1999 Stockholm Consensus Statement
The Organising Committee are pleased to report that this recent Conference was most successful. Over 100 participants from 27 countries actively contributed to the discussions on the 22 formal presentations. Our primary aim in organising the Conference was to provide a vehicle for reaching consensus on the setting of global quality specifications in laboratory medicine. This objective was achieved and lively constructive debate after the presentations were complete led to agreement on the principles laid down in the draft Consensus Statement posted here. IFCC, IUPAC and WHO kindly sponsored the Conference but it must be noted that the Consensus Statement reflects the views of the presenters and registrants who participated in the Conference and does not necessarily represent those of the sponsoring bodies.
Comments on the draft Consensus Statement are welcome from all participants. These should be sent by
"CONSENSUS STATEMENT [DRAFT]
The main outcome of the Conference was agreement that the following hierarchy of models should be applied to set analytical quality specifications.
I. Evaluation of the effect of analytical performance on clinical outcomes in specific clinical settings
II. Evaluation of the effect of analytical performance on clinical decisions in general:
A. data based on components of biological variation
B. data based on analysis of clinicians' opinions
III. Published professional recommendations
A. from national and international expert bodies
B. from expert local groups or individuals
IV. Performance goals set by
A. regulatory bodies
B. organisers of External Quality Assessment (EQA) schemes
V. Goals based on the current state of the art
A. as demonstrated by data from EQA or Proficiency Testing schemes
B. as found in current publications on methodology.
Where available, and when appropriate for the intended purpose, models higher in the hierarchy are to be preferred to those at lower levels.
The concept of such a hierarchy is described in a recent Editorial in Clinical Chemistry in which the relative merits of the above models are discussed [Clin Chem 1999;45:321- 3].
This hierarchy has also been proposed by the ISO/TC 212/WG 3 subgroup on "Analytical Performance Goals Based on Medical Needs" as the basis for the ongoing revision of ISO/CD 15196.
The following matters were also discussed and agreed:
The above hierarchy includes currently available models; however, new useful concepts will undoubtedly evolve.
Implementation of any of the models should use well-defined and described procedures.
To facilitate the future debate on the setting of analytical quality specifications, there is a need for agreement on concepts, definitions and terms.
There is a need for continuous improvement in the exchange of information on quality issues:
between clinical laboratory professionals and the diagnostics industry and
between clinical laboratory professionals and the users of the laboratory service."
Short versions of the papers presented by all of the speakers at the Conference, together with an Introduction and the final version of the Consensus Statement will be published in a Special Issue of the Scandinavian Journal of Clinical and Laboratory Investigation (September). One copy will be sent to each participant later this year.