Quality assurance in clinical perfusion.

Objective: To investigate the properties and usefulness of prospective routine registration of incidents related to cardiopulmonary bypass and its clinical significance as a quality assurance instrument. Methods: Incidents or deviations from the normal course observed during cardiopulmonary bypass procedures were registered in a computer database. Each incident was classified according to 14 pre-defined categories. The cause of each incident was evaluated, as well as patient outcome. Incidents leading to permanent or temporary injury were denoted accidents. The general- and category-related incidence rate was calculated for the observation period 1989-1997 encompassing 6918 cardiopulmonary bypass procedures. Results: The general incidence rate varied between 4.5-7.6% per year during the registration period. Most incidents (57%) occurred during established, or start of, cardiopulmonary bypass, whereas the remaining proportion of incidents were detected either before (27%) or when terminating (16%). The most common category of incidents was oxygenator failure (1.6%), followed by mechanical (1.4%) and surgical (1.2%) incidents. Accidents and fatal outcomes occurred in 0.03% of the cases. Conclusions: Routine registration of incidents yields a clinically attractive instrument of controlling safety aspects and quality measures in cardiopulmonary bypass. The observed incidence rates are somewhat higher than previously reported, probably primarily related to the methodology implemented in this study. (C) 1998 Elsevier Science B.V. All rights reserved.