The next wave of innovation in laboratory automation: systems for auto-verification, quality control and specimen quality assurance

Abstract

Laboratory automation in clinical laboratories has made enormous differences in patient outcomes, with a wide range of tests now available that are accurate and have a rapid turnaround. Total laboratory automation (TLA) has mechanised tube handling, sample preparation and storage in general chemistry, immunoassay, haematology, and microbiology and removed most of the tedious tasks involved in those processes. However, there are still many tasks that must be performed by humans who monitor the automation lines. We are seeing an increase in the complexity of the automated laboratory through further platform consolidation and expansion of the reach of molecular genetics into the core laboratory space. This will likely require rapid implementation of enhanced real time quality control measures and these solutions will generate a significantly greater number of failure flags. To capitalise on the benefits that an improved quality control process can deliver, it will be important to ensure that an automation process is implemented simultaneously with enhanced, real time quality control measures and auto-verification of patient samples in middleware. Therefore, it appears that the best solution may be to automate those critical decisions that still require human intervention and therefore include quality control as an integral part of total laboratory automation.

Integrating Patient-Based Real-Time Quality Control (PBRTQC) in a New Field: Inter-Comparison between Biochemical Instrumentations with LDL-C

“…The Committee on Analytical Quality of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCLM) has also clearly stated that using PBRTQC in clinical practice should be encouraged [7,22]. It has shown substantial value and promise in clinical practice and research in laboratories of all sizes and has succeeded in becoming a next-generation quality management tool for the improvement of error detection [23,24]. Moreover, scientific studies have demonstrated the applicability of PBRTQC as an effective IQC method in the field of molecular diagnostics and point-of-care testing (POCT) [23,24].…”

“…It has shown substantial value and promise in clinical practice and research in laboratories of all sizes and has succeeded in becoming a next-generation quality management tool for the improvement of error detection [23,24]. Moreover, scientific studies have demonstrated the applicability of PBRTQC as an effective IQC method in the field of molecular diagnostics and point-of-care testing (POCT) [23,24].…”

Clinical application of intelligent technologies and integration in medical laboratories

“…The Cobas® 8000 system (Roche, Basel, Switzerland) is an automated assembly line that can independently handle sample processing, analysis, storage, sorting, decapping, calibration, and capping. Because of the increasing complexity of automation, real‐time automated quality control measures are an indispensable part of an intelligent laboratory [9]. Abbott Diagnostics recently released a highly automated system for pre‐analytical tasks that connects to a multi‐instrument core laboratory, thereby facilitating integration with third‐party systems and enhancing test integration across different laboratory disciplines.…”

“…Abbott Diagnostics recently released a highly automated system for pre-analytical tasks that connects to a multiinstrument core laboratory, thereby facilitating integration with third-party systems and enhancing test integration across different laboratory disciplines. These centralized systems have been proven to decrease human errors and improve analyzer performance [4] and have been widely and maturely used in clinical biochemistry, clinical immunity, and clinical testing [10] although they have primarily been applied in microbiology laboratories [9,11]. A system based on deep learning that uses preprocessed serum images to assess serum quality may potentially be used as an accurate, efficient, and lowinterference solution in clinical laboratories [12].…”

A Lean-Based Approach to Overcome Laboratory Challenges Using Process Excellence (PEx) Methods & Integrated Solutions – Experience of a Tertiary Care Laboratory from Mumbai

“…There is an increased demand in the current diagnostic industry to improve Turn around time & efficiency in laboratory. Technology and process improvement methods have greatly helped labs in overcoming the common challenges like improving efficiency in the face of volume increase, manpower constraints and space optimization 5 .…”