Clinical labs performing next-generation sequencing (NGS) demand more from a Laboratory Information Management System (LIMS) than either non-clinical NGS labs or clinical labs delivering non-NGS tests. That’s because NGS puts unique challenges on the infrastructure required to deliver reliable, high-quality results in a cost-effective, timely, and regulatory-compliant manner.
We’ve had a lot of conversations with our NGS lab customers about what they need in a DNA LIMS software system. You can find some of their comments in our white paper, “Next-Generation Sequencing Comes of Age.” In this post, we’d like to offer five capabilities that clinical NGS labs should insist on when evaluating and deploying DNA LIMS software to manage NGS workflows.
#5: IQ and OQ Validation Starter Scripts
As mentioned in Demystifying CLIA and the Role of LIMS in Clinical Labs , all labs operating under CLIA must validate the workflows, technologies, and lab processes they use to deliver services. Because vendors can’t predict how different NGS labs may implement their tools, we can’t deliver pre-validated systems. But we can provide tools to make validation easier.
Thermo Fisher Scientific provides scripts for validating the base functionality in Thermo Scientific™ Core LIMS™ software to streamline the validation process. These scripts include Installation Qualification (IQ) and Operational Qualification (OQ) to help you validate the technical environment your laboratory information management system inhabits. These scripts get you started and can be easily customized, saving you the time of developing validation procedures from scratch. Performance Qualification (PQ) is then performed by your lab, leveraging the IQ and OQ information.
#4: Flexible Integration with NGS Workflows and Instrumentation
Clinical labs can run complicated workflows efficiently and consistently by eliminating manual processes—from sample management and reagent handling through to data acquisition and analysis. Core LIMS software can generate and consume instrument files from all of the systems involved in NGS, including Illumina, Ion Torrent, and others. Our genomics apps come preconfigured to work with sequencers, prep kits, analytical instruments, robotics, and analysis tools. Thermo Fisher™ Platform for Science™ software makes it easy for our team—or for your own developers—to create new laboratory information management system apps as technology evolves.
#3: Version Tracking for Traceability
LIMS software excels at tracking the movement of samples and data through the NGS lab. But some laboratory information management systems fail to capture the granular details about what has happened to data over time—and such details are essential to labs running under CLIA. Can you call up a dataset and see not just what it looks like now, but what it looked like when it was originally created and what was changed, by whom, and when? Core LIMS software includes detailed version tracking. Best of all, you can apply version tracking to any given record by clicking a button, enabling you to handle the different tracking requirements for research and clinical samples with the same system.
#2: Inventory Management and Tracking
Most laboratory information management systems are able to track samples from accessioning through to data analysis and reporting. Core LIMS software, though, also includes comprehensive inventory management capabilities that track locations, container types, and lot numbers for samples, along with all of the other components needed to conduct sequencing, such as reagent kits, consumables, and library and sample prep kit contents. Reduce waste, manage costs, and simplify regulatory reporting by maintaining an integrated, full chain of custody for all of the materials you need to run NGS.
#1 Automated Workflow Engine
A multifunctional, flexible, regulatory-compliant laboratory information management system — a LIMS that delivers all of the features described above and more—must ultimately enable lab personnel to work efficiently and productively. The ability to automatically move samples through queues, based on: status, results, etc., tremendously increases a lab’s efficiency. This automatically increases the ability of the lab to properly track and find all data about samples, which is especially helpful during an audit. The automation of so many processes also reduces touches by lab technicians, which invariably increase the potential for some sort of human error.
What Does LIMS Software Look Like in Action at a Clinical Lab?
In his Launch2015 presentation, Todd Arnold, managing director of the Mount Sinai Genetic Testing Laboratory, noted that labs have to get down in the weeds to determine what data will enable you to follow samples through the process. But once this is complete, Arnold advises NGS labs to think about how to present all and only the information relevant to each worker’s role. According to Arnold, “The beauty of Core LIMS is it is visually easy” to configure the laboratory information management system to support specific tasks, while providing dashboards for viewing project status and ways to query the data to monitor work over time and compare outcomes to established process and quality metrics.
Request our white paper, Next-Generation Sequencing Comes of Age, for more on DNA LIMS in genomic sequencing labs.