Quality specifications derived from objective analyses based upon clinicalneeds

The well-informed physician should be the best to judge the analytical qual ity needed for a specific clinical action. By presenting the physicians wit h well-designed case histories, it is possible to extract the clinical know ledge pertinent to analytical quality. The clinicians are asked which chang es in the concentration of an analyte will cause them to change actions con cerning the patient. It must be possible to detect these changes with a cer tain probability and this presupposes a certain analytical quality which ca n then be calculated. It is important that a strict methodology both for co nstructing case histories and for calculation of the required analytical qu ality is used.