There isn’t a single LIMS/LIS that will fit every clinical need, but following these seven best practices, you can make your LIMS/LIS implementation a success.
By Aimee O’Driscoll
A laboratory information management system (LIMS) or laboratory information system (LIS) is a crucial software solution for managing, storing, and analyzing laboratory data. These systems come in various forms and can provide a range of benefits, such as automation and standardization, increased accuracy, improved efficiencies, cost savings, and operational flexibility. However, implementing or transitioning to a new LIMS or LIS can be complex and challenging.
To ensure successful implementation, it’s essential to follow industry best practices while considering the specific needs of your laboratory.
1. Determine Goals and Key Features for LIMS/LIS Implementation
Successful LIMS/LIS implementation hinges on choosing the ideal system. But before beginning the selection process, it’s crucial to have a clear understanding of what you hope to achieve with your new system. This will help you to make informed decisions about which features and functionalities are most important and serve as a benchmark for measuring success.
“Spend sufficient time in the planning phase making sure you have thought through all deliverables and requirements,” advises Kim Futrell, senior strategic marketing manager at Orchard Software Corporation.
While specifications will differ for each organization, there are often general categories that will fit the criteria of most clinical laboratories. “The features that a lab wants the most entirely depend on the organization size, testing types, and target client base for their growth,” explains Jonathon Northover, vice president of Product Management, CompuGroup Medical US. “On the other hand, there are the basics that every lab needs to manage: orders in, results out, quality control, instrument connectivity, and so on.”
Futrell adds sample tracking, data mining, and decision-support rules to the must-have list, and provides insight into some of the beyond-basic features that many LIMS/LIS offer, including microbiology, molecular, toxicology, and point-of-care testing. She stresses the importance of using a LIMS/LIS to automate manual processes wherever possible. “Any task that is tedious and monotonous should be handled in the LIMS/LIS, allowing the technologists time to perform the hands-on tasks. The LIMS/LIS should make the jobs of laboratory professionals much easier, improving employee satisfaction and retention rates.”
In addition to specific functionality, goals, and objectives should encompass a long-term vision for the new system, including aspects such as adaptability, reliability, and efficiency.
“To remain relevant and protect against external threats (labor shortage, rising operational costs, lower margin-per-test ratios, etc.), organizations should look for a LIMS or LIS system that’s highly adaptable and configurable,” suggests Suren Avunjian, CEO of LigoLab. “And one that supports a level of rules and automation that makes error-free accessioning, processing, and reporting of specimens possible while also improving test turnaround times.”
2. Consider Budget Restrictions and Justifications
Budget must be a key consideration during the goal-setting and LIMS selection processes. But while looking at system implementation expenses, organizations must also factor in the resulting efficiencies and cost savings to justify the capital expenditures.
“We hear it all of the time,” says Avunjian. “Soon after our system has been deployed, lab operators quickly learn that they can take on more business without adding more FTEs because they are no longer limited by manual and redundant processes and an antiquated, rigid system that can’t support their business growth.”
“All of the automation and standardization that the LIMS/LIS brings translates into more accurate results reported, faster turnaround times, and more efficient technologists—and all that translates into cost savings,” says Futrell. But she notes that ROI for software is sometimes not readily measurable because there are many intangible benefits associated with it. “Decisions about the purchase of a LIMS/LIS are often out of the hands of the laboratory, but the lab’s input is vital in ensuring the best-fit product is selected. Lab managers have to do their research and make their case for the LIMS/LIS product that they know will meet their lab’s needs.”
When budgeting, Avunjian warns that you must consider all associated expenses.
“Organizations should be aware of the large up-front costs and hidden fees that come with many LIS systems. Examples include fees for changing lab report templates and adding new tests, new modules, or new seats as the laboratory scales. Hidden costs are also often associated with software upgrades and the need for added support as the lab grows,” observes Avunjian.
3. Assign an LIMS/LIS Implementation Administrator
A key component in ensuring LIMS/LIS implementation runs smoothly is the assignment of a project administrator with a strong grasp of IT systems. “This will allow a single point person within your organization or practice to gather the needs of the laboratory and those that you are servicing,” says Ed Nesbitt, vice president of Service & Support, CompuGroup Medical US. “The admin would work directly with the LIS company during initial installation of the LIS. They would advise on areas such as system build requirements, computer hardware, network infrastructure, laboratory testing equipment, and personnel training requests.”
Avunjian agrees and recommends identifying and dedicating a LIS administrator. “This person doesn’t have to have an IT background, but should be comfortable with computers and software, have excellent organizational skills, and have deep familiarity with the laboratory’s operations. In essence, they are the project leader and the one responsible for the lab staying on schedule and communicating all necessary information to all the individual departments.”
4. Choose the Right Vendor and System
Of course, not all LIMS/LIS systems are created equal, and it’s vital to choose a vendor and system that are the ideal fit for your organization.
“We recommend that organizations seek out a partner relationship rather than a vendor relationship because no laboratory can afford to switch LIMS or LIS systems often,” advises Avunjian. “This is a major decision that will have lasting implications for the laboratory, so organizational leadership should look well beyond implementation when deciding who to partner with.”
Avunjian notes that customer service is important, too, explaining that this signifies that a vendor is interested in long-term and mutually profitable client relationships. “When selecting a partner, these organizations should look for one that is known for its customer service and rapid development, thereby ensuring that constant improvements are made to the system and that it’s future proofed for years to come in terms of functionality and configurability.”
5. Ensure Interfaces are Addressed
Interfaces should be considered throughout LIMS/LIS implementation, from discovery and planning through installation and future maintenance. “Interfaces to other information systems are a must-have to work toward an interoperable system where data is readily available when and where it is needed,” explains Futrell.
And it’s particularly important to stay on top of these aspects during the later stages of implementation. “When dealing with most vendors, customers’ concerns, needs, or wants are often lost during the handoff to service,” says Nesbitt. “Any items specific to your organization should be documented during the sales process to ensure your services and implementation team is aware of it during the project scoping process.”
Avunjian provides similar advice: “If the lab will be interfacing with instruments, EHRs, and third parties, we also recommend that these interfaces be prioritized during the discovery phase of implementation because it often takes considerable time and planning to get all parties on the same page and the same interface schedule. Additionally, they should invest in building flow charts to map the processes of their current and desired workflows.”
With that in mind, minimizing the number of interfaces a LIMS introduces is ideal.
“When possible, we also recommend that laboratories choose one system over multiple disparate systems and the inherent data silos and fail points they can create,” says Avunjian. He adds that using a single, integrated suite of applications enables laboratories to do more with less and drives transparency into their operations and tighter control over their businesses.
6. Don’t Rush the LIMS/LIS Implementation Process
One of the most common mistakes in LIMS/LIS implementation is acting in haste.
“Organizations should avoid attempting to implement their LIS before they are ready,” advises Nesbitt. “Sometimes a lab lacks the staff to train or does not have analyzers on site to interface to the LIS. In some cases, the lab is only half built when the implementation is set to begin.”
Futrell agrees, acknowledging that one of the biggest pitfalls her team runs into is labs that rush to install a system and want to hurry the process and skip steps. “Implementing a LIMS/LIS is a large undertaking, and it must be taken seriously and managed carefully throughout the entire process. Be thorough and meticulous in your decision making and in your system implementation.”
Ensuring the organization is fully prepared for implementation also helps you get the most from your vendor. “Worthwhile LIS vendors will dedicate an engineer to be on site during your implementation, so try to make the best use of the time you have that expert available,” adds Nesbitt.
7. View In Situ and Conduct Thorough Testing
Due to the complexities of implementing most LIMS/LIS systems, running a pilot is usually not an option. However, you may be able to view systems in situ.
“Running a pilot would be an extensive undertaking that would require valuable resources and time,” says Futrell. “Instead, thorough research, a comprehensive RFP, software demonstrations, and recommendations from on site visits to current users for the products you are considering would be a better path.”
While a pilot might not be possible, before going live with your new system, it’s essential to conduct thorough testing to ensure that all features and functionalities are working correctly. This includes testing the system’s compatibility with other systems and applications and testing for data accuracy and integrity.
“Generally, after contract signing and during implementation, testing scenarios are created and vetted to ensure a successful go-live transition,” explains Nesbitt.
Futrell concurs that proper testing is essential: “Be sure to test all interfaces, all rules, QC, etc. The validation phase is essential for a smooth transition to go live and to uncover any last-minute problems.”
Avunjian also acknowledges the importance of the evaluation process. “Laboratory operators will need to invest the time to validate the configurations, and we provide a tailored checklist of required workflows to validate. We approach every implementation as if we were deploying the system for our own needs, sharing best practices, and adapting processes as needed,” he says. “Our pricing model is designed with the laboratory in mind and built on long-term success, not on large upfront licensing fees. We share the risk with the laboratory and guarantee a successful implementation.”
Turbocharging Testing with Middleware
Clinical laboratory middleware turbocharges testing by amplifying the benefits of adopting a new LIS/LIMS. “The primary role of middleware is to bridge communication between LIS/LIMS’ medical ordering data and sample management with a range of testing modalities, such as hematology, clinical chemistry, and immunoassay analyzers,” says Parker Tuan, senior analyst, Global Product Marketing at Beckman Coulter Diagnostics. “Middleware is responsible for automating test processes, delivering insights by flagging and guiding next steps for out-of-range results, and standardizing operations.”
“Middleware has evolved from being a common connection and results transmission pathway between LIS/LIMS and instrumentation to an efficiency enhancer that enables customization and standardization of workflows,” adds Tuan. “Middleware enables users to leverage a consistent user interface with standardized workflows while integrating instruments into a consolidated platform. This is particularly important when relying on contracted laboratory staff to address shortages to enable staff to surge between facilities.”
So, when does middleware enter the process? “Middleware is usually implemented when laboratories are focused on making improvements to complex workflows with automation and instrumentation and generally enters the picture when laboratories are implementing and interfacing new instruments with LIS/LIMS as part of broader instrumentation purchases,” explains Tuan.
He adds that all laboratories can benefit from middleware and its automated workflows to reduce the risk of errors, improve turnaround times, and reduce repetitive manual tasks.
Aimee O’Driscoll is a contributor to CLP.