This page contains a Flash digital edition of a book.

not adversely affect the existing client base. ‘The idea is that the basic technology that underlies our system will be the same for all customers,’ Wood explained. ‘We sell it as a three-layer technology, where we have the underlying technology which supports everything else. On top of that we have the applications: for the healthcare market; for the quality manufacturing market – pharmaceutical manufacturing, the oil refineries, etc.’ Abbott is by no means the only company

eyeing the healthcare, or at least the clinical diagnostics, market. In part this reflects an evolution in the nature of LIMS. In the early days of LIMS, the systems were meant to manage

Most LIMS now do many

more things than merely tracking samples, tests, and results

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 software. The critical point to note is that LIMS tend to be sample-based.

CONVERGENCE WITH HEALTHCARE INFORMATICS However, most LIMS now do many more things than merely tracking samples, tests, 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. There are LIMS that track instrumentation calibrations. These days, most LIMS systems can gather data from a variety of sources, not merely instrument-based sources. This moves them away from sample-centric functionality and closer to what is required in healthcare informatics – being patient-centred. A further impetus towards convergence of

healthcare and traditional LIMS has been the practice by large companies – particularly in the pharmaceutical industry – of outsourcing their analytical work to contract laboratories. This has meant that features such as billing systems and customer relationship management (CRM) are now commonly offered by LIMS. In countries that have private healthcare systems, such as the USA, much patient testing is also performed by independent laboratories and billing is a very important feature for healthcare informatics systems.

12 |

Lonza Bioscience’s MODA system in action: paperless mobility in the cleanroom An example of this convergence is Thermo

Fisher Scientific’s Clinical LIMS solution, which was specifically built as a LIMS but is now also being used as a patient-based system. LabWare’s approach is similar, in that the LabWare LIMS product has native features to support clinical laboratory workflow, instrument interfacing, sampling, and aliquoting. LabWare’s product architecture allows for the addition of patient management features that enable the system to be patient-centric, while maintaining all sample management and tracking capabilities. LabWare uses a configurable modular-based approach, to give a flexible, comprehensive, and regulatory compliant solution to the clinical laboratory market, which for LabWare includes hospitals, reference labs, and public health labs. Although LIMS are designed to accord with

government regulations, the regulatory issues in the clinical sector may be different, for

example, the Clinical Laboratory Improvement Amendments – clinical testing guidelines (CLIA) in the United States. Patient (personal) privacy is an important issue governed by such regulations as the United States’ Health Insurance Portability and Accountability Act (HIPAA), Canada’s Personal Information Protection and Electronic Documents Act (PIPEDA), and Europe’s developing data privacy law (see the article on page 28). Thermo Fisher Scientific’s Clinical LIMS

addresses both regulatory issues such as CLIA and HIPAA, and laboratory needs such as next- gen sequencing and plate-based planning. At the same time, none of this takes away from the workflow-based features inherent in the product. The samples/aliquots features that are in the base system can also be used with the more clinical features such as patient management, physician test request forms and medical billing. In


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  |  Page 41  |  Page 42  |  Page 43  |  Page 44