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

Area of Science:

• Clinical diagnostics
• Molecular biology
• Laboratory management

Background:

• High-complexity clinical laboratories require efficient methods for detecting SARS-CoV-2.
• Next-generation sequencing (NGS) offers a powerful tool for viral detection but requires robust quality control.
• Scalability is crucial for meeting public health demands during infectious disease outbreaks.

Purpose of the Study:

• To quantify the impact of quality control (QC) metrics on testing efficiency for SARS-CoV-2 detection using amplicon-based NGS.
• To develop and implement internal QC methods for high-accuracy testing and rapid scalability in a Clinical Laboratory Improvement Amendments-certified laboratory.
• To assess the effectiveness of the Lean Six Sigma model in optimizing laboratory workflows.

Main Methods:

• Implementation of the Lean Six Sigma model to enhance efficiency in sequencing-based COVID-19 detection.
• Development of internal quality control (QC) procedures tailored for amplicon-based NGS.
• Application of Lean Six Sigma principles to streamline laboratory processes and minimize errors.

Main Results:

• The Lean Six Sigma model application led to increased laboratory efficiency and reduced critical testing errors.
• Laboratory capacity was enhanced, allowing for higher testing volumes with optimized staffing levels.
• Significant improvements in turnaround time for SARS-CoV-2 testing were achieved.

Conclusions:

• Execution of the Lean Six Sigma model successfully increased laboratory efficiency and decreased critical testing errors.
• The implemented QC strategies have prepared the laboratory for substantial scaling, with a capacity for up to 50,000 tests per day.
• This approach demonstrates a viable strategy for enhancing diagnostic laboratory performance and scalability.