title: Minimum analytical quality specifications of inter-laboratory comparisons: agreement among Spanish EQAP organizers.
abstract: BACKGROUND
  Four Spanish scientific societies organizing external quality assessment programs (EQAP) formed a working group to promote the use of common minimum quality specifications for clinical tests. Laboratories that do not meet the minimum specifications are encouraged to make immediate review of the analytical procedure affected and to implement corrective actions if necessary.
  
  
  METHODS
  The philosophy was to use the 95th percentile of results sent to EQAP (expressed in terms of percentage deviation from the target value) obtained for all results (except the outliers) during a cycle of 1 year. The target value for a number of analytes of the basic biochemistry program was established as the overall mean. However, because of the substantial discrepancies between routine methods for basic hematology, hormones, proteins, therapeutic drugs and tumor markers, the target in these cases was the peer group mean.
  
  
  RESULTS
  The resulting specifications were quite similar to those established in the US (CLIA), and Germany (Richtlinie).
  
  
  CONCLUSIONS
  The proposed specifications stand for the minimum level of quality to be attained for laboratories, to assure harmonized service performance. They have nothing to do with satisfying clinical requirements, which are the final level of quality to be reached, and that is strongly recommended in our organizations by means of documents, courses, symposiums and all types of educational activities.
authors.affiliation: Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Barcelona, Spain. carmen.ricos@terra.es
authors.forename: Carmen
authors.initials: C
authors.lastname: Ricós
authors.forename: Francisco
authors.initials: F
authors.lastname: Ramón
authors.forename: Angel
authors.initials: A
authors.lastname: Salas
authors.forename: Antonio
authors.initials: A
authors.lastname: Buño
authors.forename: Rafael
authors.initials: R
authors.lastname: Calafell
authors.forename: Jorge
authors.initials: J
authors.lastname: Morancho
authors.forename: Gabriella
authors.initials: G
authors.lastname: Gutiérrez-Bassini
authors.forename: Josep M
authors.initials: JM
authors.lastname: Jou
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D012958:Societies, Scientific / Q000592:standards*; D013030:Spain