Icteric Interference with Clinical Chemistry Testing
Description
Supplementary file 1: Data for age in years (at time of laboratory testing) and sex (as recorded in the electronic medical record) for 94,081 unique patients. Ages greater than 89 years old are indicated as ">89". The retrospective timeframe is January 1, 2018 through December 31, 2018. Supplementary file 2: Data for 414,502 specimens submitted for clinical chemistry analysis. The retrospective timeframe is January 1, 2018 through December 31, 2018. Specific data fields include: unique specimen identification number (deidentified), patient location at time of testing (emergency department, inpatient unit, or outpatient site), sex (as recorded in electronic medical record), age in years (at time of laboratory testing), specimen hemolysis index, specimen icteric index, and specimen lipemic index. Supplementary file 3: Data for 114 clinical chemistry assays analyzed in the present study. Specific data fields include: assay name, assay vendor, package insert version relevant to the retrospective timeframe, assay package insert icteric index limit (if stated), total numbers of the specific test performed in the retrospective analysis, absolute number and percent of total specimen icteric indices that exceeded the package insert icteric index limit for the specific assay, and number of results that exceeded the package insert icteric index for a specific assay accounted for by 57 patients (4 pediatric, 53 adult; 524 total specimens) who had one or more icteric indices of 40 or higher in the retrospective timeframe. The retrospective timeframe is January 1, 2018 through December 31, 2018. Supplementary file 4: Data obtained by chart review for 57 patients (4 pediatric, 53 adult; 524 total specimens) who had one or more specimens with an icteric index of 40 or higher. The retrospective timeframe is January 1, 2018 through December 31, 2018. Specific data fields include: de-identified patient number, age in years (at time of laboratory testing), sex (as recorded in electronic medical record), diagnosis category from chart review that most likely accounted for severe icterus (grouped into broad categories of alcohol-related liver disease, biliary tract disease, liver disease related to infection, neoplasm/tumor, and other), additional/specific diagnoses, whether patient was deceased within 1 year of laboratory testing, and whether patient was deceased within 3 years of laboratory testing.
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The retrospective timeframe is January 1, 2018 through December 31, 2018. All data was obtained from patient data in the electronic medical record from the University of Iowa Hospitals and Clinics (Iowa City, Iowa, United States). A reporting tool within the electronic medical record, known as Epic Reporting Workbench, was used to retrieve data for 114 clinical chemistry tests performed in the retrospective timeframe. Only data from patients who had clinical chemistry testing performed at the University of Iowa Hospitals and Clinics were included; no data was obtained from diagnostic vendors of any of the laboratory assays used for clinical testing. Hemolysis/icterus/lipemia (HIL) indices were obtained from Middleware software (Instrument Manager) from Data Innovations (Burlington, VA). Specimen accession numbers were used to link patient data, laboratory testing results, and HIL indices. The clinical chemistry instrumentation was a cobas 8000 system with two c702, three c502, and five e602 analyzers (Roche diagnostics, Indianapolis, IN, USA). The present study includes data for 105 assays using Roche Diagnostics reagents and 9 assays using reagents from other manufacturers that were run on the Roche cobas 8000 instrumentation. All serum/plasma specimens had HIL indices determined by spectrophotometry, which were then used for autoverification rules . The analyzers take an aliquot of the patient specimen and dilute in 0.9% sodium chloride saline to measure the absorbance (primary/secondary wavelength) for hemolysis at 570 nm/600 nm, icterus at 480 nm/505 nm, and lipemia at 660 nm/700 nm. Detailed chart review was performed for 57 patients who had one or more specimens with an icteric index of 40 or higher.