Patient safety and clinical risk in the clinical laboratory haematological process

Patient safety, defined as the prevention of harm to patients, is the ultimate goal for medical laboratories. Risk management principles should therefore be considered an integral part of laboratory processes, especially of those activities directly impacting on patient care. This work aims to identify the most critical phases of haematological process and the risk reduction actions that improve patient safety. Risk analysis of the laboratory haematological process was carried out through Failure Mode, Effects and Analysis Criticality methodology. A form including the phases of the process, error modes and their possible effects, errors occurrence, detectability and severity scores and risk index (RI), has been prepared and sent to eight Italian laboratories. A multidisciplinary team performed the analysis in each laboratory, then two team leaders of the project comprehensively analysed the collected data. The process was divided in 8 phases (medical prescription, request acceptance, sample collection, transportation, reception and processing, results reporting and validation), 25 activities (17 pre-analytical, 4 intra-analytical, 4 post-analytical) and 43 failure modes. RI, calculated for each activity, ranged from 11 to 33. The most critical topics (RI >25) were: patient identification, peripheral blood smear review, interpretative comments and report validation. Staff training plays a central role in the entire laboratory haematological process and in the phases identified as critical. An effective management related to the attainment and maintenance of skills represents the best action in order to reduce risks of adverse events for patients. The promotion of procedures aimed to harmonize the interpretative comments and peripheral blood smear review is also pivotal.