Quality assurance within clinical chemistry—a brief review emphasizing ‘good laboratory practice’

Abstract

Goals for analytical quality within clinical chemistry should be recognized in order to select proper analytical methods including internal quality control systems, which in principle could guarantee the analytical quality. However, such an ideal scheme is only successful if the whole analytical milieu is well functioning. This can be achieved by following rules of good laboratory practice (GLP). Good laboratory practice includes among other things laboratory management, organization and education of the staff, written instructions for all laboratory procedures, regular check of instruments, reagents and utensils, careful laboratory work, proper reports to the clinician and discussions with the clinician whether the laboratory service is sufficient, for example, in relation to the analytical repertoire and the reporting time. Development of better calibration and quality testing materials is essential to improve quality. More elaborate external quality assessment programmes, which should also cover a much larger number of analyses, than are presently covered, is recommended. All types of clinical chemistry analyses should be covered by quality assurance including those carried out in the doctors' office and in private homes.

Key words:

• analyte simulating effect
• analytical bias
• external quality assessment
• good laboratory practice (GLP)
• internal quality control
• matrix effect
• quality assurance
• quality control
• quality testing material
• random analytical variation