General Nordie Recommendations about
Quality Controland Quality Assurance
in Clinical Chemistry
Decided by the Board of the Nordic Society of
Clinical Chemistry (NSCC) in Oslo on March
6-7
1989 after approval by the national soci–
eties of clinical chemistry.
l. The laboratory should formulate its ambi–
tions for quality in a broad sense. Information
from the laboratory should include quality
specifications for the analyses performed. Fur–
thermore, information about request-report
times should be provided for different types of
investigations.
It
is understood that this is a
process that will require some time and some
guidance from the Nordie Committee on Qual–
ity Control of the NSCC.
2. The laboratory should try to select meth–
odology which fulfil the "medical needs". Qual–
ity should be built into the methods e.g. by
careful calibration and by stabilizing the instru–
mentation.
3. The laboratory should design control sys–
tems which ensure the intended quality to be
achieved. The system ought to provide the
management and the personnel of the laborato–
ry with information about the analytical meth–
ods (bias, different estimates of imprecision),
the control proeectures (probabilities of false
Klinisk Kemi i Norden
rejections and error detection), and quality-cost
relations. Multistep procedures, e.g. "nested
stages of control" are recommended in order to
achieve control in more complex automated
analytical systems.
It
is also desirable that the
control system (using different techniques) has
the ability to monitor and reveal gross errors.
4. The laboratory should develop local rules
of good laboratory practice-and implement
them. Writing a quality manual could be a part
of this work. Annual audit should be per–
formed.
5. The laboratory should participate in effec–
tive interlaboratory programs of quality assur–
ance aiming at minimized bias of the analytic
methods. The Nordie countries are for many
reasons-similar methodology and medical care
systems-a suitable area for co-ordinated inter–
laboratory programs. Coliabaration is facilitat–
ed in the Nordic countries if a system is intro–
duced for transferring data and for characteriz–
ing analytical methods. A proposal for data
transfer developed by the Committee on Qual–
ity Control (NKK) of the Nordie Society of
Clinical Chemistry is recommended.
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