Clinical Laboratory Automation Buying Guide

Flow Cytometry Buying Guide image
1. Why Total Automation?
2. Understanding your Workflow
3. Lean Six Sigma
4. Types of Laboratory Automation
5. Planning
6. Conclusion

The prospect of automating a laboratory can be a daunting one. This guide is intended as a starting point for laboratory managers who are about to undertake the process. In this document we will consider the advantages of automation, points to consider during planning, and types of laboratory automation.


Why Total Automation?

The first clinical laboratories were automated in the mid 1990’s and many pathology departments have now implemented a degree of automation to enable them to meet current demands. The goal of automation is to optimize lab performance by improving quality, lowering laboratory costs, reducing turnaround times, improving productivity, avoiding labeling errors and minimizing repetitive manual tasks for staff. Total automation refers to the automation of all processes that occur between sample arrival and entry into the lab, through to archiving and/or disposal of the sample post-testing.

There is much to consider before implementing such a system, but done correctly and planned well, the rewards are great. Automation does not have to be an ‘all or nothing’ approach. Many laboratories have partially automated their processes, for example it is possible to automate the front-end of specimen processing, enabling a facility to reap some of the benefits associated with automation without having to completely overhaul the department.

Understanding your Workflow

The key to implementing a successful automated system is a comprehensive understanding of your workflow. This will enable you to design a system that provides optimum efficiencies for your laboratory. Laboratories vary enormously in terms of workflow, workload, in-patient/out-patient work ratio, physical laboratory space, data inputting requirements etc.

The starting point for automating a process is to fully understand that process. Follow each specimen type from its entry into the laboratory, through pre-analytical processing, analysis, result output and specimen storage. Processes need to be scrutinized and optimized before the next step in the process is taken. Key to this stage of the planning is that you do not want to automate a bad process!

Lean and Six Sigma management methods should be employed here to help you to streamline your workflow.

Lean Six Sigma

The concept of Lean working originated in Japan in the 1950’s and was initially developed and refined by Toyota in the automobile industry. A Lean laboratory is one which is focused on delivering results in the most efficient way possible either in terms of cost or speed, or both. In a clinical laboratory, the goal is to use less effort, fewer resources and less time to analyze the incoming patient specimens.

Six Sigma is a managerial tool that was developed by Motorola in the 1980’s and in its simplest form can be defined as variance reduction. It aims to reduce the cost of products, eliminate defects, and decrease variability in processing. It consists of five steps: define, measure, analyze, improve, and control.

There is a wealth of information regarding Lean online; however some important Lean Principles are as follows:

  • Elimination of waste: The main focus of Lean is to eliminate all forms of waste that add no value to the product or service provided. Forms of waste include: Defects; Over-production; Waiting; Transport; Motion; Inventory; Over-processing; Under-Utilizing People; Inappropriate Automation.
  • Value-stream mapping: The methodology of value-stream mapping means diagramming and analyzing services (value streams) into their component process steps, and eliminating any steps that don’t deliver value. This can be important in highlighting differences between what we think is happening in a process, and what is actually happening in a process. The removal of steps which create waste improves flow, optimizes activity, improves quality and reduces costs.
  • Flow: Another fundamental concept of Lean, flow refers to the continual movement of products or services through a process. Interruptions to the flow can cause bottlenecks and delays. Work should be pulled through process rather than pushed, however most processes are designed as push processes. This is because they are easier to manage and do not rely on significant communication between the stages. The changing of processes to work in ‘pull’ mode is a key part of moving to Lean and demand from downstream should define activity upstream.

Lean Six Sigma combines the two important improvement processes of Lean and Six Sigma: Six Sigma principles making work better, and Lean principles making work faster. These complementary approaches allow managers to plan for laboratory automation by developing the best plan possible, with the most effective use of resources available.

Further information on Lean can be found at: The Lean Enterprise Institute, Inc. (LEI)

Diagnostic manufacturers specializing in total automated solutions for the clinical laboratory increasingly offer a workflow assessment. A typical assessment involves the vendor watching a process as it exists currently, determining where the bottlenecks occur, and then determining how improvements can be made both now and in the future. Even if you are not going for a total automation approach, a professional workflow assessment could still provide you with extremely valuable information on how best to optimize the efficiency of your laboratory.

Types of Laboratory Automation

Open vs Closed Automation Systems

This is quite probably the most important decision to make when planning for your laboratory system. An open system is an automation line on which both the software and hardware can incorporate all types of analyzers, and different makes of pre- and post-analytical instrumentation.

For an open system you purchase the track separately and then custom build your system based on your laboratory requirements. The major advantage of this is that it gives the laboratory the freedom to pick and choose the instrumentation for the automation line as well as giving a large amount of flexibility in track layout and design. Some vendors form partnerships with external track suppliers and are able to offer the track as part of an arranged agreement with the laboratory. The disadvantage of an open system is that it requires significant work and validation on the behalf of the laboratory to determine which instruments and track system to include.

Image: Rapid Response Universal Specimen Handling (RRUSH®) system, Labotix®

A closed system is usually a pre-defined package of instrumentation and automation lines from a specific vendor. This may include other manufacturer’s equipment but this will be specified and chosen by the vendor. The hardware and software in a closed system is designed to be specific to the vendor’s analyzers which can make incorporation of an outside instrument extremely difficult, if not impossible. Closed systems do not offer the flexibility of open systems and are more difficult and costly to modify, however the major advantages of installing them are that they are organized by the vendor, they are complete systems, and they are ready to use upon installation.

Image: Sysmex HST-NTM Total Hematology Automation System, Sysmex

Continuous Flow & Batch Processing

Sample flow through a laboratory takes one of two forms in a fully automated laboratory. In batch processing, samples are prepared for processing by pre-analytical integrated instruments, then in high-throughput laboratories, large numbers of specimens will be racked-up and transported to instrument starting points. Batch processing offers the advantage of allowing laboratories to be efficient with QC and reagents. A disadvantage of batch processing is that it is necessary to take numerous aliquots at the pre-analytical stage leading to potential problems with sample retrieval and quality management.

Image: Cobas 8100 Intelligent Automated Workflow Series, Roche Diagnostics

Continuous flow systems allow single patient specimens to be placed on a continuously moving conveyor belt which stops at all analyzers necessary for the appropriate tests to be performed. These systems are becoming increasingly popular for the enhanced workflow efficiency that they offer; from a LEAN perspective, continuous flow provides consistent flow of process – eliminating wasteful steps and the potential for error.

Image: Aptio™ Automation, Siemens Healthcare Diagnostics

Pre-Analytical & Post Analytical

Pre-analytical refers to the preparation of specimens prior to processing and can vary considerably depending on the type of laboratory and the sample types being handled. The method of processing will depend on whether a continuous flow or batch processing approach is being used. Integrated instruments which de-cap, centrifuge, sort and aliquot samples are available. There are instruments available which are capable of interfacing with both continuous flow and batch processing automation.

Image: Power Processor Sample Handling System, Beckman Coulter

Alternatively, modular components can be utilized to perform de-capping, centrifugation and aliquoting processes as part of the continuous automation line.

Image: VersaCell® System, Siemens Healthcare Diagnostics

The last approach is to perform pre-analytical tasks manually however this really should be avoided. Manual de-capping and aliquoting in particular can cause carpal tunnel injury and are repetitive tasks for staff.

Post-analytical instrumentation requires removal of samples to a holding area or stockyard from which it may be retrieved if additional testing is required. Exit robots vary in their capabilities; some sort samples for distribution to other laboratories, some have a refrigeration unit, and others have aliquot modules. The type of instrument that you require will depend very much on your further testing requirements.

Image: AutoMate™ 2500 Family Sample Processing Systems, Beckman Coulter.

Planning

General planning, begun as early as possible, will smooth the transition to the new automation system.

  • Tube size and manufacturer is extremely important and must be compatible with your chosen track and instruments. Factors to consider include size of tubes, insufficient samples and pediatric samples. Specimen containers will need to be standardized across all units, and this process needs to be well into place by the time the new system is installed. You will also need to consider data entry, barcoding and specimen labelling requirements.
  • The workflow data collected during your laboratory analysis/assessment should be considered so that you can be sure that your chosen system will be able to handle workload requirements. In particular, attention should be paid to workload variations over the course of a day, STAT requirements, and staffing levels.
  • Physical layout of the laboratory needs to be considered, and staff who will be working with the system need to be closely consulted throughout the whole process. Data entry sites, electrical sockets, pillars, posts, doors, etc, will all affect the layout of your system. Total automation systems have significant space requirements and this can be a limiting factor at the planning stage.
  • Staff training is crucial for obvious reasons when installing new systems and instruments. However broader educational training may help to allay some concerns that arise with the topic of total automation. Laboratory managers and diagnostic manufacturers talk about implementing automated systems to utilize staff skills appropriately, and to maximize the efficiency of a laboratory. Clinical scientists and technicians may see it as a way of cutting staffing costs and reducing the skill level of a department. Open and honest discussions should be encouraged during the whole planning process and the benefits of automating processes fully explained.
  • The intelligent technology behind an automation solution is critical. The laboratory information system (LIS) organizes flow of patient’s specimens as well as import and export of lab data. Therefore it optimizes workflow, as well as supporting daily operations such as auto-verification and quality control. Consideration should be given to the LIS that accompanies any automated solution, and associated costs such as software upgrades and hardware requirements must be taken into account.

Video: See inside one of the largest automated laboratories in the world. In this video, Dr Claudio Pereira, Clinical Director at DASA discusses the automated solutions that are in place at the DASA Brazilian laboratories.

Conclusion

Purchasing or updating an automation system is a significant investment for any laboratory. Every lab is different and must be assessed individually. Managers must take into account the current needs of the laboratory but must also future-proof any system so that it meets the long term needs of the department. Before starting the process, it is important to identify the opportunities for improvement and gain acceptance from all stakeholders. The single piece of advice repeated most often during the research of this buying guide, was to visit other laboratories and speak to other managers who have gone through the implementation process. Read case studies and learn from the experience of others. Proper preparation and planning should leave you with an automated solution designed uniquely to fit the needs of your laboratory for many years to come.

Download a PDF version of the Clinical Laboratory Automation Buying Guide.

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