pathology examination, including core biopsies of unsatisfactory or suspicious lesions, can further improve the diagnostic yield.

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., (Copyright 2003 Wiley-Liss, Inc.)

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., (Copyright 2003 Wiley-Liss, Inc.)

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.

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.

Although intraoperative touch preparations (TPs) often are performed in conjunction with frozen sections, the comfort level of using TPs in actual practice and the effect of TP quality and cytologic experience on diagnostic accuracy have not been measured. To investigate the utility of intraoperative TPs and to compare them with that of frozen sections, five pathologists of differing levels of cytologic experience retrospectively reviewed 122 intraoperative TPs and frozen sections. Accuracy rates for individual pathologists were calculated and the accuracy using TPs was compared to that of frozen sections. TP accuracy was correlated with TP quality and cytologic experience. The mean rates of correct, incorrect, and atypical TP diagnoses were 88.5%, 4.1%, and 7.4%, respectively. The mean rates of correct, incorrect, and deferred frozen section diagnoses were 86.1%, 2.5%, and 11.9%, respectively. For the four pathologists with cytologic experience, both TP and frozen section diagnostic accuracy rates were similar; however, the pathologist who lacked cytologic experience had lower TP diagnostic accuracy. All pathologists who had cytologic experience requested a frozen section for cases with an atypical or incorrect TP diagnosis. In cases with a correct TP diagnosis a frozen section was requested 46.3% of the time. TPs of greater technical quality were associated with higher diagnostic accuracy. In conclusion, the use of performing TP and frozen section are complementary and result in increased diagnostic accuracy. For some pathologists, TPs may replace frozen sections in over 50% of cases., (Copyright 2002 Wiley-Liss, Inc.)

Objective: To evaluate cytologic criteria for separating atypical glandular cells of undetermined significance favor endometrial origin (AGUS-EM), on Papanicolaou-stained (Pap) smears into favor benign and favor malignant categories., Study Design: All patients who had a Pap smear diagnosis of AGUS-EM, not further qualified, followed by tissue follow-up were identified from the surgical pathology and cytopathology files from January 1992 through December 1996. The Pap smears were scored blindly for the presence or absence of 40 cytologic criteria, and univariate analysis was performed to determine which criteria were most indicative of malignancy by tissue follow-up., Results: The presence of an atrophic smear, nuclear size greater than twice that of an intermediate cell nucleus and absence of clusters with irregular borders were highly indicative of adenocarcinoma, although other criteria were also helpful in identifying malignancy., Conclusion: There are no combinations of cytologic criteria that definitely separate AGUS-EM cases into those with benign or malignant findings on follow-up. However, some isolated criteria were useful in the differential diagnosis in a [table: see text] significant number of cases.

Follow-up of Papanicolaou (Pap) tests diagnosed as atypical squamous cells of undetermined significance (ASCUS) or atypical glandular cells of undetermined significance (AGUS) by a cytotechnologist and downgraded to benign by a pathologist has not been measured. Squamous intraepithelial lesion (SIL) follow-up rates were obtained for Pap tests diagnosed as ASCUS (288) or AGUS (94) and downgraded to benign and for Pap tests diagnosed as repair (231). Statistically significant associations were seen between 7 cytotechnologists and between 7 pathologists and ASCUS, AGUS, downgraded ASCUS, and downgraded AGUS rates. The percentage of downgraded ASCUS cases compared with all ASCUS cases per pathologist ranged from 4.8% to 43.7%. Statistically significant associations between pathologists and SIL follow-up rates for downgraded ASCUS diagnoses were seen. The SIL follow-up rate for repair (7.9%) was similar to that for a downgraded ASCUS (11.0%) or AGUS (7.3%). The parameters of downgraded ASCU and AGUS Pap test interpretations are good quality indicators of individual performance and overall laboratory quality.