At what point does it make sense to upgrade to a more formal or structured laboratory information management system (LIMS)? Read the whitepaper to find out.
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Many labs shy away from the notion of upgrading to a LIMS because they are currently using Microsoft® Excel® or Google Spreadsheets with a certain amount of success. We agree that these can be great tools for some labs – labs that always run the same type of workflow and that process a small number of samples. But what if your lab clearly doesn’t fit into this mold? What if your lab is changing and evolving to process new samples and offer new services? At what point does it make sense to upgrade to a more formal or structured solution?
We think about these questions a lot, especially since we get the opportunity to work with research and clinical labs at varying stages of maturity. In our experience, we have identified a clear tipping point – a point at which it makes sense to upgrade to an actual Laboratory Information Management System (LIMS). The arrival at this tipping point considers both the investment in time and money of selecting and implementing a system as well as potential benefits gleaned from a system. We tend to think of this tipping point as the point at which lost opportunity becomes greater than the cost of making a change.
Are you at this tipping point? To help you decide, we’ve compiled a list of four questions. If the answer to any of these questions is “yes,” then it may be time to seriously consider making the leap to a LIMS.
If so, you wouldn’t be alone. The number of sequencing labs attached to clinical practice continues grow at a breathtaking rate. In 2013 alone, it’s estimated that the number of clinical genomics lab doing next generations sequencing climbed to 20-25%. The transition can be difficult. For starters, integrating next generation sequencing into a clinical environment presents numerous challenges in terms of sample processing, quality control, management and reporting.
Sample tracking has to be failsafe. Quality control must be paramount. Adding to this difficulty is the fact that operating in a clinical environment is often unchartered territory–many labs have to learn and implement new guidelines while keeping existing operations running. Another challenge? When operating in a clinical environment, the burden of paperwork can be huge. One lab we know used to have to fill out 16 forms each time a new sample was run in their clinical environment.
The Medical College of Wisconsin (MCW) is a perfect example of a lab that upgraded to a LIMS to keep pace with their challenging clinical environment. While they were already making quick work of processing patient samples, upgrading to a LIMS has enabled them to integrate patient data, track samples with absolute confidence, and eliminate the burden of so much paperwork. The LIMS system has actually given them the opportunity to get rid of many of their file cabinets and also amply prepares them for the audits required to keep their compliance status. They can quickly locate any sample, find out what date it was processed, what was done to it, who did it, and so forth—all requirements for operating in a clinical environment.
Yet another reason to consider upgrading to a LIMS is if you are seeing an increase in the diversity, complexity, or volume of samples. If all your lab ever did was one type of sample using one workflow, with a specified number of samples coming in, you might never need a LIMS. However,managing various workflows and constantly adapting to new technology and protocols can be challenging. Add to this a high sample volume and the occasional one-off sample, and things can get quite complex. As one lab manager put it for us, his eternal challenge is finding the balance between offering the cutting edge service that new technologies provide with codifying procedures and workflows so that his lab can not only keep up with technology but optimize. After all, he must run his lab as a business.
Case in point: one lab we know was successfully using an elaborate system of Google spreadsheets to manage their samples. But they knew it was only a matter of time before they had to invest in a LIMS: the increasing volume and diversity of samples made filling out the spreadsheets cumbersome, difficult to track, and prone to human error. Upgrading to a LIMS enabled this lab to continue to offer their customers the cutting edge services they were used to but also get more efficient in the lab. The LIMS system the lab purchased – Clarity LIMS – provides preconfigured workflows for common instruments, such as Illumina® HiSeq and MiSeq. The workflows lock down lab procedures to aid with efficiency but can also be modified if lab protocols dictate. The end result was more accurate and efficient sample processing and the ability to offer cutting edge services by quickly adapting to new workflows when required.
For many labs, the decision to trade in spreadsheets for a LIMS boils down to wanting to provide better service for their customers. For research labs, this means getting on top of lab operations, achieving operational efficiencies, and turning a tidy profit – in other words, running the lab like a business.
For clinical labs, this is most often an issue of more effectively tracking samples and having the utmost in confidence that results are correct. Translation: sample mixups, like what 23andMe experienced and addressed, are time-consuming, costly, and impact trust given to you by customers. Spreadsheet software has a difficult time addressing these challenges. For one, spreadsheets lack the workflow and collaboration tools that can lead to a highly productive lab and error-proof sample tracking. Spreadsheets also can’t correct you when you are wrong like a LIMS capable of locking down certain procedures. Additionally, spreadsheets lack sophisticated status and reporting tools that can greatly aid in divulging productivity and customer reporting.
The customer service or experience you want to provide often depends on your environment and the samples you run. For one clinical sequencing lab we know, providing better service meant shaving time off of sample processing. Although they were already reporting diagnostic data to clinicians and patients relatively quickly, they endeavored to speed sample processing time. The unique features in the LIMS they chose enabled them to reduce the possibility of human error, use preconfigured workflows for common instruments, and take advantage of the workflow features available in the system to keep samples moving through their pipeline quickly. They even used some of the automation features to kick off secondary and tertiary analysis processes. Ultimately, they discovered that they could deliver this diagnostic information to their patients even sooner. Having confidence in their results also helped them make the best therapeutic decisions possible for their patients.
Mistakes are costly. Most, if not all mistakes, are due to human error. And when it comes to any sort of data entry, human factors experts estimate a 5% error rate. Can your lab afford to make errors? What is at stake? Take the 23andMe situation, for example, in which 96 customers received the wrong personal information about their genetic makeup due to a sample mixup. It’s unclear how much this mistake affected 23 and Me’s bottom line. However, it is clear that the company had to do quite a bit of work to overcome its mistake and regain customer trust. Labs working with patient data are all in the same boat – they have to be able to accurately track samples and report accurate information to patients and their care providers.
Not all mistakes involve patient data. Some mistakes are as mundane as a misused reagent. And at upwards of $600 per reagent kit, these mistakes aren’t inexpensive.
So, naturally, if you had the opportunity to reduce human error, wouldn’t you take it? MCW, mentioned earlier, is one lab that jumped at the chance to reduce the possibility of human error. Operating in their clinical environment, they realized the impact of any mistake. Their often very sick and vulnerable patient population not only relies on receiving quick results but on their accuracy, as therapeutic decisions are made based on the results. And virtually any other lab engaged in providing more personalized treatments would find themselves in the same dilemma. When MCW uses their LIMS, the amount of data entry they have to do is drastically reduced since reagent lot numbers simply have to be entered once and are populated throughout the system. No more tracking down multiple spreadsheets – they enter the lot number once, and they are done.
So, where do you stand? If you answered yes or even “maybe” to any of these questions, then it might be time to read the writing on the wall. Some see the writing but avoid it, worried that an upgrade to a LIMS is too costly, too time-consuming, and an all-around headache. However, knowing where your lab is headed and choosing the right LIMS makes all the difference. When you choose a system that corresponds with the way that you work in your lab and find a savvy vendor who can guide you through the process, implementation and adoption are straightforward. And that’s when the writing on the wall turns into an opportunity for your lab to reduce errors, provide better customer service, gain compliance, and achieve operational efficiencies.