Drug and Market Development

It's almost impossible these days to find a workplace that doesn't utilize computers in some capacity. In both medical and industrial laboratories, computers have virtually taken over day-to-day sampling and login procedures in the form of LIMS (Laboratory Information Management Systems), specialized software programs that coordinate and streamline lab operations. Still, there are some holdouts from the medieval days of paper ledgers and manually drawn charts, toiling with pencil and eraser to organize the masses of data which every lab must process. If a lab is inundated under piles of paper files and test reports which can only be located by digging through filing cabinets or old boxes, it's time to consider bringing their operation into the 21st century with a LIMS.

Purchasing a LIMS is quite possibly the most crucial decision a lab will ever make. Evaluating and selecting a LIMS is like choosing between chocolates in a box; they appear mostly similar, they all are called "LIMS," but they come in different colors, flavors, database choices, and the all-important 'look and feel.' Some LIMS are good at data management, but fall short in lab information management. Other LIMS have been developed to address the needs of a specific market, and thus lack flexibility to meet the needs of many labs. The end result is that many labs end up purchasing a LIMS and then spending obscene amounts of time and money in trying to make it work. The problem is so pervasive that many representatives of the LIMS industry are perceived as "liars and cheats."

The horror stories about setting up a LIMS in the lab are true: statistics have shown that 60% of all LIMS purchased are never fully implemented. This is often because the task was bigger than first anticipated and not enough time and/or proper resources (usually manpower) were dedicated. Any lab that is interested in purchasing a LIMS can minimize their risk by spending a little time to learn about LIMS and the features and benefits they offer. When a lab is contemplating the purchase of its first LIMS, the most important issue to be considered is their requirements and expectations from the system. Leigh Richardson, president and CEO of Telecation, Inc., a Lakewood, Colorado-based supplier of LIMS for a variety of industries, gives her suggestions for purchasing a LIMS.

"It's essential to have a complete understanding of the data and information flow required by your laboratory before you can begin to evaluate the various commercial LIMS available," states Richardson. "For example, labs providing support to a manufacturing process usually have very different data flow than a municipal lab performing wastewater analysis. To ensure that you understand this flow, you may wish to create a diagram depicting the flow of samples in the lab."

The following factors must be considered before purchasing a LIMS:

• software
• hardware
• implementation costs, including software configuration and customization
• software installation and training
• support
• updates

Software

The acquisition of a LIMS is a major purchase for most labs, so it is important to understand all the up-front costs associated with the purchase. The software's cost is only a fraction of the expenses associated with installing a new LIMS. Therefore, it is important that the final LIMS selection not be made solely on the cost of the software.

When evaluating LIMS packages, look for systems that closely follow your lab's data flow. Many LIMS were designed for a specific type of lab, and may not provide the data flow, features, and flexibility you need. If the system appears to address a high percentage of the lab's data handling requirements as it comes "out of the box," then it is potentially a good fit. Keep in mind, however, that data flow includes login options, status tracking, data marking, audit trails, and other features that are vital to lab operations. If the software appears to be organized logically into samples and tests, this is an excellent start.

"When a prospective client calls to ask about LIMS, we first try to determine the lab's goals regarding their data and information management," says Richardson. "We then compare these goals to our products, to see if we can address at least 70% of the lab's requirements 'out of the box.' If the final 30% or less require modifications, such as the addition of descriptive fields, definition of additional reports, etc., then the product can be considered a 'good fit' for that lab. If, however, we determine that our products would require major modification, we then point the lab to other vendors with suitable products," explains Richardson.

Hardware

An unexpected expense often arises when the ideal appearing software won't work with the lab's existing equipment. Once an initial evaluation of each LIMS is complete and the lab has narrowed its choices to one or two systems, a hard look will have to be given to the hardware and networking requirements of each. Budget forecasts for the LIMS project should include new hardware, networking, cabling, and possible computer upgrades.

Implementation/Installation

In general, about one-third of the overall LIMS implementation costs are associated with the configuration of the LIMS software and making program changes required to meet the lab's needs. Configuration usually entails populating reference tables and libraries for sample or product types, tests to be performed, analytical methods, detection limits, quality control libraries, developing instrument interface routines, etc... When evaluating the amount of work involved in the implementation of a LIMS for your laboratory, the LIMS Administrator must:

• make a list of what needs to be present in the LIMS for initial implementation;
• compare this list to each LIMS as they come "out of the box";
• determine if the LIMS administrator can make changes to the program if necessary;
• if so, determine the level of expertise required to make the changes; and
• if the changes will require direct interaction from the vendor, the lab will need an accurate estimate of the costs for such changes.

Historically, LIMS have fit into two categories: 1) the "turnkey" system, where all functions are predefined by the LIMS program, and 2) the "programmable" system, where most, if not all, features are custom-tailored to the individual laboratory. While the turnkey LIMS is ready-to-roll as installed, its functions cannot be modified to suit the ever-changing and unique needs of the modern laboratory. Conversely, while the programmable LIMS can be altered to meet those requirements, the system is not usable until the time-consuming and expensive customization process has been completed, and the lab must pay more each time it needs additional configurations to the system.

For LIMS where the front-end application is open to extensive user modification, configuration may also include modification of existing forms (screens), creation of user-defined forms, custom data entry forms, etc... For some LIMS, these types of changes cannot be performed by the user without accessing and modifying the program's source code. If your lab is locked out of the underlying application and cannot make these types of changes themselves, you will have to request the changes from the vendor as "customizations" to your system. "Many manufacturers will claim their LIMS can be customized or modified to integrate user-specific features, but what they don't tell the customers is that such work will cost them thousands of dollars," Richardson reveals. "These manufacturers lock everything up tight as a drum, and then charge for every modification. What happens then is that the cost of the LIMS becomes never-ending. That's why we leave our Aspen LIMS open, so the system can continue to grow with the users and accommodate modifications as their needs change. In the laboratory industry, needs change regularly."

Richardson explains that openness to user modifications was central in Telecation's development of Aspen, Telecation's latest LIMS. Aspen is a 32-bit client/server system designed and built using Visual Basic MS Access 8.0, which is part of the MS Office 97 Professional suite. It provides the advantages of both turnkey and programmable LIMS with none of their drawbacks by being flexible and allowing the user to incorporate laboratory-specific routines, fields, naming conventions and reports themselves, without the inconvenience and expense of hiring programmers.

Many of the Windows-based LIMS currently on the market were written using visual development tools as the front-end program, which links to a database back-end. Some of these tools, such as Visual Basic and Powerbuilder, compile the query routines into their source code. Few LIMS vendors sell source code, and if they do, it is at considerable cost. This means that the lab must go back to the vendor in order to incorporate field additions, modify queries, and so forth. "One of the things that differentiates us from our competition is that we separate the application front-end from the database back-end, and that we leave our LIMS open for user modification," says Richardson. "Customers can use Access 8.0, Oracle 7 and 8, MS SQL Server, DB2, and Sybase as their database of choice. It's flexible this way so labs can add fields, modify the screens, add calculations and other things they might need without always having to return to us. I think the best feature of Aspen is its openness and flexibility of the system."

The lab must also determine whether the LIMS administrator can perform the software installation or if the vendor must install the software. If on-site installation is required, you will need to get a quotation for the cost of this service, which will likely be based on the number of workstations using the LIMS as well as the network topology. Again, Telecation's Aspen stands out in this area. "It was designed from the ground up to allow labs to use it right out of the box. If you can run "a:setup" you can easily install Aspen," states Richardson.

Support

LIMS vendors offer a wide variety of support options. During the first year, the lab has a greater need for technical support than in later years, due to the number and level of questions that routinely arise during initial LIMS implementation and fine-tuning. Some vendors provide support via the Internet, phone, fax, and even remote modem. It is vital that the lab asks for cost breakdowns, and understands the type and level of support provided by the each vendor. The lab should clarify if the cost for programming assistance is the same as that for answering routine questions?

There are stories where a salesman "implied" that onsite training and "some level" of implementation assistance was included in the cost of the LIMS. The salesman may have had the intention of personally assisting the lab, but since that support wasn't included as a line item on the purchase order, the vendor was not obligated to provide it. "The most common complaint we hear when talking to labs looking to replace existing LIMS is that they thought items that had been discussed and even viewed in demonstrations were included in the purchase price of the LIMS, only to find out that they were 'extra cost' options not included in the system specs when pricing was discussed and agreed upon," Richardson recounts.

Make no assumptions. If you are unsure what is included, ask, and be sure to get the answer in writing. Demo systems are sometimes modified by the vendor to include features or special reports that the vendor feels will be of interest to their prospective customer. Be sure to ask if each item is included in the cost. If a feature is desired, ask what the vendor calls it, then be sure to include it in the system specifications in the quotation. If you don't ask, you may be unpleasantly surprised.

Software Updates

In light of the current practice of certain major software vendors who "release quickly, patch often" and issue regular, "essential" updates which offer no significant improvements, a lab needs to ask detailed questions about the LIMS providers' bug fix-policy before making the plunge. Some vendors may require your facility to maintain a current software update contract in order to obtain technical support; others try to bundle updates and support in the same contract. Be sure to understand both the short-and long-term costs and exact obligations associated with any contracts you enter into.

"Software updates have long been used by vendors as a way to squeeze more money out of their customers through 'bug fixes,'" notes Richardson. "At Telecation, we don't adhere to this philosophy. We offer bug fixes free of charge. Registered users can log on to our website any time, see lists of known bugs, and download the fix. Software updates should enhance the LIMS. If that enhancement is not valuable to a client's laboratory, they shouldn't have to purchase it in order to keep their LIMS 'up to date.'"

Richardson concludes that one of the reasons for Telecation's success in the LIMS industry is because their Staff Project Coordinators are computer software 'power users' who have worked in the lab. "Because of our various analytical backgrounds, we are better able to grasp the needs of a lab from the user's perspective, while also understanding how databases, spreadsheets, and other software can work together to address those needs."

Leigh Richardson is president and CEO of Telecation, which was founded in 1985 as a consulting company providing personnel training and support services for analytical laboratories. A leading developer of Windows-based LIMS, Telecation currently has over 300 LIMS installations around the world representing a wide variety of laboratory industries. In 1997 Strategic Directions International rated Telecation as one of the top three LIMS providers.

For more information on LIMS, contact Telecation

7112 W. Jefferson Ave.
Suite 307
Lakewood, CO 80235
Tel: +(1) 800 584 9964
Fax: +(1) 303 987 0984
Email: sales@telecation.com

An Online D&MD™ Publication copyright © 1999
DRUG & MARKET DEVELOPMENT

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