The LIS certainly evolved over the past 35 years, from a basic database system to an automated, robust solution. The LIS, depending on which version you implement, can determine and define your lab’s workflow or be highly customized to fit its workflow and defined specialized test offerings.
One key question facing the industry is, do laboratories get needed features and functionality to stay competitive by adding extension modules — or do LIS developers 1) continue to build out LIS functionality to meet the lab’s needs or 2) follow the latest laboratory trends?
The answer is, honestly, both. Labs no longer serve just physicians or hospitals; sometimes the patient is the direct customer, what with the advent of and increase in boutique or specialized tests. The LIS is a fundamental component in any lab, private or commercial, large or small, a single facility or part of a large, regional network. It should be the hub for everything from patient demographics, to full historical data, lab and test trending, analysis – and should be able to do rules-based and intelligent testing based upon any number of factors: test results, patient demographics, and historical data from different disciplines.
Vendors and early LIS developers could not have predicted where the needs of the lab would go today, those that stayed in tune with their customers have grown their solutions to meet the needs of their customers. LIS systems have always been segmented or vertical in nature (e.g., clinical or anatomic pathology [AP]), for example, the AP LIS that could support cytology. The medical lab’s evolution demonstrates an LIS needs to be “everything” since many labs have to incorporate clinical, AP, molecular, cytology, dermato-pathology, and more, under one proverbial roof.
The LIS now needs to support outreach and EMR integration, requiring technology often outside the original scope of a system’s design. Thus, many LIS vendors are partnering to develop LIS solutions they did not have initially. So, a clinical LIS vendor is now developing an AP LIS. That is no better and no different than buying two disparate systems fraught with issues of true integration, scalability, and comprehensive testing and management-level reporting.
While a lab is better off buying the best vendor’s best-of-breed solution(s), the best answer is one in which a vendor develops a single solution with a truly unified database. The clinical LIS is the least complex of available LIS systems.
Adding AP functionality and workflow to an inherently clinical solution is similar to starting over, spending years of true market implementation, and using customers and early adopters of that solution as the test bed. No, a single solution based upon an AP LIS naturally adapts to support clinical lab needs and workflow, mirroring the evolution of AP as it blends with clinical pathology.
Expanding an AP solution with focuses on molecular, surgical, cytology and dermato-pathology to support clinical LIS functionality is the logical, more process-oriented approach. Instrument interfaces for automation are any lab’s goal, clinical or AP.
Understanding what vendors do well and selecting solutions that will work best for a lab’s goals, budget, and time frame stimulate success and growth, or help to maintain market share.
With the quickly changing regulatory landscape, vendors’ focusing on specific modules or functionality will better provide protections and functionality that allow the lab to have the confidence in its testing, its reporting, and its business operations while the vendor stays current on what applications are needed to support lab compliance.
Lisa-Jean Clifford is the CEO of Psyche Systems Corp. in Milford, MA.
