Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Taking the next step/Respond to or open dialogue with vendors

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6.3 Respond to or open dialogue with vendors

If you went the route of the RFI, you hopefully received more than a few well-crafted responses. Your RFI presumably included a small but critical set of requirements that needed to be addressed, and the vendors who responded dutifully addressed those critical requirements. Even if you didn't send out an RFI, you at least did your own research about some of the big players in the laboratory informatics space, and you may have even opened an initial dialogue with a few of them. If all has gone well, you're now at the point where you've narrowed down the pool of vendors but still have a basket of them to continue dialogue with. (If you're not comfortably at this point after an RFI or engagements with multiple vendors, you may need to either reconsider the effectiveness of your RFI or engagements or enlist help from a knowledgeable and experienced consultant to help steer you back on-course.)

As dialogue continues with vendors, you'll have several points to address:

1. What do I want their LIMS to do for me?

2. How does their solution fit into our previously discussed budget?

Regarding question one, you've already laid some of the groundwork for that with the help of your handful of critical requirements (and the associated research that went into developing them). Outside of those critical requirements, a laboratory informatics solution should also provide clearly definable benefits to how you operate your clinical diagnostics or research laboratory. These expected benefits should tie in with your overall business mission and goals. Using a laboratory information management system (LIMS) as an example, here are a few of the benefits a well-developed LIMS can provide to practically any laboratory. Whenever you go through the discovery process with a vendor, you'll be asking how their system provides these and other benefits through its functionality. A quality LIMS can provide:

• increased accuracy: the minimization or elimination of transcription and other errors;
• streamlined processes: ensuring each process step in a protocol/method is completed in the proper order, with all requirements met, updating sample statuses automatically;
• automation: integration with instruments, allowing for automatic uploading of samples and returning of results;
• regulatory and standards compliance: functionality that aids with compliance, including reporting results to state and local authorities;
• data security: role-based, configurable, secure access to data, processes, reporting, etc.;
• flexible reporting: reporting tools that allows for the design and generation of certificates of authority and other reports to lab- and regulation-based specs;
• instant data retrieval: query tools for finding data instantly according to any criteria (date range, test, product type, etc.); and
• configurability and cost-effectiveness: a user-configurable system (as opposed to hard-coded, requiring development for any modifications) that is flexible enough to adapt to rapid changes in test volume and type over time, without breaking the bank.

As for the second question, budgeting is always a tricky topic, both internally and when discussing it with vendors. We already mentioned in the previous section that addressing the acquisition and long-term maintenance budget of your solution(s) must be addressed as part of your lab's business considerations. (And we already mentioned some cost considerations in 2.1.6; this discussion will add a few more points.) The fact that laboratory informatics systems like the LIMS or the laboratory information system (LIS) come in all kinds of price ranges makes it difficult to judge if a given system, as priced, is appropriate for your lab and its budget. There are some basic cost realities associated with LIMS or LIS acquisition, which will help you understand where the vendor price comes from, and how it figures into your lab's budget (though some of these concepts may also apply to other informatics systems).

1. Vendor pricing is generally based on how many will be using the system. This can be measured in concurrent users (how many will be using the system at any one time) or named users (the number of total users who will ever use the system, by name). Additionally, laboratory informatics vendors increasingly offer the option of a cloud-hosted subscription, which of course has the advantage of not requiring your own IT department, and allowing labs to defray cost over time, with little or no actual license fee. Think about your usage strategy and choose the pricing format that makes the most sense for you.

2. Most costs are related to the work involved with installing, configuring, and migrating data to the system. Try to choose a solution that has what you need out of the box, as much as possible. The more customized or unique options you ask for up-front, the more it tends to cost, as extra items are a function of the time it takes developers to add them.

3. "User-configurable" beats "vendor-configurable" on cost-effectiveness. Some vendors offer a free or low-cost option, but don't be fooled. They are in business to make money, and they are counting on the fact that you'll need to pay them to make things work, add necessary functionality, and provide support and training. If you can find a vendor who offers a genuinely user-configurable system, and whose manuals and other support materials are clearly helpful and available so that you can adjust things the way you want, when you want, then that will go a long way toward budget efficiency and longevity.

4. Additional interfaces and reporting requirements cost money. If necessary, consider phasing in any additional instrument and software interfaces over time, as revenue eases cash flow. You can go live with your system operations more quickly, entering results manually until you can afford to interface your instruments one-by-one. This goes for reports as well; a simple reporting module that meets regulatory requirements will do. You can make your reports and other exportable documents more attractive later.

Ideally, your budget has room for roughly $40- to $80,000 minimum (including setup, training, interfaces, etc.) for a quality, full-featured professional LIMS or LIS, with $300 to $900 per month (depending on number of users) for ongoing subscriptions. At around five concurrent users, the economics start to favor purchasing perpetual licenses rather than paying for a subscription. Purchased licenses will also entail ongoing annual or monthly costs as well (e.g., maintenance, support, warranty for updates etc.) Subscriptions (if available) are generally aimed at smaller labs. If you will be growing and scaling up, it may be a great way to get started, but make sure you have the option to switch to perpetual licenses later.

With much of this information in hand, you're likely ready to move on to finalizing the requirements specification and choosing a vendor, but not before you've sat through a few highly useful demonstrations.

6.3.1 The value of demonstrations

A demonstration of laboratory informatics solution is an integral part of making your final decisions. The demo offers a unique and valuable opportunity to see in-person how data and information is added, edited, deleted, tracked, and protected within the context of the application; you can ask about how a function works and see it right then and there. Equally, it is an excellent time to compare notes with the vendor, particularly in regard to the critical requirement that were addressed in your RFI (or through direct communication with the vendor). You can ask the vendor in real-time to answer questions about how a specific task is achieved, and the vendor can ask you about your lab's system and workflow requirements and how you best envision them being implemented in the system (e.g., does this interface seem intuitive?).

A demonstration is typically performed online, which is useful for a couple of reasons, COVID-19 notwithstanding. First, it means you can schedule and reschedule at your convenience, with little in the way of logistics to arrange. Second, the demonstration session is likely to be recorded (verify this), so everyone is clear on what was promised and what wasn't, how processes were shown to work, etc. Additionally, you can later review parts you may have missed, forgotten, or not quite understood, and you can share it with others, who then also get a look at the proposed system in action.

Be careful about falling for the temptation of presenting a full URS or other specification document to the vendor during the demonstration. You'll want to wait until after participating in several software demonstrations to consider presenting your full specification document to the vendor, and that's assuming that you've grown enamored with their solution. By waiting to finalize your lab's requirements specification until after the demos, a common error is avoided: too often labs think the first thing they must do is create a requirements list, then sit back and let the informatics vendors tell them how they meet it. Remember that even though most labs thoroughly understand their processes, they likely don't have as strong a grasp on the informatics portion of their processes and workflows. Participating in a demo before finalizing your list of specified requirements—or having only a minimal yet flexible requirements list during the demo—is a great way to later crosscheck the software features you have seen demonstrated to your lab's processes and any initial requirements specification you've made. After all, how can you effectively require specific medical diagnostic and research functions of your laboratory informatics software if you don't fully know what such an industry-specific system is capable of? After the demonstrations, you may end up adding several requirements to your final specifications document, which you later pass on to your potential vendors of choice for final confirmation.