Automation System: Strategic Management

Abstract

In recent years, a global trend to standardise and robotise laboratory tasks has to be pointed out, mainly consisting in automation of pre-analytic and post-analytic steps of the global analysis process. These changes bring positives advantages for patients by reducing the turnaround time of analysis and for laboratories by improving specimen processing, global quality procedure, tubes flow, laboratory productivity and finally by reducing human errors and mistakes done for sample identification. Another consequence is the transfer of staff members from pre-analytic and post-analytic operations to higher value tasks, a true benefit for laboratories and status enhancing for them. To summarise this evolution we could say that, in one hand, automation proves to be very useful for patients according to the increase in quality control process and the T.A.T reduction and, in an another hand, for laboratories by increasing competitiveness in the actual bitter context of health care. The aim of this study was to appraise the various automation systems (including total laboratory automation, modular automation and exclusively dedicated systems) from Tecan®, Bayer diagnostics®, Beckman Coulter®, Dade Behring®, Olympus®, Ortho clinical diagnostics®, Roche diagnostics®, Sarstedt® and Thermo clinical labsystems® to point out their forces and weaknesses and also try to propose an appropriate method for an accurate development of automation in our laboratories. To this end, we focused our examination on the true capacity of modules, modules’ compatibility with different kind of laboratory activities, capability of each system considering their throughput, flexibility and their faculty to sort out racks by sectors (biochemistry, immunology and haematology). We also screened the effectiveness of the mechanical and software assisted by-pass system (especially for the decapper and centrifuge modules) and finally on the real ability of the L.A.S (lab automation system) to interact with the L.I.S (lab informatics’ system). To make our table of decision we used as criteria of selection the NCCLS quality and standardisation requirements and on recommendations about quality and good lab practices of the European directives ISO 17025 and ISO 15189 applied by E.A (European accreditation) for the laboratory agreement. We found that all those systems are not equal one to another and we could first highlight on the importance of studying laboratory activity to make a correlation with all systems and find the better compromise between those two activities. Secondly there is a need to analyse all parameters of automation systems to select the more efficient one. For a good appraisal of these systems we recommend to separate and analyze each step to pinpoint areas of potential improvement. To conclude we could underline that laboratory automation, principally in pre-analytic and post-analytic phases brings solutions for increasing productivity and quality in laboratories and for towards an optimal management of the care process. Automation is easier said than done and it’s important to consider a few rules and principles for the implementation of such systems.

Introduction

Automation is implementing in laboratories for change especially the pre-analytic and post-analytic steps of the global analysis process a known labour intensive bottleneck. These changes bring positives advantages for patients by reducing the turnaround time of analysis and for laboratories by improving specimen processing, global quality procedure, tubes' flow, laboratory productivity, technician’s valuable time, reduced chance for human error and finally by reducing human errors and mistakes done for sample identification. For summarize this tendency, its affecting laboratory professionals, changing laboratory technologies and the organizational framework, producing economical effects (both time and money) but where rapid response is require as same as possibility of add or emergency laboratory service (STAT). So, in the actual hard health care context, Automation importance is recognized.

Aim of The Study

The aim of this study was to appraise the various automation systems (including total laboratory automation, modular automation and exclusively dedicated systems) from Tecan®, Bayer diagnostics®, Beckman Coulter®, Dade Behring®, Olympus®, Roche diagnostics®, Sarstedt® and Thermo clinical labsystems® to point out their forces and weaknesses and also try to propose an appropriate method for an accurate development of automation in our laboratories. To this end, we focused our examination on the true capacity of modules, modules’ compatibility with different kind of laboratory activities, capability of each system considering their throughput, flexibility and their faculty to sort out racks by sectors (biochemistry, immunology and hematology) (Table 1). We also screened the effectiveness of the mechanical and software assisted by-pass system (especially for the decapper and centrifuge modules) and finally on the real ability of the L.A.S (lab automation system) to interact with the L.I.S (lab informatics’ system). To make our table of decision (Table 2) we used as criteria of selection the NCCLS quality and standardization requirements, especially based on five ways: communication, focuses on information Exchange between computers; Electromechanical interface, focuses on the integration of mechanical equipments; Specimen containers and racks, the transportation system; Specimen Identification, specifications of bar code labeling and identification, Status indicator and troubleshooting. An Automation systems evaluation have to consider also recommendations about quality and good lab practices of the European directives ISO 17025 and ISO 15189 (2) applied by E.A (European accreditation) for the laboratory agreement.

Preliminary Tasks

Workflow (total Volume, Daily Volume, Timing Study) Laboratory Activity (Chemistry, immunochemistry, Hematology, Toxicology) Collect data (Methods and Analyzers used, Evaluation of Temperature requirements, Conceptual Feasibility, Needs Assessment, Outside Consultants, Evaluation of Alternatives, Used of Project Planning) (1).

Conclusion And Perspectives

We found that all those systems are not equal one to another and we could first highlight on the importance of studying laboratory activity to make a correlation with all systems and find the better compromise between those two activities. Secondly there is a need to analyse all parameters of automation systems to select the more efficient one. For a good appraisal of these systems we recommend to separate and analyze each step to pinpoint areas of potential improvement. To conclude we could underline that laboratory automation, principally in pre-analytic and post-analytic phases brings solutions for increasing productivity and quality in laboratories and for towards an optimal management of the care process. Automation is easier said than done and it’s important to consider a few rules and principles for the implementation of such systems.

Table 1: The various automation systems classified in Modular, Total or Dedicated. MODULAR TOTAL DEDICATED BECKMAN Power Processor System Log-in, sorting, Centrifugation, Cap removal, Aliquoting, Buffer system Bidirectional with LIS / Connectivity with various analyzers. BAYER ADVIA Workcell: conveyor, input and output ADVIA Labcell: add Centrifugation and Decapping ADVIA Centralink for data's analysis No aliquoter / Closed to Bayer Analyzers. TECAN Genesis Fe 500 Workcell Tube Loading, Centrifugation, Decapping, Secondary Tube Labeling, Aliquoting, Destination Sorting (By Analyzers). THERMOCLINICAL TCA Automation Multitube Carrier, Conveyors, Controller, Exit Module, Entry Module, Centrifuge Module, Decapper module, Aliquoter/Labeler Module, Check Module,Buffer Module, By-passs Modules, Drawer for Analyser Specific Racks . DADE BEHRING StreamLAB Workcell For high volume lab Sample Input / Output, Centrifugation, Decapping, Sample Wheel, Track transport module Closed to Behring Analyzers. OLYMPUS OLA 4000: output trays for offline analyzers and disposal /No Centrifuge, No Aliquoter OLA 2500 decapping, sorting, labeling, aliquoting steps (liquid + clot Detection) / No centrifuge OLA 1500 decapping and sorting / No centrifuge Camera station: reco-gnition of tube type, size but also sample material Bidirectional interface For OLA 2500 and 1500. ROCHE MPA : Centrifugation, Decapping, Aliquoting and Labelling, Recapping, Sorting, Sample Transportation. SARSTEDT Sarstedt Decapper Compatible with Hitachi and Olympus Racks PVS .

Table 2: table of decision for automation system choice NEEDS SOLUTIONS COMMENTS Laboratory Automation? ROBOTIC/ STANDARDISATION Laboratory Activity ? Price Index, Files, Tubes or Requests Workflow Study Particular Technical Charges Book Activity Peak (Hours-Days) ? Need of an Aliquoting System? Serial or Parallel System ? What Laboratory sectors need Automation? Totality of the Lab ? Only one Sector ? Just one step of the Analysis ? Total Laboratory Automation (TLA) Modular Systems (Open or Closed?) Dedicated pre-post analytical Tasks Consolidation > Rigid / Cost >Flexible/ Progressive > Compact / Verify the Throughput >Fusion/Connectivity of Analyzers Necessary Automated Units? - Input Module ------ - Centrifuge ---------- - Decapper ----------- - Aliquoting System- - Conveyor ----------- - Buffer Module - Sorting Unit ---------- -Capacity ? -Capacity ? Cooling ? By-pass ? -All Tubes Types? By-pass ? -Speed ? Parameters ? -Kind of Racks ? Physical link with Lab Analyzers (Open or Closed System) -Capacity ? Archiving ? Modular Systems permit Evolution of the System Considering Needs and Lab economical possibilities… But more space consuming than dedicated systems. Evaluate the true Capability of re-pass and reflex test Selectivity of the System of Choice? Different Tubes, different needs Measurement of Capability of mechanical By-pass or software capability of By-pass Especially for Decapping, Centrifuge Units and Aliquoting Units Traceability – Security? Taking part of The Laboratory Quality System Include Tracking of Samples System safety by Conveyor Conformity with agency and Rules for Quality System and Lab Agreement LIS–LAS interactivity? Make a comple-mentary Unit Effectiveness of Bidirectional exchange and evaluation in the lab Capacity of «Adds» Real Time Integration Actual LAS do not corresponding to this Harmony

References

1- Hawker. C et al. Automated Transport and Sorting System in a Large Reference Laboratory: Part I. Evaluation of Needs and Alternatives and Development of a Plan. Clinical Chemistry, 48:10, 1751-1760, 2002. 2-General requirements for the competence of testing and calibration laboratories. ISO / FDIS 15189: Quality management in the medical laboratory. ISO / IEC 17025, 1999.