Clin Biochem Rev. 2012 August; 33(3): 85–88.

Pre-analytical steps, the major source of mistakes in laboratory diagnostics, arise during patient preparation, sample collection, sample transportation, sample preparation, and sample storage. However, while it has been reported that the pre-analytical phase is error-prone, only recently has it been demonstrated that most errors occur in the ‘pre-pre-analytical phase’. This comprises the initial procedures of the testing process performed by healthcare personnel outside the laboratory walls and outside the direct control of the clinical laboratory. Quality indicators (QIs) should therefore cover all steps in the pre-analytical phase, from test requesting to sample storage. In the present paper, the state-of-the-art of QIs in laboratory testing is described. The focus is on the experience of a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) in developing a model of QIs, 16 of which concern the pre-analytical phase.

American Journal of Clinical Pathology,2009, 131, 418-431.

We summarize information on quality indicators related to laboratory testing from published literature and Internet sources to assess current gaps with respect to stages of the laboratory testing process, the Institute of Medicine (IOM) health care domains, and quality measure evaluation criteria. Our search strategy used various general and specific terms for clinical conditions and laboratory procedures. References related to a potential quality indicator associated with laboratory testing and an IOM health care domain were included. With the exception of disease- and condition-related indicators originating from clinical guidelines, the laboratory medicine quality indicators reviewed did not satisfy minimum standard evaluation criteria for quality or performance measures (ie, importance, scientific acceptability, and feasibility) and demonstrated a need across the total laboratory testing process for consistently specified, useful, and evidence-based, laboratory-related quality and performance measures that are important to health outcomes and meaningful to health care stakeholders for which laboratories can be held accountable.