In clinical diagnostic laboratories, end-to-end testing of complex LIMS workflows is a critical part of the laboratory validation process. Performing these tests manually takes a Herculean effort. They’re hugely time-consuming and prone to error. Automated testing is an obvious solution, but these tests can also be expensive and take considerable time to create. That’s why we developed a reliable and […]
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In our previous post, we talked about the importance of data provenance for clinical diagnostics laboratories—that is, tracing the origin and changes to critical data such as electronic health records, analytical results, and workflow records. But no conversation about data is complete without also considering the ontology used. Proper data management is crucial for labs If your laboratory wants to […]
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In clinical diagnostics labs, there’s a pressing need for data provenance—tracing the origin and changes over time of critical data such as electronic health records, analytical results, and workflow records. Provenance is information about entities, activities, and people involved in producing a piece of data or thing, which can be used to form assessments about its quality, reliability, or trustworthiness. […]
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A lab’s informatics system is critical for its effective operation. As we discussed in a previous post, in the early stages of a lab’s business development, a complex system might not be necessary—the lab could simply use word processing or spreadsheet software. But as labs develop new tests and ramp up throughput, a robust informatics system becomes increasingly necessary. In […]
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For low-throughput labs, manual processing might be the simplest and best way to operate. But for high-throughput labs, automation is the key tool needed to boost speed and efficiency. Every process you currently perform manually is an opportunity for incremental improvement. So, it makes sense to automate as many processes as possible once your monthly throughput exceeds a certain threshold. […]
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Laboratory informatics is a critical piece of the puzzle for clinical diagnostic lab startups. Without some serious thought about how they’ll manage their instruments, software, and data management tools, labs can find themselves travelling along a well-worn but meandering path—even though there’s a more direct route to managing operations and optimizing their processes for efficiency. Frequently, startup labs get their […]
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The Agile methodology is one of the most common project management methods for software development, and for good reason. Its iterative nature lends itself to an ideal build process. Add clearly-defined team roles and a lightweight Scrum framework—with short, focused bursts of work called Sprints, which typically last 1–4 weeks—and you have an approach that enables teams to work together […]
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When you’re automating your clinical lab, one of the first things you should look for is an opportunity to integrate instruments with your laboratory information management system (LIMS). This is a great way to reduce manual processing and boost the lab’s speed, efficiency, and accuracy. Integrating liquid handlers can provide a high return on investment. These robots are commonly used […]
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Once you’ve selected your laboratory information management system (LIMS), it’s time to implement it within your lab’s software environment. A critical part of this process for regulated labs is validating the LIMS and ensuring requirements traceability. In a nutshell, to meet regulatory requirements, your lab needs to be able to: Show that the software does what it was intended to […]
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NGS clinical diagnostic labs face growing complexity in their software solutions as they attempt to adapt to a market with evolving requirements and stakeholder expectations. It’s not that they want to add to their systems in a piecemeal fashion—it’s quite the opposite. Most lab managers would prefer to buy a single complete solution that meets all of their current and […]
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