Estrogen Receptor, Progesterone Receptor, and Human Epidermal Growth Factor Receptor 2 Expression Rates in Invasive Breast Carcinoma: A Study of 21 Institutions.

CONTEXT.­: Laboratories performing predictive marker testing for breast carcinoma are encouraged to compare patient results to published benchmarks. OBJECTIVE.­: To collect expression rates for estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) in invasive breast carcinoma from multiple laboratories. DESIGN.­: Participants submitted data from up to 50 primary cases during the study period. Participants reported ER, PgR, and HER2 results in addition to demographic and histologic information. Participants also provided annual institution-level expression rates. RESULTS.­: A total of 21 institutions submitted data for 687 cases. Aggregate positivity rates for ER and PgR were 85.6% and 75.1%, respectively. Receptor positivity rates were higher in well-differentiated (grade 1) tumors (ER, 97.4%; PgR, 88.0%) compared with moderately differentiated (grade 2) tumors (ER, 92.4%; PgR, 84.0%) and poorly differentiated (grade 3) tumors (ER, 61.8%; PgR, 48.0%). Expression rates were higher in postmenopausal women (ER, 87.2%) than premenopausal women (ER, 79.6%) and higher in lobular carcinomas (ER, 98.7%; PgR, 85.3%) than ductal carcinomas (ER, 84.1%; PgR, 74.5%). The aggregate HER2 positivity (score 3+) rate was 9.0%. The aggregate HER2 equivocal (score 2+) rate was 14.5%. Of 81 equivocal (score 2+) cases, 70 (86.4%) were nonamplified. CONCLUSIONS.­: The data from this study provide multi-institutional benchmark data to assist laboratories performing periodic comparisons as part of a quality management program. Overall expression rates were generally similar to those of other published reports, with the exception of the ER-negative and HER2-positive rates, both of which were somewhat lower.

Validating Whole Slide Imaging Systems for Diagnostic Purposes in Pathology.

CONTEXT.­: The original guideline, "Validating Whole Slide Imaging for Diagnostic Purposes in Pathology," was published in 2013 and included 12 guideline statements. The College of American Pathologists convened an expert panel to update the guideline following standards established by the National Academies of Medicine for developing trustworthy clinical practice guidelines. OBJECTIVE.­: To assess evidence published since the release of the original guideline and provide updated recommendations for validating whole slide imaging (WSI) systems used for diagnostic purposes. DESIGN.­: An expert panel performed a systematic review of the literature. Frozen sections, anatomic pathology specimens (biopsies, curettings, and resections), and hematopathology cases were included. Cytology cases were excluded. Using the Grading of Recommendations Assessment, Development, and Evaluation approach, the panel reassessed and updated the original guideline recommendations. RESULTS.­: Three strong recommendations and 9 good practice statements are offered to assist laboratories with validating WSI digital pathology systems. CONCLUSIONS.­: Systematic review of literature following release of the 2013 guideline reaffirms the use of a validation set of at least 60 cases, establishing intraobserver diagnostic concordance between WSI and glass slides and the use of a 2-week washout period between modalities. Although all discordances between WSI and glass slide diagnoses discovered during validation need to be reconciled, laboratories should be particularly concerned if their overall WSI-glass slide concordance is less than 95%.

Medicaid Utilization and Spending among Homeless Adults in New Jersey: Implications for Medicaid-Funded Tenancy Support Services.

Policy Points Large numbers of homeless adults gained Medicaid coverage under the Affordable Care Act, increasing policymaker interest in strategies to improve care and reduce avoidable hospital costs for homeless populations. Compared with nonhomeless adult Medicaid beneficiaries, homeless adult beneficiaries have higher levels of health care needs, due in part to mental health issues and substance use disorders. Homeless adults are also more likely to visit the emergency department or require inpatient admissions. Emergency care and inpatient admissions may sometimes be avoided when individuals have high-quality community-based care and healthful living conditions. Offering tenancy support services that help homeless adults achieve stable housing may therefore be a cost-effective strategy for improving the health of this vulnerable population while reducing spending on avoidable health care interventions. Medicaid beneficiaries with disabling health conditions and more extensive histories of homelessness experience the most potentially avoidable health care interventions and spending, with the greatest opportunity to offset the cost of offering tenancy support benefits. CONTEXT: Following Medicaid expansion under the Affordable Care Act, the number of homeless adults enrolled in Medicaid has increased. This has spurred interest in developing Medicaid-funded tenancy support services (TSS) for homeless populations as a way to reduce Medicaid spending on health care for these individuals. An emerging body of evidence suggests that such TSS can reduce avoidable health care spending. METHODS: Drawing on linked Homeless Management Information System and Medicaid claims and encounter data, this study describes the characteristics of homeless adults who could be eligible for Medicaid TSS in New Jersey and compares their Medicaid utilization and spending patterns to matched nonhomeless beneficiaries. FINDINGS: More than 8,400 adults in New Jersey were estimated to be eligible for Medicaid TSS benefits in 2016, including approximately 4,000 living in permanent supportive housing, 800 formally designated as chronically homeless according to federal guidelines, 1,300 who were likely eligible for the chronically homeless designation, and over 2,000 who were at risk of becoming chronically homeless. Homeless adults in our study were disproportionately between the ages of 30 and 64 years, male, and non-Hispanic blacks. The homeless adults we studied also tended to have very high burdens of mental health and substance use disorders, including opioid-related conditions. Medicaid spending for a homeless beneficiary who was potentially eligible for TSS was 10% ($1,362) to 27% ($5,727) more than spending for a nonhomeless Medicaid beneficiary matched on demographic and clinical characteristics. Hospital inpatient and emergency department utilization accounted for at least three-fourths of "excess" Medicaid spending among the homeless groups. CONCLUSIONS: A large group of high-need Medicaid beneficiaries could benefit from TSS, and Medicaid funding for TSS could reduce avoidable Medicaid utilization and spending.

Breast Specimen Processing and Reporting With an Emphasis on Margin Evaluation: A College of American Pathologists Survey of 866 Laboratories.

CONTEXT: - The College of American Pathologists (CAP) developed protocols for reporting pathologic characteristics of breast cancer specimens, including margin status. The Society of Surgical Oncology (SSO) and the American Society for Radiation Oncology (ASTRO) published treatment guidelines regarding margins in patients with invasive cancer; and SSO, ASTRO, and the American Society of Clinical Oncology (ASCO) recently published guidelines for patients with ductal carcinoma in situ. OBJECTIVE: - To assess current practices among pathologists with regard to the processing/reporting of breast specimens, assess compliance with CAP cancer protocols, and assess alignment with SSO/ASTRO and SSO/ASTRO/ASCO guidelines. DESIGN: - A survey concerning breast specimen processing/reporting was distributed to pathologists enrolled in the CAP Performance Improvement Program in Surgical Pathology. RESULTS: - Ninety-four percent (716 of 764 respondents) and 91% (699 of 769 respondents) define positive margins as "tumor on ink" for invasive cancer and ductal carcinoma in situ, respectively, in compliance with CAP cancer protocols and with SSO/ASTRO and SSO/ASTRO/ASCO guidelines. Of 791 respondents who provided details regarding methods for margin evaluation, 608 (77%) exclusively examine perpendicular margins, facilitating guideline compliance. However, 183 of 791 respondents (23%) examine en face margins in at least a subset of specimens, which may preclude guideline compliance in some cases. When separate cavity (shave) margins are examined, while 517 of 586 respondents (88%) ink these specimens, 69 of 586 (12%) do not, and this may also preclude guideline compliance in some cases. CONCLUSIONS: - A substantial proportion of survey participants report margin status for breast cancer specimens in a manner consistent with CAP cancer protocols, and in alignment with SSO/ASTRO and SSO/ASTRO/ASCO guidelines. However, there are opportunities for some laboratories to modify procedures in order to facilitate more complete adherence to guidelines.

Uniform Labeling of Blocks and Slides in Surgical Pathology: Guideline From the College of American Pathologists Pathology and Laboratory Quality Center and the National Society for Histotechnology.

CONTEXT: The labeling of paraffin blocks and microscopic glass slides in the practice of surgical pathology varies from institution to institution and introduces potential risk of preanalytic error. Currently there are no evidence-based guidelines regarding the uniform labeling of these materials. OBJECTIVE: To develop recommendations that will address the need for adequate patient identification and provide a consistent method of identifying slides originating from a particular block. DESIGN: - The College of American Pathologists Pathology and Laboratory Quality Center and the National Society for Histotechnology convened a panel of pathologists and histotechnologists with expertise in histology laboratory quality practices to develop labeling recommendations. A systematic evidence review was conducted to address 6 main key questions. Recommendations were derived from strength of evidence, open comment feedback, and expert panel consensus. RESULTS: Twelve guideline statements were established to assist pathology laboratories in developing standardized block and slide labeling practices. These guidelines call for the use of 2 patient identifiers, 1 of which includes the accession number and case type, on all paraffin blocks and slides. Recommendations were also developed to address the order and format in which identifying elements should appear. CONCLUSIONS: Uniform labeling of paraffin blocks and slides derived from patient specimens will provide an important enhancement to patient safety by assuring that all preparations derived from a patient's tissue can be uniquely and unambiguously linked to that patient. Adoption of standardized practices additionally will improve patient care by facilitating interpretation of histologic sections when they are referred in consultation to a second institution.

The College of American Pathologists and National Society for Histotechnology workload study.

Limited data exist in regard to productivity and staffing in the anatomic pathology laboratory. In 2004, the National Society for Histotechnology (NSH) conducted a pilot study to examine productivity and staffing in the histology laboratory. After review of the data, The College of American Pathologists (CAP)/NSH Histotechnology Committee concluded that a larger survey was required to further address and expand on the pilot study findings. In 2007, a total of 2674 surveys were sent out to North American laboratories. From the responses, comparisons of laboratory demographics and productivity were examined by institution type and workload volume. Productivity was measured as the number of paraffin-embedded tissue blocks processed per full-time equivalent per year. This manuscript presents and discusses the data collected from the CAP/NSH Workload Study.

Significant and unexpected, and critical diagnoses in surgical pathology: a College of American Pathologists' survey of 1130 laboratories.

CONTEXT: The Joint Commission and the College of American Pathologists have emphasized improved communication as a strategy to improve patient safety and reduce errors. OBJECTIVE: To determine current policies and practices concerning critical and/or significant and unexpected results in anatomic pathology. DESIGN: A survey was distributed with the 2007 D mailing of the Performance Improvement Program slides. The survey included questions that determined laboratory size, practice setting, and anatomic pathology critical and/or significant and unexpected result policies and practices. RESULTS: Surveys from 1130 laboratories were received. A total of 75% had a written policy regarding anatomic pathology critical and/or significant and unexpected results; 25% did not. A total of 30% of laboratories with written policies stated that their policies included guidelines but did not include specific examples. A total of 33% listed 5 or fewer specific examples, 18% listed more than 5 examples, and 19% stated that they had a specifically defined list of significant and unexpected and/or critical diagnoses. The conditions that were listed included malignancies (48% of all laboratories), findings not expected by the clinical history (45%), life-threatening infections (45%), no chorionic villi in products of conception (37%), inflammatory or immunologic processes (19%), and organ rejection (14%). Laboratories with a higher median number of accessioned surgical and cytology cases and independent laboratories tended to have policies with more than 5 specific examples or precise lists of must-call diagnoses (P < .001). CONCLUSIONS: This survey illustrates current anatomic pathology policies and practices with respect to critical and significant and unexpected results.

Reporting guidelines for clinical laboratory reports in surgical pathology.

CONTEXT: The surgical pathology report (SPR) is an essential part of patient care because it documents the pathologic findings in tissues removed from patients for diagnostic or therapeutic reasons. Despite the importance of the SPR, exhaustive guidelines outlining the various elements of the SPR have not, to our knowledge, been published. OBJECTIVES: To outline recommendations delineating the required, preferred, and optional elements that should be included in the SPR. These guidelines, if implemented, will bring uniformity to the reporting of surgical pathology specimens. DATA SOURCES: The Surgical Pathology Resource Committee of the College of American Pathologists compiled and prioritized the elements that have been included in various institutional SPRs. Additional data sources include the College of American Pathologists Laboratory Accreditation Program checklists and the recommendations of the Association of Directors of Anatomic and Surgical Pathology. Each element was assigned a priority of required, preferred, or optional. These priorities were discussed and consensus was reached. This report does not address issues of formatting or style substantively. CONCLUSIONS: These recommendations afford a framework for the creation of an SPR containing all of the components that are required or optimal for patient care.

A new rabbit monoclonal antibody (4B5) for the immunohistochemical (IHC) determination of the HER2 status in breast cancer: comparison with CB11, fluorescence in situ hybridization (FISH), and interlaboratory reproducibility.

The 2 methodologies in current clinical use to assess HER2 status in breast cancer are: fluorescence in situ hybridization (FISH) (gene amplification) and immunohistochemistry (protein over-expression). A consistent finding has been that 3% to 15% of breast cancers over-express HER2 protein without evidence for gene amplification. Accurate determination of the HER2 status has implications for selecting patients most likely to respond to trastuzumab. We report here our preliminary experience with a new anti-HER2 rabbit monoclonal antibody, 4B5. The evaluation of HER2 status in 2 different cohorts of breast cancer cases (Single Institution (SI) and Multinational (MN)) with a total of 322 breast cancer cases was performed on an automated staining system (Ventana Medical Systems, Inc, Tucson, AZ) and scored by 3 pathologists (0-3+), for comparison with CB11 staining results (PATHWAY) and FISH (PathVysion). Interlaboratory reproducibility of automated staining results and interpretation was determined on a subset of the SI cohort at 3 separate laboratories. Rabbit monoclonal 4B5 demonstrated sharper membrane staining with less cytoplasmic and stromal background staining than CB11. In the SI cohort, the staining results for 4B5 were highly comparable with those obtained for CB11 with an overall concordance of 93.3%. In the multinational cohort, the overall concordance with CB11 was 84.7%. This lower level of concordance was associated with a much higher overall agreement of 4B5 with FISH (89.5%), compared with agreement of CB11 with FISH (81.2%). The difference in the performance of CB11 in the MN cohort versus the SI cohort may be due to differences in tissue fixation and processing in a centralized, high volume laboratory in an academic medical center versus multiple sites in the international community with potentially nonstandardized techniques. The staining results with 4B5 indicate that it has a more robust performance than CB11 because the correlation of 4B5 with FISH was nearly equivalent (88.2% MN; 89.3% SI) in both cohorts. Interlaboratory reproducibility was also excellent (kappa 1.0). RMoAb 4B5 provides excellent sensitivity, specificity, and interlaboratory reproducibility for the detection of HER2 status in breast cancer.