Is there any process in health care that can run at or above Six Sigma level? Transfusion medicine has achieved above and beyond Six Sigma, confirming that a Six Sigma level of quality can be achieved not only in aviation or manufacturing but in health care as well.
Transfusion medicine is one of the most regulated and earliest adopters of a quality system approach to quality management. Let us look at how transfusion medicine measures up when we translate this statistic into Six Sigma.
Based on the FDA Center for Biologics Evaluation and Research (CBER) "Fatalities Reported to FDA Following Blood Collection and Transfusion" annual summary, there were 52 transfusion-related fatalities in the fiscal year of 2007 (October 1, 2006, through September 30, 2007). According to the National Blood Collection and Utilization Survey conducted by AABB, a total of 30,044,000 units of blood components were transfused in 2006. Three opportunities for defect (preanalytical, analytical, and postanalytical) will be used to determine transfusion safety in the United States. By using the formula from the previous page, we can determine both the DPMO and process sigma.
DPO = 52/(30,044,000 x 3) = 0.0000005769
DPMO = 0.0000005769 x 106 = 0.58
Process Sigma = 6.36
Transfusion medicine did not achieve the Six Sigma level of quality overnight. Other industries operating at the Six Sigma level, such as the aviation industry, have taken decades to achieve this level of quality.
