Citations

Abstract Background Minimizing blood specimen recollection due to specimen integrity issues is a continuous quality improvement goal in the neonatal intensive care unit (NICU). Specimen integrity issues, such as clotting or hemolysis, are often the result of improper specimen collection processes and lead to blood loss requiring transfusion, additional painful procedures, and delays in patient care. Data collected from Mayo Clinic Hospital - Methodist Campus NICU at Mayo Clinic in Rochester, MN between January – July 2019 showed that clotted complete blood count (CBC) specimens accounted for one-third of rejected neonatal specimens followed by hemolyzed specimens for direct bilirubin (DBIL) testing. The aim of this project was to reduce the percent of CBC and DBIL tests canceled/specimens rejected due to specimen integrity issues in the NICU from 17% to 10% using the Plan-Do-Study-Act methodology. Methods A multidisciplinary quality improvement (QI) team was formed, inclusive of both NICU and laboratory representatives. Bedside direct observations (n=28) were performed by NICU nurses to help identify inconsistencies in the blood collection processes. A total of three Plan-Do-Study-Act (PDSA) cycles were conducted during the 2020-2021 time period. An assessment card was created and revised with each PDSA cycle. The card was completed by the nurse(s) present during the blood collection and initially identified the lab tests ordered, collection tubes, collection type (venipuncture, venous, capillary), number of tube inversions required, staff present during collection, any delays during collection, and whether the draw was deemed successful. Additionally, staff education videos for nursing and laboratory phlebotomy staff were created to demonstrate correct collection tube inversion technique. Results Direct observation identified inconsistent practices in tube inversion during specimen collection. The first PDSA cycle (n=207 collections, April 1 – July 13, 2021) introduced a verbal inversion count and utilization of the assessment card. The following cycle (n=336 collections, July 14 – October 10, 2021) implemented an educational video and modified the assessment card to include start and end time of the draw. The third cycle (n=243 collections, October 11 – November 30, 2021) used a simplified assessment card including patient label, tests ordered, tube type and inversions. The combined rejection rates for CBC and DBIL tests were 4.3%, 3.8% and 2.8% for the 1st, 2nd and 3rd PDSA cycles, respectively. Conclusions Our QI initiative reduced the specimen rejection rate for clotted CBC and hemolyzed DBIL specimens from 17% to 2.8% in the NICU. Interventions focused on improving tube inversion techniques and promoting collaborative relationships between phlebotomists and nursing staff. The use of educational videos and completion of assessment cards during collections were effective at reducing specimen rejection rates.

Abstract Immune-mediated thrombotic thrombocytopenic purpura (iTTP) is characterized by recurring episodes of thrombotic microangiopathy, causing ischemic organ impairment. Black patients are overrepresented in iTTP cohorts in the United States, but racial disparities in iTTP outcome and response to therapy have not been studied. Using the United States Thrombotic Microangiopathies Consortium iTTP Registry, we evaluated the impact of race on mortality and relapse-free survival (RFS) in confirmed iTTP in the United States from 1995 to 2020. We separately examined the impact of rituximab therapy and presentation with newly diagnosed (de novo) or relapsed iTTP on RFS by race. A total of 645 participants with 1308 iTTP episodes were available for analysis. Acute iTTP mortality did not differ by race. When all episodes of iTTP were included, Black race was associated with shorter RFS (hazard ratio [HR], 1.60; 95% CI, 1.16-2.21); the addition of rituximab to corticosteroids improved RFS in White (HR, 0.37; 95% CI, 0.18-0.73) but not Black patients (HR, 0.96; 95% CI, 0.71-1.31). In de novo iTTP, rituximab delayed relapse, but Black patients had shorter RFS than White patients, regardless of treatment. In relapsed iTTP, rituximab significantly improved RFS in White but not Black patients. Race affects overall relapse risk and response to rituximab in iTTP. Black patients may require closer monitoring, earlier retreatment, and alternative immunosuppression after rituximab treatment. How race, racism, and social determinants of health contribute to the disparity in relapse risk in iTTP deserves further study.

COVID-19 convalescent plasma (CCP) was one of the first therapeutic options available for the treatment of SARS-CoV-2 infections and continues to be used selectively for immunosuppressed patients. Given the emergence of novel SARS-CoV-2 variants which are resistant to treatment with available monoclonal antibody (MAb) therapy, CCP remains an important therapeutic consideration.

Abstract Background Measurement of cholesterol within lipoprotein subfractions may aid in cardiovascular disease prediction. Simple, homogenous enzymatic assays for the direct measurement of lipoprotein subfractions have been developed to measure small dense low-density lipoprotein cholesterol (sdLDL-C), high-density lipoprotein-3 cholesterol (HDL3-C), and triglyceride-rich lipoprotein (TRL-C) cholesterol. The objective of this study was to determine biological variability for sdLDL-C, HDL3-C, and TRL-C in a healthy reference population to facilitate interpretation of these analytes. Methods Serum samples were collected from 24 healthy subjects (n = 14 female/10 male) daily for 3 days while non-fasting, and daily for 5 days, weekly for 4 weeks, and monthly for 6 months after overnight fasting. sdLDL-C, HDL3-C, and TRL-C cholesterol were measured by homogenous enzymatic assays. Sources of variability (between-subject, within-subject, and analytical) were calculated using random-effects regression models. Reference change value (RCV) and index of individuality (II) for each time period were determined from the variance components. Results Analytic variability (daily, weekly, and monthly CVA) was <3% for each analyte. Monthly within-subject variability (CVI) was 17.1% for sdLDL-C, 7.4% for HDL3-C, and 25.7% for TRL-C. Most of the monthly variation was attributed to between-subject variation for all 3 analytes. Overall RCVs for monthly measurements were 18.1 mg/dL for sdLDL-C, 6.1 mg/dL for HDL3-C, and 16.0 mg/dL for TRL-C. IIs were <0.6 for sdLDL-C and HDL3-C, and 0.81 for TRL-C. Conclusions sdLDL-C, HDL3-C, and TRL-C showed moderate within-subject variability, but high between-subject variability, in a healthy reference population. Given the high individuality of each analyte, population-based reference intervals may be inadequate to detect clinically significant changes.

AbstractBackgroundAlthough racial and ethnic identities are associated with a multitude of disparate medical outcomes, surveillance of these subpopulations in the occupational clinic setting could benefit enormously from a more detailed and nuanced recognition of racial and ethnic identity.MethodsThe research group designed a brief questionnaire to capture several dimensions of this identity and collected data from patients seen for work‐related conditions in four occupational medicine clinics from May 2019 through March 2020. Responses were used to calculate the sensitivity and specificity of extant racial/ethnic identity data within our electronic health records system, and were compared to participants' self‐reported industry and occupation, coded according to North American Industry Classification System and Standard Occupational Classification System listings.ResultsOur questionnaire permitted collection of data that defined our patients' specific racial/ethnic identity with far greater detail, identified patients with multiple ethnic identities, and elicited their preferred language. Response rate was excellent (94.2%, n = 773). Non‐White participants frequently selected a racial/ethnic subcategory (78.1%–92.2%). Using our race/ethnicity data as a referent, the electronic health record (EHR) had a high specificity (>87.1%), widely variable sensitivity (11.8%–82.2%), and poorer response rates (75.1% for race, 82.5% for ethnicity, as compared to 93.8% with our questionnaire). Additional analyses revealed some industries and occupations disproportionately populated by patients of particular racial/ethnic identities.ConclusionsOur project demonstrates the usefulness of a questionnaire which more effectively identifies racial/ethnic subpopulations in an occupational medicine clinic, permitting far more detailed characterization of their occupations, industries, and diagnoses.

AbstractBackgroundCeramides are bioactive lipid species that mediate numerous cell-signaling events. Elevated plasma ceramides concentration constitutes a risk factor for several pathologies. Multiple studies have affirmed the plasma concentrations of 4 specific ceramides (Cer16:0, Cer18:0, Cer24:0, and Cer24:1) can predict cardiovascular disease risk. Furthermore, these ceramides can be altered by many lipid-lowering therapies. Understanding the biological variability within an individual, and within a population, will further inform the clinical use of plasma ceramides as a biomarker. In this study, we aimed to define the intra- and interbiological variability of ceramides in a healthy reference population in a weekly and monthly manner.MethodsFasting plasma from 24 healthy adults was collected daily (5 days), weekly (4 weeks), and monthly (7 months). Ceramide concentrations were measured with liquid chromatography–mass spectrometry (LC–MS). For analysis, we used random-effects regression models to estimate variance components.ResultsThe analytical variability was smaller compared to the biological variability overall. The greatest variation reported was between-subject variation for all ceramide species. The critical difference-reference change value (RCV) for within-subject variations monthly were 0.07 mcmol/L (Cer16:0), 0.04 mcmol/L (Cer18:0), 1.09 mcmol/L (Cer24:0), and 0.27 mcmol/L (Cer24:1). The index of individuality (IOI) of ceramides were 0.82 (Cer16:0), 0.96 (Cer18:0), 1.06 (Cer24:0), and 0.89 (Cer24:1). The most consistent ceramide species was Cer18:0 with the lowest within- and between-subject critical differences in weekly and monthly measurements.ConclusionsOverall, this study demonstrates that the variability of ceramide concentrations at different time points is minimal within individuals, allowing a single draw to be sufficient at least in a yearly time frame.