The laboratory’s role in patient care has been evolving and morphing for decades, but never more so than in the last 3–5 years. With changes in regulation, reimbursement, test focus, and patient access to information, and especially with the rise in general of patient-centric care, the lab has become the central cog in a very strategic wheel of healthcare. This is a significant departure from the perception of the past that the lab’s role was simply to provide a test result. In this environment, laboratories are looking to their technology infrastructure to support new initiatives, drive out inefficiencies, and improve their service offerings. As backbone technology for laboratories, laboratory information systems (LIS) ensure that maximum efficiencies and improved patient care are being realized in order to minimize cost and maximize reimbursement.
A key aspect to be considered by each laboratory is the extremely valuable data that can give labs insights into their business operations. These data include information such as test turnaround times, accessioning times per case, repeat runs of certain tests or specific instruments, cases corrected by accessioner/pathologist/technologist, instances when an external customer has been sending in fewer (or more) tests, specific types of tests, how long or how many attempts it takes to get a payor to pay a claim –the list is a long one. These are all pieces of information that can show trends a lab can act upon to improve its business. These data provide insight for each lab to understand where its strengths and weaknesses lie as a business. All of this discrete data are information that can be processed, analyzed, and used to incorporate new processes and make changes to existing ones or updates in training, interfaces, and automation to become more profitable, have better turnaround times, and focus on areas that have higher and faster reimbursements and customer retention, all the while enhancing personalized medicine. This makes the LIS a central repository of all of the data coming into, and going out of, the lab.
There are many types of data that the LIS has access to – not just the obvious ones of patient data, demographics, test results, and diagnosis – and all are extremely valuable not only in the testing the lab is doing, but also in the big data picture. In today’s laboratories, an LIS is not optional. Many laboratories today have complex workflows that require a sophisticated LIS. While often those who work outside of the lab see the LIS as a black box that receives orders and sends back results, today’s LIS involves intricate software that is vital to support laboratories and their role in patient care. There are several benefits of an appropriate LIS.
- Positive patient identification and accurate patient demographics by eliminating hand-written names that are incomplete or illegible are eliminated, and using barcode-printed labels for accurate labeling
- Monitoring result discrepancies through delta checking, allowing laboratorians to alert a provider to changes in a patient’s condition
- Management review by storing proof of review by the managerial staff for the analytical review of the test systems for defined tests or selected personnel
- Quality control keep/store reports or documentation readily available for inspections. A scheduler creates paperless schedules for the staff on external QC, maintenance, and assignments. The LIS assists with ensuring the QC is acceptable and can disable release of results if certain criteria are not met
- Automated test reflex or testing cascade enable providers to order a test while the rules automatically order the appropriate tests based on the initial results. Auto-verification rules allow rapid flow of results within the predefined ranges into the patient chart, eliminating the need for review of test results. The user can set up ordering rules and automatic reflex testing rules based on results, eliminating the risk of forgetting to do a reflex test and generating the electronic billing change
- Standing order and call documentation to track of orders and document attempts and outcomes of contact with a patient, enabling better patient outcomes
- Result dissemination in a timely manner. Electronic bidirectional interfaces with EMRs, practice management systems, and reference lab systems enable accurate, up-to-date information in the LIS and all systems
Over the past decade, the volume of data generated by diagnostic testing has outpaced the organization, reporting, and interfacing features of traditional LIS. And, because during most of this time, it was typically a handful of medical laboratories that performed advanced molecular and genetic testing, this market was not big enough to justify IT companies developing more sophisticated LIS products to serve what was, at that time, a small market segment. Meanwhile, what has changed in the marketplace during the past 48 months is the availability of more multianalyte assays, load-and-walk-away analyzers, and automation that enable pathology groups and community hospital labs to establish and offer a growing menu of molecular assays and genetic tests.
To meet the demand for LIS that competently and capably manage the high volume of data generated by the current generation of molecular and genetic tests, most LIS providers and vendors are scrambling to add capabilities to their traditional LIS products to help streamline and manage laboratory workflows, reporting, billing, and other essential aspects of daily operation. These software products are designed to enable labs to handle the growing volume of data that powers personalized medicine. By design, they have capabilities that go beyond the traditional LIS products, mostly because of the often huge volumes of raw data they must collect, store, and analyze. However, there is no standard LIS designed due to the fact that laboratories are highly diverse and have different requirements. Therefore, a LIS is developed, customized, and configured according to the needs of a laboratory.
Today’s mature LIS are complex and detailed. They include advanced features that promote clinical care and patient safety (e.g., patient match queue, duplicate testing alerts, outreach support, advanced decision-support rules, sophisticated analyzer interfaces, specimen tracking, quality control, quality assurance, etc.). The most sophisticated LIS will likely eliminate the need for middleware, as the functionality is included in the LIS. Many such features have been in the LIS for years and continue to be improved upon based on user input, such as, improvement in human computer interaction (HCI) to make LIS use more intuitive, continuous development of configurable decision-support rules to increase lab efficiency and productivity, and advancement in analytics and dashboard capabilities allowing laboratories to track important metrics that can have organization-wide impact.
The global LIS market is poised to grow at a CAGR of around 9.9 percent from 2017 to 2025 to reach approximately USD 3.1 billion by 2025, predicts Research and Markets. The rising prevalence and incidence of chronic diseases, strong government support and initiatives to promote healthcare IT implementation, increasing adoption of LIS to enhance lab efficiency, integration of LIS and HER systems, and introduction of new and advances products are expected to drive the market. However, the high cost of LIS, high maintenance and service expenses and interoperability issues, and lack of skilled professionals in the healthcare industry are hindering the growth of the market.
The software segment is expected to emerge as one of the most lucrative component segment in the global LIS market. Market acceptance of new software products and rise in product enhancements are expected to drive rise in advent of innovative LIS systems over the years. The cloud-based delivery mode segment is expected to emerge as the dominant segment in the global market. It is currently the most attractive segment in terms of revenue in the market, however, high and unpredictable costs of ownership of on-premise delivery mode is expected to lead to decrease in revenue growth of the on- premise segment during 2017–2025.
In terms of value, the North American region is dominating the global market at present owing to the growing trend of designing, development, and implementation of LIS system; various technological advancements; and the growing healthcare sector. In addition to increasing disease incidences, government initiatives to promote the use of LIS have resulted in Europe becoming the fastest growing market. The Asia-Pacific region is also expected to show a rapid growth over the years.
Some of the key players identified in the global market include 3M Company, AAC Infotray, Abbott Informatics (Starlims), Autoscribe Informatics, Baytek International, Cerner Corporation, Compugroup Medica, Epic Systems Corporation, Evident, Genologics – Illumina, H&A Scientific, Labvantage Solutions, Labwar, Mckesson Corporation, Medical Information Technology, Merge Healthcare Incorporated, Novatek International, Orchard Software Corporation, PerkinElmer, Roper Technologies, SCC Soft Computer, Sunquest Information Systems (Acquired By Roper Technologies), Swisslab, and Thermo Fisher Scientific.
Today’s LIS is a very complex software with numerous specialized capabilities dependent on each laboratory’s needs. The addition of niche functionality, such as voice recognition, scheduling, imaging, billing, pathology, and molecular, has shaped the LIS into an intricate clinical information system. There might not be a single LIS product that fulfills the complete needs of some laboratories, so additional modules or middleware must be added. Additionally, as laboratories evolve in the value-based healthcare arena, emphasis is shifting to new areas, such as molecular and point-of-care testing (PoCT). Labs have new analytics to track to support efficiency within the healthcare organization (HCO). Ideally, an LIS should be able to rapidly incorporate new functionalities to keep up with changes in the lab market.
Integration. The need for LIS interfaces to other systems (e.g., analyzers, reference laboratories, public health labs, tumor registries, billing systems, and EHRs) continues to be important. Regardless of the LIS, this need will persist as healthcare focuses on interoperable systems and laboratories update their test methodologies and make analyzer changes.
Outreach. Laboratory outreach is becoming another big focus as the healthcare system continues to experience multiple consolidations and mergers to develop Integrated Delivery Networks that have the economy of scale to succeed in value-based care models. Revenue-providing laboratory outreach activities require the LIS for detailed tracking of client needs.
PoCT. The demand for PoCT is increasing as the healthcare system strives to improve patient satisfaction and improve access and outcomes across the patient care continuum. Having the rapid turnaround time that PoCT affords can speed diagnosis and subsequent treatment, and in many instances save downstream costs.
Analytic reports. Labs are expected to track internal analytics such as test utilization, staffing levels, and quality measures, and the LIS can be vital in providing these reports. Tracking of patients for certain disease states, such as diabetes or monitoring of anticoagulation, can support current healthcare metrics that demonstrate a quality focus.
Molecular and genetic testing. An increasing focus on personalized medicine and advances in technology are driving the demand for molecular and genetic testing. Laboratories that perform these tests need information systems that can support complex molecular testing workflows, algorithms, and large amounts of data storage and handling.
Lab leaders are increasingly looking to LIS vendors for a mentor- or coach-style relationship, and forward-thinking vendors are offering that service. With all of the recent changes in testing regulations and reimbursements, as well as test types merging and evolving – such as crossover molecular, PGx, etc. – labs need to be able to focus on the medical side of their business. Their technology providers need to give them a clear direction on how to best leverage their IT investment. Vendors need to provide coaching throughout setup, implementation, automation, and integration with all aspects of the lab’s IT infrastructure, and beyond.
Vendors need to partner and develop technology integrations with one another to provide all aspects of patient information data flow that are relevant for a physician to make an accurate diagnosis and develop a customized treatment plan. After all, no one can understand the technology and technical capabilities better than the vendors, as it relates to how to best gain efficiencies and utilize technology to support laboratory objectives. And they need to be able to act on that understanding by giving labs valuable direction.
As laboratories transition to become valuable cost centers, having a robust LIS can improve the lab’s efficiency and its ability to contribute to organization-wide savings and improvements in patient care. The LIS must continually advance to meet the testing requirements, including new molecular testing, and assist the lab in delivering the data required to ensure maximum efficiency and the best possible patient care. Digital revolution in India is significant as it promises to bring a multidimensional metamorphosis, and with continued change and uncertainty in healthcare’s future direction, laboratories need an LIS that is highly responsive to their needs and to the changing healthcare landscape.