A Review of the Literature

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 diseaseand 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 evidencebased, 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. Laboratory testing and services have an important role in the provision of health care and in utilization and reimbursement. Assessing the quality of laboratory services using quality indicators or performance measures requires a systematic, transparent, and consistent approach to collecting and analyzing data. A comprehensive approach would address all stages of the laboratory total testing process,1 with a focus on the areas considered most likely to have important consequences on patient care and health outcomes. Quality indicator data should be collected over time to identify, correct, and continuously monitor problems and improve performance and patient safety by identifying and implementing effective interventions and for the purpose of increased consistency and standardization of key processes among clinical laboratories. Certain laboratory medicine quality indicators have been advocated for use as internal quality assessment tools.2-4