Reaching consensus on communication of critical laboratory results using a collective intelligence method.

Background: 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.

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.

Rationale for using data on biological variation.

The aims of this study are: 1) to use the data included in the biological variation (BV) database to address the usability of BV estimates; and 2) to use different examples from the authors' laboratories to illustrate the use and the usefulness of BV data in laboratory medicine. The BV database is an essential tool for laboratory management. Examples of application of data derived from BV are given in this paper, such as analytical performance specifications that have been included in various quality control software designed to optimize operative rules; also they have been incorporated as acceptability limits in external quality assurance reports.

Lack of transferability between two automated immunoassays for serum IGF-I measurement.

Background: IGF-I is a clinically relevant protein in the diagnosis and monitoring of treatment of growth disor- ders. The Growth Hormone Research Society and the International IGF Research Society have encouraged the adoption of a universal calibration for immunoassays to improve standardization of IGF-I measurements, but currently commercial assays are calibrated either against the old WHO IRR 87/518 or the new WHO 02/254. We compared two IGF-I immunochemiluminescent assays: IMMULITE® 2000 (Siemens) and LIAISON® (DiaSorin), which differ in their standardization, and verified their precision according to quality specifications based on biological variation and their linear range.

Biological variation database: structure and criteria used for generation and update.

Background: Numerical data on the components of biological variation (BV) have many uses in laboratory medicine, including in the setting of analytical quality specifications, generation of reference change values and assessment of the utility of conventional reference values.

Methods: Generation of a series of up-to-date comprehensive database of components of BV was initiated in 1997, integrating the more relevant information found in publications concerning BV. A scoring system was designed to evaluate the robustness of the data included.

Harmonization in hemolysis detection and prevention. A working group of the Catalonian Health Institute (ICS) experience.

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.

External quality assurance programs as a tool for verifying standardization of measurement procedures: Pilot collaboration in Europe.

Introduction: Current external quality assurance schemes have been classified into six categories, according to their ability to verify the degree of standardization of the participating measurement procedures. SKML (Netherlands) is a Category 1 EQA scheme (commutable EQA materials with values assigned by reference methods), whereas SEQC (Spain) is a Category 5 scheme (replicate analyses of non-commutable materials with no values assigned by reference methods).

Aim: The results obtained by a group of Spanish laboratories participating in a pilot study organized by SKML are examined, with the aim of pointing out the improvements over our current scheme that a Category 1 program could provide.

Quality indicators and specifications for key analytical-extranalytical processes in the clinical laboratory. Five years' experience using the Six Sigma concept.

Background: The results of 5 years of experience (2004-2008) with process-based quality management using quality indicators for key laboratory processes (analytic and extra-analytic) in a group of clinical laboratories affiliated with the Catalan Health Institute are presented. Our purpose was to analyze the evolution of the indicators, identify processes that require corrective measures, and obtain specifications that are more robust than the preliminary ones proposed in a previous study by the same group.

Methods: The yearly average was recorded for each indicator in each laboratory, the yearly interlaboratory median was calculated, and the changes occurring were studied to determine their continuity in the 5-year period.

Indicators and quality specifications for strategic and support processes related to the clinical laboratory: four years' experience.

Background: Quality specifications for indicators of the key analytic processes have been defined by international consensus. However, only preliminary specifications for laboratory-related strategic and support processes have been developed. The present study attempts to increase the robustness of the preliminary proposed specifications.

Quality indicators and specifications for strategic and support processes in laboratory medicine.

Background: This work is the second part of a study regarding indicators and quality specifications for the non-analytical processes in laboratory medicine. Five primary care and five hospital laboratories agreed on the indicators for two strategic processes (quality planning and project development) and various support processes (client relationships, instrument and infrastructure maintenance, safety and risk prevention, purchases and storage, personnel training).

Methods: In the majority of cases, the median values recorded over 1 year is considered to be the state-of-the-art in our setting and proposed as the quality specification for the indicators stated.

Within-subject biological variation in disease: collated data and clinical consequences.

Quantitative data on the components of biological variation (BV) are used for several purposes, including calculating the reference change value (RCV) required for the assessment of the significance of changes in serial results in an individual. Pathology may modify the set point in diseased patients and, more importantly, the variation around that set-point. Our aim was to collate all published BV data in situations other than health.

Biological variation at long-term renal post-transplantation.

In laboratory testing the reference change value (RCV) is used to detect changes in a patient's clinical status, even before clinical signs are evident. In a previous study we determined the biological variation (BV) of a number of constituents during early post-transplantation in kidney recipients to calculate useful RCVs for this purpose. RCVs for creatinine and urate were identified as the most suitable and were different from those calculated from the normal population.

Are equally spaced specimen collections necessary to assess biological variation? Evidence from renal transplant recipients.

The established method for determining the components of biological variation (BV) requires equispaced time intervals between samplings. In a previous study, we determined BV in renal post transplantation patients, taking advantage of the samples obtained within their clinical treatment protocol (not necessarily equispaced). To confirm the validity of this practice, we sought to determine if the use of varying sampling intervals has an effect on the results obtained in such biological variation studies.

European multicentre evaluation of the Super Aution SA-4220 urinalysis analyser.

A multicentre evaluation of the urine test strip analyser Super Aution-4220 was carried out in six laboratories. The analytical performance of the instrument with regard to imprecision, linearity, detection limit, drift, carry-over and method comparison was studied. Using the Aution stick 8 test strip the pH, glucose, protein, ketones, bilirubin, blood, urobilinogen and leukocyte esterase were analysed.

Effects of polyunsaturated fatty acids on rat glomerulosclerosis induced by hypercholesterolaemic diet.

Association between lipids and renal disease has been reported recently. Its pathogenic mechanisms remain unknown. The aims of this study were to establish: (1) if a cholesterol-rich diet, alone or associated with nephrectomy, produces nephropathy; and (2) if a treatment with omega-3 polyunsaturated fatty acids (PUFA) reduces glomerulosclerotic lesions.

Potential interfering substances on Falcor-600 and Dax-48 analytical systems.

The increasing availability and use of automatic analysers in clinical chemistry have revealed a number of endogenous interferences. We evaluated the effect of bilirubin, haemolysis and lipaemia on the Falcor-600 analytical system (Menarini Diagnostics) and the Dax-48 (Bayer Diagnostic). We studied the potential endogenous interferences in the measurement of serum glucose, urea, creatinine, cholesterol, triacylglycerols, total bilirubin, total protein, aspartate aminotransferase, alanine aminotransferase and gamma-glutamyltransferase on both analysers; and albumin, direct bilirubin, uric acid, inorganic phosphorus, iron, calcium, magnesium, chloride, sodium, potassium, alkaline phosphatase, amylase, lactate dehydrogenase and creatine kinase on the Dax-48.

Peritoneal transport evaluation in peritonitis: comparison between methods.

Peritoneal dialysis patients may need solute permeability transport evaluation during acute peritonitis. The aim of this study was to assess if the simplified mass transfer coefficient (MTCS) or the peritoneal equilibration test (PET) was equivalent to the complex MTC (MTCX) in solute transport evaluation during acute peritonitis in continuous ambulatory peritoneal dialysis (CAPD) patients. We studied 15 episodes of peritonitis (PTIS).

Criteria for the assessment of analyser practicability.

This article lists the theoretical criteria that need to be considered to assess the practicability of an automatic analyser. Two essential sets of criteria should be taken into account when selecting an automatic analyser: 'reliability' and 'practicability'. Practibility covers the features that provide information about the suitability of an analyser for specific working conditions.

Evaluation of the IL-Phoenix chemistry electrolyte analyser.

This paper reports an evaluation of the IL-Phoenix Chemistry/Electrolyte Analyser; the evaluation was carried out in accordance with internationally recognized guidelines. The evaluation was performed in three steps: evaluation in routine conditions; assessment of interferences; and study of practicability. Seven constituents were studied under routine working conditions.

Mass transfer coefficient: comparison between methods.

The mass transfer area coefficient (MTC) is the best parameter for solute transport evaluation in continuous ambulatory peritoneal dialysis (CAPD) patients. We compared three simplified MTC methods (calculated according Garred, Krediet, or Lindholm) and the peritoneal equilibration test (PET) (Twardowski) to complex MTC (MTCX) (Randerson and Farrell) for urea and creatinine, by means of 29 tests performed in 24 stable CAPD patients. There were no significant differences (paired t-test) between MTCX and each of the simplified MTC, except for creatinine MTC calculated by Krediet's method, which was significantly different (MTCX: 9.

Peritoneal function tests: usefulness of simplified methods.

The Peritoneal Equilibration Test (PET) as standardized by Twardowski (T) and simplified Mass Transfer Coefficients (MTC) as per Garred (G) and Krediet (K) have been employed in our patients to assess: 1) the reproducibility of results, 2) correlation between methods, and 3) usefulness of patient categorization by simplified methods in contrast to PET patterns. We have performed 29 standardized PET (Dianeal 2.5%) in 24 stable CAPD patients.