Background: In February 2001 Good Samaritan Hospital in Dayton, Ohio, conducted a Failure Mode and Effect Analysis (FMEA) on the blood transfusion process to reduce the risk of problems inherent in the procedure. DEVELOPING THE FMEA: The major steps of the analysis were to identify problems (failure modes), define their causes, and surmise the effects if failures occurred. Numerical scores were assigned for the likelihood of failure occurrence, the severity of the effects, and the possibility that the failure would escape detection. These scores were multiplied and reported as a risk priority number (RPN) for each failure mode. Solutions (process redesign actions) and monitoring plans (design validation) were developed to address the failure modes with the highest RPNs. PRESENTING THE FMEA: In March 2001 the FMEA document was presented to the Safety Board, which approved design changes such as use of a blood barrier system that restricts access to the blood until a patient-specific code is dialed.
Results: Measures were developed to analyze results, and rapid-cycle Plan-Do-Study-Act methodology was used to test and document redesign changes; most became the standard operating procedure. The new process accomplished its purpose of preventing serious, avoidable errors. No outcome errors occurred from March 2001 through June 2001 or in the 8 months following housewide implementation on June 18, 2001.
Discussion: FMEA was a valuable tool in error-trapping the blood transfusion process. Yet the FMEA process was time-consuming, tedious, and difficult and should be reserved for an organization's highest-priority processes.