Performance criteria and quality indicators for the pre-analytical phase

Clin Chem Lab Med. 2015 May;53(6):943-8. doi: 10.1515/cclm-2014-1124.


The definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for analytical quality specifications.

MeSH terms

  • Clinical Laboratory Techniques / standards*
  • Humans
  • Medical Errors* / prevention & control
  • Patient Safety
  • Quality Indicators, Health Care / standards*
  • Reference Standards