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ACB-CLIN-CHEM-GEN  1999

ACB-CLIN-CHEM-GEN 1999

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Subject:

Quality Specifications in Laboratory Medicine

From:

"Ian Godber" <[log in to unmask]>

Reply-To:

Ian Godber

Date:

Wed, 12 May 1999 11:31:31 +0100

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (114 lines)

The following is a forwarded message from Callum Fraser taken from 
the conference;
STRATEGIES TO SET GLOBAL QUALITY SPECIFICATIONS IN
LABORATORY MEDICINE - STOCKHOLM April 24-26 1999;

*********************************************************

CONSENSUS AGREEMENT REACHED IN STOCKHOLM

The Organising Committee are pleased to report that the 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 [[log in to unmask]] 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:
[log in to unmask]). 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.
*********************************************************



Dr Ian Godber
Biochemical Medicine     Phone (01382) 660111 (x33364 or 33691)
Ninewells Hospital           Fax (01382) 645333
Dundee, DD1 9SY          Email [log in to unmask]


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