Journal of Applied Laboratory Medicine最新文献

{"title":"What Is Diagnostic Stewardship?","authors":"Kimberly C Claeys, K C Coffey, Daniel J Morgan","doi":"10.1093/jalm/jfae130","DOIUrl":"10.1093/jalm/jfae130","url":null,"abstract":"<p><strong>Background: </strong>Diagnostic stewardship is a set of clinically based changes to the ordering, processing, and reporting of diagnostic tests designed to improve patient outcomes (through decreased inappropriate testing, and reduced patient harm from wrong, delayed, or missed diagnosis). It shares a common philosophy with laboratory stewardship but has some key differences.</p><p><strong>Content: </strong>Laboratory stewardship focuses primarily on pre- and post-analytical components of the testing process. Laboratory stewardship encourages laboratorians to engage clinical partners in discussion around the impact of pre- and post-analytical components of testing. Diagnostic stewardship extends laboratory stewardship into clinical medicine as it considers the clinician's interaction and experience with the ordering system and attempts to modify clinical thinking, even before a test is ordered. Diagnostic stewardship then goes beyond the post-analytic laboratory interpretation of results to contextualize those results in evidence-based best practice recommendations. Compared to laboratory stewardship, diagnostic stewardship is clinician led vs laboratorian led, utilizes clinician-focused terminology rather than laboratory-specific language, and incorporates clinician decision support and behavioral economics to drive behavior change.</p><p><strong>Summary: </strong>There are many complementary principles and activities between laboratory and diagnostic stewardship, and collaboration allows both programs to grow and improve patient overall quality of care.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"10 1","pages":"130-139"},"PeriodicalIF":1.8,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142922078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Survey of Laboratory Stewardship Governance at US Academic Medical Centers.","authors":"Charles S Eby, Noor Al-Hammadi, Kathy Dodds, Deepak Sunkavalli, Ann M Gronowski","doi":"10.1093/jalm/jfae136","DOIUrl":"https://doi.org/10.1093/jalm/jfae136","url":null,"abstract":"<p><strong>Background: </strong>Efforts to appropriately utilize laboratory tests have been underway for several decades. However, limited information is available regarding the status of laboratory stewardship at academic medical centers. Prior to initiating a laboratory stewardship committee, a study was initiated to gain insights from peer institutions.</p><p><strong>Methods: </strong>An online REDCap survey was created and emailed to US pathology department leaders at 94 academic medical centers.</p><p><strong>Results: </strong>Response rate was 40%. Sixty-eight percent (n = 26) of respondents indicated that they have a laboratory stewardship committee. There was variability among academic medical institutions regarding governance, committee structure and responsibilities, and assessment of laboratory stewardship committee performance. There was consensus for inclusion of: hospital administration and clinical leadership; informatics (IT) support, and a multidisciplinary clinical team combined with laboratory medicine expertise. Of the 32% (n = 12) without a committee, 4 started one but found it unsustainable, and 6 were unsuccessful at starting a program. Respondents without a current laboratory stewardship program cited lack of leadership support, insufficient management and IT resources, and unclear vision and goals as major factors. Fifty-eight percent of those without a laboratory stewardship committee predicted their hospital would establish one within the next 5 years.</p><p><strong>Conclusions: </strong>Survey results provide insights into the status of laboratory stewardship efforts at peer institutions. Awareness of the structural and leadership components critical to successful and sustained initiatives will improve the quality and value of clinical laboratory services.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"10 1","pages":"13-25"},"PeriodicalIF":1.8,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Teaching the Laboratory's Role in Diagnostic Stewardship: Engaging Pathology Residents in a Quality Initiative to Improve Autoverification Rates.","authors":"Jack A Maggiore, Constantine E Kanakis, Anastasia Gant Kanegusuku, Stephen E Kahn","doi":"10.1093/jalm/jfae124","DOIUrl":"https://doi.org/10.1093/jalm/jfae124","url":null,"abstract":"<p><strong>Background: </strong>Our institution involves our pathology residents in departmental quality initiatives and in identifying needs for operational improvements. The solutions achieved by these projects have effects beyond the laboratory, and ultimately help to improve diagnostic stewardship by supporting the clinician's ability to obtain necessary biochemical information at the right time. A project highlighting a successful venture is described here in which our investment in new total laboratory automation was not meeting our goals for autoverification rates, resulting in less than expected improvements to turnaround times (TAT).</p><p><strong>Methods: </strong>To improve efficiency of the new laboratory automation, our third-year pathology residents examined the limitations to the verification process and current delta checks. They performed a literature review for the most updated evidence-based practices, examined clinical metrics such as TAT. The residents assessed their findings combined with the laboratory's quality goals, and contributed to updating middleware rule modifications. Several chemistry analyte software rules were revised while others were eliminated.</p><p><strong>Results: </strong>After implementation of the modifications autoverification rates improved from 78% to 89% within 2 months of rule revisions. Average TAT for STAT basic metabolic profile improved from 51 to 46 minutes.</p><p><strong>Conclusions: </strong>This study demonstrates the benefits of involving pathology residents in quality improvement initiatives. Residents are skilled resources capable of evaluating laboratory workflow processes in the context of clinical need. In this process, the residents experience the responsibilities of laboratory administration and learn the role of the laboratory in diagnostic stewardship.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"10 1","pages":"66-72"},"PeriodicalIF":1.8,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic Stewardship-Our Past, Our Current Status, and Future Promise.","authors":"Lee H Hilborne, Allison B Chambliss","doi":"10.1093/jalm/jfae106","DOIUrl":"https://doi.org/10.1093/jalm/jfae106","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"10 1","pages":"200-204"},"PeriodicalIF":1.8,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Building a Stewardship Committee: Technical Tips from the Trenches.","authors":"Elise A Occhipinti","doi":"10.1093/jalm/jfae119","DOIUrl":"https://doi.org/10.1093/jalm/jfae119","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"10 1","pages":"205-206"},"PeriodicalIF":1.8,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Electronic Health Record Design Impacts Clinician Ordering Behavior: An Interrupted Time Series Analysis.","authors":"Eli P Wilber, Eileen M Burd, Eric C Fitts, Jesse T Jacob, Sujit Suchindran","doi":"10.1093/jalm/jfae097","DOIUrl":"https://doi.org/10.1093/jalm/jfae097","url":null,"abstract":"<p><strong>Background: </strong>Diagnostic stewardship is the science of improving diagnostic test use. Whether electronic health record (EHR) design influences clinician diagnostic testing behavior and electronic medical record interventions can improve diagnostic stewardship outcomes are key questions. We leveraged the natural experiment of a recent change in EHR platforms to investigate if changing how 2 commonly misused tests, blood cultures for acid-fast bacilli (AFB) and fungi, are displayed affected their use.</p><p><strong>Methods: </strong>We performed a retrospective chart review of all AFB and fungal blood cultures at 4 hospitals with a shared EHR. The preintervention and postintervention periods were 52 and 26 weeks, respectively. The culture rate was standardized per 1000 patient-days and segmented into 2-week periods. Pre- and postintervention median rates were compared with the Wilcoxon rank sum test and further analyzed with an interrupted time series (ITS) analysis using a quasi-Poisson regression model.</p><p><strong>Results: </strong>The biweekly median AFB blood culture rate decreased by 41.6% in the postintervention period (0.46/1000 patient-days vs 0.79/1000 patient-days, P < 0.001). The median rate of fungal blood cultures decreased by 54.3% in the postintervention period (0.42/1000 patient-days vs 0.92/1000 patient-days, P < 0.001). In ITS analysis, the EHR change was associated with a level change in AFB (-31.8%, 95% CI: -54.6% to +2.6%) and fungal (-44.6%, 95% CI: -59.3% to -24.7%) blood culture use.</p><p><strong>Conclusions: </strong>An electronic medical record design change resulted in decreased use of 2 commonly misused diagnostic tests. This highlights the impact of EHR design on clinician behavior and diagnostic stewardship programs' potential to reduce waste.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"10 1","pages":"73-78"},"PeriodicalIF":1.8,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lack of Association between Vitamin D Genetic Polymorphism and Virological Characteristics of Hepatitis B Infection.","authors":"Jéssica C da Silva, Amanda R Caetano, Ana C da F Mendonça, Leticia de P Scalioni, Moyra M Portilho, Cristianne S Bezerra, Vanessa A Marques, Juliana C Miguel, Karis M P Rodrigues, Cláudia A P Ivantes, Lia L Lewis-Ximenez, Livia M Villar","doi":"10.1093/jalm/jfae151","DOIUrl":"https://doi.org/10.1093/jalm/jfae151","url":null,"abstract":"<p><strong>Background: </strong>Exploring polymorphisms in vitamin D-related genes (VDR) within the Brazilian population provides a valuable model to contribute to the influence of the host genetic variants on chronic viral hepatitis B (CHB).</p><p><strong>Methods: </strong>126 CHB patients were enrolled in the current study and clinical, laboratory, and 25-hydroxyvitamin D [25(OD)D] level data were obtained. Four VDR (rs7975232, rs1544410, rs10735810, rs731236) and 2 vitamin D-binding protein/carrier globulin (GC) polymorphisms (rs4588 and rs7041) were determined using TaqMan assays and nucleotide sequencing. Association studies were conducted among viral infection parameters and the patient's genetic variants.</p><p><strong>Results: </strong>Most patients were male (52.38%) with a mean age of 44.28 (±14.24) years, self-identified as White (32.54%), and exhibited vitamin D insufficiency status (42.06%). The hepatitis B virus (HBV) genotype A was predominant (50%) and 62.7% of the patients had detectable HBV DNA levels ≤log10 3 IU/mL. A significant association was observed between HBV genotype A with ApaI and FokI single nucleotide polymorphisms. However, no statistical association between VDR polymorphisms and viral load, viral polymerase mutations, or vitamin D status was found. Vitamin D concentration did not correlate to HBV viral load.</p><p><strong>Conclusions: </strong>Most HBV-infected individuals presented vitamin D insufficiency, and VDR polymorphism was not associated with virological characteristics except with HBV genotype A, demonstrating that some human genetic signatures are related to HBV genotype distribution.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142910985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preanalytical Sedimentation Effects on Hematological Tests.","authors":"Kenneth Gard, Ian L Gunsolus","doi":"10.1093/jalm/jfae148","DOIUrl":"https://doi.org/10.1093/jalm/jfae148","url":null,"abstract":"<p><strong>Introduction: </strong>Specimens suspected of errors related to low hemoglobin or changes in hemoglobin beyond that of clinically explained variations during hospital stays are frequently redrawn under the auspices that they are contaminated. When lack of an indwelling IV eliminates contamination as a possibility, evaluation of the specimen between the time of collection and testing should occur.</p><p><strong>Methods: </strong>As part of a quality improvement project, we investigated the impact of sedimentation on collected blood specimens not immediately transferred to their respective tubes from a syringe. Each syringe of blood was allowed to stand in a vertical position on the transfer device. After 10 min, each syringe was divided into a bottom half and top half into fresh blood tubes, with half of the samples inverted prior to division. Samples were then analyzed for complete blood count.</p><p><strong>Results: </strong>These results indicate that implementing an inversion of collected specimens prior to transferring will effectively eliminate variations related to sedimentation of blood.</p><p><strong>Conclusions: </strong>Results highlight the importance of specimen handling after collection, including appropriate mixing to avoid erroneous results caused by erythrocyte sedimentation. Mixing syringes before transferring blood to collection tubes ensures a uniform sample and accurate result.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142956607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is the 99th Percentile Cutoff Still Relevant? A Single-Center Assessment of Different Thresholds for Diagnosing Antiphospholipid Syndrome.","authors":"Alexis Dadelahi, Brandon S Walker, Dipanwita Banerjee, Michael Mahler, Abdulrahman Saadalla, Vijayalakshmi Nandakumar","doi":"10.1093/jalm/jfae149","DOIUrl":"https://doi.org/10.1093/jalm/jfae149","url":null,"abstract":"<p><strong>Background: </strong>The 2023 American College of Rheumatology and modified Sapporo criteria for antiphospholipid syndrome (APS) recommend ELISA to detect anticardiolipin (aCL) and anti-β2-glycoprotein I (aβ2GP1) IgG/IgM antibodies, focusing on moderate to high levels or exceeding the 99th percentile. This study aims to establish the 99th percentile threshold for anti-phospholipid (aPL) antibodies and compare the diagnostic accuracies of these thresholds with manufacturer cutoffs using 2 methodologies.</p><p><strong>Methods: </strong>The 99th percentile cutoffs for aPL antibodies from 305 healthy donors were established using Aptiva, Particle-Based Multi-Analyte Technology (PMAT), and QUANTA Lite (QL) ELISA, following nonparametric reference interval estimation. Sera from 34 APS patients and 190 APS controls were tested. Diagnostic performances were compared at the 99th percentile-, manufacturer-, receiver operating characteristic (ROC) derived optimal-, and 95% specificity-optimized cutoffs. An expanded cohort of 61 APS patients and 1299 APS controls from a 2-year retrospective review was also included.</p><p><strong>Results: </strong>For ELISA, the 99th percentile cutoffs for aCL (IgG/IgM) and aβ2GP1 (IgG) were at the assay limit of quantification. Optimal cutoffs from the ROC curves, 95% specificity-matched and manufacturer cutoffs, showed better diagnostic accuracy than the 99th percentile. On the Aptiva PMAT platform, the 99th percentile cutoffs were lower but provided comparable diagnostic accuracies to manufacturer and optimal cutoffs, although specificity was below 95%.</p><p><strong>Conclusions: </strong>The clinical utility of 99th percentile cutoffs is assay dependent. For QL, these cutoffs were unsuitable, while Aptiva showed better alignment with clinical thresholds. Manufacturer-recommended cutoffs, supported by extensive validation, offer a reliable alternative when clinical studies are infeasible.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142899291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Total Prostate-Specific Antigen (PSA) Testing in Capillary Samples: Proof-of-Principle and Feasibility Study for Home Self-Testing for Prostate Cancer.","authors":"Ravinder Sodi, Noel Young, Alessandra Tetucci, Timothy Woolley, Vishal Shah, Isabella Maund","doi":"10.1093/jalm/jfae144","DOIUrl":"https://doi.org/10.1093/jalm/jfae144","url":null,"abstract":"<p><strong>Background: </strong>There is growing interest in the use of capillary blood sampling (CBS) for testing biochemical analytes owing to the advantages it offers including home surveillance of chronic conditions. In this study, we aimed to determine whether the use of CBS was a viable and feasible method for testing total prostate-specific antigen (TPSA) concentrations in men with prostate disease.</p><p><strong>Methods: </strong>Men with known prostate disease were recruited from a urology clinic where they were being treated or followed up. Samples were collected in serum separating tubes by the finger-prick method using validated devices. Simultaneously, venous blood was collected by venipuncture. We used validated immunoassays on both the Roche (Cobas 801) and Beckman (DXi) platforms to measure TPSA.</p><p><strong>Results: </strong>In total, 66 adult men between 26 and 64 years of age were tested. Across the concentration range of normal (0.3 µg/L) to pathological (314 µg/L), the results between CBS and venous samples were highly comparable and correlated (r = 0.997). The average bias was 0.112 µg/L or 1.07% and was not significant (P = 0.274). Overall, there was no apparent proportional or constant bias observed. Our data showed that TPSA may be stable in CBS stored at ambient temperature for up to 8 days in the samples tested using either the Roche or Beckman assays.</p><p><strong>Conclusions: </strong>This feasibility study shows that CBS and venous samples are highly correlated and there was negligible bias. Further validation work is now required for the measurement of TPSA in CBS and determining outcomes in men with prostate disease.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142899298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}