Process and risk analysis to reduce errors in clinical laboratories.

Abstract BACKGROUND: An important point in improving laboratory quality is the definition of some indicators to be monitored as measures of a laboratory trend. The continuous observation of these indicators can help to reduce errors and risk of errors, thus enhancing the laboratory outcome. In addition, the standardization of risk evaluation techniques and the definition of a set of indicators can eventually contribute to a benchmarking process in clinical laboratories. METHODS: Five Italian hospital laboratories cooperated in a project in which methodologies for process and risk analysis, usually applied in fields other than healthcare (typically aeronautical and transport industries), were adapted and applied to laboratory medicine. The collaboration of a board of experts played a key role in underlining the limits of the proposed techniques and adapting them to the laboratory situation. A detailed process analysis performed in each center was the starting point, followed by risk analysis to evaluate risks and facilitate benchmarking among the participants. RESULTS AND CONCLUSIONS: The techniques applied allowed the formulation of a list of non-conformities that represented risks of errors. The level of risk related to each was quantified and graphically represented for each laboratory to identify the risk area characteristic for each of the centers involved.