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Objective To quantify the accuracy and reproducibility of pathologists’ diagnoses of melanocytic skin lesions.Design Observer accuracy and reproducibility study.Setting 10 US states.Participants Skin biopsy cases (n=240), grouped into sets of 36 or 48. Pathologists from 10 US states were randomized to independently interpret the same set on two occasions (phases 1 and 2), at least eight months apart.Main outcome measures Pathologists’ interpretations were condensed into five classes: I (eg, nevus or mild atypia); II (eg, moderate atypia); III (eg, severe atypia or melanoma in situ); IV (eg, pathologic stage T1a (pT1a) early invasive melanoma); and V (eg, ≥pT1b invasive melanoma). Reproducibility was assessed by intraobserver and interobserver concordance rates, and accuracy by concordance with three reference diagnoses.Results In phase 1, 187 pathologists completed 8976 independent case interpretations resulting in an average of 10 (SD 4) different diagnostic terms applied to each case. Among pathologists interpreting the same cases in both phases, when pathologists diagnosed a case as class I or class V during phase 1, they gave the same diagnosis in phase 2 for the majority of cases (class I 76.7%; class V 82.6%). However, the intraobserver reproducibility was lower for cases interpreted as class II (35.2%), class III (59.5%), and class IV (63.2%). Average interobserver concordance rates were lower, but with similar trends. Accuracy using a consensus diagnosis of experienced pathologists as reference varied by class: I, 92% (95% confidence interval 90% to 94%); II, 25% (22% to 28%); III, 40% (37% to 44%); IV, 43% (39% to 46%); and V, 72% (69% to 75%). It is estimated that at a population level, 82.8% (81.0% to 84.5%) of melanocytic skin biopsy diagnoses would have their diagnosis verified if reviewed by a consensus reference panel of experienced pathologists, with 8.0% (6.2% to 9.9%) of cases overinterpreted by the initial pathologist and 9.2% (8.8% to 9.6%) underinterpreted.Conclusion Diagnoses spanning moderately dysplastic nevi to early stage invasive melanoma were neither reproducible nor accurate in this large study of pathologists in the USA. Efforts to improve clinical practice should include using a standardized classification system, acknowledging uncertainty in pathology reports, and developing tools such as molecular markers to support pathologists’ visual assessments.

Though numerous quality assurance (QA) measures are in place for the practice of gynecologic cytopathology, many of them are not clearly defined and may be variably used by laboratories worldwide. To assess current practice patterns regarding the implementation of selected gynecologic cytology QA metrics to help develop guidance for laboratories. A supplemental questionnaire was mailed to laboratories participating in the 2022 College of American Pathologists (CAP) Gynecologic Cytopathology (PAP Education) Program requesting data regarding their QA measures in gynecologic cytology. A total of 562 laboratories responded to the supplemental questionnaire; responses from 511 laboratories were analyzed further. Of 492 laboratories, most considered Papanicolaou (Pap) tests from patients with untreated abnormal cytology in the previous year (386; 78.5%) or with an abnormal gynecologic biopsy finding (concurrent or within the past year) (331; 67.3%) as high-risk for negative rescreening. Many laboratories (436 of 511; 85.3%) required pathologist review of Pap tests for indications other than reactive/abnormal cells (eg, endometrial cells in women 45 years of age and older). For assessing cytologists' performance, 88.5% (399 of 451) of respondents recorded the discrepancy rate between cytologist's and pathologist's interpretations. For monitoring pathologists' performance, most laboratories (243 of 389; 62.5%) evaluated cases with significant cytologic-histologic discrepancy. The CAP survey provided a detailed assessment of current QA practices regarding gynecologic cytology, which can aid laboratories in making decisions related to enhancement of QA in their setting. As the guidelines and tools for cervical cancer screening evolve, QA metrics will need to be accordingly refined.

Genomic reports are primarily organized in a narrative and unstructured format with variations in content and format. Regulatory requirements and professional guidelines for genetic test reporting exist but provide little guidance for effective communication of information. To assess clinical genomic reporting practices across 5 disciplines within molecular diagnostics, including germline, somatic solid tumors, somatic hematologic malignancies, pharmacogenomics, and prenatal cell-free DNA screening. Reporting practices were assessed by using a structured review of clinical genomic reports from multiple laboratories in 5 molecular disciplines spanning different practice settings. Report content was reviewed by the presence/absence of from 27 to 44 elements, including 23 elements required by the College of American Pathologists and/or the Clinical Laboratory Improvement Amendments of 1988 (CLIA). If present, the element's location on the report was recorded. A total of 69 genomics reports from 31 laboratories were reviewed. Overall, the reports were compliant with regulatory requirements but showed variability in both format and content. Six of 7 required reporting elements (per CLIA, 42 CFR [Code of Federal Regulations] 493.1291) were included in 90% of the reports. However, these elements were often located in different report sections. Only patient demographics were always found in a specific report section (header). These results show that reports are overall compliant with regulatory requirements, despite some reporting elements being less consistently reported. The lack of consistent presentation of the data elements presents an opportunity to improve the communication of molecular testing results to clinicians and patients.

To evaluate the impact of Artificial Intelligence Assisted Prevention and Management for Delirium (AI-AntiDelirium) on improving adherence to delirium guidelines among nurses in the intensive care unit (ICU). Between November 2022 and June 2023, A cluster randomized controlled trial was undertaken. A total of 38 nurses were enrolled in the interventional arm, whereas 42 nurses were recruited for the control arm in six ICUs across two hospitals in Beijing, comparing nurses’ adherence and cognitive load in units that use AI-AntiDelirium or the control group. The AI-AntiDelirium tailored delirium preventive or treated interventions to address patients’ specific risk factors. The adherence rate of delirium interventions was the primary endpoint. The other endpoints were adherence to risk factors assessment, ICU delirium assessment, and nurses’ cognitive load. The repeated measures analysis of variance was utilized to explore the influence of time, group, and time × group interaction on the repeated measurement variable (e.g., adherence, cognitive load). A cumulative total of 1040 nurse days were analyzed for this study. The adherence to delirium intervention of nurses in AI-AntiDelirium groups was higher than control units (75 % vs. 58 %, P < 0.01). When compared to control groups, AI-AntiDelirium was found to be significantly effective in both decreasing extraneous cognitive load (P < 0.01) and improving germane cognitive load (P < 0.01). This study supports the effectiveness of AI-AntiDelirium in enhancing nurses’ adherence to evidence-based, individualized delirium intervention and also reducing extraneous cognitive load. A nurse-led systemshould be applied by nursing administrators to improve compliance with nursing interventions among ICU nurses.

The aim of the study was to determine the impact of peripheral blood (PB) smear review by a pathologist when requested by a technologist or provider to measure the rate of pathologist-detected clinically relevant findings. To report and analyze the results of clinically relevant morphologic findings on PB smears that were pathologist reviewed because of either a request from a technologist or an order from a provider. During a 4-week study period, participants enrolled in the College of American Pathologists Q-Probes program submitted data on PB smear reviews including review request source, reason for review request, and if the pathologist's review resulted in a clinically relevant morphologic finding. Twenty-two institutions submitted data on 835 eligible PB smears. Pathologists identified clinically relevant findings on a median 53.4% of technologist-requested PB smear reviews and a median 14.3% of provider-ordered PB smear reviews. The most frequently identified pathologist finding on technologist-requested PB smear reviews was \"blasts\" in 91 of 532 (17.1%) followed by \"atypical (possibly neoplastic) lymphocytes\" in 74 of 532 (13.9%); the most frequent finding on provider-ordered reviews was \"other\" in 55 of 315 (17.5%) followed by \"immature cells/left shift in myeloid cells or monocytes\" in 12 of 315 (3.8%). Pathologists agreed with technologists' indications for review in 458 of 513 requested reviews (89.3%). Institutions that conducted postanalytic follow-up on previously reviewed PB smears had a higher rate of clinically relevant findings detected on technologist-requested smears. Pathologist review of PB smears flagged by technologists for review frequently yielded clinically relevant findings. This was higher in institutions that conducted postanalytic reviews. Provider-ordered reviews resulted in clinically relevant findings in a median of 14.3% of smears.

Background Clinical laboratory test results in clinical decisions have become a fundamental element of clinical practice, with laboratory results influencing approximately 70% of decisions. The sigma metrics method is used to evaluate all stages of the testing process in clinical chemistry laboratories. Objective This study aims to assess the performance of the clinical chemistry laboratory using sigma metrics across the total test process at Dessie Comprehensive Specialized Hospital. Methods A cross‐sectional study was conducted from July 1, 2024 to September 30, 2024. The study included all the eligible laboratory samples and corresponding test requests during the study period, selected using consecutive sampling techniques. Data for each variable were collected using a prepared checklist and record format by trained laboratory professionals. The data were entered into EPI Data version 3.1 and analyzed using Stata version 17. Laboratory performance was evaluated using the sigma metrics. Result The overall performance of the clinical chemistry laboratory was inadequate, with an overall sigma value of 2.9. The laboratory showed marginal performance in the analytical phase (3.5 sigma value) and low performance in the pre‐analytical and post‐analytical phases (2.8 and 2.9 sigma, respectively). However, most clinical chemistry parameters demonstrated satisfactory sigma metric values (≥ 3). Conclusion The hospital administration should provide training for all staff involved in laboratory sample collection and processing, focusing on quality control, reagent handling, and adherence to SOPs, along with continuous performance monitoring. Clinical laboratory test results guide ~70% of clinical decisions. Using sigma metrics, the clinical chemistry laboratory at Dessie Comprehensive Specialized Hospital showed overall inadequate performance (2.9 sigma), with marginal performance in the analytical phase (3.5) and low performance in the pre‐ and post‐analytical phases (2.8 and 2.9). Strengthening staff training in sample collection and processing is essential to improve laboratory quality.

The College of American Pathologists Hematology and Clinical Microscopy Committee implemented a hemoglobinopathy proficiency testing and education program to monitor and assess the performance of participating laboratories. To evaluate the performance of clinical laboratories for hemoglobinopathy proficiency testing from 2005 to 2023. The hemoglobinopathy challenges are composed of clinical case summaries and electrophoretic and chromatographic gel and tracing images. The participants are asked to determine (1) what hemoglobin chain is affected and (2) the hemoglobinopathy diagnosis. A total of 365 to 676 laboratories were enrolled in the proficiency testing program each year. Overall, the error rates for determination of the affected globin chain and a hemoglobinopathy diagnosis ranged from 0.6% to 56.5% and 0.5% to 86.5%, respectively. Twenty-three of 66 surveyed hemoglobinopathies (34.8%) had an error rate exceeding the consensus threshold of 20%. The globin gene detection error rate of the compound hemoglobinopathies was significantly higher when compared with just the α (P = .01) and β (P = .003) gene disorders. However, the error rate for the overall compound α/β-globin interpretation, although high at 23%, was not statistically significant when compared with just the α- or β-globin chain disorders. In repeat testing of the variants, there was no consistent improvement in performance. The program participants demonstrated variable performance with one-third of the surveys exceeding the 20% error rate. The error rate for compound hemoglobinopathies was even higher. Our data illustrate a critical need for continuing educational efforts with an algorithmic approach to hemoglobin disorders.

Laboratories can play a critical role in the conduct of clinical trials. Management of different aspects of the clinical laboratory processes is essential and can determine the success of a trial. Activities within the laboratory process encompassing pre-analytical, analytical, and post-analytical processes ought to be thoroughly monitored. In this paper, we present an outline of approaches for sample collection, sample transport, sample storage, sample analysis, and data management, in a laboratory setting. The paper highlights that clinical trials are more likely to be completed successfully if there is rigorous adherence to organized quality management approaches in the laboratory. We also discuss the challenges encountered that include sample quality issues, equipment downtime, absence of reference ranges generated from the local population among others, and approaches implemented to overcome these. If implemented, the approaches described here are expected to improve the quality and integrity of the data produced in laboratories which in turn will contribute to successful clinical trial conduct.

[...]many laboratories use a locally developed system of Microsoft Word or similar documents for their policies and perform document control using a combination of spreadsheets and manual updating and version control. Very often this is managed by the laboratory itself, without any significant technical or administrative support from the institution. Because these products have only limited access and version controls, the medical director may not always know if a document has been altered. [...]the commit message becomes the primary means of navigating between versions.