Analytical performance specifications based on how clinicians use laboratory tests. Experiences from a post-analytical external quality assessment programme

Analytical performance specifications can be based on three different models: the effect of analytical performance on clinical outcome, based on components of biological variation of the measurand or based on state-of-the-art. Models 1 and 3 may to some degree be combined by using case histories presented to a large number of clinicians. The Norwegian Quality Improvement of Primary Care Laboratories (Noklus) has integrated vignettes in its external quality assessment programme since 1991, focusing on typical clinical situations in primary care. Haemoglobin, erythrocyte sedimentation rate (ESR), HbA(1c), glucose, u-albumin, creatinine/estimated glomerular filtration rate (eGFR), and Internationl Normalised Ratio (INR) have been evaluated focusing on critical differences in test results, i.e., a change from a previous result that will generate an "action" such as a change in treatment or follow-up of the patient. These critical differences, stated by physicians, can translate into reference change values (RCVs) and assumed analytical performance can be calculated. In general, assessments of RCVs and therefore performance specifications vary both within and between groups of doctors, but with no or minor differences regarding specialisation, age or sex of the general practitioner. In some instances state-of-the-art analytical performance could not meet clinical demands using 95% confidence, whereas clinical demands were met using 80% confidence in nearly all instances. RCVs from vignettes should probably not be used on their own as a basis for setting analytical performance specifications, since clinicians seem "uninformed" regarding important principles. They could rather be used as a background for focus groups of "informed" physicians in discussions of performance specifications tailored to "typical" clinical situations.