Spanish society of laboratory medicine external quality assurance programmes: evolution of the analytical performance of clinical laboratories over 30 years and comparison with other programmes.

The purpose of this study is to understand the evolution of the analytical performance of the laboratories participating in the Spanish society of laboratory medicine (SEQC) external quality assurance (EQA) programmes during its 30 years of operation and to compare it with the performance of other EQA programmes to establish whether the results are similar. The results obtained during this period are evaluated by applying the biological variability (BV) and state of the art-derived quality specifications. In addition, the results are compared with those obtained by other EQA programme organisations.

Critical appraisal and meta-analysis of biological variation studies on glycosylated albumin, glucose and HbA.

Objectives: Numerous biological variation (BV) studies have been performed over the years, but the quality of these studies vary. The objectives of this study were to perform a systematic review and critical appraisal of BV studies on glycosylated albumin and to deliver updated BV estimates for glucose and HbA, including recently published high-quality studies such as the European Biological Variation study (EuBIVAS).

Methods: Systematic literature searches were performed to identify BV studies.

Biological variation of metabolic cardiovascular risk factors in haemodialysis patients and healthy individuals.

Background: Maintenance haemodialysis (HD) is associated with a very high cardiovascular risk and the assessment of metabolic cardiovascular risk factors is essential for an adequate diagnosis and management. The aim of the study has been to estimate the biological variation (BV) of serum lipids, calcium, inorganic phosphorus, 25-OH vitamin D, C-reactive protein and plasma intact parathyroid hormone (PTHi) and total homocysteine, to evaluate whether HD alter the homeostatic set-point of these magnitudes.

Methods: Blood samples were collected from 18 HD patients in steady-state conditions, one per month during 6 months, and from 11 healthy volunteers at weekly intervals over 5 weeks.

Impact of implementing a category 1 external quality assurance scheme for monitoring harmonization of clinical laboratories in Spain.

Background: The objective of the present study was to examine the evolution of the analytical performance specifications (APS) used in External Quality Assurance (EQA) schemes, as well as the efficacy of a category 1 EQA scheme in monitoring the harmonization of clinical laboratory results in Spain.

Methods: A review of the literature on the types of quality specifications used in schemes in other countries and their evolution was performed. In addition, a comparative analysis of the potential impact that different APS from eight countries had on clinical decision-making was made based on three measurands: sodium, thyroid-stimulating hormone (TSH), and activated partial thromboplastin time (aPTT).

Standardization in laboratory medicine: Two years' experience from category 1 EQA programs in Spain.

Introduction: Standardization is the ability to obtain interchangeable results leading to same medical interpretation. External quality assessment (EQA) is the main support of the on-going harmonization initiatives. Aim of study was to evaluate results obtained from two years category 1 EQA program experience in Spain and determine the impact of applying this type of EQA program on the analytical standardization.

The Biological Variation Data Critical Appraisal Checklist: A Standard for Evaluating Studies on Biological Variation.

Background: Concern has been raised about the quality of available biological variation (BV) estimates and the effect of their application in clinical practice. A European Federation of Clinical Chemistry and Laboratory Medicine Task and Finish Group has addressed this issue. The aim of this report is to () describe the Biological Variation Data Critical Appraisal Checklist (BIVAC), which verifies whether publications have included all essential elements that may impact the veracity of associated BV estimates, () use the BIVAC to critically appraise existing BV publications on enzymes, lipids, kidney, and diabetes-related measurands, and () apply metaanalysis to deliver a global within-subject BV (CV) estimate for alanine aminotransferase (ALT).

Category 1 external quality assessment program for serum creatinine.

Background: The Commission of Analytical Quality and the Committee of External Quality Programs of Spanish Society of Laboratory Medicine (SEQC) in collaboration with the Dutch Foundation for the Quality organized the first national category 1 External Quality Assessment Programs (EQAP) pilot study. The aim is to evaluate the standardization of serum creatinine measurements in the Spanish laboratories through a category 1 external quality assurance program with commutable material and reference method assigned values.

Methods: A total of 87 Spanish laboratories were involved in this program in 2015.

Biologic Variation Approach to Daily Laboratory.

Biological variation gives valuable information about how the living organism regulates its constituents within and between subjects; this information on the behavior of body components allows us to derive consequences concerning reference populations and intervals. With a more pragmatic approach biological variation has three uses: setting the appropriate analytical performance specification for each analyte to limit the amount of error that laboratory could introduce in its measurements, to help distinguish health from disease, and to implement internal quality control with the automatic verification of results.

Biological variation of cardiac troponin T in patients with end-stage renal disease and in healthy individuals.

Background: Serum cardiac troponin T concentrations are important predictors of cardiovascular and all-cause mortality in end-stage renal disease. In patients with end-stage renal disease, assessment of serial results is essential to distinguish between a cardiovascular event and chronic elevation. We employed a high-sensitivity serum cardiac troponin T assay to evaluate the long-term biological variation in end-stage renal disease patients and in healthy individuals; these biological variation data were used to define the reference change value and the analytical goals.

Biological variation of free plasma amino acids in healthy individuals.

Background: Biological variation data for free plasma amino acids are lacking from the more comprehensive databases. Therefore, we determined the intra- and inter-individual components of variation in healthy subjects. These data were used to define desirable goals for imprecision, bias and total error, indices of individuality and reference change values.