title: How to define a significant deviation from the expected internal quality control result.
abstract: BACKGROUND
  Internal quality control (IQC) is an everyday practice described in several documents. Its planning requires the definition of quality goals and a documentation system able to provide alarms as soon as the goals are not reached. We propose the use of the uncertainty approach to develop an effective alarm system.
  
  
  METHODS
  The use of the uncertainty information to verify the conformity to specifications is described. A top-down approach to the definition of the uncertainty of the method is described. Once the uncertainty is calculated, the complete measurement result (result ± expanded uncertainty) is compared with the maximum permissible error (quality goal). An alternative and more immediate presentation is obtained defining an "acceptance zone" derived from the maximum permissible error reduced on either sides by expanded uncertainty. This approach is applied to two analytes: glucose and creatinine.
  
  
  RESULTS
  The relationship between quality goal and expanded uncertainty defines the width of the acceptance zone; if uncertainty is equal or larger than the quality goal, the goal is not attainable.
  
  
  CONCLUSIONS
  The proposed approach uses an information, expanded uncertainty, that each laboratory seeking ISO 15189 accreditation should already have. The data presentation is immediate and easy to interpret allowing a direct comparison between the performance of the method and the quality goals.
authors: Ferruccio
authors: F
authors: Ceriotti
authors: Duilio
authors: D
authors: Brugnoni
authors: Sonia
authors: S
authors: Mattioli
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D003404:Creatinine / Q000032:analysis / Q000592:standards; D004282:Documentation; D005947:Glucose / Q000032:analysis / Q000592:standards; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D035501:Uncertainty
chemical_list: D003404:Creatinine; D005947:Glucose