Introduction: Hepatitis B virus (HBV) affects 296 million people globally, causing 780 000 annual deaths. It has been estimated that 12-43 million individuals are co-infected with hepatitis D virus (HDV). In Spain, the prevalence of HBsAg in adults is 0.
View Article and Find Full Text PDFObjectives: Most errors in laboratory medicine occur in the pre- and post-analytical phases of the total testing process (TTP). In 2014, the Spanish Society of Laboratory Medicine (SEQC) started the current Preanalytical Phase EQA Programme, with the objective of providing a tool for the improvement of the preanalytical phase. The aim of this study was to review the evolution of quality indicators (QI) and the comparability of established performance specifications (PS) with other EQA programmes.
View Article and Find Full Text PDFObjectives: Serum indices included in clinical chemistry instruments are widely used by laboratories to assess the quality of samples. Instruments that report quantitative results allow an evaluation of their diagnostic performance in a similar way to other biochemical tests. The Spanish Society of Laboratory Medicine (SEQC-ML) launched a monthly External Quality program of serum indices in 2018 using three lyophilized materials of simultaneous annual distribution.
View Article and Find Full Text PDFObjectives: The stability of the analytes most commonly used in routine clinical practice has been the subject of intensive research, with varying and even conflicting results. Such is the case of alanine aminotransferase (ALT). The purpose of this study was to determine the stability of serum ALT according to different variables.
View Article and Find Full Text PDFIntroduction: Diabetes mellitus (DM) is one of the most prevalent diseases worldwide. The objective of this study was to find out under what preanalytical conditions routine and diagnostic glucose tests are performed across Spanish laboratories; and also what criteria are used for DM diagnosis.
Materials And Methods: An online survey was performed by the Commission on Quality Assurance in the Extra-Analytical Phase of the Spanish Society of Laboratory Medicine (SEQC-ML).
Background: The stability limit of an analyte in a biological sample can be defined as the time required until a measured property acquires a bias higher than a defined specification. Many studies assessing stability and presenting recommendations of stability limits are available, but differences among them are frequent. The aim of this study was to classify and to grade a set of bibliographic studies on the stability of five common blood measurands and subsequently generate a consensus stability function.
View Article and Find Full Text PDFBackground: There is no consensus in the literature about what analytes or values should be informed as critical results and how they should be communicated. The main aim of this project is to establish consensual standards of critical results for the laboratories participating in the study. Among the project's secondary objectives, establishing consensual procedures for communication can be highlighted.
View Article and Find Full Text PDFBackground: Preanalytical variables, such as sample collection, handling and transport, may affect patient results. Preanalytical phase quality monitoring should be established in order to minimize laboratory errors and improve patient safety.
Methods: A retrospective study (2001-2013) of the results obtained through the Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC) External quality assessment (preanalytical phase) was performed to summarize data regarding the main factors affecting preanalytical phase quality.
Background: Hemolysis is the main cause of non-quality samples in clinical laboratories, producing the highest percentage of rejections in the external assurance programs of preanalytical quality. The objective was to: 1) study the agreement between the detection methods and quantification of hemolysis; 2) establish comparable hemolysis interference limits for a series of tests and analytical methods; and 3) study the preanalytical variables which most influence hemolysis production.
Methods: Different hemoglobin concentration standards were prepared using the reference method.
Background: Verification uses logical algorithms to detect potential errors before laboratory results are released to the clinician. Even though verification is one of the main processes in all laboratories, there is a lack of standardization mainly in the algorithms used and the criteria and verification limits applied. A survey in clinical laboratories in Spain was conducted in order to assess the verification process, particularly the use of autoverification.
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