Hematology External Quality Assessment Laboratory, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain.
CORE Laboratory, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain.
Int J Lab Hematol. 2018 Jun;40(3):284-291. doi: 10.1111/ijlh.12783. Epub 2018 Feb 5.
It is important for clinical laboratories to maintain under control the possible sources of error in its analytical determinations. The objective of this work is to perform an analysis of the total error committed by laboratories using the data extracted from the Spanish External Quality Assessment Program in Hematology and to compare them with the specifications based on the biological variability proposed by the Ricós group.
We analyzed a total of 3 89 000 results during the period 2015-2016 from the following quantitative schemes of Spanish External Quality Assessment Program: complete blood count, blood coagulation tests, differential leukocyte count, reticulocytes, hemoglobin A , antithrombin, factor VIII, protein C, and von Willebrand factor. It has been considered as an indicator of the current performance the value of total error that 90% of laboratories are able to achieve, taking into account 75% of their results.
We found some magnitudes whose biological variability specifications are achievable by most of the laboratories for either minimum, desirable, or optimum criteria: white blood cells, red blood cells, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, platelets, fibrinogen, neutrophils, lymphocytes, eosinophils, von Willebrand factor, and protein C. However, current performance for mean corpuscular hemoglobin concentration and hemoglobin A only allows to meet the specifications based on the state of the art.
Our results reflect the feasibility of establishing specifications based on biological variability criteria or the state of the art, which may help to select the proper criteria for each parameter.
临床实验室必须控制分析测定中可能出现的误差源。本研究的目的是分析使用西班牙血液学外部质量评估计划中提取的数据，对实验室所犯的总误差进行分析，并将其与基于 Ricós 小组提出的生物学变异性的规范进行比较。
我们分析了 2015-2016 年期间来自西班牙外部质量评估计划的以下定量方案的总共 389000 个结果：全血细胞计数、凝血试验、白细胞分类计数、网织红细胞、血红蛋白 A、抗凝血酶、VIII 因子、蛋白 C 和血管性血友病因子。我们将 90%的实验室能够达到的总误差值作为当前性能的指标，同时考虑到其 75%的结果。
我们发现了一些生物学变异性规范可被大多数实验室达到的参数的大小，无论是最小、理想还是最佳标准：白细胞、红细胞、血红蛋白、血细胞比容、平均红细胞体积、平均红细胞血红蛋白、血小板、纤维蛋白原、中性粒细胞、淋巴细胞、嗜酸性粒细胞、血管性血友病因子和蛋白 C。然而，目前的平均红细胞血红蛋白浓度和血红蛋白 A 的性能仅允许满足基于最新技术的规范。
我们的结果反映了基于生物学变异性标准或最新技术建立规范的可行性，这有助于为每个参数选择适当的标准。
