Risk Assessment Using a Fishbone Diagram

How to Subscribe
MLS & MLT Comprehensive CE Package
Includes 182 CE courses, most popular
$109Add to cart
Pick Your Courses
Up to 8 CE hours
$55Add to cart
Histology CE Package$69Add to cart
Histology CE User Increase$69Add to cart
Individual course$25Add to cart
Need multiple seats for your university or lab? Get a quote
The page below is a sample from the LabCE course Concept and Construction of a Laboratory Individualized Quality Control Plan. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Concept and Construction of a Laboratory Individualized Quality Control Plan (online CE course)
Risk Assessment Using a Fishbone Diagram

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 as indicated by 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 situations in each category that could generate erroneous test results. Causes under each category could be broken down further into sub-causes. For example, specimen integrity could include such things as a clotted specimen, hemolysis, and incorrect collection tube.