The Role of Proficiency Testing in Ensuring Quality: Findings From the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference Working Group 3 (original) (raw)
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Archives of Pathology & Laboratory Medicine, 2013
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Archives of Pathology & Laboratory Medicine, 2013
Context.—There are many long-standing quality monitors for cytopathology laboratories and their cytotechnologists and pathologists. Many of these monitors are based on tradition and empirical good intentions. There is no established standard as to how results of these monitors should be used in a quality assurance program. Objective.—To review practices that are typically part of a general quality program in cytopathology laboratories and to provide statements regarding good laboratory practices that laboratories may find useful in a quality assurance program in their own setting. Data Sources.—An expert working group evaluated results from a national laboratory survey, responses from follow-up questions posted on a Web site, and findings from the literature. The group created statements on good laboratory practices related to general quality practices and quality assurance in gynecologic cytopathology. These were discussed and voted on at a consensus conference. Conclusions.—Labora...
Scientific Issues Related to the Cytology Proficiency Testing Regulations
Acta Cytologica, 2006
The member organizations of the CETC feel strongly that there are significant flaws associated with the proposed proficiency test and its implementation. The most immediate modifications include lengthening the required testing interval, utilizing stringently validated and continuously monitored slides, changing the grading scheme and changing the focus of the test from individuals to laboratory level testing, as described above. Integration of new computer-assisted and location-guided screening technologies into the testing protocol is necessary for the testing program to be compliant with the current CLIA law. The regulation also needs to be flexible enough to accommodate new technologies that are implemented in laboratory practice, education and administration of the test. The changes recommended in this document address the most immediate technical and scientific concerns with the current implementation of PT for gynecologic cytology. The CETC will be submitting a subsequent document, following full review of the current regulations, with recommendations for changes, justifications and impact.
Quality management in gynecologic cytology using interlaboratory comparison
Archives of pathology & laboratory medicine, 2000
To describe a comprehensive integrated laboratory quality management plan for gynecologic cytology. Cytopathology laboratory performance monitors with interlaboratory comparison. Utilizing College of American Pathologists Q-Probes studies, the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology, and other published data, a quality management program for gynecologic cytology involving diagnostic statistics, screening limits and competency assessment, retrospective rescreening, real-time rescreening, cytology-biopsy correlation, follow-up of patients with abnormal cytology results, turnaround time, examination of unknown slides (survey programs), and new technology is described. Regular coordinated monitoring of performance, with longitudinal and interlaboratory comparison utilizing the methods described, provides an opportunity to optimize gynecologic cytology service.
Archives of pathology & laboratory medicine, 2009
• Context.-Minimum cellular criteria for satisfactory Papanicolaou tests were established with the Bethesda System in 2001, and unsatisfactory rates are used as a qualityreporting measure. Objective.-To evaluate practices and unsatisfactory rates from laboratories responding to the 2007 College of American Pathologists supplemental questionnaire survey. Design.-In 2007, a supplemental questionnaire was mailed to 1621 laboratories enrolled in the 2006 College of American Pathologists Interlaboratory Comparison Program in Gynecologic Cytology (PAP Education), requesting data from the 2006 calendar year. Unsatisfactory rates, reasons for unsatisfactory specimens, laboratory size, and specimen preparation type were analyzed. Results.-A total of 42% of the laboratories responded to the survey. Most of those laboratories (637 of 674; 94.5%) used the Bethesda System minimum cellularity criteria. Of those laboratories responding, 79% (527 of 667) used the Bethesda System criteria for atrophic or postirradiation specimens. Unsatisfactory rates have increased since 1996. SurePath preparations were associated with the lowest unsatisfactory rate (50th percentile, 0.30; 95th percentile, 1.3), conventional Papanicolaou tests had the highest 95th percentile rates (50th percentile, 1.0; 95th percentile, 5.90), and ThinPrep specimens had the highest median percentile (50th percentile, 1.1; 95th percentile, 3.4). The most-common reason for unsatisfactory Papanicolaou tests was too few squamous cells. Air-drying artifact was the least-common reason for unsatisfactory reporting for liquid-based preparations. Conclusions.-Use of the Bethesda System criteria for unsatisfactory specimens is widespread. Unsatisfactory rates have increased since 1996; however, the median rates are 1.1% or less for all preparations. Results from the College of American Pathologists PAP Education supplemental questionnaire continue to provide valuable benchmarking data for cytologic quality-improvement programs in laboratories.
Cancer, 2017
Although objective measures of cytotechnologist (CT) and cytopathologist (CP) performance exist, challenges remain. Two assumptions deserve examination: CPs' interpretations are correct, and CTs and CPs render interpretations independently of each other. This study presents a CT-CP interpretation comparison and provides insight into these assumptions. Every gynecologic cytology specimen examined by both a CT and a CP from December 2004 to March 2015 was extracted from the laboratory information system; glandular interpretations were excluded. Excel and SAS were used for CT-CP pair analysis. CT-CP pairs with fewer than 32 specimens (the lowest quartile) were excluded. For the remaining CT-CP pairs, 30 specimens or 10% of the specimens (whichever was higher) were randomly selected for comparison by a weighted κ statistic. κ values greater than 0.6 represented good agreement within CT-CP pairs. This study evaluated 7116 of 53,241 gynecologic cytology specimens (13.4%) that received...
Archives of Pathology & Laboratory Medicine, 2013
Context.-Cytopathology experts, interested stakeholders, and representatives from the College of American Pathologists, the Centers for Disease Control and Prevention, the American Society of Cytopathology, the Papanicolaou Society of Cytopathology, the American Society for Clinical Pathology, and the American Society of Cytotechnology convened the Gynecologic Cytopathology Quality Consensus Conference to present preliminary consensus statements developed by working groups, including the Cytologic-Histologic Correlations Working Group 4, using results from surveys and literature review. Conference participants voted on statements, suggested changes where consensus was not achieved, and voted on proposed changes. Objectives.-To document existing practices in gynecologic cytologic-histologic correlation, to develop consensus statements on appropriate practices, to explore standardization, and to suggest improvement in these practices. Data Sources.-The material is based on survey results from 546 US laboratories, review of the literature from 1988 to 2011, and the College of American Pathologists Web site for consensus comments and additional survey questions. Conclusions.-Cytologic-histologic correlations can be performed retrospectively, during initial case review, or both. At minimum, all available slides should be reviewed for a high-grade squamous intraepithelial lesion Papanicolaou test with negative biopsies. The preferred monitor for correlations is the positive predictive value of a Papanicolaou test. Laboratories should design cytologic-histologic correlation programs to explore existing or perceived quality deficiencies.
Quality Control for Cytology Laboratory in the USA
Thyroid FNA Cytology, 2019
Quality control in the cytology laboratory comprises many aspects of laboratory practice that are common to all medical laboratories but some that are unique. In the application to cytology, there are further, special considerations. This chapter describes quality control and quality assurance activities specific to cytology which requires continuous monitoring and are mandatory by the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations. This chapter also describes how to document review activities and monitor their effectiveness in improving performance in gynecological, non-gynecological, and fine needle aspiration cytology techniques.