Risk assessment should be a team effort.
A team approach:
- Utilizes group knowledge
- Highlights possible variations in a process
- Indicates areas where more data should be collected
One of the tools that can be used by the laboratory team performing the risk assessment is the cause-and-effect diagram, also referred to as the "fishbone" diagram because of its appearance. The cause-and-effect diagram provides a structure for identifying areas that are contributing to a problem. In the diagram below, the problem (effect) is incorrect test results. The five general categories specified by CLIA are placed on the diagram. These are sources of potential failures/errors (specimen, environment, reagent, test system, testing personnel).
The team will then brainstorm to identify possible causes in each category that could result in incorrect test results. Causes under each category could be broken down further into sub-causes. For example, specimen integrity could include such things as clotted specimen, hemolysis, and incorrect collection tube.