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How a Regulated Lab Ended Up Owning the Code of a Commercial LIMS

A surprising number of labs today still use pen and paper to manage lab samples, analysis, and reporting. But for forward-looking labs, a laboratory information management system (LIMS) offers a way to work more effectively through standardized workflows, tests, and procedures.

That was the conclusion reached by the shareholders of an environmental contract lab. Recognizing that if they continued to rely solely on pen and paper, they wouldn’t be able to keep up with their competitors and forecasted workload, they decided to invest in a LIMS. Their goal was to reduce transcription times, simplify troubleshooting, and automate much of the lab’s data processing and record management.

One of the lab’s quality assurance (QA) chemists, who shared this story with me, said that the lab “had rooms dedicated to binders full of paper with QA/QC results.” It’s no wonder she was excited to help select a LIMS that would meet the lab’s needs. Although, I suspect she didn’t anticipate spending the next two years exploring various options.

Moving away from a paper-based system

The lab shortlisted several LIMS based on the environmental sector’s unique challenges. For example, the team needed to:

  • Capture customer and contact information.
  • Track samples coming in and which customer they belonged to.
  • Assign the right tests for each sample.
  • Trace the samples throughout the workflow and across various departments — from when they’re logged in, released to the lab, and run on an instrument (e.g., mass spectrometer); to when the data is processed and reviewed, QA/QC checks are done, and they are reported out; to when the customer is invoiced.

The team also considered whether a generic or industry-specific LIMS would be best. One thing to know about industry-specific LIMS is that their screens use specialized terms familiar to lab staff. They support samples being processed in line with industry standards and have a foundation that can help model what is done in the lab. In other words, an environmental LIMS is not the same as a manufacturing LIMS, and both are different from a generic LIMS.

In this case, the lab’s stakeholders selected a LIMS developed for the environmental sector.

Taking ownership of the LIMS source code

Having selected a LIMS, the lab probably thought this challenge was behind it. But several years later, when the vendor that had developed the LIMS was acquired by another company, the LIMS was shelved. That meant support for the product was outsourced and there would be no further upgrades to the core system.

The lab had a choice. Either replace the LIMS with a different product, and lose all the work it had done on it in the intervening years, or buy the source code outright and continue to customize the product and make any upgrades or changes needed in-house. The lab chose this second option, purchasing the LIMS source code from the new company for a lump sum.

Customizing the LIMS to meet the lab’s needs

Over the next decade, the lab continued to work with and develop the LIMS. The team started with simple features like tracking samples and customers, then moved on to incorporate data and evaluations, until the product was tied into almost every facet of the business. Managed and developed by onsite teams, it was the source of truth for all the lab’s operations, customized specifically for their purposes.

What started as a commercial off-the-shelf (COTS) product essentially turned into a completely custom LIMS. As a result, the lab reached a tipping point. Even if the team found a new LIMS with more modern architecture and numerous other benefits, they had invested so much in the custom work that they could not justify the costs of transitioning to a new LIMS. Costs of transitioning can include:

  • Skilled resources to ensure the new LIMS can do everything the existing solution does, including customizations.
  • Running the two LIMSs in parallel until the new solution can be validated, something that could take six months or more.
  • Reworking processes in the lab to work with the new LIMS — each LIMS comes with a set of restrictions that will require the lab to make compromises.

Not surprisingly, the lab continues to use this heavily customized LIMS today.

A common path and lessons to be learned

This story is not unique to environmental contract labs. It’s one that we hear again and again from our molecular diagnostics lab clients, and it’s why labs are often paralyzed when they try to decide which path is best for them.

At Semaphore, we think the right question to ask is not “Should we get a LIMS?” but “Which is the right LIMS for us?”, or more importantly “What are we trying to accomplish that we want the software to support?”.

The staff in your lab have lives, worries, and issues on their minds, so if your lab’s processes require them to do repetitive calculations, they are bound to make mistakes. If you want to have a great reputation for quality data, you need to minimize the potential for errors. A LIMS can help your lab be more efficient, productive, and effective.

If your lab does not have a LIMS yet, here are six things to keep in mind:

  1. Customized off-the-shelf LIMS solutions are not all equal. A smaller LIMS vendor might be super responsive, but there’s a risk in terms of the size of the team supporting the LIMS. To mitigate this risk, you need to be willing to partner with the vendor and invest in their success. Larger vendors may be less responsive, but they are less likely to be acquired like in the case above.
  2. Sunk costs might mean continuing to work on a selected LIMS no matter what, but there will always come a point in time when you’ll need to re-platform, unless the LIMS you select is on a platform that is future-proof.
  3. Remember that you’ll need to get buy-in from a number of stakeholders, so you’ll want to have a solid list of requirements upfront, and show how the selected LIMS meets all these requirements. Indeed, it could be that after gathering requirements you discover you’d be better served by a different category of software, such as a laboratory information system (LIS).
  4. When you’re conducting your analysis and documenting your lab’s processes, use a collaborative approach. For example, we find that using a whiteboard is more useful than a spreadsheet. It’s interactive and less restrictive in terms of formatting. You can draw anything you like and it’s real-time, so you’re not stalling the group’s thought processes (if you stall out, people will start thinking about something entirely different and not stay on task). Whiteboard sketches are also useful for developing reports because they force you to think about the rows and columns you need.
  5. Whether you choose to build or buy a LIMS will depend on your strategic roadmap. It’ll also depend on how much and what types of configuration or customization you’ll need to do and the expense involved. Either way, remember that the human factor is a big deal in any lab, so any decision you make needs to take that into consideration.
  6. You don’t have to tackle all your lab’s requirements at once. You can start with the basic functions, and then iterate and add to them over time.

If your lab is trying to decide whether or not to implement a LIMS, you might be interested in our other posts on how to select a LIMS. Have a question? Feel free to reach out to us.

 

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Eban Tomlinson heads up Business Development at Semaphore Solutions. Eban leverages his deep technical informatics expertise combined with clinical genomics and genetics project experience to help Semaphore redefine the field of clinical laboratory informatics.