Abstract

INTRODUCTION
Many different solutions are now available to automate pre-analytical tasks which still remain the most time consuming manual activities in diagnostic laboratories. However, there is some controversy going on, as some laboratories are happy with a particular solution, while others admit that after a period of time, they have not gained the efficiency they sought. Obviously, this has something to do with individual laboratory processes and how well a particular solution fits in.
TECAN and Abbott have come together to maximize Tecan's expertise in reliable automation solutions for diagnostic laboratories and Abbott's history in diagnostic instrumentation.
The GENESIS FE 500 is the integral piece in Abbott's flexible laboratory automation solution.

GENESIS FE 500, and Abbott Architect & Aeroset
How can you measure the effectiveness to be gained with new equipment BEFORE installation? How can you justify the investment necessary PRIOR to purchase? How can you calculate the payback period BEFORE having spent the money? And, most important, how can you be sure that a particular solution will be as effective as advertised by the manufacturer in YOUR SPECIFIC laboratory environment?
TECAN's answer to all these questions can be found in the newly developed GENESIS FE Workflow Analysis (WFA).
THE GENESIS FE WORKFLOW ANALYSIS
In order to assess the benefits of the GENESIS FE workcell in a specific laboratory setting, a thorough analysis of the current workflow is required. While our product specialists and sales representatives have been trained to guide customers through the GENESIS FE Workflow Analysis, the relevant information has to come from the customer.
The relevant information is an accurate estimate of time and cost of manual labor currently needed to accomplish all tasks which will be automated by the GENESIS FE 500.
Based on this relevant information and a predefined set of simulation data, the GENESIS FE Workflow Analysis software compares the manual process with the automated process, regarding time and cost to perform the same tasks.
The GENESIS FE Workflow Analysis software then calculates the payback period and also the FTE (Full Time Equivalent) savings.
Having our customers so deeply involved offers a lot of advantages:
A true and specific situation will be reflected, with all results dependent on the strongest source of accurate input available -the individual customer
Calculation paths are easy to follow, all formulas used within the GENESIS FE Workflow Analysis software are visible to the customer
After completion, all data entry and result sheets will be available as a booklet. The booklet and its content can be used by laboratory managers as a powerful tool to outline the effectiveness of pre-analytical laboratory automation by introducing the GENESIS FE workcells.
HOW DOES THE GENESIS FE WORKFLOW ANALYSIS SOFTWARE WORK?
The GENESIS FE Workflow Analysis software comes on a CD-ROM, with an introduction on how to enter the required data.
General customer data, such as address, contacts, etc., are to form a record.
Sample arrival information is filled in showing when and how many samples arrive in a laboratory on an average day (refer to Figure 2, Arrival Pattern). This is an important factor in determining the number of GENESIS workcells needed and also impacts the average processing time. On a side note, it is amazing to see how fast the GENESIS FE workcell recovers from peak loads, which exceed the hourly throughput of the system, back to average processing times. Even if peak loads occur that are higher than the average throughput of the GENESIS FE workcell, in most cases there is no need for an additional GENESIS FE workcell. As different sample arrival patterns occur, different workflow analyses can be calculated, stored and compared.

Arrival Pattern
Sample type and primary/secondary tube distribution are calculated along with the aliquot and centrifugation ratios. These two figures have an important impact on the throughput of any pre-analytical system.
Two different modes are available in the result sheet to calculate the total manual effort. It can be done by entering either the timing details or the FTE's needed to accomplish the pre-analytical labor, that is to be automated by the GENESIS FE work-cell. We recommend calculating results in both modes to use it as a crosscheck. A FTE time/cost calculation is also provided, numbers such as salary, vacation, etc., are important to get accurate results. When entering timing details, you can enter actual data or choose default values, which represent typical and average values found during market research and tests.
The GENESIS FE workcell needs a minimum of human intervention during daily operation and maintenance. The time needed to perform these activities can be viewed in the chart showing the operator workload distribution.
The results of the Workflow Analysis will be calculated using the data entered and the predefined set of simulation data. Information is presented to show how effective the GENESIS FE workcell will be once it is introduced to the laboratory process. And, most importantly, not just for any laboratory process but for each individual process of a particular customer.
The following statistics are generated:
GENESIS FE workcell throughput numbers
Laboratory statistics (number of tubes received, distribution, etc.)
Total manual efforts currently required
Detailed FTE savings and payback period calculation
Comparison chart FTE usage: manual vs. GENESIS FE workcell (refer to Figure 3., FTE Usage)

FTE Usage

Workflow Analysis Result
Of course, financial savings are not the only benefits the GENESIS FE workcells offer. There are a lot more advantages to the introduction of a GENESIS FE workcell in the pre-analytical process of a laboratory:
Continuity in sample preparation quality
Increase in productivity
Efficient use of laboratory space due to small footprint
Increased safety for laboratory staff
We will be happy to perform the Genesis FE Workflow Analysis in your laboratory now. Based on a Co-Promotion Agreement, ABBOTT Diagnostics is marketing the GENESIS FE 500 worldwide. Therefore please contact your Abbott Sales Representative for more information.
WHERE ARE WE TODAY — A GENESIS FE WORKCELL STATUS REPORT
When the GENESIS FE 500 prototype was first presented at MEDICA 98 in Düsseldorf, the customer response was overwhelming. For the first time in the pre-analytical history one workcell combined all necessary functions:
Pre-sorting
Centrifugation
Decapping
Secondary tube labeling
Aliquoting
Racking

GENESIS FE 500
Customer interest has continued to increase. At each diagnostic trade show we get very positive feedback from customers.
Meanwhile, the engineers at TECAN AG have progressed quickly, extremely motivated by the huge interest in the GENESIS FE 500. All development milestones have been met, and at AACC 99 in New Orleans we were able to show a fully functional GENESIS FE 500.
At AACC 99, customer excitement reached an all time high as the features of the GENESIS FE 500 were explained. The small footprint, the amount of functionality integrated and the advantage of its open architecture, which allows the use of different tubes as well as racks from all diagnostic manufacturers, convinced many visitors.
The GENESIS FE workcell software, which consists of the GUI (Graphical User Interface) and the editor, was also shown at AACC 99 for the first time. This powerful and very user-friendly software package was a very important factor in making the GENESIS FE 500 the first choice for a lot of customers.
THE GENESIS FE WORKCELL SOFTWARE
The GENESIS FE workcell editor consists of two main parts, the laboratory organization parameters and the instrument parameters. Within the laboratory organization area all process relevant parameters are to be entered. Different sample types are assigned to tests, tests to analyzers and analyzers to workgroups. This organisation is very important, as it helps to fit any laboratory organisation and any mix of analyzers.
The instrument area of the GENESIS FE workcell editor contains all instrument specific parameters, such as sample tube specifications, analyzer rack and workcell carrier issues, as well as the GENESIS FE workcell destination area configuration.
All information of the GENESIS FE workcell editor have to be stored in a database on the GENESIS FE computer.
The GUI shows the following information at a glance:
Real time status report of the system
Real time status of all processing modules
Supply control for disposable tips, secondary tubes and bar code labels
Control of tube cap disposal bag, aliquot system liquid level and aliquot system liquid waste level
Real time status of the user configurable destination area
Real time status and routing report for each specimen
System startup and shutdown are activated by the GUI. Additionally, each processing module can be stopped, bypassed and started again. This allows taking single processing modules offline (e.g., for maintenance or repair), while the GENESIS FE workcell continues processing sample tubes, allowing minimum downtime of the system.

Graphic User Interface
GENESIS FE WORKCELL — SAFETY, RELIABILITY, MAINTENANCE AND SERVICE
TECAN has an excellent reputation for building high-tech, high-quality products. We are proud of that, but we are also fully aware of the GENESIS FE workcell's unique strategic position in a diagnostic laboratory. With this awareness we have considered the most extreme measures regarding process quality, user safety, system reliability, minimum downtime and ease of maintenance and service.
Only the best quality components from trusted, reliable sources are used. As an ISO 9001 certified company, all of our suppliers comply to the same high standards and regulations as we do. We have set very ambitious MTBF and MTBS goals, and constantly run life cycle tests with all modules as well as with the entire system, to ensure that these goals are met.
All components of the system undergo rigorous testing before they are built into the GENESIS FE workcell. The system itself is extensively tested regarding functionality and reliability before being shipped to the customer.
After set up at the customer site, an installation qualification, operating qualification and performance qualification will be performed to ensure smooth operation and reliability starting at day one.
The Genesis FE workcell features a unique modular system architecture. Each processing station can be taken offline for maintenance or repair while all other processes continue operating. All modules can be easily accessed and exchanged, allowing extremely short repair times. If a problem occurs, the Graphical User Interface appears immediately with recovery procedures and solutions.
There is a choice of different service packages available with the purchase of a GENESIS FE workcell, each fitting the individual service requirements of our customers. Service and maintenance activities are performed by a authorized field service network worldwide. Together with a well-educated hotline team, they will provide competent help and short response times and on-site visits.
Training packages specifically tailored to fit the needs of the GENESIS FE workcell operators will also be available. This training will include operating instructions, maintenance instructions and basic troubleshooting training.
WHERE ARE WE HEADING?
After extensive in-house and field-testing, we will launch the GENESIS FE 500 at the end of first quarter 2000 and immediately start with installations.
We have already started to build the infrastructure necessary to support the GENESIS FE workcells worldwide. Additional sales representatives, product managers and specialists, trainers, field service engineers, application specialists and hotline personnel have been hired and are currently undergoing training on the GENESIS FE workcell to be ready for the market launch.
New products based on the GENESIS FE workcell concept are already in our development pipeline. The complete automation of the post-analytical process, like intelligent archiving, automated reflex/retesting, fast and easy re-locating as well as safe tube disposal will be our number one development priority.
It will remain TECAN's goal to bring flexible and versatile automation solutions to our customers to fit their individual requirements.
