Towards quality specifications in extra-analytical phases of laboratory services: What information on quality specifications should be communicated to clinicians, and how?

Abstract

Quality specifications, the level of performance required to facilitate clinical decision-making, not only have a central role in quality management in clinical laboratories, but are also essential for assuring the interpretation and utilization of laboratory information by clinicians. Laboratory tests have been grouped into five categories and the most suitable ways to communicate quality specifications to clinicians have been proposed. In particular, for tests with a uni-modal distribution, decision limits should replace the traditional reference values. For tests with a bi-modal distribution, in addition to reference values, some flags based on the uncertainty of laboratory data, can be included in the report. For tests used in patients monitoring and in evaluating the response to therapy, the reference change value or the most effective threshold of the difference between two consecutive results should be indicated. For tests/test batteries that require interpretative comments, these should be added on a regular basis. Lastly, pre- and post-test counseling is mandatory for genetic testing.