The Nordie Protein Project
A NORDKEM-project on Analytical Quality Management
Kristian Bj0ro\ Ole Blaabjerg
2 ,
Arto Icen3, Kerttu lrjala4, and Per Hyltoft Petersen
2 5
J.
Dept Med
J,
Rikshaspitalet, N-0027 Oslo
J,
Norway
2. Dept Clin Chem, Odense University Hospital, DK-5000 Odense
C,
Denmark
3. lnst f Clinical Chemistry, Helsingfors University, SF-00290 Helsingfors, Finland
4. University Central Hospital of Turku. Central Lobaratory Kiinamyllykatu 4-8, SF-20520 Turku, Finland
5. Correspondance to Per Hyltoft Petersen
INTRODUCTION
In 1986 The Nordie Committee on Quality
Contro
l
decided to establish The Nordie Protein
Project as a mode! for analytical Quality Achie–
vement in The Nordie Countries. The project
should combine the elements of a quality policy,
quality improvement, and quality control -
and, thereby, serve as a model for a more general
approach to Nordie analytical quality manage–
ment within Clinical Chemistry.
From 1987 the project was supported from
Nordkem and cooperation was established with
Labquality, the Uppsala computer group (Tors–
ten Aronsson), The Finnish protein group, The
Danish protein group, The Danish Society of
Clinical Chemistry, and IFCC s working group
on specific plasma proteins. Preliminary re–
ports have been published
{1 ,
2, 3, 4, 5, 6).
Basic Concept
These are three indispensable elements of ana–
lytical quality
(1):
A. Knowledge of the needed (or desired) quality
in order to judge whether a certain procedu–
re/ performance is good or poor, i.e. goals for
analytical quality (quality specifications).
B. Establishment of the needed/ desired analyti–
cal quality in the laboratory (i) by choice of ex–
terna! factors (analytical principle, equipment,
reagents, and standarization/ calibration) and
(ii) by proper implementation and performan–
ce, and
C.
Documentation of the current analytical per–
formance in externa! quality assessment sche–
mes, and by intemal control, rnanitaring the
Klinisk kemi i Norden 4, /992
long-term stability and guaranteeing the daily
analytical quality of reported results.
In the project these three basic elements are
coordinated (Fig.
l)
in order to fulfil an overall
strategy.
GOALS FOR
ANALYTICAL QUALITY
GREATlON OF
CONTROL OF
ANALYTICAL QUALITY
ANALYTICAL QUALITY
Fig.
J.
The three basic elements oj analytical qua/ity
Overall Strategy
The overall strategy is to establish common refe–
rence intervals for healthy individuals for nine
plasma proteins in the Nordie CountriesNOTE
l.
In consequence the following must be fulfilled:
a. Distributions of thenineproteins must be in–
vestigated and described over the countries.
b. Based on these distributions the quality spe–
cifications must be defined for the laboratory
to use the common reference intervals.
c. A common standardization/calibration is
needed.
d. Analytical proeectures must be in accordance
with the quality specifications.
e. Control systems must be established in order
to document the needed quality.
NOTE
1:
The populations must be homogeneous for the
quantity.
15
