Unsatisfactory reporting rates: 2006 practices of participants in the college of american pathologists interlaboratory comparison program in gynecologic cytology (original) (raw)
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Cancer, 2004
BACKGROUNDThe objective of the current study was to determine the effect of reprocessing bloody ThinPrep® (TP) samples using a glacial acetic acid technique on the unsatisfactory rate.The objective of the current study was to determine the effect of reprocessing bloody ThinPrep® (TP) samples using a glacial acetic acid technique on the unsatisfactory rate.METHODSDuring a 12-month study period, all TP gynecologic samples received by the Cytology Laboratory from inpatient, outpatient, and community-based clinics at the University of Texas Southwestern Medical Center and the Parkland Health and Hospital System in Dallas, Texas, were enrolled prospectively into the study. The initial TP slides were evaluated for specimen adequacy based on the 2001 Bethesda System. Any TP sample that contained abnormal cells, by definition, was not considered unsatisfactory. The criteria for reprocessing included scant cellularity in a background of abundant blood. Biopsy correlations for all abnormal cytologic diagnoses were established between TP smears and follow-up biopsies.During a 12-month study period, all TP gynecologic samples received by the Cytology Laboratory from inpatient, outpatient, and community-based clinics at the University of Texas Southwestern Medical Center and the Parkland Health and Hospital System in Dallas, Texas, were enrolled prospectively into the study. The initial TP slides were evaluated for specimen adequacy based on the 2001 Bethesda System. Any TP sample that contained abnormal cells, by definition, was not considered unsatisfactory. The criteria for reprocessing included scant cellularity in a background of abundant blood. Biopsy correlations for all abnormal cytologic diagnoses were established between TP smears and follow-up biopsies.RESULTSDuring the course of the 1-year study period, a total volume of 57,296 TP samples were evaluated by the study laboratory. Prior to reprocessing, the laboratory unsatisfactory rate was 8.32% (4767 of 57,296 TP samples). After reprocessing those samples that were compromised by blood (2593 of 4767 TP samples), the unsatisfactory rate was reduced to 5.47% (3134 of 57,296 TP samples), with an overall reduction by 34.25% (2.85 of 8.32 TP samples). Of 2593 samples that were reprocessed, 62.98% (1633 of 2593 TP samples) changed from inadequate to adequate for the purposes of evaluation. Of those 1633 adequate samples, 1509 samples (92.41%) were negative for intraepithelial lesion or malignancy, 72 samples (4.40%) were atypical squamous cells of unknown significance, 5 samples (0.31%) were atypical glandular cells of undetermined significance, 36 samples (2.20%) were low-grade squamous intraepithelial lesions, 10 samples (0.61%) were high-grade squamous intraepithelial lesions, and 1 sample (0.06%) was adenocarcinoma.During the course of the 1-year study period, a total volume of 57,296 TP samples were evaluated by the study laboratory. Prior to reprocessing, the laboratory unsatisfactory rate was 8.32% (4767 of 57,296 TP samples). After reprocessing those samples that were compromised by blood (2593 of 4767 TP samples), the unsatisfactory rate was reduced to 5.47% (3134 of 57,296 TP samples), with an overall reduction by 34.25% (2.85 of 8.32 TP samples). Of 2593 samples that were reprocessed, 62.98% (1633 of 2593 TP samples) changed from inadequate to adequate for the purposes of evaluation. Of those 1633 adequate samples, 1509 samples (92.41%) were negative for intraepithelial lesion or malignancy, 72 samples (4.40%) were atypical squamous cells of unknown significance, 5 samples (0.31%) were atypical glandular cells of undetermined significance, 36 samples (2.20%) were low-grade squamous intraepithelial lesions, 10 samples (0.61%) were high-grade squamous intraepithelial lesions, and 1 sample (0.06%) was adenocarcinoma.CONCLUSIONSThe authors conclude that the reprocessing of unsatisfactory ThinPrep® cervicovaginal cytology samples decrease the unsatisfactory rate considerably, with an increase in the detection of significant abnormal cervicovaginal lesions. Cancer (Cancer Cytopathol) 2004. © 2004 American Cancer Society.The authors conclude that the reprocessing of unsatisfactory ThinPrep® cervicovaginal cytology samples decrease the unsatisfactory rate considerably, with an increase in the detection of significant abnormal cervicovaginal lesions. Cancer (Cancer Cytopathol) 2004. © 2004 American Cancer Society.
Archives of Pathology & Laboratory Medicine, 2013
Context.—Gynecologic cytopathology is a heavily regulated field, with Clinical Laboratory Improvement Amendments of 1988 mandating the collection of many quality metrics. There is a lack of consensus regarding methods to collect, monitor, and benchmark these data and how these data should be used in a quality assurance program. Furthermore, the introduction of human papilloma virus testing and proficiency testing has provided more data to monitor.Objective.—To determine good laboratory practices in quality assurance of gynecologic cytopathology.Data Sources.—Data were collected through a written survey consisting of 98 questions submitted to 1245 Clinical Laboratory Improvement Amendments–licensed or Department of Defense laboratories. There were 541 usable responses. Additional input was sought through a Web posting of results and questions on the College of American Pathologists Web site. Four senior authors who authored the survey and 28 cytopathologists and cytotechnologists wer...
A Quality Control Study of Liquid-Based Cytology Test Papanicolaou
International Journal of Reliable and Quality E-Healthcare, 2014
During the last decade, there is a stringent and ongoing requirement by regulatory bodies, and often enforced by law, for the implementation of measures increasing the confidence of cytological laboratories (expressed as requirement for accreditation via ISO 15189 or 17025). In this study, we present a quality control and assurance (QC&QA) method and results based on Cytology-Histology (C-H) and Cytology-Cytology (C-C) comparisons, on the basis of real data related to cervical cancer. The proposed QC&QA methodology allows the assessment of laboratory performance over time and the assessment of the laboratory as a facility and individual personnel as well. Moreover, we propose a high-level design for a Laboratory Information System capable of supporting the proposed methodology. The usual methodology to regularly control laboratory performance (once or twice per year), is not nowadays efficient, LIS implementation following the proposed scheme can support instant QC&QA, thus ensuring...
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...
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.
Cancer, 2006
BACKGROUND. Efficient quality control is essential to ensure high sensitivity of Papanicolaou (Pap) smears. For this purpose, rescreening of 10% random negative smears is increasingly felt to be ineffective. Rapid rescreening (RR) of all negative Pap smears is more practical and has received widespread acceptance, especially in Europe, although its sensitivity is difficult to monitor and its retrospective nature may influence the vigilance of the screeners. The method of rapid prescreening (RPS) overcomes these drawbacks because rapid review of Pap smears precedes full screening. METHODS. All routine conventional Pap smears (n ¼ 8364) over 2 months underwent RPS by 12 cytotechnologists, followed by full screening. Data were analyzed to determine correlation between the RPS sensitivity of individual cytotechnologists and both their sensitivity in full screening and their years of experience as cytotechnologists. RESULTS. There was a striking variability in sensitivity (15.4%-72.7%) among the 12 screeners with an atypical squamous cells of undetermined significance (ASCUS) threshold. There was no correlation between RPS sensitivity of individual cytotechnologists with either their sensitivity in full screening or their years of experience as cytotechnologists. CONCLUSIONS. The skills required of a cytotechnologist for achieving a high sensitivity in RPS are apparently different from those of full screening and are independent of the sensitivity of the screeners at full screening or of the years of experience as cytotechnologists.