A validation of placental pathology reports by ethnicity in New Zealand, through systematic analysis of histological slides.

INTRODUCTION: Reliability studies of placental examination have shown differing interobserver agreement for certain pathological features, a lack of uniform reporting criteria and variable experience among pathologists. In previous analyses we have shown that placental pathology differs by ethnicity. This validation study was performed to investigate whether bias related to ethnicity is a feature of placental pathology reporting in New Zealand (NZ). METHODS: 199 of 1726 eligible perinatal death cases between 2008 and 2017 were selected at random for this audit-type study, including 51 cases from South Asian, Maori and NZ European ethnicity and 46 cases from Pacific mothers. Stored histology slides were blinded and re-examined by an experienced perinatal pathologist, and linked to the corresponding original pathology report. Interobserver agreement (overall, by ethnicity and by gestational age) was described by proportional differences and kappa coefficients. RESULTS: Total interobserver agreement between original placental reporting and the validation review was 89.7 %, which differed by pathological feature. There was generally more underreporting than overreporting (3.6 % and 6.7 %, respectively). There was little disagreement by ethnicity (decidual vasculopathy [p = 0.03]), although there were more differences by gestational age (villous morphology [p < 0.01], chorioamnionitis [p = 0.03], high-grade villitis of unknown etiology [p < 0.01], and placental haemorrhage [p = 0.03]). DISCUSSION: No systematic bias in placental pathology reporting in NZ was identified by ethnicity or gestational age, as observed differences could be related to the underlying prevalence of pathology. We identified more underreporting than overreporting of pathology in the original reports, emphasizing the importance of placental investigation by specialised perinatal pathologists.

Authentic Pathology Specimen Reception: A Valuable Resource for Developing Biomedical Science Student Competencies and Employability.

Background/Introduction: The pathology specimen reception is fundamental to the services provided by Biomedical Science laboratories worldwide. To ensure patient safety and that samples are of adequate quality to send for analysis, prospective Biomedical Scientists should have a robust knowledge of the processes involved and the acceptance criteria of the pathology specimen reception. This knowledge has been highlighted by employers as a current gap in Biomedical Science graduates and therefore needs to be addressed within higher education settings. To do this, this study aimed to 1) design a practical session to simulate the key processes of the pathology specimen reception and 2) to understand Biomedical Science students' opinions on these activities and the development of transferable skills required for post-graduate employment. Methods: The practical session was designed based on industrial requirements and academic knowledge of student skill sets to ensure suitability. Qualitative information regarding participant demographics and career interests was acquired through open-answer or multiple-choice questions. Quantitative student feedback was acquired via questionnaires utilising a 5-point Likert scale (n = 77). Results: The scenario-based practical session provided students with a positive learning experience with 98.7% of participants enjoying the session, with 87.0% stating they learned a lot by completing the session. It was also identified that participants preferred this style of learning to that of conventional higher education teaching modalities with 97.4% stating they would prefer simulated employment focussed scenarios embedded into the curriculum more often. The majority of participants also thought this session was helpful for the development of their key transferrable skills including teamworking, communication, and confidence. When stratified based on demographic data, there was minimal difference between cohorts and in the majority of cases, those participants from non-traditional university entry backgrounds had a more positive experience and better transferable skill development following the completion of this style of learning experience. Conclusion: This study highlights simulation-based learning as a tool to develop core Biomedical Science knowledge, build student graduate capital, and ensure the preparedness of students for post-graduation employment.

Nationwide implementation of a multifaceted tailored strategy to improve uptake of standardized structured reporting in pathology: an effect and process evaluation.

BACKGROUND: Implementation strategies are aimed at improving guideline adherence. Both effect and process evaluations are conducted to provide insights into the success or failure of these strategies. In our study, we evaluate the nationwide implementation of standardized structured reporting (SSR) in pathology. METHODS: An interrupted time series analysis was conducted to evaluate the effect of a previously developed implementation strategy, which consisted of various digitally available elements, on SSR in pathology laboratories. A segmented regression analysis was performed to analyze the change in mean SSR percentages directly after the strategy introduction for pathology reporting and specific subcategories. In addition, we analyzed the change in trend in the weekly percentages after strategy introduction, also for subgroups of tumor groups, retrieval methods, and type of laboratory. The change in SSR use after the strategy introduction was determined for all pathology laboratories. We further conducted a process evaluation in which the exposure to the strategy elements was determined. Experiences of the users with all strategy elements and the remaining barriers and potential strategy elements were evaluated through an eSurvey. We also tested whether exposure to a specific element and a combination of elements resulted in a higher uptake of SSR after strategy introduction. RESULTS: There was a significant increase in an average use of SSR after the strategy introduction for reporting of gastrointestinal (p=.018) and urological (p=.003) oncological diagnoses. A significant increase was present for all oncological resections as a group (p=.007). Thirty-three out of 42 pathology laboratories increased SSR use after the strategy introduction. The "Feedback button", an option within the templates for SSR to provide feedback to the provider and one of the elements of the implementation strategy, was most frequently used by the SSR users, and effectiveness results showed that it increased average SSR use after the strategy introduction. Barriers were still present for SSR implementation. CONCLUSIONS: Nationwide SSR implementation improved for specific tumor groups and retrieval methods. The next step will be to further improve the use of SSR and, simultaneously, to further develop potential benefits of high SSR use, focusing on re-using discrete pathology data. In this way, we can facilitate proper treatment decisions in oncology.

Inter-laboratory performance of ICE histopathology scoring to identify UN GHS Category 1 surfactants and non-extreme pH detergents.

The inter-laboratory performance of Isolated Chicken Eye (ICE) histopathology scoring was assessed for predicting EU CLP/UN GHS Cat. 1 surfactants. Furthermore, the predictive capacity of ICE histopathology was evaluated for the combined dataset of surfactants and existing data for non-extreme pH (2 < pH < 11.5) detergents. Use of ICE histopathology led to increased sensitivity compared to the ICE test method alone for surfactants. When combined with the existing dataset of detergents, use of histopathology in addition to the standard ICE test method decreased the false negative rates from 64% (14/22) to 27% (6/22); increased accuracy from 53% (16/30) to 77% (23/30); and led to acceptable level of false positives (from 0/8 to 1/8 (12.5%). Moreover, good reproducibility of ICE histopathology predictions conducted on the same slides was found between pathologists and peer-reviewers from three independent laboratories (10/12 or 83%) and over time. Use of ICE histopathology was therefore found suitable to predict EU CLP/UN GHS Cat. 1 surfactants and non-extreme pH detergents. In addition, appropriate reproducibility of ICE histopathology was found, provided that i) an internal peer-review system was in place; ii) original slides were assessed to enable evaluation of three dimensional effects; and iii) appropriate training and proficiency appraisal were conducted.

Validity and Reproducibility of Immunohistochemical Scoring by Trained Non-Pathologists on Tissue Microarrays.

BACKGROUND: Scoring of immunohistochemistry (IHC) staining is often done by non-pathologists, especially in large-scale tissue microarray (TMA)-based studies. Studies on the validity and reproducibility of scoring results from non-pathologists are limited. Therefore, our main aim was to assess interobserver agreement between trained non-pathologists and an experienced histopathologist for three IHC markers with different subcellular localization (nucleus/membrane/cytoplasm). METHODS: Three non-pathologists were trained in recognizing adenocarcinoma and IHC scoring by a senior histopathologist. Kappa statistics were used to analyze interobserver and intraobserver agreement for 6,249 TMA cores from a colorectal cancer series. RESULTS: Interobserver agreement between non-pathologists (independently scored) and the histopathologist was "substantial" for nuclear and membranous IHC markers (κrange = 0.67-0.75 and κrange = 0.61-0.69, respectively), and "moderate" for the cytoplasmic IHC marker (κrange = 0.43-0.57). Scores of the three non-pathologists were also combined into a "combination score" (if at least two non-pathologists independently assigned the same score to a core, this was the combination score). This increased agreement with the pathologist (κnuclear = 0.74; κmembranous = 0.73; κcytopasmic = 0.57). Interobserver agreement between non-pathologists was "substantial" (κnuclear = 0.78; κmembranous = 0.72; κcytopasmic = 0.61). Intraobserver agreement of non-pathologists was "substantial" to "almost perfect" (κnuclear,range = 0.83-0.87; κmembranous,range = 0.75-0.82; κcytopasmic = 0.69). Overall, agreement was lowest for the cytoplasmic IHC marker. CONCLUSIONS: This study shows that adequately trained non-pathologists are able to generate reproducible IHC scoring results, that are similar to those of an experienced histopathologist. A combination score of at least two non-pathologists yielded optimal results. IMPACT: Non-pathologists can generate reproducible IHC results after appropriate training, making analyses of large-scale molecular pathological epidemiology studies feasible within an acceptable time frame.

Modifying phrases in surgical pathology reports: introduction of Standardized Scheme of Reporting Certainty in Pathology Reports (SSRC-Path).

Pathologists often incorporate modifying phrases in their diagnosis to imply varying levels of diagnostic certainty; however, what is implied by the pathologists is not equivalent with what is perceived by the referring physicians and patients. This discordance can have significant implications in management, safety, and cost. We intend to identify lack of consistency in interpretation of modifying phrases by comparing perceived level of certainty by pathologists and non-pathologists, and introduce a standard scheme for reporting uncertainty in pathology reports using the experience with imaging reporting and data systems. In this study, a list of 18 most commonly used modifying phrases in pathology reports was distributed among separate cohorts of pathologists (N = 17) and non-pathology clinicians (N = 225) as a questionnaire survey, and the participants were asked to assign a certainty level to each phrase. All the participants had practice privileges in Brown University-affiliated teaching hospitals. The survey was completed by 207 participants (17 pathologists, 190 non-pathologists). It reveals a significant discordance between the interpretations of the modifying phrases between the two cohorts, with significant variations in subgroups of non-pathology clinicians. Also there is disagreement between pathologists and other clinicians regarding the causes of miscommunication triggered by pathology reports. Pathologists and non-pathology clinicians should be mindful of the potential sources of misunderstanding of pathology reports and take necessary actions to prevent and clarify the uncertainties. Using a standard scheme for reporting uncertainty in pathology reports is recommended.

Impact of education on institutional and faculty rates of atypical squamous cells.

INTRODUCTION: Papanicolaou test quality metrics include the ASC rate, ASC:SIL ratio, and ASC HPV+ rate. What a laboratory should do when metrics show a worrisome trend is not well defined. In 2015, our laboratory noted a worrisome trend in our quality metrics and decided to implement a systemic education program in 2016; we monitored the effectiveness of our program. METHODS: An educational intervention was designed for March/April 2016. Cytotechnologist education consisted of: group meeting on March 10 to discuss metrics, lecture, and written materials on ASC-US criteria, a quiz on challenging ASC-US cases, encouragement to seek consultation, and each cytotechnologist received quarterly individual metrics. The cytopathologist education consisted of: group meeting on April 16 to discuss metrics, encouragement to bring borderline cases to consensus conference, and each faculty received quarterly individual metrics. The ASC rate, ASC:SIL ratio, and ASC HPV+ rate was collected for the institution and each individual faculty in 2016 for January to March (pre-interventions, Q1), April to June (post-interventions, Q2), and July to September (post-interventions, Q3). ASC-H was included in the calculation of ASC %, ASC:SIL, and ASC HPV+ rates. RESULTS: There was a substantial decline in the lab ASC rate and ASC:SIL ratio, and the ASC HPV+ rate increased. Individual faculty changes in ASC:SIL ratio and ASC HPV+ rate also improved. CONCLUSIONS: In our institution, an educational program has been very effective in improving Papanicolaou test metrics. It is helpful to perform re-education at all levels within the department.

ACGME Milestones 2.0: why and what's new for cytopathology?

BACKGROUND: Primary stakeholders in the Accreditation Council for Graduate Medical Education (ACGME) Milestones Project are: ACGME, Residency Programs, Residents, Fellowship Programs, Fellows, and Certification Boards. The intent of the Milestones is to describe the educational and professional developmental trajectory of a trainee from the first stages of their postgraduate education through the completion of their clinical training. The Milestones 2.0 project includes changes made based on experience with Milestones 1.0. METHODS: The ACGME solicited volunteers to participate in the development of subspecialty Milestones 2.0. The workgroup was charged with reviewing/making any additions to the four "Harmonized Milestones", developing subspecialty specific milestones for the Patient Care and Medical Knowledge competencies, and creating a supplemental guide. The Milestones were finalized following review of input from an open comment period. RESULTS: The Cytopathology Milestones 2.0 will go into effect July 2021. They include additional subcompetencies in the 4 harmonized competency areas and cytopathology-specific edits to the patient care and medical knowledge subcompetencies. Although the number of subcompetencies has increased from 18 to 21, within each subcompetency, the number of milestone trajectories has decreased. Additionally, within each subcompetency, the wording has been streamlined. A supplemental guide was created and Milestones 1.0 were compared to 2.0; however, curriculum mapping has been left to programs to develop. CONCLUSIONS: The ultimate goal of the Cytopathology Milestones 2.0 is to provide better real-time documentation of the progress of cytopathology fellows. The expected outcome is to produce highly competent cytopathologists, improving the care they provide, regardless of the program at which they trained.

Extreme winter weather: A force to be remembered in dermatopathology.

It is important for the dermatopathologist to be adept in differentiating tissue artifacts from normal tissue variants and pathologies. Numerous tissue artifacts have been described to date; however, once we are familiar with the common artifacts that appear in our practice, we may not immediately recognize other confounders. For example, dermatopathologists in more temperate regions of the country may not be familiar with freezing artifact. In this case series, we present three common diagnoses in dermatopathology that were obscured by the extreme winter weather that severely impacted the Southern United States in February 2021 and discuss methods to prevent these artifacts.

On Pathology Laboratory Recruitment and Retention.

OBJECTIVES: The specific aims of the study are to analyze relationships between the personality traits of laboratory professionals and choice of profession and preferred work settings. METHODS: Data from practicing laboratory professionals were collected via a web-based survey tool to gather information about personality types, choice of profession, and work setting preferences among medical laboratory professionals. RESULTS: Results of the survey showed that INFJ (Introversion, Intuition, Feeling, Judging) is the most common medical laboratory personality type across the various laboratory work settings and that there are no significant differences between the practitioners' personality type and the choice of profession within pathology. The study revealed laboratorians from higher-volume laboratories were 1.2 times more likely to prefer Judging than lower-volume laboratories, and younger medical laboratory practitioners were 2.3 times more likely to gravitate toward Perceiving than their older counterparts. CONCLUSIONS: The results of this study shed light on how employers can build on the personality preferences of the laboratory workforce to improve personal job satisfaction and laboratory productivity, quality, and work culture. The research implications are useful for laboratory recruitment and retention.

Actualización de la recomendación para la determinación de biomarcadores en el carcinoma colorrectal. Consenso Nacional de la Sociedad Española de Oncología Médica y de la Sociedad Española de Anatomía Patológica / Update of the recommendations for the determination of biomarkers in colorectal carcinoma. National Consensus of the Spanish Society of Medical Oncology and the Spanish Society of Pathology

En esta actualización del consenso de la Sociedad Española de Oncología Médica (SEOM) y la Sociedad Española de Anatomía Patológica (SEAP) se revisan los avances producidos en el análisis de biomarcadores en cáncer colorrectal (CCR) avanzado, así como en los marcadores de susceptibilidad del CCR hereditario y los biomarcadores moleculares del CCR localizado. También se evalúan la información publicada recientemente sobre la determinación imprescindible de las mutaciones de KRAS, NRAS y BRAF y la conveniencia de determinar la amplificación del receptor del factor de crecimiento epidérmico 2 (HER2), la expresión de las proteínas de la vía reparadora de ADN y el estudio de las fusiones de NTRK. Desde el punto de vista anatomopatológico, se revisa la importancia de analizar la presencia de células tumorales aisladas o en pequeños grupos de menos de 5 en el frente invasivo tumoral del CCR y su valor pronóstico en el CCR. También se revisa la incorporación de tecnologías pangenómicas, como la secuenciación de nueva generación (next-generation sequencing [NGS]) y la biopsia líquida, en el manejo clínico del paciente con CCR. Todos estos aspectos se desarrollan en la presente guía que, como la anterior, permanecerá abierta a cualquier revisión necesaria en el futuro

This update of the consensus of the Spanish Society of Medical Oncology (Sociedad Española de Oncología Médica - SEOM) and the Spanish Society of Pathology (Sociedad Española de Anatomía Patológica - SEAP), reviews the advances in the analysis of biomarkers in advanced colorectal cancer (CRC) as well as susceptibility markers of hereditary CRC and molecular biomarkers of localized CRC. Recently published information on the essential determination of KRAS, NRAS and BRAF mutations and the possible benefits of determining the amplification of human epidermal growth factor receptor 2 (HER2), the expression of proteins in the DNA repair pathway and the study of NTRK fusions are also evaluated. From a pathological point of view, the importance of analysing the tumour budding and poorly differentiated clusters and its prognostic value in CRC is reviewed, as well as the impact of molecular lymph node analysis on lymph node staging in CRC. The incorporation of pan-genomic technologies, such as next-generation sequencing (NGS) and liquid biopsy in the clinical management of patients with CRC is also outlined. All these aspects are developed in this guide which, like the previous one, will be revised when necessary in the future

Revised Reporting (Issuing Addenda and Amendments) in Pathology.

OBJECTIVES: The purpose of this study was to align the current experiences and best practices in revised reporting (issuing of addenda and amendments) in pathology. Pathology specialties explored in the survey include anatomic pathology, surgical pathology, cytopathology, and hematopathology. METHODS: The study used a cross-sectional design in which an online revised reporting survey was deployed to a large national sample represented by pathologists, pathology residents, pathology fellows, pathology managers, and laboratory directors. RESULTS: Qualitative and quantitative results from this survey highlight significant variation in standards for creating, issuing, and tracking quality indicators related to addenda and amendments. The most notable findings were a lack of standardization and the potential for widespread adoption of revised reporting best practices within and between pathology services. CONCLUSIONS: Survey insight provides the potential for improving patient safety outcomes, engaging with consumers of our reports, providing a current state view of revised reporting, and assessing the attitudes of pathologists and laboratory professionals on how their individual approaches and team-based workflows achieve revised reports. The data generated from this survey will provide patient safety opportunities associated with accurate pathology reporting and will encourage further development of optimal pathology revised reporting guidelines.

The 2019 Genitourinary Pathology Society (GUPS) White Paper on Contemporary Grading of Prostate Cancer.

CONTEXT.­: Controversies and uncertainty persist in prostate cancer grading. OBJECTIVE.­: To update grading recommendations. DATA SOURCES.­: Critical review of the literature along with pathology and clinician surveys. CONCLUSIONS.­: Percent Gleason pattern 4 (%GP4) is as follows: (1) report %GP4 in needle biopsy with Grade Groups (GrGp) 2 and 3, and in needle biopsy on other parts (jars) of lower grade in cases with at least 1 part showing Gleason score (GS) 4 + 4 = 8; and (2) report %GP4: less than 5% or less than 10% and 10% increments thereafter. Tertiary grade patterns are as follows: (1) replace "tertiary grade pattern" in radical prostatectomy (RP) with "minor tertiary pattern 5 (TP5)," and only use in RP with GrGp 2 or 3 with less than 5% Gleason pattern 5; and (2) minor TP5 is noted along with the GS, with the GrGp based on the GS. Global score and magnetic resonance imaging (MRI)-targeted biopsies are as follows: (1) when multiple undesignated cores are taken from a single MRI-targeted lesion, an overall grade for that lesion is given as if all the involved cores were one long core; and (2) if providing a global score, when different scores are found in the standard and the MRI-targeted biopsy, give a single global score (factoring both the systematic standard and the MRI-targeted positive cores). Grade Groups are as follows: (1) Grade Groups (GrGp) is the terminology adopted by major world organizations; and (2) retain GS 3 + 5 = 8 in GrGp 4. Cribriform carcinoma is as follows: (1) report the presence or absence of cribriform glands in biopsy and RP with Gleason pattern 4 carcinoma. Intraductal carcinoma (IDC-P) is as follows: (1) report IDC-P in biopsy and RP; (2) use criteria based on dense cribriform glands (>50% of the gland is composed of epithelium relative to luminal spaces) and/or solid nests and/or marked pleomorphism/necrosis; (3) it is not necessary to perform basal cell immunostains on biopsy and RP to identify IDC-P if the results would not change the overall (highest) GS/GrGp part per case; (4) do not include IDC-P in determining the final GS/GrGp on biopsy and/or RP; and (5) "atypical intraductal proliferation (AIP)" is preferred for an intraductal proliferation of prostatic secretory cells which shows a greater degree of architectural complexity and/or cytological atypia than typical high-grade prostatic intraepithelial neoplasia, yet falling short of the strict diagnostic threshold for IDC-P. Molecular testing is as follows: (1) Ki67 is not ready for routine clinical use; (2) additional studies of active surveillance cohorts are needed to establish the utility of PTEN in this setting; and (3) dedicated studies of RNA-based assays in active surveillance populations are needed to substantiate the utility of these expensive tests in this setting. Artificial intelligence and novel grading schema are as follows: (1) incorporating reactive stromal grade, percent GP4, minor tertiary GP5, and cribriform/intraductal carcinoma are not ready for adoption in current practice.

Guidelines for clinical trials using artificial intelligence - SPIRIT-AI and CONSORT-AI†.

The rapidly growing use of artificial intelligence in pathology presents a challenge in terms of study reporting and methodology. The existing guidelines for the design (SPIRIT) and reporting (CONSORT) of clinical trials have been extended with the aim of ensuring production of the highest quality evidence in this field. We explore these new guidelines and their relevance and application to pathology as a specialty. © 2020 The Authors. The Journal of Pathology published by John Wiley & Sons, Ltd. on behalf of The Pathological Society of Great Britain and Ireland.