David rothfield memorial oration: defining analytical performance goals

Abstract

Since 1999, the ‘Consensus Agreement’ from the Stockholm Conference has provided professionally accepted guidance as to a hierarchical approach to setting analytical performance goals. However, many aspects of laboratory medicine have changed since then. In consequence, the 1 st EFLM Strategic Conference on ‘Defining analytical performance goals 15 years after the Stockholm Conference on Quality Specifications in Laboratory Medicine’ was held on 24–25 November, 2014. The conference developed a proposal for a modified and updated consensus statement. There was general agreement that three different models, again set in a hierarchy, should be used to set analytical performance goals. The proposal is simple. Model 1 is based on the effect of analytical performance on clinical consequences, which can be assessed using different approaches including outcome studies, simulations of uses of test results, and surveys of clinicians’ and/or experts’ opinions investigating clinical settings. Model 2 is the widely used strategy based on components of biological variation. Model 3 is founded on state of the art, but that should be based on the highest level technically achievable or, alternatively, could be defined as the analytical quality achieved by a certain percentage of laboratories. Whether this new approach becomes widely adopted remains to be assessed.