Clinical quality vs analytical performance: what are the right targets and target values?

For optimal performance of laboratory tests, testing processes should be designed to provide clinically useful quality and QC procedures should be selected to assure that the necessary clinical quality is achieved in routine production. One important issue is how to define clinical quality. Today’s practice guidelines, quality regulations, and quality standards provide some targets for analytical quality, but they fail to adequately address clinical quality. Target values for precision and accuracy are not the same as clinical quality, though analytical performance certainly contributes to the clinical quality of test results. How can we proceed in our quest to improve quality when there are inconsistencies and inadequacies in the specifications found in practice guidelines, regulations, and standards? Today target values are often being set for the wrong targets. A better approach is possible if we focus on test interpretation guidelines to define clinical quality, then derive specifications for the accuracy and precision that are appropriate for the method, as well the QC rules and numbers of control measurements that are necessary to guarantee the desired quality will be achieved in routine operation of the testing process.