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ContextThe College of American Pathologists periodically surveys laboratories to determine changes in cytopathology practices. We report the results of a 2011 gynecologic cytology survey.ObjectiveTo provide a cross-sectional survey of gynecologic cytology practices in 2010.DesignIn 2011, a survey was sent to 1604 laboratories participating in the College of American Pathologists gynecologic cytology interlaboratory comparison education program and proficiency testing programs requesting data from 2010 on the following topics: terminology/reporting, cytotechnologist workload, quality assurance, reagents, and ancillary testing.ResultsSix hundred and twenty-five laboratories (39%) replied to the survey. The nonstandard use of "low-grade squamous intraepithelial lesion cannot exclude high-grade squamous intraepithelial lesion" is used by most laboratories to report the presence of low-grade squamous intraepithelial lesion with possibility of high-grade squamous intraepithelial lesion. Most laboratories also report the presence or absence of cells from the transformation zone. Most respondents do not limit cytotechnologist screening workload during the work shift. Only about one-third of laboratories (188 of 582; 32%) use image-assisted screening devices. Rapid prescreening as a quality assurance measure is used by only 3.5% (21 of 594) of the laboratories. When used for screening, most laboratories use the imager for retrospective review of slides to detect human locator and interpretive errors. Most laboratories receive both liquid-based cytology samples (mainly ThinPrep, Hologic, Marlborough, Massachusetts) and conventional Papanicolaou tests. Expiration dates of liquid-based cytology test vials are not usually recorded.ConclusionsThe field of gynecologic cytology is evolving rapidly. These survey results offer a snapshot of national gynecologic cytology practices in 2010.

The article discusses research which examined the prevalence of syphilis serology testing algorithm among laboratory participants in the College of American Pathologists proficiency testing program. The study surveyed the prevalence in the use of reverse-sequence algorithm, traditional algorithm and individual syphilis tests. Advantages of reverse-sequence testing algorithm include earlier diagnosis, higher sensitivity in late latent and tertiary syphilis and fewer biological false positives.

* Context.--In 2016, the College of American Pathologists (CAP) launched the first next-generation sequencing (NGS) in silico bioinformatics proficiency testing survey to evaluate the performance of clinical laboratory bioinformatics pipelines for the detection of oncology-associated variants at varying allele fractions. This survey focused on 2 commonly used oncology panels, the Illumina TruSeq Amplicon Cancer Panel and the Thermo Fisher Ion AmpliSeq Cancer Hotspot v2 Panel. Objective.--To review the analytical performance of laboratories participating in the CAP NGS bioinformatics (NGSB) surveys, comprising NGSB1 for Illumina users and NGSB2 for Thermo Fisher Ion Torrent users, between 2016 and 2019. Design.--Responses from 78 laboratories were analyzed for accuracy and associated performance characteristics. Results.--The analytical sensitivity was 90.0% (1901 of 2112) for laboratories using the Illumina platform and 94.8% (2153 of 2272) for Thermo Fisher Ion Torrent users. Variant type and variant allele fraction were significantly associated with performance. False-negative results were seen mostly for multi-nucleotide variants and variants engineered at variant allele fractions of less than 25%. Analytical specificity for all participating laboratories was 99.8% (9303 of 9320). There was no statistically significant association between deletion-insertion length and detection rate. Conclusions.--These results demonstrated high analytical sensitivity and specificity, supporting the feasibility and utility of using in silico mutagenized NGS data sets as a supplemental challenge to CAP surveys for oncologyassociated variants based on physical samples. This program demonstrates the opportunity and challenges that can guide future surveys inclusive of customized in silico programs. [ABSTRACT FROM AUTHOR]

* Context.--The College of American Pathologists surveys provide national benchmarks of pathology practice for laboratories. Objective.--To investigate breast fine-needle aspiration (FNA) biopsy practice in domestic and international laboratories in 2019. Design.--We analyzed data from the College of American Pathologists Breast FNA Practice Supplemental Questionnaire that was distributed to laboratories participating in the 2019 College of American Pathologists Non-Gynecologic Cytopathology Education Program. Results.--Sixty-one percent (499 of 816) of respondent laboratories routinely evaluated breast FNAs. Cystic lesions were the most common indication, and radiologists primarily performed FNAs in most settings. Forty-five percent (220 of 491) of laboratories performed ancillary studies on breast FNA samples, but 33.8% (70 of 207) did not report fixation time for breast biomarker studies. Only 54.5% (271 of 497) of laboratories had a standardized reporting system and only 16.8% (82 of 488) were aware of the International Academy of Cytology Yokohama Breast FNA Biopsy Cytology Reporting System. There were significant differences among different types of institutions in several aspects of breast FNA practice, including frequency of concurrent FNA and core needle biopsy for the same lesion, primary personnel who performed the FNA, etc. Significant differences existed between domestic and international laboratories in slide preparation, ancillary studies, fixation time reporting, standardized/descriptive diagnosis, and International Academy of Cytology Yokohama Reporting System awareness. Conclusions.--This is the first survey from the College of American Pathologists Cytopathology Committee to investigate breast FNA practices. The data reveal significant differences in breast FNA practice among different types of institutions and between domestic and international laboratories, and provide a baseline for future breast FNA studies in a variety of practice settings. [ABSTRACT FROM AUTHOR]

* Context.--Repair is a challenging diagnosis and a significant source of false-positive (FP) interpretations in cervical cytology. No large-scale study of performance of repair in the liquid-based era has been performed. Objective.--To evaluate the performance of repair in the College of American Pathologists Pap Education and Proficiency Testing (PT) programs. Design.--The FP rate for slides classified as repair was evaluated by preparation type, participant type (cytotechnologist, pathologist, or laboratory), and program. The specific misdiagnosis category and individual slide performance were also evaluated. The rate of misclassification of slides as repair by participants for other diagnostic categories in the Pap Education program was assessed. Results.--The overall FP rate was 1700 of 12 715 (13.4%). There was no significant difference by program or preparation type. Within the Education program there was no difference by participant type, but pathologists' FP rate in the PT program (47 of 514, 9.1%) was significantly better than cytotechnologists in the PT program (51 of 380, 13.4%) and pathologists in the Education program (690 of 4900, 14.1%). High-grade squamous intraepithelial lesions/cancers (HSIL+) accounted for 1380 of 1602 FP interpretations (86%) in Education, but 43 of 98 (43.9%) in PT. Most slides had a low rate of misclassification, but a small number were poor performers. False-negative diagnosis of HSIL+ as repair was less common, ranging from 0.7% to 1.8%. Conclusions.--Despite initial indications that liquidbased cytology might reduce the rate of misclassification of repair, FP interpretations remain common and are no different by preparation type. Misclassification is most commonly as HSIL or carcinoma, potentially resulting in significant patient harm. [ABSTRACT FROM AUTHOR]

Context.--Detection of high-risk human papillomavirus (HR-HPV) in squamous cell carcinoma is important for classification and prognostication. In situ hybridization (ISH) is a commonly used HR-HPV--specific test that targets viral RNA or DNA. The College of American Pathologists (CAP) provides proficiency testing for laboratories performing HR-HPV ISH. Objective.--To compare the analytical performance of RNA- and DNA-based ISH methods on CAP HR-HPV proficiency tests. Design.--Data from the 2016-2018 CAP HPV ISH proficiency testing surveys were reviewed. These surveys consist of well-characterized samples with known status for HR-HPV, including 1 to 2 copies, 50 to 100 copies, 300 to 500 copies, and no copies of HR-HPV per cell. Results.--Ninety-five participants submitted 1268 survey results from 20 cores. Overall, RNA ISH had a significantly higher percentage of correct responses than DNA ISH: 97.4% (450 of 462) versus 80.6% (650 of 806) (P < .001). This disparity appears to be the consequence of a superior sensitivity of RNA ISH compared to DNA ISH for samples with 1 to 2 and with 50 to 100 copies of HRHPV per cell: 95.2% (120 of 126) versus 53.8% (129 of 240), P < .001, respectively, and 100% (89 of 89) versus 76.3% (119 of 156), P < .001, respectively. Conclusions.-An assessment of CAP HR-HPV proficiency test performance indicates that RNA ISH shows significantly higher accuracy than DNA ISH owing to higher analytical sensitivity of RNA ISH in tumors with low (1-2 copies per cell) to intermediate (50-100 copies per cell) HR-HPV viral copy numbers. These data support the use of RNA over DNA ISH in clinical laboratories that perform HR-HPV testing as part of their testing algorithms. [ABSTRACT FROM AUTHOR]

* Context.--Unsatisfactory Papanicolaou (Pap) tests pose a unique set of challenges to the laboratory with regard to their processing, review, reporting, and performance of human papillomavirus (HPV) testing. There are no standardized guidelines for the review process and handling of unsatisfactory Pap tests. Objective.--To assess the current practice patterns regarding various aspects of the unsatisfactory Pap test, from processing to reporting, across laboratories worldwide. Design.--A supplemental questionnaire was mailed to laboratories participating in the 2020 College of American Pathologists (CAP) Gynecologic Cytopathology (PAP Education) Program, requesting data regarding the unsatisfactory Pap test. Results.--Of 1520 participating laboratories, 619 (40.7%) responded, and the responses of 577 laboratories were included for further analysis. Only 64.6% (373 of 577) laboratories used the unsatisfactory Pap test criteria as specified by the 2014 Bethesda System. About threequarters of the respondents (433 of 576; 75.2%) routinely rescreened unsatisfactory Pap tests. Routine repreparation of such Pap tests was performed by 54.9% (316 of 576) of laboratories, and 52.0% (293 of 563) used glacial acetic acid for repreparing excessively bloody specimens. HPV test results were reported for unsatisfactory Pap tests, always or sometimes, by 62.4% (353 of 566) of respondents. Conclusions.--This CAP survey reveals important information regarding the practice patterns pertaining to several aspects of the unsatisfactory Pap test. It also provides valuable insight into the quality assurance measures that can be implemented for such tests. Future studies can further aid in the standardization of all components of the handling of unsatisfactory Pap tests for overall quality improvement. [ABSTRACT FROM AUTHOR]

Context.--Assessment of customer satisfaction is a vital component of the laboratory quality improvement program. Objective.--To survey the level of physician satisfaction with hospital clinical laboratory services. Design.--Participating institutions provided demographic information and survey results of physician satisfaction, with specific features of clinical laboratory services individually rated on a scale of 5 (excellent) to 1 (poor). Results.--Eighty-one institutions submitted 2425 surveys. The median overall satisfaction score was 4.2 (10th percentile, 3.6; 90th percentile, 4.6). Of the 16 surveyed areas receiving the highest percentage of excellent/good ratings (combined scores of 4 and 5), quality of results was highest along with test menu adequacy, staff courtesy, and overall satisfaction. Of the 4 categories receiving the lowest percentage values of excellent/good ratings, 3 were related to turnaround time for inpatient "STAT" (tests performed immediately), outpatient STAT, and esoteric tests. The fourth was a new category presented in this survey: ease of electronic order entry. Here, 11.4% (241 of 2121) of physicians assigned below-average (2) or poor (1) scores. The 5 categories deemed most important to physicians included quality of results, turnaround times for inpatient STAT, routine, and outpatient STAT tests, and clinical report format. Overall satisfaction as measured by physician willingness to recommend their laboratory to another physician remains high at 94.5% (2160 of 2286 respondents). Conclusions.--There is a continued trend of high physician satisfaction and loyalty with clinical laboratory services. Physician dissatisfaction with ease of electronic order entry represents a new challenge. Test turnaround times are persistent areas of dissatisfaction, representing areas for improvement. [ABSTRACT FROM AUTHOR]

Context.—Many production systems employ standardized statistical monitors that measure defect rates and cycle times, as indices of performance quality. Clinical laboratory testing, a system that produces test results, is amenable to such monitoring. Objective.—To demonstrate patterns in clinical laboratory testing defect rates and cycle time using 7 College of American Pathologists Q-Tracks program monitors. Design.—Subscribers measured monthly rates of outpatient order-entry errors, identification band defects, and specimen rejections; median troponin order-to-report cycle times and rates of STAT test receipt-to-report turnaround time outliers; and critical values reporting event defects, and corrected reports. From these submissions Q-Tracks program staff produced quarterly and annual reports. These charted each subscriber's performance relative to other participating laboratories and aggregate and subgroup performance over time, dividing participants into best and median performers and performers with the most room to improve. Each monitor's patterns of change present percentile distributions of subscribers' performance in relation to monitoring durations and numbers of participating subscribers. Changes over time in defect frequencies and the cycle duration quantify effects on performance of monitor participation. Results.—All monitors showed significant decreases in defect rates as the 7 monitors ran variously for 6, 6, 7, 11, 12, 13, and 13 years. The most striking decreases occurred among performers who initially had the most room to improve and among subscribers who participated the longest. All 7 monitors registered significant improvement. Participation effects improved between 0.85% and 5.1% per quarter of participation. Conclusions.—Using statistical quality measures, collecting data monthly, and receiving reports quarterly and yearly, subscribers to a comparative monitoring program documented significant decreases in defect rates and shortening of a cycle time for 6 to 13 years in all 7 ongoing clinical laboratory quality monitors. [ABSTRACT FROM AUTHOR]

Context.—The Q-Tracks program, created in 1999, is a quality monitoring subscription service offered by the College of American Pathologists. Objective.—To establish benchmarks in quality metrics, monitor changes in performance over time, and identify practice characteristics associated with better performance Design.—The Q-Tracks program provides ongoing study of multiple metrics offered in most laboratory disciplines. The design enables measuring the effects of process changes and comparisons with other participating laboratories. Each laboratory Q-Tracks monitor has a primary quality indicator and additional secondary indicators. Results.—To date, 19 Q-Tracks monitors have been offered, with 12 currently active monitors. Q-Tracks are primarily conducted in hospital-based laboratories in the United States, Canada, and 21 other countries. Common to most Q-Tracks monitors is a demonstration of performance improvement by subscribers with long-term participation. This finding was seen in preanalytic, turnaround time, and postanalytic measures. Q-Tracks monitors contribute to the overall demonstration and improvement of laboratory and hospital quality because they address core quality measures for the College of American Pathologists Laboratory Accreditation Program and multiple Joint Commission National Patient Safety Goals. Conclusions.—The Q-Tracks program has established multiple benchmarks in most disciplines of the laboratory and has demonstrated significant performance improvement in benchmarks and individual laboratories over time. [ABSTRACT FROM AUTHOR]

Context.--Substantial variability between different antibody titration methods has been identified since the development and introduction of the uniform procedure in 2008. Objective.--To determine whether more recent methods or techniques decrease interlaboratory and intralaboratory variation measured using proficiency testing. Design.--Proficiency test data for antibody titration between 2014 and 2018 were obtained from the College of American Pathologists. Interlaboratory and intralaboratory variations were compared by analyzing the distribution of titer results by method and phase, comparing the results against the supplier's quality control titer, and by evaluating the distribution of paired titer results when each laboratory received a sample with the same titer twice. Results.--A total of 1337 laboratories participated in the antibody titer proficiency test during the study period. Only 54.1% (5874 of 10 852) of anti-D and 63.4% (3603 of 5680) of anti-A reported responses were within 1 titer of the supplier's intended result. Review of the agreement between laboratories of the same methodology found that 78.4% (3139 of 4004) for anti-A and 89.0% (9655 of 10 852) of laboratory responses for anti-D fell within 1 titer of the mode response. When provided with 2 consecutive samples of the same titer (anti-D titer: 16), 85% (367 of 434) of laboratories using the uniform procedure and 80% (458 of 576) using the other method reported a titer difference of 1 or less. Conclusions.--Despite advances, interlaboratory and intralaboratory variance for this assay remains high in comparison with the strong reliance on titer results in clinical practice. There needs to be a reevaluation of the role of this test in clinical decision-making. [ABSTRACT FROM AUTHOR]

Context.--Machine learning applications in the pathology clinical domain are emerging rapidly. As decision support systems continue to mature, laboratories will increasingly need guidance to evaluate their performance in clinical practice. Currently there are no formal guidelines to assist pathology laboratories in verification and/or validation of such systems. These recommendations are being proposed for the evaluation of machine learning systems in the clinical practice of pathology. Objective.--To propose recommendations for performance evaluation of in vitro diagnostic tests on patient samples that incorporate machine learning as part of the preanalytical, analytical, or postanalytical phases of the laboratory workflow. Topics described include considerations for machine learning model evaluation including risk assessment, predeployment requirements, data sourcing and curation, verification and validation, change control management, human-computer interaction, practitioner training, and competency evaluation. Data Sources.--An expert panel performed a review of the literature, Clinical and Laboratory Standards Institute guidance, and laboratory and government regulatory frameworks. Conclusions.--Review of the literature and existing documents enabled the development of proposed recommendations. This white paper pertains to performance evaluation of machine learning systems intended to be implemented for clinical patient testing. Further studies with real-world clinical data are encouraged to support these proposed recommendations. Performance evaluation of machine learning models is critical to verification and/or validation of in vitro diagnostic tests using machine learning intended for clinical practice. [ABSTRACT FROM AUTHOR]

Context.--Next-generation sequencing (NGS)--based assays are used for diagnosis of diverse inherited disorders. Limited data are available pertaining to interlaboratory analytical performance of these assays. Objective.--To report on the College of American Pathologists (CAP) NGS Germline Program, which is methods based, and explore the evolution in laboratory testing practices. Design.--Results from the NGS Germline Program from 2016--2020 were analyzed for interlaboratory analytical performance. Self-reported laboratory testing practices were also evaluated. Results.--From 2016--2020, a total of 297 laboratories participated in at least 1 program mailing. Of the 289 laboratories that provided information on tests offered, 138 (47.8%) offered only panel testing throughout their enrollment, while 35 (12.1%) offered panels and exome testing, 30 (10.4%) offered only exomes, 9 (3.1%) offered only genomes, and 15 (5.2%) offered panels, exomes, and genomes. The remainder (62 laboratories, 21.4%) changed their test offerings during the 2016--2020 timeframe. Considering each genomic position/interval, the median detection percentage at variant positions across the 2016--2020 mailings ranged from 94.3% to 100%, while at reference positions (no variant detected), the median correct response percentage was 100% across all mailings. When considering performance of individual laboratories, 89.5% (136 of 152) to 98.0% (149 of 152) of laboratories successfully met the detection threshold (≥90% of the variants present), while 94.6% (87 of 92) to 100% (163 of 163) of laboratories met the 95% specificity threshold across mailings. Conclusions.--Since the inception of this program, laboratories have consistently performed well. The median sensitivity and specificity of detection of sequence variants included in this program (eg, single nucleotide variants, insertions, and deletions) were 100.0%. [ABSTRACT FROM AUTHOR]

* Context.--Next-generation sequencing--based approaches using RNA have increasingly been used by clinical laboratories for the detection of fusion genes, intragenic rearrangements, and exon-skipping events. Correspondingly, the College of American Pathologists (CAP) has advanced RNA sequencing proficiency testing (PT) to ensure optimal performance of these assays. Objective.--To report on laboratory performance and practices of RNA sequencing for the detection of fusion genes, intragenic rearrangements, and exon-skipping events using CAP PT data from 8 mailings (2018-A through 2021-B). Design.--CAP PT RNA sequencing program results from 153 laboratories across 24 proficiency test specimens, interrogating 22 distinct engineered fusion transcripts, were analyzed for correct identification of the fusion event, associated performance variables, and laboratory practices. Results.--Overall, the 4-year program detection rate (sensitivity) was 95.5% (1486 of 1556 results). False-negative rates were 3.6% (53 of 1463) and 18.3% (17 of 93) for fusion gene and intragenic rearrangement/exon-skipping events, respectively. Only 19 false-positive results were reported among the 8 PT mailings, and most were likely the result of preanalytical or postanalytical errors. There were no practice characteristics (eg, instrumentation, sequencing method) significantly associated with the fusion detection results. Conclusions.--These data reveal a high overall sensitivity and specificity for fusion gene detection by participating laboratories using clinical RNA sequencing. Performance was comparable across all laboratories, regardless of methodology. The fraction of false-negative results for intragenic rearrangement/exon-skipping events was greater than that for the chimeric fusion genes. False-negative results could not be attributed to any specific practice characteristics. [ABSTRACT FROM AUTHOR]

Context.-- The Sustainable Predictive Oncology Therapeutics and Diagnostics quality assurance pilot study (SPOT/Dx pilot) on molecular oncology next-generation sequencing (NGS) reportedly demonstrated performance limitations of NGS laboratory-developed tests, including discrepancies with a US Food and Drug Administration-approved companion diagnostic. The SPOT/Dx pilot methods differ from those used in proficiency testing (PT) programs. Objective.-- To reanalyze SPOT/Dx pilot data using PT program methods and compare to PT program data.Also see p. 136. Design.-- The College of American Pathologists (CAP) Molecular Oncology Committee reanalyzed SPOT/Dx pilot data applying PT program methods, adjusting for confounding conditions, and compared them to CAP NGS PT program performance (2019-2022). Results.-- Overall detection rates of KRAS and NRAS single-nucleotide variants (SNVs) and multinucleotide variants (MNVs) by SPOT/Dx pilot laboratories were 96.8% (716 of 740) and 81.1% (129 of 159), respectively. In CAP PT programs, the overall detection rates for the same SNVs and MNVs were 97.2% (2671 of 2748) and 91.8% (1853 of 2019), respectively. In 2022, the overall detection rate for 5 KRAS and NRAS MNVs in CAP PT programs was 97.3% (1161 of 1193). Conclusions.-- CAP PT program data demonstrate that laboratories consistently have high detection rates for KRAS and NRAS variants. The SPOT/Dx pilot has multiple design and analytic differences with established PT programs. Reanalyzed pilot data that adjust for confounding conditions demonstrate that laboratories proficiently detect SNVs and less successfully detect rare to never-observed MNVs. The SPOT/Dx pilot results are not generalizable to all molecular oncology testing and should not be used to market products or change policy affecting all molecular oncology testing. [ABSTRACT FROM AUTHOR]

Context.--Substantial variability between different antibody titration methods has been identified since the development and introduction of the uniform procedure in 2008. Objective.--To determine whether more recent methods or techniques decrease interlaboratory and intralaboratory variation measured using proficiency testing. Design.--Proficiency test data for antibody titration between 2014 and 2018 were obtained from the College of American Pathologists. Interlaboratory and intralaboratory variations were compared by analyzing the distribution of titer results by method and phase, comparing the results against the supplier's quality control titer, and by evaluating the distribution of paired titer results when each laboratory received a sample with the same titer twice. Results.--A total of 1337 laboratories participated in the antibody titer proficiency test during the study period. Only 54.1% (5874 of 10 852) of anti-D and 63.4% (3603 of 5680) of anti-A reported responses were within 1 titer of the supplier's intended result. Review of the agreement between laboratories of the same methodology found that 78.4% (3139 of 4004) for anti-A and 89.0% (9655 of 10 852) of laboratory responses for anti-D fell within 1 titer of the mode response. When provided with 2 consecutive samples of the same titer (anti-D titer: 16), 85% (367 of 434) of laboratories using the uniform procedure and 80% (458 of 576) using the other method reported a titer difference of 1 or less. Conclusions.--Despite advances, interlaboratory and intralaboratory variance for this assay remains high in comparison with the strong reliance on titer results in clinical practice. There needs to be a reevaluation of the role of this test in clinical decision-making. [ABSTRACT FROM AUTHOR]

Context.--Therapy targeted at human epidermal growth factor receptor 2 (HER2; also known as ERBB2) was used initially for breast and gastroesophageal carcinoma and has more recently been adopted for endometrial serous carcinoma (ESC) and colorectal carcinoma (CRC). There is evidence that predictive biomarker testing algorithms for HER2 must be tumor type specific and that an algorithm validated for one tumor type cannot be applied to another. Objective.--To describe current laboratory practices for HER2 assessment in ESC and CRC. Design.--We surveyed laboratories participating in the 2021 College of American Pathologists (CAP) HER2 immunohistochemistry proficiency testing program. Results.--The survey was distributed to 1548 laboratories and returned by 1195, of which 83.5% (998) were in the United States. For ESC, 24.0% (287) of laboratories reported performing in-house testing for HER2 by immunohistochemical staining and/or in situ hybridization; of these, 44.3% (127) performed it reflexively on all cases of ESC. The most common criterion for evaluating HER2 was the American Society of Clinical Oncology/CAP 2018 guideline for breast carcinoma (69.0%; 194 of 281), whereas only 16.0% (45) of laboratories used guidelines specific to ESC. For CRC, 20.2% (239 of 1185) of laboratories performed in-house HER2 testing, and 82.0% of these (196) did the test only at the clinician's request. A plurality (49.4%; 115 of 233) used gastroesophageal cancer guidelines when scoring CRC, 30.0% (70) used the CRC scoring system from the HERACLES trial, and 16.3% (38) used the American Society of Clinical Oncology/CAP 2018 guideline for breast carcinoma. Conclusions.--Laboratories vary in their approach to HER2 testing in ESC and CRC. Most laboratories did not report using tumor type--specific recommendations for HER2 interpretation. The lack of standardization could present a challenge to evidence-based practice when considering targeted therapy for these diseases. [ABSTRACT FROM AUTHOR]

Context.--Laboratories must demonstrate analytic validity before any test can be used clinically, but studies have shown inconsistent practices in immunohistochemical assay validation. Objective.--To assess changes in immunohistochemistry analytic validation practices after publication of an evidence-based laboratory practice guideline. Design.--A survey on current immunohistochemistry assay validation practices and on the awareness and adoption of a recently published guideline was sent to subscribers enrolled in one of 3 relevant College of American Pathologists proficiency testing programs and to additional nonsubscribing laboratories that perform immunohistochemical testing. The results were compared with an earlier survey of validation practices. Results.--Analysis was based on responses from 1085 laboratories that perform immunohistochemical staining. Of 1057 responses, 65.4% (691) were aware of the guideline recommendations before this survey was sent and 79.9% (550 of 688) of those have already adopted some or all of the recommendations. Compared with the 2010 survey, a significant number of laboratories now have written validation procedures for both predictive and nonpredictive marker assays and specifications for the minimum numbers of cases needed for validation. There was also significant improvement in compliance with validation requirements, with 99% (100 of 102) having validated their most recently introduced predictive marker assay, compared with 74.9% (326 of 435) in 2010. The difficulty in finding validation cases for rare antigens and resource limitations were cited as the biggest challenges in implementing the guideline. Conclusions.--Dissemination of the 2014 evidence- based guideline validation practices had a positive impact on laboratory performance; some or all of the recommendations have been adopted by nearly 80% of respondents. [ABSTRACT FROM AUTHOR]

* Context.--The College of American Pathologists (CAP) updated the Laboratory Accreditation Program Cytopathology Checklist to assist laboratories in meeting and exceeding the Clinical Laboratory Improvement Amendments standards for gynecologic cytologic-histologic correlation (CHC). Objective.--To survey the current CHC practices. Design.--Data were analyzed from a survey developed by the committee and distributed to participants in the CAP Gynecologic Cytopathology PAP Education Program mailing. Results.--Worldwide, CHC practice is nearly universally adopted, with an overall rate of 87.0% (568 of 653). CHC material was highly accessible. CHC was commonly performed real time/concurrently at the time the corresponding surgical pathology was reviewed. Investigation of CHC discordances varied with North American laboratories usually having a single pathologist review all discrepant histology and cytology slides to determine the reason for discordance, while international laboratories have a second pathologist review histology slides to determine the reason for discordance. The cause of CHC discordance was primarily sampling issues. The more common statistical metrics for CHC monitoring were the total percentage of cases that correlated with subsequent biopsies, screening error rate by cytotechnologist, and interpretative error rate by cytotechnologist. Conclusions.--Many laboratories have adopted and implemented the CHC guidelines with identifiable differences in practices between North American and international laboratories. We identify the commonalities and differences between North American and international institutional practices including where CHC is performed, how CHC cases are identified and their accessibility, when CHC is performed, who investigates discordances, what discordances are identified, and how the findings affect quality improvement. [ABSTRACT FROM AUTHOR]

Context.--Accuracy of blood glucose measurements in the critical value range is important for properly treating patients with severe hypoglycemia and hyperglycemia. Objective.--To evaluate the performance and reliability of point-of-care glucose (POCG) results in the critical value range among multiple facilities. Design.--Q-Probes participants retrospectively collected data from up to 50 POCG results in their critical value range including patient location, type of testing operator, repeat glucose results, and caregiver notification. A repeat measurement at 10 minutes or less that was within 15 mg/ dL of initial critical low or 20% of initial critical high value was considered a confirmed result. Results.--Fifty facilities submitted data. Of 2349 critical POCG measurements, 1386 (59.0%) were retested. The median institutional retest rate was 56%. The retest rate was significantly higher when initial results were in the critical low range, P < .001. Although 30 of 50 facilities (60%) had written procedures for retesting, this was not associated with higher retest rates (P = .34). Among 35 facilities that routinely retested critical POCG results, 23 (65.7%) had criteria defined for interpreting results. The median institutional confirmation rate for retested specimens was 81.7%. The median institutional rate for caregiver notification of critical POCG results was 85.7%. Five hundred eighty-six of 1488 critical POCG notifications (39.4%) were done on patients in whom specimens were not retested. Conclusions.--This study shows that POCG results in the critical range may be unreliable because of testing errors that are not recognized from lack of confirmatory testing. In addition, notification of critical POCG results is not consistently performed. [ABSTRACT FROM AUTHOR]

Context.--Requests for laboratory testing are canceled after a specimen has already been collected from the patient for many reasons. Regardless of the cause, test cancellation represents a significant resource expenditure for laboratories, and many cancellation events impact patient care by delaying the reporting of test results. Objective.--To survey a wide variety of hospitals to determine the rate, causes, and circumstances surrounding laboratory test cancellation events. Design.--Institutions (N = 52) prospectively monitored their test cancellation events during a 6-week period or until 75 cancellation events occurred. Information regarding the test cancellation was recorded, including the primary reason for canceling the test. The rate of test cancellation was calculated based on laboratory specimen volume. Laboratory policies relevant to test cancellation were also surveyed. Results.--A total of 3471 canceled tests were recorded by participating laboratories of 1 118 845 specimens they accessioned, resulting in an aggregate test cancellation rate of 3.1 per 1000 accessions. The most frequently reported reason for test cancellation occurred in the preanalytical phase, and was a duplicate test request, followed by specimen quality reasons including hemolyzed/clotted specimens and insufficient sample quantity for testing. Very few cancellations occurred during the analytical phase of testing. Lower test cancellation rates were reported by larger institutions and by laboratories that received fewer specimens from inpatients. Conclusions.--Cancellation of patient tests after a specimen had been collected and received remains a significant issue for clinical laboratories. Laboratories should monitor causes of test cancellation to identify targets for process improvement efforts and to improve laboratory utilization. Cancellation events due to incomplete identification or poor specimen quality potentially delay patient care. Cancellations due to duplicate orders or excessive frequency of testing represent operational challenges for the laboratory and inefficiency in the health care system. Policies related to test cancellation should be clearly specified and communicated to users of laboratory services. [ABSTRACT FROM AUTHOR]

Context.— The appropriate and timely performance of molecular testing in anatomic pathology is an indicator of quality. The National Comprehensive Cancer Network (NCCN) publishes a comprehensive treatment guideline that includes recommendations for ancillary testing. Objective.— To establish benchmarks for rates of adherence to NCCN testing recommendations through a multi-institutional study. Design.— Participants in a 2013 Q-Probes study of the College of American Pathologists reported data from molecular testing on anatomic pathology cases, excluding hematolymphoid neoplasms, breast primary carcinomas, and gynecologic cytology. Results.— Twenty-six institutions reported data from 2230 molecular testing events. In a retrospective study limited to colon, lung, and melanoma, there was strict adherence to guidelines in a median 71% (10th to 90th percentile range, 33%-90%) and there was at least loose adherence in a median 95% (10th to 90th percentile range, 57%-100%). There was adequate tissue to complete testing in a median 98% (10th to 90th percentile range, 86%-100%); in aggregate the adequacy rate for cell blocks was lower (84%, P < .001). Median test turnaround time was 8 days (10th to 90th percentile range, 4-13 days). In a prospective collection of all organ sites, there was strict adherence to guidelines in a median 53% (10th to 90th percentile range, 20%-71%), and there was at least loose adherence in a median 94% (10th to 90th percentile range, 75%-100%). Adherence to guidelines was higher for lung specimens and in institutions with more multidisciplinary conferences. Conclusions.— This multi-institutional study provides benchmarking data on appropriateness and timeliness of molecular testing in anatomic pathology. [ABSTRACT FROM AUTHOR]

Context.—The speed and accuracy of preliminary blood culture reports impacts patient management and outcomes. Objective.—To evaluate the accuracy and timeliness of preliminary blood culture results among multiple laboratories. Design.—Q-Probes participants collected turnaround time (TAT) data on preliminary Gram stains, compared accuracy of up to 100 preliminary to final culture Gram stain results, and described blood culture laboratory practices. Results.—Sixty-four laboratories and 5031 blood cultures were evaluated. All participants used continuously monitoring blood culture systems. Median TAT from initial growth detection to notification of results was 45 minutes, with the longest component being preparation of Gram stains (median time ¼ 25 minutes). Participants (N ¼ 40) reporting a continuous schedule for processing blood cultures had significantly lower overall TAT (median ¼ 37 minutes) compared with 15 participants with intermittent processing schedules (median ¼ 124 minutes), P ¼ .003. Time to complete Gram stain processing was lower (median time ¼ 21 minutes) for 39 participants using continuous processing schedule compared with 14 others (median time ¼ 67 minutes), P ¼ .03. Goals for total TAT were used by 27 of 56 participants (48.2%). Having goals did not significantly affect TAT. A total of 4962 of 5021 Gram stain results (98.8%) agreed with final culture results. The highest discrepancy rates occurred among gram-positive bacilli (20 of 335; 6.0%) and mixed cultures (22 of 106; 20.8%). Conclusions.—This study provides benchmarks for assessing blood culture quality performance. Timeliness and accuracy of preliminary blood culture reports were excellent. However, nearly one-third of laboratories did not process blood cultures continuously. This significantly prolonged reporting results, which could affect patient outcomes. [ABSTRACT FROM AUTHOR]

Context.—Ensuring laboratory tests are performed at intervals consistent with established, evidence-based guidelines in diabetic patients is an important aspect of laboratory utilization. Objectives.—To measure how frequently diabetes mellitus patients are tested for hemoglobin A1c (HbA1c ), low-density lipoprotein, and urine protein and to determine whether the frequencies with which these analytes are tested are consistent with recognized guidelines. Design.—Participants prospectively identified up to 40 patients with a current HbA1c result and at least 2 previous measurements within the past 24 months. For each patient identified with at least 3 HbA1c measurements during a 24- month period, participants also determined the number of low-density lipoprotein and spot or random urine protein tests that were performed during those 24 months. Results.—Participants from 49 institutions submitted a total of 1915 cases that met the study criteria of at least 3 HbA1c test results within the past 24 months. Approximately 95% of patients had 8 or fewer HbA1c tests in the past 24 months; 79% of patients with at least 3 HbA1c tests had at least 2 low-density lipoprotein tests and 27% had at least 2 urine protein tests reported during the 24-month study period. Conclusions.—Participating laboratories were generally successful in documenting appropriate utilization of HbA1c testing in diabetes mellitus monitoring, but had more difficulty documenting that diabetes mellitus patients had annual testing for low-density lipoprotein and urine protein. [ABSTRACT FROM AUTHOR]

Context.- Anal cytology is being used more frequently for anal cancer screening, yet many cytologists are unfamiliar with it. Objective.- To describe the performance of anal cytology in the College of American Pathologists' Interlaboratory Comparison Program in Non-Gynecologic Cytology (CAP NGC) educational slide program during a 6-year time span, from 2006 to 2011, using participant responses (pathologist, cytotechnologist, and laboratory). Design.- Concordance rates for the target diagnosis and general category for each slide challenge were analyzed. Four main factors were included in the analysis: (1) general category or specific responses, (2) program year from 2006 to 2011, (3) participant type (pathologist, cytotechnologist, or overall laboratory), and (4) preparation type (liquid-based or conventional). Results.- Participants most frequently correctly classified negative for intraepithelial lesion or malignancy, lowgrade squamous intraepithelial lesion, and herpes simplex virus infection, with concordance rates of 78.8%, 85%, and 80.2%, respectively. Performance on challenges with target diagnoses of high-grade squamous intraepithelial lesion (HSIL), squamous cell carcinoma, and ameba was poor, with concordance rates of 57.1%, 56.2%, and 41.5%, respectively. Significant improvement during the 6 years was seen in the concordance rates of participants' responses for low-grade squamous intraepithelial lesion challenges but not for HSIL. There was no significant difference in performance by slide preparation type. Conclusions.- The poor performance on anal cytology in the CAP NGC program, especially with regard to correct identification of HSIL and squamous cell carcinoma, indicates that there is a need for continued education about anal cytology. [ABSTRACT FROM AUTHOR]

Context.-Correlation of radiologic and pathologic findings is important for optimal management of patients with image-guided breast biopsies. Objectives.-To (1) evaluate the rates of radiologic and pathologic correlation in breast needle core biopsies, (2) evaluate laboratory and radiology practices associated with greater correlation rates, and (3) determine the rates at which the lack of radiologic-pathologic correlation is documented in pathology reports. Design.-The study was offered and conducted as a College of American Pathologists voluntary Q-Probes program. Participants in this study retrospectively reviewed 30 consecutive, initial, diagnostic needle core biopsy cases performed for abnormal radiologic findings. If 12 months of accessioned cases were reviewed without identifying 30 qualifying cases, participants stopped the retrospective review and included all cases identified. For each case or specimen, the participants provided detailed information about the radiologic and pathologic findings. Results.-In aggregate, a radiologic-pathologic correlation was found in 94.9% (1328 of 1399) of the cases reviewed, based on the participants' judgments. Significant differences in the correlation rates existed when cases were discussed at an interdepartmental, multidisciplinary conference (P < .001). No significant differences were found in the correlation rates of the following: whether surgeons or radiologists performed the biopsy, whether cores with calcifications were identified by any method, and whether the laboratory had one or more designated breast pathologists. Conclusions.-Participation in a multidisciplinary breast conference is useful in radiologic-pathologic correlation. Active involvement by pathologists in correlating pathologic and radiologic findings is important. [ABSTRACT FROM AUTHOR]

Context.--Accurate specimen labeling is a major patient-safety initiative by the Joint Commission and the College of American Pathologists. Inadequate specimen labels have led to patient injury from wrong patient diagnosis, wrong side treatment, and delay in diagnosis. Objectives.--To quantify the rates of mislabeled cases, specimens, blocks, and slides and to identify the sources of error and the ways in which errors are detected. Design.--In this voluntary-subscription Q-Probes study, participants prospectively reviewed surgical pathology cases for 8 weeks or until 30 errors (mislabeled cases, specimens, blocks, and slides) were identified. Information collected on each labeling error included the work location where the defect occurred, what was mislabeled, the number of items affected, the point of detection, and the consequences of the mislabeling error, along with institutional demographics and practice. The rates of mislabeled cases, specimens, blocks, and slides were tested for association with institutional demographics and practice variables. Results.--Of the 136 institutions providing information on a total of 1811 mislabeling occurrences, the overall mislabeling rates per 1000 were 1.1 cases, 1.0 specimen, 1.7 blocks, and 1.1 slides. Of all mislabeling events, 27.1% were cases, 19.8% specimens, 25.5% blocks, and 27.7% slides. The work locations at which the errors occurred were 20.9% before accessioning, 12.4% at accessioning, 21.7% at block labeling, 10.2% during gross pathology, and 30.4% at tissue cutting. Errors were typically detected in the first or second steps immediately following the error. Lower mislabeled slide rates were associated with continuous individual case accessioning and use of formal checks at accessioning. Routinely including a statement in the gross description that the specimen is labeled with the patient's name and is properly identified was also associated with lower rates of specimen mislabeling. The errors were corrected before reports were issued 96.7% of the time; for 3.2% of errors, a corrected report was issued. In 1.3% of error occurrences, participants gauged that patient care was affected. Conclusions.--This study quantified mislabeling rates across 136 institutions of cases (0.11%), specimens (0.1%), blocks (0.17%), and slides (0.11%). Errors in labeling appear nearly equally throughout the system of accessioning, gross pathology processing, and tissue cutting. Errors are typically detected in the immediate steps after the errors occurred, reinforcing the need for quality checks throughout the system. [ABSTRACT FROM AUTHOR]

Context.--Cytologic features of low-grade neuroendocrine carcinoma are well described in primary sites. There are fewer reports of the cytologic features specific to metastatic liver lesions or the frequency of misdiagnosis. Objective.--To identify discriminating cytologic features and characterize the rate of misdiagnosis of lowgrade neuroendocrine tumors metastatic to the liver in an educational interlaboratory slide comparison program. Design.-Glass slides with the specific reference diagnosis of metastatic low-grade neuroendocrine tumor involving liver were circulated to 175 laboratories, with 575 participant responses in the College of American Pathologists Interlaboratory Comparison Program in Nongynecologic Cytology. Eight specific cytologic features were assessed to identify predictors of poor performance (.10% misdiagnosis). Results.--There was an exact match diagnosis in 496 of 575 responses (86%); 555 of 575 responses (96.5%) were correctly identified as malignant. Incorrect responses included adenocarcinoma (27), hepatocellular neoplasm (21), small cell carcinoma (11), benign neoplasm not otherwise specified (6), benign liver (3) and inflammation (3). Three features were significantly associated with the misdiagnosis of adenocarcinoma: presence of large clusters (P = .02), lack of single-cell pattern (P = .02), and lack of stripped nuclei (P = .01). Conclusion.--Participants often recognize metastatic low-grade neuroendocrine carcinoma in an educational glass-slide program. Adenocarcinoma was the most common incorrect diagnosis, especially in the presence of large cellular clusters or absence of a single-cell pattern or stripped nuclei. [ABSTRACT FROM AUTHOR]

* Context.--The College of American Pathologists periodically surveys laboratories to determine changes in cytopathology practices. We report the results of a 2016 survey concerning thyroid fine-needle aspiration (FNA). Objective.--To provide a cross-sectional survey of thyroid cytology practices in 2016. Design.--In 2016, a survey was sent to 2013 laboratories participating in the College of American Pathologists Non-Gynecologic Cytology Education Program (NGC-A) requesting data from 2015-2016 on several topics relating to thyroid FNA. Results.--A total of 878 laboratories (43.6% of 2013) replied to the survey. Radiologists performed the most thyroid FNA procedures in most laboratories (70%; 529 of 756), followed by endocrinologists (18.7%; 141 of 756), and most of these were performed under ultrasound guidance (92.1%; 699 of 759). A total of 32.6% of respondents (251 of 769) provided feedback on unsatisfactory rates for nonpathology providers who performed FNA. Intraprocedural adequacy assessment was primarily performed by attending pathologists (77.4%; 490 of 633) or cytotechnologists (28.4%; 180 of 633). Most laboratories used the Bethesda System for Reporting Thyroid Cytopathology (89.8%; 701 of 781) and performed molecular testing based on clinician request (68.1%; 184 of 270) rather than FNA diagnosis. Correlation of thyroid excisions with prior cytology results most often occurred retrospectively (38.4%; 283 of 737) and was used for pathologist interpretive quality assurance purposes. Conclusions.--These survey results offer a snapshot of national thyroid FNA cytology practices in 2016 and indicate that standardized cytology terminology is commonly used; pathologists perform most immediate adequacy assessments for thyroid FNA; laboratories use correlation statistics to evaluate pathologists' performance; and molecular tests are increasingly requested for indeterminate interpretations, but reflex molecular testing is rare. [ABSTRACT FROM AUTHOR]

Context.--Fluorescence in situ hybridization (FISH) and brightfield in situ hybridization (ISH) are 2 clinically approved laboratory methods for detecting ERBB2 (HER2) amplification in breast cancer. Objective.--To compare the performance of FISH and brightfield ISH on proficiency testing administered by the College of American Pathologists Laboratory Accreditation Program. Design.--Retrospective review was performed on 70 tissue core samples in 7 separate proficiency testing surveys conducted between 2009 and 2013. Results.--The samples included 13 consensus-amplified tissue cores, 53 consensus-nonamplified cores, and 4 cores that did not reach consensus for FISH and/or brightfield ISH. There were 2552 individual responses for FISH and 1871 individual responses for brightfield ISH. Consensus response rates were comparable for FISH (2474 of 2524; 98.0%) and brightfield ISH (2135 of 2189; 97.5%). The FISH analysis yielded an average HER2 copy number per cell that was significantly higher (by 2.86; P = .02) compared with brightfield ISH for amplified cores. For nonamplified cores, FISH yielded slightly, but not significantly, higher (by 0.17; P = .10) HER2 copy numbers per cell. There was no significant difference in the average HER2 to control ratio for either consensus-amplified or consensus-nonamplified cores. Participants reported "unable to analyze" more frequently for brightfield ISH (244 of 2453; 9.9%) than they did for FISH (160 of 2684; 6.0%). Conclusions.--Our study indicates a high concordance rate in proficiency testing surveys, with some significant differences noted in the technical performance of these assays. In borderline cases, updated American Society of Clinical Oncology/College of American Pathologists cutoff thresholds that place greater emphasis on HER2 copy number per cell could accentuate those differences between FISH and brightfield ISH. [ABSTRACT FROM AUTHOR]

Context.--The classification and prognosis determination in acute leukemia (AL) are complex and it is unclear what testing is being performed in practice. Objective.--To survey physicians describing their current practice of test ordering in the diagnosis of AL. Design.--In anticipation of a guideline by the College of American Pathologists (CAP) and the American Society for Hematology on laboratory testing needed for the initial workup of AL, a baseline survey was designed by an expert panel from CAP. Members of professional societies were asked to describe their current practice of test ordering. Results.--Two hundred ninety-four responses were received with 258 respondents analyzed after the first qualifying survey question regarding initial diagnosis of AL. One hundred seventy-six of 249 respondents (70.7%) were board-certified hematopathologists. Flow cytometry and karyotype analysis were routinely performed for acute myeloid leukemia (AML) (99.1% [232 of 234] and 96.2% [225 of 234], respectively) and acute lymphoblastic leukemia (ALL) (98.3% [229 of 233] and 96.6% [225 of 233], respectively). In addition, fluorescence in situ hybridization studies were routinely performed by 81.2% (190 of 234) of respondents for AML and 85.0% (198 of 233) of respondents for ALL; other molecular studies were performed by 78.2% (183) for AML and 54.9% (128) for ALL; immunohistochemistry by 44.9% (105) for AML and 47.6% (111) for ALL; and cytochemistry by 24.8% (58) for AML and 14.2% (33) for ALL. Conclusions.--While flow cytometry and karyotyping are routinely reported as being performed for the diagnosis of AL, there is marked variation in the reporting of testing patterns for other genetic studies, immunohistochemistry, and cytochemistry. [ABSTRACT FROM AUTHOR]

Context.--Incorrectly labeled patient blood specimens create opportunities for laboratory testing personnel to mistake one patient's specimen for a specimen from a different patient. Transfusion of blood that is typed on specimens that are mislabeled can result in acute hemolytic transfusion reactions. Objective.--To assess the rates of blood bank ABO typing specimens that are mislabeled and/or contain blood belonging to another patient (so-called wrong blood in tube [WBIT]), and to compare these rates with those determined in a similar study performed in 2007. Design.--Participants enrolled in this College of American Pathologists Q-Probes study for the first quarter of 2015 tallied the number of mislabeled and WBIT ABO blood typing specimens. Outcome measurements were the number of mislabeled and WBIT instances per 1000 specimens. We also evaluated the effects of various practice characteristics, in particular the use of bar coding, on the outcome measurements. Results.--A total of 30 institutions submitting data on 41 333 ABO blood typing specimens recorded aggregate rates of 7.4 instances of mislabeling (306 specimens) and 0.43 instances of WBIT (10 of 23 234) per 1000 specimens submitted. Mislabeling rates were lower in institutions requiring that specimens be labeled with patients' birth dates than those that did not. The rates of specimen mislabeling and WBIT were otherwise unassociated with any of the other practice variables evaluated. Conclusions.--The rates of ABO blood typing specimen mislabeling and WBIT are not statistically different from those determined in a similar study performed in 2007 (P = .94 and P = .10). The use of bar coding was not associated with lower mislabeling (P = .80) or WBIT rates (P = .79). [ABSTRACT FROM AUTHOR]

* Context.--Misinterpretation of high-grade squamous intraepithelial lesion (HSIL) is an important problem in daily practice and in the College of American Pathologists (CAP) PAP Proficiency Test (PAP-PT). Objective.--To investigate factors related to misinterpretation of HSIL through responses in a proficiency test versus an educational environment. Design.--We retrospectively evaluated 28 000 responses in the PAP Education Program (PAP-Edu) and 59 140 responses in PAP-PT from 1147 field-validated HSIL slides from 2007 to 2014. The related factors, such as program types, preparation types, participant types, and program years, were evaluated. Results.--Overall, 4.0% (2379 of 59 140) of responses for HSIL slides from PAP-PT were misinterpreted as either low-grade squamous intraepithelial lesion (LSIL) or negative, significantly more than those from PAP-Edu (3.2%; 898 of 28 000). However, the false-negative rate (misinterpreted as negative) was 0.9% (519 of 59 140) for PAPPT, lower than that for PAP-Edu (1.0%; 266 of 28 000). The misinterpretation rates in PAP-PT trended down with time. Misinterpretation rates did not vary significantly by preparation methods. The misinterpretation rate for HSIL in the pathologists' responses was lower than that in cytotechnologists' responses in PAP-PT. More HSIL was misinterpreted as LSIL than as benign in both programs. Cytotechnologists interpreted HSIL as LSIL twice as much as pathologists. The most common false-negative misinterpretations were negative for intraepithelial lesion or malignancy and reparative change. Conclusions.--The higher LSIL misinterpretation rate by cytotechnologists may be related to the differences in reporting responsibilities and proficiency test grading criteria. The trend of gradually decreasing misinterpretation rates of a reference diagnosis of HSIL in the PAP-PT program may be related to higher test-taking confidence and better preparation through educational programs. The fact that pathologists performed better than cytotechnologists in PAP-PT, but not in PAP-Edu, may reflect a heightened approach and attentiveness in the test-taking environment for pathologists. [ABSTRACT FROM AUTHOR]

Context.--Nongynecologic cytology (NGC) practices are expanding in relationship to historical gynecologic cytology screening programs. Bronchopulmonary cytology is experiencing an evolution regarding new procedural types. The College of American Pathologists (CAP) tracks practice patterns in NGC by developing questionnaires, surveying participants, and analyzing respondent data. Objective.--To analyze responses to a 2013 CAP supplemental survey from the Interlaboratoy Comparison Program on bronchopulmonary NGC. Design.--The "NGC 2013 Supplemental Questionnaire: Demographics in Performance and Reporting of Respiratory Cytology" was mailed to 2074 laboratories. Results.--The survey response rate was 42% (880 of 2074) with 90% of respondents (788 of 880) indicating that their laboratories evaluated cytology bronchopulmonary specimens. More than 95% of respondents indicated interpreting bronchial washings (765 of 787) and bronchial brushings (757 of 787). A minority of laboratories (43%, 340 of 787) dealt with endobronchial ultrasound-guided samples, and an even smaller fraction of laboratories (14%, 110 of 787) saw cases from electromagnetic navigational bronchoscopy. Intraprocedural adequacy assessments by pathologists (and less often by cytotechnologists or pathologists-in-training) were routinely performed in percutaneous transthoracic aspiration cases (74%, 413 of 560) with less involvement for other case types. Most laboratories reported that newly diagnosed primary pulmonary adenocarcinomas were triaged for molecular testing of epidermal growth factor receptor and anaplastic lymphoma kinase. Conclusions.--The parameters examined in this 2013 survey provide a snapshot of current pulmonary cytopathology practice and may be used as benchmarks in the future. [ABSTRACT FROM AUTHOR]

Context.--Although the cytomorphology of adenoid cystic carcinoma (ACC) has been well described, the accuracy of this diagnosis in fine-needle aspirates (FNAs) of the salivary glands has not been extensively evaluated. Objective.--To assess participants' responses in the College of American Pathologists (CAP) Nongynecologic Cytology (NGC) Program to determine the accuracy and false-negative rate of ACC cases in salivary gland FNAs. Design.--A retrospective review of the CAP NGC Program's cumulative data from 2000-2010 was performed for the general and the specific reference diagnosis categories for ACC in salivary gland FNAs according to preparation and participant types. Results.--Of 5156 responses, the overall concordance rates for both the general category of malignancy and the specific category of ACC were 63.6% (3279 of 5156) and 38.6% (1966 of 5088), respectively, with a false-negative rate of 36.4% (1877 of 5156). The most frequent false-negative responses were pleomorphic (1080) and monomorphic (526) adenoma (1614 of 5088, 31.5%), while lymphoma was the most frequent malignant misinterpretation. There was a significant statistical difference in concordance to the reference interpretation between the reader types: 39.9% (1006 of 2521) concordance rate for pathologists compared to 33.8% (503 of 1488) for cytotechnologists. However, there was no significant statistical difference for concordance to the general category or reference interpretation, based on preparation type (Papanicolaou versus modified Giemsa stained). Conclusions.--In this interlaboratory comparison educational program, accurate identification of ACC has shown to be problematic, with ACC representing an important cause of false-negative responses. The most common diagnostic pitfall is distinguishing this entity from pleomorphic and monomorphic adenoma in the benign category and from lymphoma and adenocarcinoma in the malignant one. [ABSTRACT FROM AUTHOR]

Context.—College of American Pathologists (CAP) surveys are used to establish national benchmarks for laboratory parameters. Objective.—To evaluate changes in laboratory human papillomavirus (HPV) testing patterns in laboratories incorporating HPV testing with Papanicolaou tests in 2012. Design.—Data were analyzed from the CAP HPV Supplemental Questionnaire distributed to 1771 laboratories participating in either CAP HPV or CAP Papanicolaou proficiency testing in 2013. Results.—A total of 1022 laboratories (58%) responded. There were more high-risk (HR) HPV tests performed per institution as compared to previous surveys. There were more HPV tests performed within an institution as compared to previous surveys. Hybrid Capture 2 (HC2) remains the most common method (42.4%, 239 of 564); Cervista and cobas methods are used in 37.2% (210 of 564) and 14.9% (84 of 564) of laboratories, respectively. Human papillomavirus testing is offered as a reflex test after a Papanicolaou test result of atypical squamous cells of undetermined significance (ASC-US) in 89.6% of laboratories (476 of 531); as a cotest for women aged 30 years and older in 60.3% (404 of 531); as reflex testing after atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion (ASC-H) in 42.7% (320 of 531); and as reflex testing after atypical glandular cells (AGC) in 27.3% (145 of 531). The HPV-positive rates for ASC-US and ASC-H were similar in 2012 and 2006. Cervista (49.2%, 88 of 179) and Roche cobas (27.4%, 49 of 179) are the most common methods used for genotyping. Most laboratories use the CAP Human Papillomavirus for Cytology Program for proficiency testing. Conclusions.—There was an increase in annual volume of HR-HPV testing with a shift toward in-house HR-HPV testing. Genotyping volumes also increased. HC2 and Cervista are most commonly used, with an increasing volume of Roche cobas testing. The most common indication for HPV testing among all laboratories was ASC-US reflex testing, but an increase in HPV cotesting was observed. The data provide an update into persisting and newer trends in HPV testing practices. [ABSTRACT FROM AUTHOR]

Context.--Most information on compliance with audit criteria for red blood cell (RBC) transfusions comes from single institutions; few studies have compared practices among many hospitals. Objective.--To survey a cross-section of hospitals in 2008 for criteria and compliance with RBC transfusion guidelines, using the College of American Pathologists QProbes format. Design.--One hundred twenty-eight hospitals, representing about 4.5% (724 332 of 16 212 000) of all annual RBC usage in the United States, provided information on their RBC audit practices and their recent rates of compliance. They also each examined 50 RBC transfusion episodes for compliance with their guidelines. Results.--The participants’ median, pretransfusion hemoglobin thresholds for audit review were 8.0 to 8.9 g/dL for most clinical settings and 9.0 to 9.9 g/dL for patients with underlying cardiopulmonary disease. For the transfusion episodes examined, 60% (2063 of 6518) were for a single unit. The median of the institutional averages for pretransfusion hemoglobin was 8.1 g/dL, and the median rate of compliance was 69% (range, 0%–100%). Involvement by a pathologist or transfusion medicine expert in the audit system was associated with more-strict audit criteria and better compliance. Conclusions.--Median hemoglobin thresholds for RBC transfusion audits were somewhat higher than currently evolving recommendations, but opportunities for improvement were provided by expert involvement and by the growing frequency of 1-unit transfusions. [ABSTRACT FROM AUTHOR]

Context.—Operator training, quality control, and proper follow-up for out-of-range quality control (QC) events are crucial steps that must be adequately performed and documented to ensure excellent patient care and regulatory compliance. Objective.—To examine point-of-care testing (POCT) personnel training and QC documentation/compliance. Design.—Participants in a POCT documentation study of the College of American Pathologists Q-Probes program collected data retrospectively for glucose and urine dipstick testing regarding test operators, operator competency assessment, and QC documentation. Documentation was assessed for participant adherence to 4 quality indicators: (1) whether test operator training was up to date, (2) whether the test operator names were noted in the test records, (3) whether QC was performed, and (4) whether out-of-range QC events were followed up. Data were analyzed for associations with institutional demographic and practice variables. Results.—The institutional median number of POCT personnel was 648 for blood glucose and 76 for urine dipstick testing, with a median number of 105 948 glucose tests and 9113 urine tests performed. Ninety-four percent (3830 of 4074) of the test operators completed training or competency assessment within the prior 12 months, 96.8% (21 603 of 22 317) of the test records documented the operator, and 95.7% (19 632 of 20 514) of the expected QC events (per institutional regulations) were documented. Approximately 3% (659 of 20 514) of the QC events were outside the designated range (an average of 6 out-of-range QC events were identified per institution [n¼ 106]). Of the out-of-range QC events, 92.6% (610 of 659) had documentation of appropriate follow-up. Most laboratories (176 of 179; 98.3%) violated specimen requirements by storing POCT urine specimens for less than 24 hours. Conclusions.—There was greater than 90% compliance for POCT documentation and nearly 96% of expected QC events were properly documented. [ABSTRACT FROM AUTHOR]

Context.—The American Society of Clinical Oncology/ College of American Pathologists (ASCO/CAP) published guidelines in 2007 regarding testing accuracy, interpretation, and reporting of results for HER2 studies. A 2008 survey identified areas needing improved compliance. Objective.—To reassess laboratory response to those guidelines following a full accreditation cycle for an updated snapshot of laboratory practices regarding ASCO/ CAP guidelines. Design.—In 2011, a survey was distributed with the HER2 immunohistochemistry (IHC) proficiency testing program identical to the 2008 survey. Results.—Of the 1150 surveys sent, 977 (85.0%) were returned, comparable to the original survey response in 2008 (757 of 907; 83.5%). New participants submitted 124 of 977 (12.7%) surveys. The median laboratory accession rate was 14 788 cases with 211 HER2 tests performed annually. Testing was validated with fluorescence in situ hybridization in 49.1% (443 of 902) of the laboratories; 26.3% (224 of 853) of the laboratories used another IHC assay. The median number of cases to validate fluorescence in situ hybridization (n=40) and IHC (n=27) was similar to those in 2008. Ninety-five percent concordance with fluorescence in situ hybridization was achieved by 76.5% (254 of 332) of laboratories for IHC- findings and 70.4% (233 of 331) for IHC+ cases. Ninety-five percent concordance with another IHC assay was achieved by 71.1% (118 of 168) of the laboratories for negative findings and 69.6% (112 of 161) of the laboratories for positive cases. The proportion of laboratories interpreting HER2 IHC using ASCO/CAP guidelines (86.6% [798 of 921] in 2011; 83.8% [605 of 722] in 2008) remains similar. Conclusions.—Although fixation time improvements have been made, assay validation deficiencies still exist. The results of this survey were shared within the CAP, including the Laboratory Accreditation Program and the ASCO/CAP panel revising the HER2 guidelines published in October 2013. The Laboratory Accreditation Program checklist was changed to strengthen HER2 validation practices. [ABSTRACT FROM AUTHOR]

Context.--In cytology proficiency testing (PT), participants fail for incorrectly interpreting a high-grade squamous intraepithelial lesion or cancer (HSIL+) Papanicolaou test result as negative. This penalty may lead to a false-positive interpretation of negative slides as HSIL+ to avoid failure. Objective.--To investigate factors related to false-positive responses in a PT versus an educational environment. Design.--We analyzed 420 079 responses from 9414 validated negative reference slides in the College of American Pathologists Interlaboratory Comparison Program in Gynecologic Cytopathology (PAP Education) and compared them with responses from the Gynecologic Cytology Proficiency Testing Program for the percentage of false-positive (HSIL+) interpretations in each of 7 negative subcategories. We evaluated the influence of preparation type (ThinPrep, SurePath, and conventional Papanicolaou test), participant type (pathologist or cytotechnologist), and program time interval (preproficiency test or PT) on a false-positive response. Results.--Reference diagnosis and participant type, but not preparation type, were statistically correlated to false-positive responses. The interaction between program time interval and participant type was also significant. Pathologists had higher rates of false-positive results on preproficiency test (1.2% [800 of 68 690]) than they did on PT (0.8% [993 of 129 857]). Cytotechnologists had no differences between program time intervals (preproficiency, 0.9% [515 of 63 281] versus PT, 1.0 [1231 of 121 621]; P = .91). Negative subcategories frequently mistaken for HSIL+ were reparative changes (4.7% [427 of 9069]), atrophic vaginitis (1.8% [18 of 987]), and negative for intraepithelial lesion or malignancy (1.2% [2143 of 178 651]), but during PT, false-positive rates were significantly increased only for the negative for intraepithelial lesion or malignancy and herpes simplex virus (P < .001). Conclusions.--Pathologists had lower false-positive rates in the Gynecologic Cytology Proficiency Testing Program than they did in PAP Education, but participants were more likely to report a false-positive response (HSIL+) for negative for intraepithelial lesion or malignancy and herpes simplex virus in the Gynecologic Cytology Proficiency Test Program. [ABSTRACT FROM AUTHOR]

Context.--The rate of surgical pathology report defects is an indicator of quality and it affects clinician satisfaction. Objective.--To establish benchmarks for defect rates and defect fractions through a large, multi-institutional prospective application of standard taxonomy. Design.--Participants in a 2011 Q-Probes study of the College of American Pathologists prospectively reviewed all surgical pathology reports that underwent changes to correct defects and reported details regarding the defects. Results.--Seventy-three institutions reported 1688 report defects discovered in 360 218 accessioned cases, for an aggregate defect rate of 4.7 per 1000 cases. Median institutional defect rate was 5.7 per 1000 (10th to 90th percentile range, 13.5-0.9). Defect rates were higher in institutions with a pathology training program (8.5 versus 5.0 per 1000, P = .01) and when a set percentage of cases were reviewed after sign-out (median, 6.7 versus 3.8 per 1000, P = .10). Defect types were as follows: 14.6% misinterpretations, 13.3% misidentifications, 13.7% specimen defects, and 58.4% other report defects. Overall, defects were most often detected by pathologists (47.4%), followed by clinicians (22.0%). Misinterpretations and specimen defects were most often detected by pathologists (73.5% and 82.7% respectively, P < .001), while misidentifications were most often discovered by clinicians (44.6%, P < .001). Misidentification rates were lower when all malignancies were reviewed by a second pathologist before sign-out (0.0 versus 0.6 per 1000, P < .001), and specimen defect rates were lower when intradepartmental review of difficult cases was conducted after sign-out (0.0 versus 0.4 per 1000, P = .02). Conclusion.--This study provides benchmarking data on report defects and defect fractions using standardized taxonomy. [ABSTRACT FROM AUTHOR]

Context.-Subtyping of non-small cell lung carcinomas (NSCLCs) is necessary for optimal patient management with specific diagnoses triggering specific molecular tests and affecting therapy. Objective.-To assess the accuracy of the participants of the College of American Pathologists Interlaboratory Comparison Program in diagnosing and subtyping NSCLC fine-needle aspiration (FNA) slides, based on morphology alone, considering preparation and participant type and trends over time. Design.-The performance of program participants was reviewed for the 5-year period spanning 2007-2011. Lung FNA challenges with reference diagnoses of adenocarcinoma and squamous cell carcinoma (SCC) were evaluated for diagnostic concordance by using a nonlinear mixed model analysis. Results.-There were 10 493 pathologist and 6378 cytotechnologist responses with concordance rates of 97.4% and 97.9% for malignancy, respectively. Overall concordance rates for subcategorization were 54.6% for adenocarcinoma and 74.9% for SCC. For the exact reference diagnoses, pathologists performed better for adenocarcinoma and cytotechnologists performed better for SCC. Accurate subcategorization of adenocarcinomas significantly increased over time with 31.5% of adenocarcinomas classified as NSCLC in 2007 and 25.5% of adenocarcinomas classified as NSCLC in 2011 (P < .001). In comparing preparation types, modified Giemsa-stained smears showed the lowest overall concordance (46.8%). Modified Giemsa-stained smears with SCCs were the least likely to be accurately subcategorized (36.4%). Conclusions.-Participants are proficient at interpreting NSCLCs as malignant by FNA but are less successful at subcategorization with cytomorphology alone. During the study period, a statistically significant trend was confirmed toward greater accuracy of subcategorization of adenocarcinomas, suggesting that participants are cognizant of the impact that more specific cytomorphologic interpretations have in directing molecular triage and therapy. [ABSTRACT FROM AUTHOR]

Context.-The usefulness of spontaneous nipple discharge analysis is controversial. Nipple discharge preparations are rare in clinical practice and malignant cases are exceptional. The College of American Pathologists Interlaboratory Comparison Program in Nongynecologic Cytopathology has included nipple discharge preparations since its inception. Objective.-To evaluate participant responses in the College of American Pathologists Interlaboratory Comparison Program in Nongynecologic Cytopathology to assess the accuracy of cytologic interpretation of nipple discharge preparation. Design.-General diagnostic category (benign, suspicious, malignant), participant type (pathologist, cytotechnologist), stain (Papanicolaou, modified Giemsa), and program year (2005-2009) were analyzed using χ2 and a nonlinear mixed model for slide factor correlation structure. Results.-Of 2506 responses, 1280 (51%) were malignant, 171 (7%) were papillary, and 1055 (42%) were benign. There were 222 discordant general category responses with a false-positive/suspicious rate of 12.8% and a false-negative rate of 3.4%. The most common falsenegative diagnosis was mastitis/abscess (125 of 1272 responses; 9.8%). The most common false-positive response was papillary lesion (26 of 457 responses; 5.7%). There were no differences between stains or years. Cytotechnologists performed better than pathologists; pathologists had a higher false-negative rate than cytotechnologists (15.3% versus 7.9%, P < .001). Conclusions.-There is poor accuracy in evaluating nipple discharge preparation in the College of American Pathologists Interlaboratory Comparison Program in Nongynecologic Cytopathology. If the findings in the program parallel clinical practice, nipple discharge preparations may adversely impact patient care. A benign nipple discharge cytologic diagnosis does not exclude malignancy, and the false-positive/suspicious rate requires confirmation of a malignant nipple discharge prior to definitive patient management. [ABSTRACT FROM AUTHOR]

Context.-The College of American Pathologists' Interlaboratory Comparison Program in Gynecologic Cytology has seen an increase in enrollment in liquid-based Papanicolaou test challenges with a decrease for conventional Papanicolaou tests. Trichomonas vaginalis can be difficult to identify in all preparation types. Objective.-To evaluate 20 years of participant results from the College of American Pathologists Interlaboratory Comparison Program in Gynecologic Cytology for Trichomonas to ascertain whether performance has changed because of the introduction of liquid-based Papanicolaou and proficiency testing. Design.-Concordance rates for the target diagnosis of Trichomonas vaginalis were evaluated for 167 956 participant responses (1990-2010). A nonlinear mixed model was fit with participant type, preparation type, and a 2- level program year (1990-2005 and 2006-2010) reflecting before and after proficiency testing began. A repeatedmeasures component allowed modeling of the slidespecific performance to ensure that the overall results were not based on the performance of a few slides. Results.-Cytotechnologists had higher concordance with the target diagnosis than did pathologists (89.8% [72 992 of 81 319] versus 83.4% [72 271 of 86 637], P , .001) and better performance for each preparation type (P ¼ .003). Concordance initially dropped after the introduction of proficiency testing (P , .001) for conventional and liquid-based (SurePath) preparations by both participant types, followed by quick, parallel improvement. Conclusions.-Performance is high in the detection of Trichomonas vaginalis in the College of American Pathologists Interlaboratory Comparison Program in Gynecologic Cytology. Liquid-based Papanicolaou and proficiency testing minimally affected participant performance. Cytotechnologists performed better over time and across preparation types than did pathologists, although pathologists showed performance results parallel to that of the cytotechnologists. Awareness of the performance differences by pathologists and cytotechnologists, as well as their difference in proficiency among liquid-based techniques, may help ensure accurate results in clinical practice. [ABSTRACT FROM AUTHOR]

Context.-The College of American Pathologists (CAP) Human Papillomavirus (High-Risk) Survey for Cytopathology and Other Laboratories (CHPV) meets the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) requirements for 5 proficiency testing challenges analyzed 3 times per year. This study reports laboratory performance for CHPV from 2008 through 2010. Objective.-To identify trends in proficiency testing performance for subscribers to the CAP CHPV. Design.-CHPV responses were evaluated by using a nonlinear mixed model (significance level of .05) with a 2- factor interaction term and repeated measures component, comparing year, media, method, and intended response. Media types included Digene transport, SurePath, Thin- Prep media, or a mixture of media types. Proficiency testing challenges validated at 80% consensus. Results.-All challenges validated; 476 laboratories submitted 14 911 responses with 14 620 correct responses (98%). There were no differences between positive or negative challenges, or rate of correct responses; significant differences existed between media types by year and methods. Digene and ThinPrep media performed better than SurePath (P < .001; P =.03). There was a statistically significant difference between methods (P < .001); ''other commercial kits,'' ''other (noncommercial)'' tests, and Third Wave performed more poorly than others. Conclusions.-Laboratories performed well when testing for human papillomavirus in CHPV during a period of 3 years. All challenges performed to the 80% threshold. Significant differences were found between methods and media. The CAP CHPV survey provides useful information for laboratories choosing human papillomavirus testing methods. [ABSTRACT FROM AUTHOR]

Context.--Two quality metrics for gynecologic cytology are the subject of this review: ''prospective rescreening'' and ''retrospective rescreening.'' Objective.--To offer consensus best practice approaches based on the College of American Pathologists' laboratory-based survey funded by the Centers for Disease Control and Prevention. Design.--The College of American Pathologists submitted a paper-based survey to 1245 laboratories. After review of initial results, follow-up Web-based survey results, and a literature review, consensus best practice statements were presented at a national consensus conference. These statements were discussed and voted upon by conference participants. Results.--A total of 541 laboratories responded to survey questions about prospective and retrospective rescreening. Most laboratories (>85%) prospectively rescreen more than 10% of Pap tests interpreted as negative for intraepithelial lesion or malignancy. Most (72%) report inclusion of less than 20% high-risk cases. Most laboratories use multiple measures to define ''high risk.'' Most laboratories (96.2%) retrospectively rescreen Pap tests from the preceding 5 years only. In most laboratories (71.4%) only Pap test results with high-grade squamous intraepithelial lesion or worse prompt retrospective review. Conclusions.--The number of Pap tests from high-risk patients should be maximized in prospective and retrospective rescreening. Unsatisfactory Pap tests should also be included. All readily identifiable high-risk human papillomavirus-positive cases with an interpretation of negative for intraepithelial lesion or malignancy should be prospectively rescreened. Cervical biopsy results with high-grade cervical intraepithelial neoplasia or worse (CIN 2+) should trigger retrospective rescreening. Regular feedback should be provided to cytotechnologists and cytopathologists. Upgraded diagnoses from negative for intraepithelial lesion or malignancy to atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion, should be monitored. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Context.--The association of certain types of human papillomavirus with cervical carcinoma is well established. Human papillomavirus testing is now routinely used to screen for cervical carcinoma and precursor lesions of the cervix (cotesting and reflex testing) and these results are considered in patient triage and management. Objective.--To provide information about current laboratory practices in human papillomavirus testing and consensus best practice statements based on results from the College of American Pathologists' laboratory-based survey funded by the Centers for Disease Control and Prevention. Design.--The College of American Pathologists submitted a paper-based survey to 1245 laboratories in the United States. After review of the initial results, follow-up Web-based survey results, and a literature review by an expert working group, consensus best practice statements were constructed by working group members for presentation at a national consensus conference. These best practice statements were discussed and then voted upon by conference participants. Results.--A total of 525 laboratories responded to survey questions about human papillomavirus ordering and monitoring practices, whereas 546 responded to the overall survey. In most laboratories (87.6%), the high-risk human papillomavirus test is ordered as a reflex test by providers. A minority of laboratories (11.9%) routinely bundle low- and high-risk human papillomavirus tests. Most laboratories (84.4%) do not limit testing in patients with atypical squamous cells to women older than 20 years. More than half of laboratories (53.3%) monitor human papillomavirus positive rates in Papanicolaou tests with atypical squamous cells of undetermined significance. Conclusions.--It is not appropriate for laboratories to offer low-risk human papillomavirus testing for any clinical circumstance in gynecologic cytology. Laboratories should not order human papillomavirus testing to resolve diagnostic discrepancies. It is a valuable broad measure of laboratory quality to monitor the human papillomavirus- positive rates in Papanicolaou tests with atypical squamous cells. [ABSTRACT FROM AUTHOR]

Context.--Controversy exists about whether thyroid fine-needle aspirates (FNAs) should be processed with conventional smears or liquid-based preparations (LBPs). Objective.--To compare the performance of conventional smears to LBPs for thyroid FNA slides circulated in the College of American Pathologists Interlaboratory Comparison Program in Non-Gynecologic Cytology. Design.--Participant responses for thyroid FNA slides were compared with the reference diagnosis at the level of 3 general diagnostic categories: negative, suspicious (which included only follicular and Hürthle cell neoplasm), and malignant. For specific reference diagnoses of benign/ goiter and papillary thyroid carcinoma, the participants' specific diagnoses were analyzed and poorly performing slides were rereviewed. Results.--The 47 076 thyroid FNA slide responses, between 2001 and 2009, included 44 478 responses (94%) for conventional smears and 2598 responses (6%) for LBPs. For the general reference category negative, participant responses were discrepant in 14.9% of conventional smears compared with 5.9% for LBPs (P < .001). The specific reference diagnosis of benign/goiter was misdiagnosed as a follicular neoplasm in 7.8% of conventional smears, compared with 1.3% of LBP. For the general reference category of malignant, participant responses were discrepant in 7.3% of conventional smears compared with 14.7% of LBPs (P < .001). The specific reference diagnosis of papillary thyroid carcinoma was misdiagnosed as benign/goiter in 7.2% of LBPs, compared with 4.8% of conventional smears (p<.001). Conclusions.--LBPs performed worse than conventional smears for cases with a reference diagnosis of papillary thyroid carcinoma. However, LBPs performed better than conventional smears for cases with a benign reference diagnosis. Specific features in thyroid FNAs that may improve the diagnostic accuracy of LBPs and conventional smears are described. [ABSTRACT FROM AUTHOR]

Context.--The immunohistochemistry (IHC) laboratory represents a dynamic area of surgical pathology with limited practice guidelines. Studies have shown significant interlaboratory variability in results. Objective.--To establish baseline parameters for IHC validation procedures and practice, and to assess their feasibility of implementation. Design.--In September 2010, a questionnaire was distributed by the College of American Pathologists. It was composed of 32 questions relating to nonpredictive assays as well as non-US Food and Drug Administration (non-FDA)-approved, predictive IHC assays other than human epidermal growth factor 2 (HER2/neu). Results.-For non-FDA approved, nonpredictive IHC assays, 68% of laboratories had a written validation procedure. Eighty-six percent of laboratories validated the most recently introduced nonpredictive antibody. Seventy-five percent used 21 or fewer total cases for the validation and 40% used weakly or focally positive cases. Forty-six percent of respondents had a written procedure for validation procedures for non-FDA approved, predictive marker IHC assays other than HER2/neu. Seventy-five percent of laboratories validated the most recently introduced predictive antibody other than HER2/neu. Fewer than half used 25 or more cases for the validation, and 47% used weakly or focally positive cases. Conclusion.--Some laboratories have written validation procedures that appear to build upon HER2/neu testing guidelines. Some laboratories also manage to validate new antibodies according to those standards; however, many do not. There appears to be a need for further validation guideline development for nonpredictive and non-FDA approved predictive antibody IHC assays. [ABSTRACT FROM AUTHOR]