Lean Principles to Improve Quality in High-Throughput COVID-19 Testing Using SwabSeq: A Barcoded Sequencing-Based Testing Platform

Objective: To describe and quantify the effect of quality control (QC) metrics to increase testing efficiency in a high-complexity, Clinical Laboratory Improvement Amendments-certified laboratory that uses amplicon-based, next generation sequencing for the clinical detection of SARS-CoV-2. To enable rapid scalability to several thousands of specimens per day without fully automated platforms, we developed internal QC methods to ensure high-accuracy testing. Methods: We implemented procedures to increase efficiency by applying the Lean Six Sigma model into our sequencing-based COVID-19 detection. Results: The application of the Lean Six Sigma model increased laboratory efficiency by reducing errors, allowing for a higher testing volume to be met with minimal staffing. Furthermore, these improvements resulted in an improved turnaround time. Conclusion: Lean Six Sigma model execution has increased laboratory efficiency by decreasing critical testing errors and has prepared the laboratory for future scaling up to 50,000 tests per day.

Automated summary

By applying the Lean Six Sigma model, the laboratory has successfully increased testing efficiency, reduced errors, increased testing volume, and improved turnaround time.