title: A method for the independent assessment of the accuracy of hematology whole-blood calibrators.
abstract: An independent assessment of the accuracy with which a large manufacturer assigned values to hematologic calibrators was performed. Data were collected from 1,767 hospitals and clinics distributed over North America. Statistical analysis of the mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration of these patient data confirmed the accuracy of the values for hemoglobin, erythrocyte count, hematocrit, and erythrocyte indices for the calibrators manufactured and released during a 9-month period. This approach proved both workable and effective in detecting inaccuracies of less than 1%. Few technologist-users have the time or the equipment to verify independently the accuracy of hematologic calibrators. The manufacturers should perform ongoing, independent assessments of the accuracy of their products. The statistical analysis of patient data provides manufacturers with a suitable method.
authors.affiliation: Department of Pathology, Loma Linda University School of Medicine, California.
authors.forename: B S
authors.initials: BS
authors.lastname: Bull
authors.forename: A
authors.initials: A
authors.lastname: Richardson-Jones
authors.forename: M
authors.initials: M
authors.lastname: Gibson
authors.forename: D
authors.initials: D
authors.lastname: Twedt
mesh_terms: D002138:Calibration / Q000592:standards; D004909:Erythrocyte Indices; D005069:Evaluation Studies as Topic; D006405:Hematology / Q000295:instrumentation*; D006801:Humans; D008722:Methods; D011786:Quality Control