Increasing patient safety and efficiency in transfusion therapy using formal process definitions.

The administration of blood products is a common, resource-intensive, and potentially problem-prone area that may place patients at elevated risk in the clinical setting. Much of the emphasis in transfusion safety has been targeted toward quality control measures in laboratory settings where blood products are prepared for administration as well as in automation of certain laboratory processes. In contrast, the process of transfusing blood in the clinical setting (ie, at the point of care) has essentially remained unchanged over the past several decades. Many of the currently available methods for improving the quality and safety of blood transfusions in the clinical setting rely on informal process descriptions, such as flow charts and medical algorithms, to describe medical processes. These informal descriptions, although useful in presenting an overview of standard processes, can be ambiguous or incomplete. For example, they often describe only the standard process and leave out how to handle possible failures or exceptions. One alternative to these informal descriptions is to use formal process definitions, which can serve as the basis for a variety of analyses because these formal definitions offer precision in the representation of all possible ways that a process can be carried out in both standard and exceptional situations. Formal process definitions have not previously been used to describe and improve medical processes. The use of such formal definitions to prospectively identify potential error and improve the transfusion process has not previously been reported. The purpose of this article is to introduce the concept of formally defining processes and to describe how formal definitions of blood transfusion processes can be used to detect and correct transfusion process errors in ways not currently possible using existing quality improvement methods.