In two previous posts, I began to explore both the similarities and differences between LISs and LIMs (see: LIS vs. LIMS: It's Time to Blend the Two Types of Lab Information Systems, LIMS and Preclinical Workflow: Another Dimension of the LIS/LIMS Discussion). Larry Wimberly of Wimberly Consulting Services, who has a very long and distinguished history in the LIS industry, sent me an email, commenting on the differences between the two types of systems. His ideas provide some important insights and are listed below:
- One of the major differences between LIMS and LIS systems is what the LIMS vendors refer to as workflows and are analogous to the protocols used in anatomic pathology. In the case of clinical trials, the lab work is performed for, and paid by, the sponsor of the trial, usually a pharmaceutical company as opposed to a physician/patient in the case of an LIS.
- Each study managed by an LIMS requires that a research protocol be established stipulating, for example, the number of times that a research subject will be tested and the type of tests to be performed each time. These details may differ for each testing cycle. For instance, the initial cycle of lab testing may contain a number of tests that will be used for baseline comparisons against future specimens from the same subject during the trial. Each succeeding test cycle in the protocol usually has to be performed within a specific time window and may include a subset of these initial tests as well as new tests. Results are usually reported to both the sponsor and the primary investigator in the case of a research study or clinical trial.
- Another part of the reporting requirements managed by an LIMS is special flagging of results outside of the reference ranges, which is actually a change in a result compared to its baseline value. These reference ranges are usually established in the first testing cycle and/or defined by the study sponsor. This approach to reference ranges is very different from that used by the typical hospital clinical lab and reported by LISs.
- When a research specimen arrives in the lab, it first needs to be identified as to its study, the test cycle, and the research subject. Important for this process is that each test cycle requires a specific "collection kit" including items such as specimen containers, blood drawing instructions, and the test order form. These kits also include mailing labels for their initial distribution and pre-accessioned specimen labels to ensure that the specimen collection process is made more efficient. This is one of the reasons that CRO labs are so interested in having pre-accessioned specimens. In fact, their preference is to have the LIMS, on a timely basis, generate a pick-list so that these collection kits can be assembled.
- In the case of public health labs which tend to favor LIMSs over LISs, most of their focus in the past has been on environmental testing for analytes such as heavy metals and other contaminants. These types of studies lend themselves more to a LIMS than a traditional LIS. I’m not aware of any LIS system that can handle these types of testing/reporting protocols very efficiently.
- Most LIMSs are not really patient centric and can't compete very well in the traditional clinical lab environment. However, large-scale diabetes testing programs would be improved with a LIMS-based approach. For these types of patient. a testing protocol could be developed based on the disease stage of each of them. For example, some patients would be tested annually and others quarterly using different test profiles each quarter. The test results would be sent to both the physician and patient and also copied to the relevant EMR/PHR. In this way, a complete record for each patients would be compiled and accessible. Also reminders could be sent out on a timely basis with follow-ups for patients who don’t respond.
- I believe that with the advent of earlier detection of disease, more rigorous patient follow-ups, and greater attention to health maintenance, there would be significant benefits from the merger of the features/functions of the LIMS and LIS. Of course the corollary to this is that clinical protocols such as the one described above for patients with diabetes will not use the LIS as their primary locus but rather the direct patient care systems. Regardless of where the actual locus of control and responsibility for these protocols lies, I believe that LISs will need to adopt some of these new functionalities in order to support these emerging clinical surveillance programs.
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