Measuring quality in anatomic pathology.

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

Urine cytology discrepancies: frequency, causes, and outcomes.

Although urine cytology is used for the early detection and surveillance of urothelial carcinoma, there has been little study of the frequency, causes, and outcomes of cytologic-histologic discrepancies. We obtained histologic follow-up in 361 (6.2%) of 5,785 voided, 124 (19.5%) 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.

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

We measured the frequency and outcome of cervical cancer prevention failures that occurred in the Papanicolaou (Pap) and colposcopy testing phases involving 1,646,580 Pap tests in 4 American hospital systems between January 1, 1998, and December 31, 2004. We defined a screening failure as a 2-step or greater discordant Pap test result and follow-up biopsy diagnosis. A total of 5,278 failures were detected (0.321% 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.

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.

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.

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.

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.

Willingness to pay for new Papanicolaou test technologies.

The amount of money a woman is willing to pay for liquid-based cytology technology has not been measured. In the present study, 175 women answered a questionnaire asking how much they would pay to decrease their risk of dying of cervical cancer if a new (liquid-based) Papanicolaou (Pap) test was used in place of the conventional smear. When women assumed that the new Pap test reduced the risk of dying of cervical cancer from 1 in 37,000 to 1 in 50,000, the mean amount they were willing to pay was $237. If women had more than 2 children, they were willing to pay more for the new Pap test than women with 2 or fewer children. These data indicate that liquid-based and conventional Pap tests are undervalued and that cost-effectiveness studies generally have not taken into account the preference of women for new Pap test technologies.

Barriers to the implementation of patient safety initiatives.

Since release of the Institute of Medicine Report "To Err is Human:Building a Safer Health System" in 1999, a huge effort has been expended on error-related clinically applied research and on the implementation of new standards and practices related to quality improvement and patient safety. Nonetheless, measurable improvements in the quality of delivered care and reductions in medical errors have been variable and modest in most cases. Multiple barriers to the implementation of patient safety and error reduction initiatives have been identified in the literature. The greater part of this article is devoted to three fundamental barriers: physicians' intolerance for uncertainty, health professionals' fears, and an organizational structure and culture that are incongruent with increasing patient safety.

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.

Estimation of performance and sequential selection of diagnostic tests in patients with lung lesions suspicious for cancer.

CONTEXT: Measuring variation in clinician test ordering behavior for patients with similar indications is an important focus for quality management and cost containment. OBJECTIVE: To obtain information from physicians and nonphysicians regarding their test-ordering behavior and their knowledge of test performance characteristics for diagnostic tests used to work up patients with lung lesions suspicious for cancer. DESIGN: A self-administered, voluntary, anonymous questionnaire was distributed to 452 multiple-specialty physicians and 500 nonphysicians in academic and private practice in Pennsylvania, Iowa, and North Carolina. Respondents indicated their estimates of test sensitivities for multiple tests used in the diagnosis of lung lesions and provided their test selection strategy for case simulations of patients with solitary lung lesions. Data were analyzed using descriptive statistics and the chi(2) test. RESULTS: The response rate was 11.2%. Both physicians and nonphysicians tended to underestimate the sensitivities of all minimally invasive tests, with the greatest underestimations reported for sputum cytology and transthoracic fine-needle aspiration biopsy. There was marked variation in sequential test selection for all the case simulations and no association between respondent perception of test sensitivity and their selection of first diagnostic test. Overall, the most frequently chosen first diagnostic test was bronchoscopy. CONCLUSIONS: Physicians and nonphysicians tend to underestimate the performance of diagnostic tests used to evaluate solitary lung lesions. However, their misperceptions do not appear to explain the wide variation in test-ordering behavior for patients with lung lesions suspicious for cancer.

Sensitive cytologic criteria for the identification of follicular variant of papillary thyroid carcinoma in fine-needle aspiration biopsy.

The cytologic diagnosis of follicular variant of papillary thyroid carcinoma (FVPTC) can be extremely challenging and may be associated with false negative diagnoses. The purpose of this study was to determine the minimal cytologic criteria needed to identify FVPTC. We examined sixty-nine fine-needle aspiration (FNA) cases, processed with Diff-Quik and Papanicolaou stains, that were either diagnostic or suspicious of FVPTC. All cases had histologic confirmation. These cases included 29 FVPTC, 18 classic papillary thyroid carcinoma (PTC), 17 follicular neoplasm (6 adenomas, 10 carcinomas, 1 neoplasm NOS), 2 lymphocytic thyroiditis and 3 nodular goiter. Seven of the most commonly cited cytomorphologic features, including flat syncytial sheets, nuclear enlargement, fine chromatin, nuclear grooves, nuclear pseudoinclusions, and amount of colloid and cytoplasm, were evaluated. A diffuse distribution of fine chromatin, nuclear grooves, and colloid was seen more often in FVPTC than in follicular neoplasm (p<0.01). The combination of flat/syncytial sheets, nuclear enlargement, and fine chromatin was observed in all our cases of FVPTC, and is therefore considered a sensitive marker in detecting FVPTC. Logistic regression analysis revealed colloid to be the only positive predictor in favor of FVPTC over classic PTC.

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

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

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.

Pathology resident attitudes and opinions about pathologists' assistants.

CONTEXT: Changes in health care economics and organization have resulted in increased use of nonphysician providers in most health care settings. Attitudinal acceptance of nonphysician providers is important in the current health care environment. OBJECTIVES: To obtain descriptive information regarding pathology resident attitudes and opinions about pathologists' assistants in anatomic pathology practice and to assess the implications of resident attitudes and opinions for pathology practice and training. DESIGN: A self-administered, mailed, voluntary, anonymous questionnaire was distributed to a cross-sectional sample of pathology residents in the United States (2531 pathology residents registered as resident members of one of the national pathology professional organizations). The questionnaire contained (1) items relating to resident demographics and program characteristics, (2) Likert-scale response items containing positive and negative statements about pathologists' assistants, (3) a multiple-choice item related to pathologists' assistants scope of practice, and (4) an open-ended item inviting additional comments. Both quantitative and qualitative analysis of responses was performed. RESULTS: The overall response rate was 19.4% (n = 490); 50% of the respondents were women, and 77% reported use of pathologists' assistants in their program. Most respondents were 25 to 35 years old and in postgraduate years 3 through 5 of their training, and most were located in the Midwestern United States. The majority of residents expressed overall positive attitudes and opinions about pathologists' assistants and felt that pathologists' assistants enhanced resident training by optimizing resident workload. A minority (10%-20%) of residents expressed negative attitudes or opinions about pathologists' assistants. Additionally, some residents reported a lack of knowledge about pathologists' assistants' training or roles. CONCLUSIONS: Increased resident education and open discussion concerning pathologists' assistants may be beneficial for optimizing resident attitudes about and training experiences with pathologists' assistants.

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.