Quality Requirements

CONSENSUS AGREEMENT

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
e-mail [This email address is being protected from spambots. You need JavaScript enabled to view it.] or FAX [+353 1 455 9073] before the end of May. The Editorial Group [Callum Fraser, Anders Kallner, Desmond Kenny and Per Hyltoft Petersen] will then evaluate the comments received and prepare a final version that we are sure will be very widely published in a variety of formats.

"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.

Reprints will only be available as the complete set of articles. Reprints can be ordered from the secretariat of the conference (Email: This email address is being protected from spambots. You need JavaScript enabled to view it.). The price for the first copy will be USD 55; additional copies prepaid before July 31 will cost USD 35. Payment includes airmail. Payment should be made to Postgirot Bank, Swiftcode PGSISESS, account number 599143-5.