Quality improvement opportunities in gynecologic cytologic-histologic correlations: findings from the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference working group 4.

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.

Practices of participants in the college of american pathologists interlaboratory comparison program in cervicovaginal cytology, 2006.

CONTEXT: Liquid-based preparations (LBPs) and human papillomavirus testing have led to changes in cervical cytology practices. The College of American Pathologists attempts to track practice patterns using a supplemental questionnaire, which allows laboratories to report diagnostic practices. OBJECTIVE: To analyze the 2006 reporting practices and to compare the results with the 2003 survey data. DESIGN: Questionnaire was mailed to 1621 laboratories. Participants included laboratories enrolled in the 2006 College of American Pathologists Gynecologic Proficiency Testing Program or the educational Interlaboratory Comparison Program in Gynecologic Cytology. RESULTS: Of the 679 responding laboratories (response rate, 42%), most (97.8%; n = 664) had implemented the Bethesda 2001 terminology. The median rate for all preparations with low-grade squamous intraepithelial lesions was 2.5% (2.9% for LBPs) compared with a 2003 median rate of 2.1%; the increase was confined to LBPs. Rates for high-grade squamous intraepithelial lesions (median, 0.5%) and atypical squamous cells have changed little. High-grade squamous intraepithelial lesions and unsatisfactory rates varied at statistically significant levels between types of LBPs. Most atypical squamous cell cases were subclassified as undetermined significance (median, 4.3%). The median ratio of atypical squamous cells to squamous intraepithelial lesions and carcinomas for all specimen types combined was 1.5, similar to the 2003 median ratio of 1.4. The median rates for findings of squamous cell abnormalities for 2006 were significantly higher for LBPs than for conventional smears. CONCLUSIONS: Most responding laboratories have implemented the Bethesda 2001 terminology. There is an increase in LBP low-grade squamous intraepithelial lesion rates when compared with 2003 data. Liquid-based preparations have higher median squamous intraepithelial lesion and atypical squamous cell rates.

Unsatisfactory reporting rates: 2006 practices of participants in the college of american pathologists interlaboratory comparison program in gynecologic cytology.

CONTEXT: -Minimum cellular criteria for satisfactory Papanicolaou tests were established with the Bethesda System in 2001, and unsatisfactory rates are used as a quality-reporting 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.

Guidelines for the reporting of nongynecologic cytopathology specimens.

CONTEXT: Gynecologic cytology terminology and report formatting have been nationally standardized since the implementation of The Bethesda System of 1988, but standard reporting for nongynecologic cytology has never been formally addressed on the same scale. OBJECTIVES: To promote patient safety through uniform reporting in nongynecologic cytology (including fine-needle aspiration cytology) and to improve communication between laboratories and health care providers. DATA SOURCES: Sources include the College of American Pathologists Cytopathology Resource Committee; the College of American Pathologists Council on Scientific Affairs Ad Hoc Committee on Pathology Report Standardization; the College of American Pathologists Laboratory Accreditation Program inspection checklists; the Joint Commission for Accreditation of Healthcare Organizations; and the Clinical Laboratory Improvement Amendments of 1988. CONCLUSIONS: We describe the major elements of quality nongynecologic cytology reporting and discuss areas of controversy in cytology reporting. Standardized nongynecologic specimen reporting will expand the concept of common report elements already widely implemented in gynecologic cytology reporting. The intent is to improve communication with the health care team while remaining in compliance with federal mandates and accreditation guidelines.

The Becton Dickinson FocalPoint GS Imaging System: clinical trials demonstrate significantly improved sensitivity for the detection of important cervical lesions.

Location-guided screening in cervical cytology offers a potentially significant advance over routine manual screening. A prospective, 2-armed, masked clinical trial of the BD FocalPoint GS Imaging System using SurePath slides (BD Diagnostics-TriPath, Burlington, NC) compared routine manual screening and quality control rescreening with computer-assisted, field-of-view screening and device-directed quality control rescreening. The results obtained in the 2 arms were compared with adjudicated reference diagnoses for each slide. Sensitivity, specificity, and negative predictive value were calculated for the detection of atypical squamous cells of undetermined significance and greater (ASC-US+), low-grade squamous intraepithelial lesion and greater (LSIL+), and high-grade squamous intraepithelial lesion and greater (HSIL+) groups. We evaluated 12,313 slides. The detection sensitivities for HSIL+ were increased by 19.6% (P < .0001) and for LSIL+ were increased by 9.8% (P < .0001) in the computer-assisted arm, with small statistically significant decreases in specificity. For ASC-US+ sensitivity and specificity, the study arms were not statistically different. Use of this system might be expected to improve accuracy for clinically important entities without increasing equivocal case detection.

Appeals in gynecologic cytology proficiency testing: review and analysis of data from the 2006 College of American Pathologists gynecologic cytology proficiency testing program.

CONTEXT: In 2006, 9643 participants took the initial College of American Pathologists (CAP) Proficiency Test (PT). Failing participants may appeal results on specific test slides. Appeals are granted if 3 referee pathologists do not unanimously agree on the initial reference diagnosis in a masked review process. OBJECTIVES: To investigate causes of PT failures, subsequent appeals, and appeal successes in 2006. DESIGN: Appeals were examined, including patient demographic information, Centers for Medicare and Medicaid Services category (A, B, C, or D), exact reference diagnosis, examinees per appeal, examinee's Centers for Medicare and Medicaid Services category, referee's Centers for Medicare and Medicaid Services category, slide preparation type, and slide field validation rate. RESULTS: There was a 94% passing rate for 2006. One hundred fifty-five examinees (1.6%) appealed 86 slides of all preparation types. Forty-five appeals (29%) were granted on 21 slides; 110 appeals (72%) were denied on 65 slides. Reference category D and B slides were most often appealed. The highest percentage of granted appeals occurred in category D (35% slides; 42% of participants) and the lowest occurred in category B (9% slides; 8% of participants). The field validation rate of all appealed slides was greater than 90%. CONCLUSIONS: Despite rigorous field validation of slides, 6% of participants failed. Thirty percent of failing participants appealed; most appeals involved misinterpretation of category D as category B. Referees were never unanimous in their agreement with the participant. The participants and referees struggled with the reliability and reproducibility of finding rare cells, "overdiagnosis" of benign changes, and assigning the morphologically dynamic biologic changes of squamous intraepithelial lesions to static categories.

Human papillomavirus testing and reporting rates: practices of participants in the College of American Pathologists Interlaboratory Comparison Program in Gynecologic Cytology in 2006.

CONTEXT: Oncogenic, high-risk human papillomavirus (HR-HPV) testing is used to evaluate women who are older than 20 years with atypical squamous cells of undetermined significance (ASC-US) and in conjunction with a screening Papanicolaou test in women older than 30 years. OBJECTIVES: To evaluate the 2006 laboratory practice data from laboratories incorporating human papillomavirus (HPV) testing with the Papanicolaou test. DESIGN: To use the College of American Pathologists (CAP) Supplemental Questionnaire Survey for 2006 to determine laboratory practices of participants in the CAP Interlaboratory Comparison Program in Cervicovaginal Cytology. RESULTS: A total of 679 laboratories responded to the questionnaire. Most (73%) refer HPV testing to reference laboratories. Nine percent perform HPV testing in cytology. Forty-five percent offer low-risk HPV (LR-HPV) testing. The most common reflex is ASC-US, although HR-HPV is also offered with low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), or any other Papanicolaou test result. Digene Hybrid Capture II is the most common method. Human papilloma virus median test volumes are 55 monthly. Frequency distributions of HPV test volumes are significantly different from those found in 2003. Laboratories performing in-house testing reported significantly higher monthly HPV volumes (P < .001). Median rates for HR-HPV positivity are 36.6% for ASC-US, 50.0% for atypical squamous cells, cannot exclude HSIL (ASC-H), and 4% for women 30 years of age and older in conjunction with a screening Papanicolaou test. CONCLUSIONS: Reference HPV testing remains the most common pattern. The most common reflex indication is for ASC-US, but HPV testing is modified locally to include a variety of scenarios. LR-HPV testing is commonly offered despite its lack of clinical significance. These data form a baseline for ongoing monitoring of HPV testing practice trends.

Validation of AutoPap primary screening system sensitivity and high-risk performance.

OBJECTIVE: To confirm or deny the reported sensitivity of the AutoPap Primary Screening System (AutoPap) (TriPath Imaging Inc., Burlington, North Carolina, U.S.A) in a moderate-sized laboratory and to determine performance characteristics for the "clinically high risk" (CHR) patient population. STUDY DESIGN: Archives were searched for low and high grade squamous intraepithelial lesion (LSIL, HSIL), adenocarcinoma in situ (AIS) and cancer (Ca) with follow-up biopsies demonstrating a lesion of at least the reported Pap smear's severity. Smears fulfilling these criteria and a matched normal, control slide from the same day of preparation were subjected to evaluation on the AutoPap. Two hundred eighty-three smears from 254 patients were enrolled in the study, including 80 LSIL, 178 HSIL, 5 AIS and 20 Ca. Specific criteria established CHR status. Fisher's exact test was applied to determine AutoPap performance differences for non-CHR and CHR populations. RESULTS: AutoPap successfully classified as "Review" all cases as follows: 91.2% LSIL (73/80), 96.6% HSIL (172/178), 100% AIS (5/5), and 100% Ca (20/20). Fisher's exact P values, pLSIL = 1.00 and pHSIL+ = .411, confirmed statistically equivalent performance. CONCLUSION: The results confirmed the sensitivity data reported in the Food and Drug Administration-approved labeling of the AutoPap and indicated no statistically significant differences in performance characteristics in a CHR population when compared to patients without CHR status for all grades of abnormality examined.