Independent Consultant - TSC Consulting Newtown, Pennsylvania, United States
Background/Case Studies: Given the reliance on immunohematology analyzers to perform the vast majority of pretransfusion testing, it is essential for those analyzers to routinely function at high performance levels. The reliability of the instrument is critical, as many transfusion services and blood banks depend on the efficiency and productivity of the analyzer to manage the workload of the laboratory. Even with back-up solutions at times when the instrument is down, keeping pace with the workload effectively can be challenging. Evaluating the reliability of an analyzer over time demonstrates its capability to consistently meet laboratory performance standards.
Study
Design/Methods: This study evaluated several parameters as a measure of reliability of the instruments (Ortho Vision® Analyzer (OV) and Ortho Vision® Max Analyzer (OVM)) and how they impacted analyzer dependability. The following factors were considered and measured: unscheduled service visits, hardware modifications, software updates, in-factory design improvements, training and artificial intelligence application for system diagnosis.
Results/Findings: The overall impact on OV of unscheduled visits was from the analyzer launch year at 4.8/yr down to 2.2/yr, a 54% improvement. For the OVM, an instrument of higher complexity, unscheduled visits decreased from launch year at 7.2/yr down to 4.0/yr, an improvement of 44%. Some of the impactful factors that drove ongoing improvement included hardware modifications, application software changes, software improvements addressing cybersecurity and system operability, and in-factory production improvements. Numerous training modules were utilized for field service to enhance service and support capability.
Conclusions: A Continuous Quality Improvement culture is used to identify areas for improving analyzer reliability. Implementing these improvements has had a significant impact on dependability of the analyzers, improving serviceability, performance, and operability with reductions in diagnostic and service time. Combined with remote access, preemptive monitoring and troubleshooting these analyzers and service tools have made reliability a key factor in user instrument selection.
