laboratory informatics
What is the difference between a LIMS and a LIS?
Gloria Metrick highlights a significant trend in informatics software: the growing convergence between sample-centric laboratory and patient-centric clinical systems
I
n a recent article on the Scientific Computing World website, Change and continuity, Tom Wilkie described how Starlims, now under the ownership of the multinational corporation
Abbott, is looking to expand into the healthcare informatics sector. Te article pointed out that in the past, the healthcare informatics market and the traditional LIMS market have been very separate. Even the acronyms are different: LIS versus LIMS. It’s an appropriate moment therefore to take
a more general look at, and try to shed light on, developments in these two areas of informatics. Where LIMS stands for ‘laboratory information management system’ and LIS stands for ‘laboratory information system,’ it is no wonder that many people are uncertain of the difference between the two. Add to that, the fact that the two systems have converged somewhat in functionality over the years, and the confusion mounts.
Traditional definitions Tere is no such thing as a ‘traditional’ LIMS or LIS. While our industries have created broad definitions, no actual system matches those theoretical definitions one hundred per cent. A more productive approach is to consider what the systems tended to be used for initially.
LIMS: past to present In the early days of LIMS, these systems were meant to manage samples in the laboratory, usually an analytical laboratory. Features of these systems were that they tracked samples, tests, and results throughout their locations and testing, and that they kept track of the actual test results recorded and the calculations performed. Some of these systems even allowed data to be gathered directly from instruments and instrument soſtware. Te critical point to note is that LIMS tend to
be sample-based. In the many years that have elapsed since
those early systems, most LIMS now do many more things than merely tracking samples, tests,
www.scientific-computing.com l
and results. In fact, some LIMS track things that are definitely not true samples. For example, quite a few LIMS have stability modules, which track stability pulls. Tere are LIMS that track instrumentation calibrations. Tese days, most LIMS systems can gather data from a variety of sources, not merely instrument-based sources. In addition, some LIMS now have LIS-like features.
LIS: past to present Te original LIS systems were intended as ‘clinical’ systems. In this context, the term ‘clinical’ refers to clinical diagnostics and the patient; but did not include clinical drug trials. Tis can be confusing terminology, as many pieces of soſtware will now also manage clinical trials and the term ‘clinical’ is sometimes used in that
REGULATORY
ISSUES ARE ADDRESSED BY BOTH TYPES OF SYSTEM
respect as well. For the purposes of this article, the term ‘clinical’ will be used to refer to clinical diagnostic-based systems. Tese systems tended to offer features that manage the actual patient data and testing details, rather than addressing the workflow. Te critical point to note here is that LIS tend to be patient-based.
Crossover of features Tese days, LIS systems have incorporated more and more of what would have, in the past, been considered to be LIMS features. In order to serve many markets, some LIMS and LIS products have begun to encroach on each other’s territory. Some LIS systems now have full capability to manage the testing and samples that are taken as part of a patient’s records. More LIS systems now allow those samples to be tracked for location and status of testing, for example, as well as allowing more flexible workflows. Additionally, more LIS systems are now capable of importing
@scwmagazine
data from instruments and other sources.On the other side, there are LIMS that are now allowing for the different auditing that is needed for patient testing. Most customers of LIMS are not interested in who reads a record, but only who changes or deletes it. In a LIS, it is important to track who has had any kind of access to a patient record, whether they are merely reading it or changing it. Since much patient testing is performed by
independent laboratories, billing has been an important feature for LIS systems – especially in private healthcare systems, such as that in the USA. However, in recent years LIMS systems have been routinely used by contract laboratories that require billing and CRM (customer relationship management), as well, so these types of features are now commonly offered by both LIS and LIMS systems.
Regulatory issues Regulatory issues to meet clinical needs now tend to be addressed by both types of systems that wish to serve this market. One example in the United States is CLIA (Clinical Laboratory Improvement Amendments – clinical testing guidelines). Patient (personal) privacy is an important issue in much of the world and these systems must follow the United States’ HIPAA (Health Insurance Portability and Accountability Act), Canada’s PIPEDA (Personal Information Protection and Electronic Documents Act), or Europe’s ECHR (European Convention on Human Rights). Internationally, these types of systems need to address HL7 (Health Level 7 – a framework for electronic data exchange). However, there are some regulations that do
not necessarily come specifically from the clinical side, such as the United States’ GLP (Good Laboratory Practice) and 21 CFR Part 11 (the US Food and Drug Administration’s compliance rules for electronic records). Tese issues affect many sample-based situations.
Specific examples Trish Meek, director of product strategy for the informatics business at Termo Fisher Scientific, gave an account of the company’s Clinical LIMS solution. While this product was specifically built as a LIMS, it is now being used also as a patient-based system to compete directly as a LIS. It addresses both regulatory issues such as CLIA
APRIL/MAY 2015 15
➤
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40