LIMS and the Future: The Elephant in the Lab

What is the future of LIMS? How will laboratory systems evolve, and what will they depend on? And most importantly, what do you need to keep in mind as you picture your laboratory in that bright future?

If you ask any vendor today how LIMS will evolve, they will all have a ready answer. “Of course, a real LIMS must have A and B functions! Those are the ones we emphasize,” one vendor will say.  – “No, A and B are optional, – another will argue. – But C and D, which we provide, are crucial”. Each vendor sees the development vector based on their perceptions. 

And they are all right! There will always be a lab that needs A and B and one that won’t move without C and D. It’s like groping at an elephant in the dark. One person finds its legs and says it’s a column, another feels its trunk and says it’s a pipe, a third says it’s a seat, and a fourth says it’s a wall. The idea that it is an elephant only becomes clear once there is light.

Like with the elephant, you can observe the lab from many angles. Let’s try to take our laboratory elephant out into the sunshine, examine it from all sides, and understand how this animal will evolve.

1. The laboratory as a medical organization

Just as the trunk is the most significant feature of an elephant, the fundamental feature of the laboratory is its direct involvement in the treatment of the patient. 

In the past, the physician and the clinic were at the center of the treatment process. The laboratory stood modestly on the periphery, giving the doctor papers filled with numbers. 

The patient is now at the center of the process. The doctor, the clinic, and the laboratory are equal planets revolving around him for his benefit. 

That is why the importance of the laboratory has increased. The patient-centered model has made it just as important as the clinic. The lab provides gigabytes of valuable information on which the clinician bases her conclusions. It has all the characteristics of a medical facility, and has its ways of protecting medical confidentiality. It evaluates the quality of the information it provides, structuring a model that reduces risk to the patient. The laboratory is in contact with other healthcare facilities during the clinical process. 

The first task is difficult. The laboratory physician has the opportunity to look at the clinician and learn what the patient’s clinical pathway is. What if the lab is independent? First, it’s miles away. Second, the clinician and the lab physician don’t understand why they should even talk to each other. They have different competencies and it’s hard for them to find a common language. There is no understanding of what the laboratory physician may do in the clinical process. It’s usually only brought up when something goes wrong. “Oh,” they say, “the lab must have screwed up.” 

It would be nice if it were the opposite. The laboratory physician, a laboratory director, is a competent professional. He is familiar with a lab  practice and has a medical background. He can’t be completely useless in managing the patient and choosing the test. Contact with him can be very useful for the clinician.

In general, the laboratory is a magic place. Sometimes a lab does not only help to make decisions but makes them itself immediately, almost automatically. We have developed a rapid test for A-streptococcus in sore throats – we can give an antibiotic without waiting for the doctor. 

For the patient’s benefit, the laboratory should do a little – just a little! – marketing. Not to push unnecessary tests, of course, but to remind of the necessary ones, to show the possibilities of choice, and to facilitate the work of the clinician, who already has a lot of things to think about. This also has the result of increasing the patient’s propensity to comply with the doctor’s recommendations. Here is where analytics come in: who needs what, how it relates to clinical guidelines, and how to tactfully remind the patient that it is time for the test.

The lab also collects data from hundreds of thousands of patients. A doctor will never see that many people in such a short period. The lab accumulates and identifies patterns. And it’s also helping with treatment.

For the lab to be more effectively involved in patient management, we strive to integrate the LIMS more with EMR. Thus, the clinician will get important information: what test is needed, when, and with what analytical methods. That will increase the value of the lab to the clinician.

The second task is risk reduction which is easier, but no less important. You must be very precise because a mistake can cost a patient their life. The laboratory runs a wide variety of tests performed in large volumes. So LIMS has to give us complete confidence in our results. 

2. The laboratory as a production facility

Let’s move on. 

Our laboratory elephant stands on durable, reliable pillars. These legs are the laboratory’s economy, the structure of its revenues, and expenses. 

A real elephant often has leg problems. Similarly, a lab often has issues with its economic pillars. For example, you must have a billing system in which clients pay for all the tests. (The real problem is to provide only those tests they pay you for. You want to do more tests, but if you give some for free, it’s possible nobody needs them).

Then there’s the hardware, which doesn’t make your life any easier. Most of the time it comes in modules and has its middleware inseparable from the hardware itself. LIMS must learn to interact with this middleware to make the instrument effective. While the LIMS adapts, you won’t achieve the maximal capacity. Sometimes it may be easier to pass the problem to third-party systems that are more cooperative with the hardware than LIMS.

It’s important to realize that just because a vendor has made a great LIMS doesn’t necessarily mean they have an equally great consumables management system. Or that it has an outstanding equipment lifecycle and usage management system. Nor can you tell in advance whether a lab needs hardware or cost management functionality and whether you should include them in the LIMS functionality. One thing is for sure: the lab does need it. And it is up to you to decide which electronic “brain” will do it, LIMS or an external system, whichever is more convenient for you. 

3. The laboratory as a logistics system

The digestive system of a large mammal, the elephant, is complex and beautiful. Equally awe inspiring is the logistics of the laboratory. 

It seems simple. But when there are millions of samples, the supposedly clear system becomes opaque. We don’t even know where the mouth is and where its, so to say, outlet is. At what point do we begin to observe the logistics of sample movement?

Let’s take the brain-to-brain loop as a working hypothesis: logistics begins when the clinician has an idea to order something. It ends when the clinician looks at the analysis and decides what to do with the patient. It turns out that the power of LIMS as a logistics system extends far beyond the laboratory.

Of course, it would be nice to have the entire process contained within one software. But we have to remember that the clinician also has his system. He is used to it and doesn’t want any other. Not only that but in addition to the clinician and the lab, there are a whole bunch of people and organizations that handle the specimen. For example, it could be a delivery from a doctor’s office before the test, and then an outside company sends the results back. 

So LIMS must provide interoperability to unify the process. It is crucial to have continuity in the LIMS when you transfer a sample from one system to another. In some countries, people say of clinical laboratories, “A lab is… where they lose test tubes all the time.” But it doesn’t have to be this way. You have to track the logistics chain, learn how to manage it, and make it so that each person may work in their system while you retain total control of all the processes.

4. Lab as IT center

What else does our lab elephant have? A brain! 

The lab is a great information hub. If the IT architecture is unreliable, if the data structure is wrong, or if it does not provide clarity of understanding and ease of reporting, the lab becomes chaotic. On the contrary, the ideal lab strives to make zero mistakes and not lose anything throughout the process. It is a realm of divine order where coherent work simmers. The lab stores, processes, collates, and interprets data. You restrict the access to information by level. There are records with instructions: what it is, when it occurred, where it came from, and how to interpret it correctly. Separate is the data that the laboratory needs for itself: reference values, additional clinical information about patients needed to interpret tests, and quality control results. All these vast amounts of information stand neatly on their shelves. The structure of the shelves is clear and logical, so you can easily create any internal or external report. In a good laboratory, you get a lot of data from a small amount of biomaterial. It becomes a clinician’s assistant. 

You can use these vast amounts of laboratory data not only for the good of a particular patient but also for research.

The laboratory as an IT hub comes into play when scientists conduct Phase IV post-marketing studies (RWE-RWD). The world is now moving from universal medicine to a stratified one: scientists are finding small groups of patients for whom this technology will be particularly effective. RWE-RWDs show how treatment works in reality when we don’t control for compliance or exclude comorbid patients. Many medical technologies need laboratory solutions to use them. The lab helps understand how to apply the technology, and for whom its value will be maximal. The role of these studies has grown dramatically and will continue that way, and the lab is a great place to collect data for them. However, we can’t say that the LIMS architecture suits them well now. 

We must not forget population studies, from which scientists can evaluate the benefit of the entire health system. The laboratory is a place that helps manage the health of the population as a whole: assessing the effectiveness of vaccinations, morbidity, and complication rates. 

And the laboratory is also a great place for innovation. With Covid, we’ve learned how to quickly develop test systems that allow us to get solutions here and now. The companies that have created vaccines are great, but test system creators are also heroes, for they have created test systems in less than six months, from December 2019 to May 2020. 

All of this makes labs a practical platform for healthcare development.