Workflow improvement and financial gain after integration of high-throughput sample processing system with flow cytometer in a high-volume pathology laboratory: Results from a prospective comparative study using Lean principles

Abstract

Background: Highly efficient clinical laboratories are essential for monitoring many human illnesses. Ampath Laboratory Services, the largest pathology lab in South Africa, analyzes large numbers of peripheral blood samples for CD4 levels yearly.

Objective: To assess productivity and quality of a newer integrated automated solution, the BD FACSDuet™ Sample Preparation System/BD FACSLyric™ Flow Cytometer using conventional assessment methods and Lean concepts.

Materials and methods: This prospective study compared the performance of the BD FACS™ Sample Preparation Assistant [SPA] III and BD FACSCanto™ II Flow Cytometer with the newly introduced integrated system (BD FACSDuet™/BD FACSLyric™). They were validated for accuracy, precision, and external quality assessment. Process mapping and Lean assessment helped identify steps leading to waste. An economic model was developed to characterize workflow and economic impact associated with total daily hands-on time, processing time, and reworks.

Results: Strong linear correlation was present between both systems. Precision and accuracy studies revealed that all coefficient of variation (CV)% values were below 20% of allowable limits. External proficiency assessments were within limits. The fully automated workflow of BD FACSDuet™/BD FACSLyric™ permitted better consistency with significantly shorter processing time and batch processing and reduced operator interventions. Lean assessment identified defects with motion, over-processing, waiting, and non-utilized talent. Significant reductions in hands-on and total daily processing time that could increase daily specimen testing efficiency and fewer reworks were associated with the BD FACSDuet™/BD FACSLyric™. Lean improvements translated to significant economic savings associated with operator costs and unnecessary reagent consumption.

Conclusion: BD FACSDuet™/BD FACSLyric™ is an accurate, reliable, and cost-effective fully automated system for high-volume flow cytometry labs that perform T-cell enumeration using a single-platform and single-tube approach.

Keywords: CD4 cells; Flow cytometer; Laboratories; Lean process; Workflow.