Background/Case Studies: Our production laboratory conducts blood donor screening using advanced, fully automated testing platforms to deliver timely and accurate results to our customers. Annually, we process over 7.5 million samples and generate approximately 50 million test reports for whole blood, source plasma, and specialty plasma collectors. To further minimize quality events and improve operational efficiency, we piloted an error grading system designed to classify errors more effectively. This system enhances visibility into low-impact errors while seamlessly integrating with our Quality Events Management System.
Study
Design/Methods: Laboratory Management devised an error management framework, classifying errors into three distinct levels. Level 1 errors consist of those resulting in no impact, have source documentation, or require error correction. These errors are captured for tracking and trending using established thresholds determined by frequency/impact. Level 2 errors result in minimal or potentially low impact with no formal corrective or preventative action required. A level 3 error, the most critical, would have a high impact and require formal corrective and preventative actions. Level 2 & 3 errors are documented within our Quality Events Management System as incidents and events. The piloted framework was initiated the week of 04/23/2024.
Results/Findings: The error management framework encouraged increased reporting by techs, increased visibility to process inefficiencies, increased closure rates for quality events, and reduced the Cost of Poor Quality (COPQ) metrics. Previously, quality events were launched by laboratory management, but with the implementation of the error management framework, the laboratory technologists became reporters for the various errors. Those that were once accepted as part of the process were brought to the attention of the lab, leading to various process improvements. This framework also led to improvements in quality event closure rates from 27 days in Q4 2023 and 23 days in Q1 2024 to 17 days in Q2 2024 and 16 days in Q3 2024. Additionally, COPQ metrics were reduced by 58%, from an average monthly cost of $26,543 (May 2023-March 2024) to an average monthly cost of $11,123 (April 2024-Decemeber 2024).
Conclusions: The piloting of the error management framework allowed us to capture and track quality errors and process inefficiencies. Previously, these errors would not have been identified and tracked as there was no impact and, therefore, were not deviations. The improved visibility and reporting allowed successful implementation of process improvements, reduced average event closure times by 9 days between Q4 2023 and Q3 2024, and reduced average monthly COPQ metrics by $15,420 (58%).
