Souers, Rhona J.

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.

BackgroundThe Bethesda System for Reporting Thyroid Cytopathology (TBSRTC) offers a six‐tiered diagnostic scheme for thyroid Fine Needle Aspiration (FNA): Benign, Atypia of Undetermined Significance/Follicular Lesion of Undetermined Significance (AUS/FLUS), suspicious for follicular neoplasm, suspicious for malignancy, malignant, and unsatisfactory with an aim to standardize diagnostic criteria. Reported rate of AUS/FLUS category in the literature has varied from 3% to 20.5%.MethodsThe aim of this study was to assess interobserver variability among cytopathologists to assess reproducibility of the AUS/FLUS category. Seven cytopathologists brought FNA cases (a mixture of atypical and non‐atypical FNA diagnosis) diagnosed using TBSRTC from their respective institutions which were reviewed and diagnosed by the participants. The analysis assessed interobserver variability among 7 cytopathologists and determined characteristics on the slides which were associated with concordance to the institutional diagnosis.ResultsSeventy eight of 125 (62.4%) benign cases were classified as benign by the reviewers and 26 (21%) were called AUS/FLUS on review. A third of the AUS/FLUS cases were called benign on review and 28.2% were classified as suspicious for neoplasia/malignancy. Roughly a third each of the suspicious for follicular neoplasm/suspicious for malignancy cases were classified as AUS/FLUS.DiscussionWhen pathologists from different institutions shared their slides, concordance was high for specimens with adequate cellularity and those that were clearly benign but thresholds varied for the other indeterminate categories. Most definite categorization of the AUS/FLUS category was seen on review. Diagn. Cytopathol. 2017;45:399–405. © 2017 Wiley Periodicals, Inc.

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.

Context Turnaround time (TAT) for large or complex surgical pathology specimens is an indicator of efficiency in anatomic pathology and may affect coordination of patient care. Objective To establish benchmarks for TAT and to identify practice characteristics that may influence TAT. Design Participants in a 2012 Q-Probes quality improvement program of the College of American Pathologists retrospectively reviewed all surgical pathology cases from the prior 6 months to identify up to 50 cases coded as Current Procedural Terminology (CPT) code 88307 (excluding biopsies) or 88309. Participants reported the times and dates of accessioning and final sign-out. Results A total of 56 institutions reported on 2763 large or complex cases, which included 70% with CPT code 88307 and 30% with CPT code 88309. Cases requiring special handling comprised 51.5%, and 48.5% were routine. Among all institutions the median TAT was 2.72 calendar days (10th–90th percentile range, 6.23–1.22 days). Longer TAT occurred in governmental institutions (median, 6.06 versus 2.13 days; P < .001) and in institutions that mandate overnight fixation for some specimen types (median, 3.83 versus 2.07 days; P = .03). Longer TAT was associated with CPT code 88309 (median, 3.99 versus 2.82 days; P < .001), special handling (median, 4.13 versus 1.94 days; P < .001), frozen section (median, 3.38 versus 2.92 days; P < .001), radical cancer resection (P < .001), and malignant cases (P < .001). Turnaround time was not significantly affected by either pathology training programs or routine weekend sign-out. Conclusion This study provides benchmark data for TAT in large or complex surgical pathology specimens. Turnaround time was good overall, but the range among participating institutions was wide.

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.

Context.— Both the regulations in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the checklists of the College of American Pathologists (CAP) Laboratory Accreditation Program require clinical laboratories to verify performance characteristics of quantitative test systems. Laboratories must verify performance claims when introducing an unmodified, US Food and Drug Administration–cleared or approved test system, and they must comply with requirements for periodic calibration and calibration verification for existing test systems. They must also periodically verify the analytical measurement range of many quantitative test systems. Objective.— To provide definitions for many of the terms used in these regulations, to describe a set of basic analyses that laboratories may adapt to demonstrate compliance with both CLIA and the CAP Laboratory Accreditation Program checklists for performing calibration verification and for verifying the analytical measurement range of test systems, to review some of the recommended procedures for establishing performance goals, and to provide data illustrating the performance goals used in some of the CAP's calibration verification and linearity surveys. Data Sources.— The CAP's calibration verification and linearity survey programs, the CLIA regulations, the Laboratory Accreditation Program requirements, and published literature were used to meet these objectives. Conclusions.— Calibration verification and linearity and analytical measurement range verification should be performed using suitable materials with assessment of results using well-defined evaluation protocols. We describe the CAP's calibration verification and linearity programs that may be used for these purposes.

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.

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.