Pre-analytical specimen handling problems resulted in a 1.3% possible error rate due to temperature issues. Rework and extra handling steps ultimately allowed testing, but caused a delay in the process.
What is the main cause of 1.3% of the samples arriving at the laboratory facility at an inappropriate temperature?
Design: Six Sigma DMAIIC process using tools such as; Process Mapping, Cause & Effect, Workplace Design, and Design of Experiments (DOE)
Setting: National Clinical Reference Laboratory
Participants: Test Send-out department, Logistics, Flight Operations, and Six Sigma Black Belt team members
Interventions: Reduction of Non-Value Add steps, SOP, Visual Workplace, Work Cell Design, DOE Optimization of shipping components, Scorecard, and Control Plan
Main outcome measures: Shipping defects due to temperature issues by Business Unit and by Region.
Project resulted in a 30.6% reduction in temperature related shipping defects, minimized specimen touch points, and reduced chance of mis-directed shipments. Prevented countrywide implementation of shipping container that did not meet temperature expectations and would have resulted in increased defects across the company.
Timely identification and feedback, as well as a control plan, can reduce future occurrences of defects. Maintaining frozen temperature is dependent on insulation of shipping container, quantity of dry ice used, and transport time. Six Sigma tool such as Design of Experiments may be used to optimize these parameters to prevent specimen stability problems.
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