5 Important Elements of Lab Informatics Implementation Success

Now that you’ve made the big decision and invested in a new or upgraded laboratory informatics system (whether it be LIMS, LES, CDS, or ELN), how do you ensure that your implementation will be a success? At CSols, ensuring implementation success is one of the things we specialize in, and we’ve acquired the expertise to determine what can make or break a project. If your implementation includes the following five elements, you’ll be well on your way to success.

First and Foremost: Project Leadership

Don’t settle for a traditional project manager; a laboratory informatics project not only needs tactical management skills for the technical implementation, but also needs strategic skills to manage the organizational changes that the implementation will require. Organizational change management (OCM) expertise and in-depth experience with lab informatics systems implementations significantly increase the likelihood of project success.

A project leader should join your laboratory informatics project in the pre-planning stage, when you’re defining the project team, budget, and scope. Their knowledge of previous informatics projects allows them to identify realistic milestones and deliverables and then communicate them, so that the business and the end users understand the expectations, goals, and benefits. The Project Leader’s ability to manage a project holistically will increase stakeholder buy-in from the start and improve user adoption after go-live.

Your project leader helps you realize the value of your chosen system through…

Effective Communication

Effective communication is one of the best ways to ensure all stakeholders learn the value that your new system will provide. Effective communicators speak knowledgeably about the laboratory, regulatory, and IT functions that are needed in an implementation, and facilitate communication between IT and the lab. They do this by presenting messages in varying ways so that all types of learners can benefit.

• Traditional face-to-face meetings, lunch and learns, or video conferences with various user groups to ensure that everyone’s concerns are addressed
• Well-prepared demonstrations and training plans help all stakeholders see how to navigate the new system and let you troubleshoot at the same time
• Thoughtful choice of appropriate meeting attendees improves time management and meeting productivity
• Varying modes of communication, including e-mail, video updates, and instant messaging, take advantage of different skill sets among your audiences

Active listening is also an important part of effective communication, to ensure that feedback is welcomed and constructive.

Effective communication is an absolute necessity when it comes to…

Thorough Requirements Gathering

Communication is, of course, a two-way process that involves both conveying and receiving information, a tactic that is used for the next element of implementation success. The full potential of an implementation can be realized when sufficient time is invested in requirements gathering. Interviewing stakeholders and subject matter experts (including non-laboratory team members) is one technique to understand their needs and gather meaningful user requirements. Knowing what to ask and how to transcribe the responses requires knowledge of how the lab works, as well as the lab informatics system.

Gathering requirements effectively requires knowing what is critical to the laboratory so that those requirements can be prioritized appropriately. Not all requirements will be addressed in phase 1 of the implementation. The goal is not to waste time with requirements that aren’t useful or that can’t be quantified. When the critical requirements are documented correctly, they can be easily understood by the business and the developers. When those critical requirements are implemented in phase 1, the business will see the value sooner.

Thorough requirements gathering and documentation helps you understand how to best use out-of-the-box functionality. Making use of the existing standard functionality as much as possible reduces implementation time and lets you quickly make use of the full value of your new informatics system.

Nonetheless, you will also benefit from…

Well-Documented Configuration and Customization

Well-planned and documented configuration and customization will enable your users and the business to get the most from your informatics system immediately after go-live, and will save headaches down the road when any new work needs to be done on your LIMS, CDS, LES, or ELN. Thorough documentation of your configurations and customizations also provides a blueprint of your system, describing how the system was implemented and what decisions were made, as well as centralizing all details for ease of use during future enhancements and improvements.

Thorough documentation also facilitates (should it be needed)…

Proper Validation

If you are working in a regulated industry, your informatics system may come with a vendor validation package. What’s included in the vendor validation package may not be sufficient for your system as implemented, because your system will include business processes that the vendor cannot be well versed in. If your informatics system is validated properly for your specific intended use, you will have a system that is fit for purpose and that will stand up to an FDA audit. This is important because no one wants to get a 483 form from the FDA.

The inclusion of these five important elements will help ensure that your implementation is a success. Some of these things can even be done remotely, which is important during a pandemic (for instance), or any time that travel may not be feasible.  

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Would you consider your lab informatics implementation a success? Why or why not?