Search

Objective To provide faster laboratory data reporting, we evaluated the accuracy of Sysmex XN (Sysmex Inc, Kobe, Japan) absolute neutrophil count (ANC) in the presence of analyzer flagging. Methods Sysmex XN and manual microscopy ANC were compared with 80 autovalidated control specimens and with 280 study specimens with analyzer flagging regarding immature granulocytes (IG) >3% or other leukocyte abnormalities. Specimens with ambiguous neutrophil clusters were excluded. Results A slight positive overall method bias was seen for Sysmex XN compared to manual microscopy (n = 280), 0.025 (95% confidence interval [CI], –0.023 to 0.069) × 109/L. With IG > 10% (n = 123) the bias was larger, but not clinically significant, 0.17 (95% CI, 0.060–0.25) × 109/L. No clinically significant difference was seen in neutropenic (ANC < 1.5 × 109/L) specimens (n = 91), 0.070 (95% CI, –0.013 to 0.14) × 109/L. Conclusion These data indicate that Sysmex XN ANC can be reported in the presence of certain analyzer flagging to improve patient care. [ABSTRACT FROM AUTHOR]

European Union (EU) Directive 2013/55/EC (The Recognition of Professional Qualifications) allows Member States to decide on a common set of minimum knowledge, skills and competences that are needed to pursue a given profession through a Common Training Framework. To be adopted the framework must combine the knowledge, skills and competences of at least one third of the Member States. Professionals who have gained their qualifications under a Common Training Framework will be able to have these recognised automatically within the Union. The backbone of the European Federation of Clinical Chemistry and Laboratory Medicine's (EFLM) proposed Common Training Framework for non-medical Specialists in Laboratory Medicine is outlined here. It is based on an Equivalence of Standards in education, training, qualifications, knowledge, skills, competences and the professional conduct associated with specialist practice. In proposing the recognition of specialist practice EFLM has identified 15 EU Member States able to meet Equivalence and in whom the profession and/or its training is regulated (an additional EU Commission requirement). The framework supports and contributes to the Directive's enabling goals for increasing professional mobility, safeguarding consumers and ensuring a more equitable distribution of skills and expertise across the Member States. It represents EFLM's position statement and provides a template for professional societies and/or competent authorities to engage with the EU Commission. [ABSTRACT FROM AUTHOR]

The ultimate goal of harmonization, crucial to quality in laboratory medicine, is to improve patient outcomes by providing accurate, actionable laboratory information. Patients and healthcare professionals assume that clinical laboratory tests performed by different laboratories at different times on the same type of sample are comparable, and that results can be reliably and consistently interpreted. In this context the reporting units for tests can have a considerable influence on the numeric result. The harmonization of measurement units in laboratory report, leads to the provision of interchangeable and comparable results, thus maximizing the validity of laboratory information, and assuring a more accurate diagnosis and better treatment for the patient. However, although considerable efforts have been made in recent years, the criticisms continue. This opinion paper, prepared jointly by EFLM Committee Harmonization (C-H) and Committee Postanalytical phase (C-POST), describes the “general pragmatic approach” proposed in the drafting of guidelines for the harmonization of measurement units in reporting results, in order to ensure they are used as widely as possible. [ABSTRACT FROM AUTHOR]

Objectives: Preanalytical phase is an elemental part of laboratory diagnostics, but is prone to humane errors. The aim of this study was to evaluate performance in preanalytical phase external quality assessment (EQA) cases. We also suggest preventive actions for risk mitigation., Methods: We included 12 EQA rounds (Labquality Ltd.) with three patient cases (36 cases, 54-111 participants, 7-15 countries) published in 2018-2023. We graded performance according to percentage of correct responses in each case as ≥900 % excellent, 70-89 % good, 50-69 % satisfactory, 30-49 % fair and <30 % poor. Performance was simultaneously failed with ≥10 % of responses leading to harmful events., Results: Overall performance was excellent in 7, good in 12, satisfactory in 10, fair in 4 and poor in 3 cases. Additionally, 7 cases showed failed performance. Routine requests with incorrect sample tubes or incorrect sample handling were detected with good performance. Lower performance was seen with sudden abnormal results, with rare requests, with false patient identification (never-events) and with incorrect test requests. Information technology (IT) solutions (preanalytical checklists, autoverification rules and patient specific notifications) could have prevented 33 of 36 preanalytical errors., Conclusions: While most common errors were detected with good performance, samples with rare requests or those requiring individualised consideration are vulnerable to human misinterpretation. In many instances, samples with preanalytical errors should have been identified and rejected before reaching the laboratory or being directed to analysis. Optimising IT solutions to effectively detect these preanalytical errors allows for focus on infrequent events demanding accessible professional consultation. EQA preanalytical cases may help in education of correct actions in these occasions., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)