Nakhleh, Raouf E.

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 Additional reviews of diagnostic surgical and cytology cases have been shown to detect diagnostic discrepancies. Objective To develop, through a systematic review of the literature, recommendations for the review of pathology cases to detect or prevent interpretive diagnostic errors. Design The College of American Pathologists Pathology and Laboratory Quality Center in association with the Association of Directors of Anatomic and Surgical Pathology convened an expert panel to develop an evidence-based guideline to help define the role of case reviews in surgical pathology and cytology. A literature search was conducted to gather data on the review of cases in surgical pathology and cytology. Results The panel drafted 5 recommendations, with strong agreement from open comment period participants ranging from 87% to 93%. The recommendations are: (1) anatomic pathologists should develop procedures for the review of selected pathology cases to detect disagreements and potential interpretive errors; (2) anatomic pathologists should perform case reviews in a timely manner to avoid having a negative impact on patient care; (3) anatomic pathologists should have documented case review procedures that are relevant to their practice setting; (4) anatomic pathologists should continuously monitor and document the results of case reviews; and (5) if pathology case reviews show poor agreement within a defined case type, anatomic pathologists should take steps to improve agreement. Conclusions Evidence exists that case reviews detect errors; therefore, the expert panel recommends that anatomic pathologists develop procedures for the review of pathology cases to detect disagreements and potential interpretive errors, in order to improve the quality of patient care.

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.— 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.

AbstractBackgroundLiver biopsy has been the reference standard when evaluating fibrosis due to recurrent hepatitis after liver transplantation. Magnetic resonance elastography estimates liver stiffness, correlating to fibrosis.AimTo investigate the utility of elastography in staging liver fibrosis in transplant recipients with hepatitis C.MethodsFifty‐four patients, ≥12 months post‐transplant, underwent elastography within three months of biopsy. Discriminatory capability for METAVIR fibrosis stages F0–2 vs. F3–4 and receiver operating characteristic curve (ROC) analysis were determined.ResultsOn biopsy, 27 patients had METAVIR fibrosis score 0–1; 12 had a 3 or 4. There was significant correlation between histologic fibrosis and shear stiffness (R² = 0.588, p < 0.0001). Using a cutoff value of 3.5 kPa, elastography was 91% sensitive and 72% specific in differentiating fibrosis scores of ≥3 from 0 to 1. The AUC of elastography in predicting a fibrosis score of ≥3 was 0.92. Multivariate analysis revealed no correlation between the grade of histologic inflammation and liver stiffness measured by magnetic resonance elastography (R² = 0.265, p = 0.47).ConclusionMagnetic resonance elastography is an accurate non‐invasive technique for excluding stage ≥3 graft in recipients with hepatitis C.