[Comparability study of analytical results between a group of clinical laboratories]. / Intercambiabilidad de resultados entre los diferentes laboratorios clínicos Catlab.

OBJECTIVE: To describe the study of the comparability of the measurements levels of biological tests processed in biochemistry in Catlab's 4 laboratories. MATERIAL AND METHODS: Quality requirements, coefficients of variation and total error (CV% and TE %) were established. Controls were verified with the precision requirements (CV%) in each test and each individual laboratory analyser. Fresh serum samples were used for the comparability study. The differences were analysed using a Microsoft Access® application that produces modified Bland-Altman plots. RESULTS: The comparison of 32 biological parameters that are performed in more than one laboratory and/or analyser generated 306 Bland-Altman graphs. Of these, 101 (33.1%) fell within the accepted range of values based on biological variability, and 205 (66.9%) required revision. Data were re-analysed based on consensus minimum specifications for analytical quality (consensus of the Asociación Española de Farmacéuticos Analistas (AEFA), the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC), the Asociación Española de Biopatología Médica (AEBM) and the Sociedad Española de Hematología y Hemoterapia (SEHH), October 2013). With the new specifications, 170 comparisons (56%) fitted the requirements and 136 (44%) required additional review. Taking into account the number of points that exceeded the requirement, random errors, range of results in which discrepancies were detected, and range of clinical decision, it was shown that the 44% that required review were acceptable, and the 32 tests were comparable in all laboratories and analysers. CONCLUSIONS: The analysis of the results showed that the consensus requirements of the 4 scientific societies were met. However, each laboratory should aim to meet stricter criteria for total error.

[UNE-EN ISO 15189 accreditation of the preanalytical phase of a clinical laboratory]. / Acreditación según la norma UNE-EN ISO 15189, de la fase preanalítica del laboratorio de análisis clínicos Catlab.

OBJECTIVES: Description of the procedures followed in Catlab's pre-analytical area for UNE-EN ISO 15189 accreditation, and implementation of quality indicators to evaluate the standard requirements in the pre-analytical phase processes. MATERIAL AND METHODS: Description of Catlab's 2 self-developed computer applications: Catlab Program Incidents (CPI) and Refrigerator Management Program (RMP). Both of them, among other applications, documentation and quality indicators, had enabled us to achieve UNE-EN ISO 15189 accreditation and have traceability in the pre-analytical phase. RESULTS: Results of 4 quality indicators are shown. In the customers satisfaction measurement indicator, 97.3% clinicians value positively (quite/lot) different aspects of the laboratory. The indicator of pre-analytical incidents went from 7.2% in 2011 down to 4.4% in 2014. In the prompt transport of late arrival samples, 3 of the routes (33%) did not reach the acceptable target. And finally, the indicator of default opening time of sample coolers, 100% of the routes reached the desired objective in the second quarter of 2014. CONCLUSIONS: The use of those applications, allowed us to design quality control indicators of the processes in the pre-analytical phase; from sample extraction to its analytical process in the laboratory, enhancing the collaboration with extraction sites, and allowing improvement actions to be established.

[Loss of antibiotic sensitivity of Pseudomonas aeruginosa strains during treatment]. / Pérdida de sensibilidad a los antibióticos de cepas de Pseudomonas aeruginosa en el curso del tratamiento.

BACKGROUND: Loss of sensitivity to betalactamic, quinolones and aminoglucoside antibiotics has been described during treatment of infections produced by strains of Pseudomonas aeruginosa. Sixteen nosocomial strains isolated over a year during which sensitivity to one or several antibiotics of the above mentioned groups had been lost during the course of treatment were studied. METHODS: The strains were identified by conventional techniques. Sensitivity to antibiotics was studied by determination of the minimum inhibitory concentration in solid medium, according to the guidelines of the National Committee for Clinical Laboratory Standards. Plasmidic beta-lactamases were identified by analytic isoelectric focusing. Hyperproduction of chromosomic lactamase was studied by a qualitative technique. The 0 antigens were studied against rabbit antisera. The pyocinetype was determined according to the Fyfe method. Plasmids were detected by alkaline lysis extraction and electrophoresis in agarose gel. RESULTS: The 16 strains in which changes in sensitivity were observed during the course of treatment represent 4.47% of all P. aeruginosa isolates during one year. Loss of sensitivity to betalactamic antibiotics was observed in 10 strains, in one to aminoglucosides, in two to ciprofloxacin, simultaneously to aminoglucosides and ciprofloxacin in one and to betalactamic and ciprofloxacin in another two. Six of the 13 patients (46%) required a change in antibiotic treatment. CONCLUSIONS: The convenience of following the sensitivity of the strains of Pseudomonas aeruginosa isolated in a patients is suggested to thereby avoid therapeutic failure and the potential danger of clonal dissemination of the strains which have lost sensitivity.