Quality specifications: self pleasure for clinical laboratories or added value for patient management?

Analytical quality specifications play a key role in assuring and continuously improving high-quality laboratory services. However, I believe, that there are two "missing links" in the effective management of quality specifications in the delivery of laboratory services. The first is the evidence that pre-analytical variation and related problems are not taken into great consideration by laboratory professionals. The second missing link is the communication of quality specifications to clinicians and other possible stake-holders. If quality specifications represent "the level of performance required to facilitate clinical decision-making", they cannot be used only for internal quality management procedures but must be communicated to facilitate clinical reasoning, decision-making and patient management. A consensus should be achieved in the scientific community on these issues to assure better utilization of laboratory data and, ultimately, improved clinical outcomes.