Quality assurance in clinical perfusion

Objective: To investigate the properties and usefulness of prospective rout ine registration of incidents related to cardiopulmonary bypass and its cli nical significance as a quality assurance instrument. Methods: Incidents or deviations from the normal course observed during cardiopulmonary bypass p rocedures were registered in a computer database. Each incident was classif ied according to 14 pre-defined categories. The cause of each incident was evaluated, as well as patient outcome. Incidents leading to permanent or te mporary injury were denoted accidents. The general- and category-related in cidence rate was calculated for the observation period 1989-1997 encompassi ng 6918 cardiopulmonary bypass procedures. Results: The general incidence r ate varied between 4.5-7.6% per year during the registration period. Most i ncidents (57%) occurred during established, or start of, cardiopulmonary by pass, whereas the remaining proportion of incidents were detected either be fore (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 cas es. Conclusions: Routine registration of incidents yields a clinically attr active instrument of controlling safety aspects and quality measures in car diopulmonary bypass. The observed incidence rates are somewhat higher than previously reported, probably primarily related to the methodology implemen ted in this study. (C) 1998 Elsevier Science B.V. All rights reserved.