Quality Department, Biomedical Diagnostic Center, Hospital Clínic of Barcelona, Barcelona, Spain.
Quality Department, Laboratories, Hospital de la Santa Creu i Sant Pau of Barcelona, Barcelona, Spain.
Biochem Med (Zagreb). 2022 Oct 1;32(3):030901. doi: 10.11613/BM.2022.030901. Epub 2022 Aug 5.
To ensure the quality of the new-born screening (NBS), our laboratory reviewed the analytical procedure to detect subjective steps that may represent a risk to the patient. Two subjective activities were identified in the extra-analytical phases: the classification of dried blood spots (DBS) according to their quality and the assignment of haemoglobin patterns. To keep these activities under control, inter-rater studies were implemented. This study aimed to evaluate the inter-rater reliability and the effectiveness of the measures taken to improve the agreement between observers, to assure NBS results' quality.
Dried blood spots specimens were used for the inter-rater studies. Ten studies were performed to assess DBS quality classification, and four to assess the assignment of haemoglobin patterns. Krippendorff's alpha test was used to estimate inter-rater reliability. Causes were investigated when alpha values were below 0.80.
For both activities, the reliability obtained in the first studies was inadequate. After investigation, we detected that the criterion to classify a DBS as scant was not consolidated, and also a lack of consensus on whether or not to report Bart's haemoglobin depending on its percentage. Alpha estimates became higher once the training was reinforced and a consensus about the appropriate criteria to be applied was reached.
Inter-rater reliability assessment helped us to ensure the quality of subjective activities that could add variability to NBS results. Furthermore, the evolution of the alpha value over time allowed us to verify the effectiveness of the measures adopted.
为了确保新生儿筛查（NBS）的质量，我们的实验室审查了分析程序，以发现可能对患者造成风险的主观步骤。在分析前阶段确定了两个主观活动：根据其质量对干血斑（DBS）进行分类，以及分配血红蛋白模式。为了控制这些活动，实施了观察者间研究。本研究旨在评估观察者间的可靠性和为提高观察者间的一致性而采取的措施的有效性，以保证 NBS 结果的质量。
使用干血斑标本进行观察者间研究。进行了十项研究以评估 DBS 质量分类，进行了四项研究以评估血红蛋白模式的分配。Krippendorff 的 alpha 检验用于估计观察者间的可靠性。当 alpha 值低于 0.80 时，调查原因。
对于这两种活动，第一次研究获得的可靠性不足。调查后，我们发现分类为稀少的 DBS 的标准不统一，以及对于是否根据其百分比报告 Bart's 血红蛋白也缺乏共识。一旦加强了培训并就适用的适当标准达成共识，alpha 估计值就会更高。
观察者间可靠性评估有助于我们确保可能使 NBS 结果产生变异性的主观活动的质量。此外，alpha 值随时间的演变使我们能够验证所采用措施的有效性。
