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Whenever a healthcare laboratory decides to upgrade the way it manages its data, managers must confront questions regarding LIMS and LIS like:
- Do we get a laboratory information system (LIS) or a laboratory information management system (LIMS)?
- How exactly is a LIS different from a LIMS?
- Are an LIS and LIMS the same thing?
Historically, the two technologies were quite distinct. Today, these software categories have become so similar that talking about the two is almost a distinction without a difference. Almost.
LIS and LIMS solutions evolved from separate starting points and, while increasingly similar, have not converged completely. Laboratory managers choosing an informatics solution for clinical applications need to know how the remaining differences will shape how their labs operate today and into the future.
What is an LIS?
As computer and networking technology became more accessible in the late twentieth century, clinical laboratories adopted digitization to improve turnaround times, quality of service to physicians, and ultimately patient outcomes. Software developers wrote LIS applications to meet the unique priorities of clinical testing.
As a result, the LIS model revolves around the patient.
Consider this simplified case of a 1990s-era medical clinic. Nurses collected blood, urine, and other specimens during a patient’s visit. The clinic’s laboratory ran these specimens through various assays and compiled a report of that patient’s results. The physician reviewed the results and their examination notes to diagnose the patient and develop a treatment plan.
LIS software was designed to optimize this patient-centric process, from specimen collection to reporting. Its database consolidated test results with all the relevant patient information, including demographics and medical history.
Adopting an LIS also streamlined the healthcare industry’s unique billing processes by, for example, integrating codes from the American Medical Association’s Current Procedural Terminology (CPT) and the Centers for Medicare and Medicaid Services’ Healthcare Common Procedure Coding System (HCPCS). An LIS eliminated data entry errors, automatically populated claim forms, and ensured speedy reimbursement.
Another healthcare-specific benefit of an LIS was the way it protected patient information. Early in the industry’s digitization, public concerns about access to their medical information spurred new regulations, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA), designed to keep patient data private and secure. LIS developers responded by introducing access controls, encryption, and other features to keep patient records confidential.
While the patient-centric model of an LIS improved productivity in clinical settings, it was not without limitations. As initially conceived, an LIS supported the more ad hoc, low-volume testing requirements of a healthcare clinic. Even in a hospital, the workloads in a clinical lab depended on the nature of that day’s patients. A technician might wait for several specimens to arrive before performing simple urinalysis assays, but the volume and rate of testing were too low to require regular batch processing.
What is a LIMS?
The technological trends that led to LIS adoption in clinical labs also spurred digitization in industrial, government, and research laboratories. The software developed to support these markets, the LIMS, was designed to meet the shared requirements for quality and efficiency in high-volume settings.
As a result, the LIMS model revolves around the sample.
Consider a 1990s-era pharmaceutical lab. Samples were collected from raw ingredients, throughout production, and the final product arrived in the lab, where staff conducted chemical, toxicological, microbiological, and other tests to evaluate manufacturing quality. This or another company lab would support research and development, clinical trials, and regulatory approval.
LIMS software was developed to optimize quality and efficiency by helping to move samples through the process as efficiently as possible while guaranteeing the test results’ data integrity. Most industries relied on routine, high-volume, high-throughput testing—often using batch processes—which allowed labs to apply quality improvement techniques to improve their operations.
In addition, a LIMS supported the lab’s efforts to comply with industry and regulatory compliance frameworks for laboratory quality management, such as ISO/IEC 17025 and the FDA’s Current Good Manufacturing Practices (CGMP). The LIMS provided an auditable database of testing performance that made compliance much easier to achieve.
The sample-centric model driving LIMS development had implications of its own. For example, data integrity and traceability were much more important than data security. When companies or government agencies investigated incidents, such as contaminated food products reaching consumers, a LIMS let them quickly find the root cause thanks to features like sample tracking and change controls.
Are the LIS and LIMS still different?
Much has changed in the four decades since LIS and LIMS applications first entered laboratories in their respective industries.
LIMS applications evolved into LIMS platforms. Built upon a core codebase, a LIMS platform can support multiple industries through simple configurations without costly code development. Vendors that already served pharmaceutical and other healthcare-adjacent industries added patient-centric features to create clinical LIMS solutions.
At the same time, many LIS developers borrowed features from their LIMS counterparts to support the changing nature of clinical testing and to diversify into other industries. By adopting a platform-based architecture, some LIS vendors became, for all intents and purposes, LIMS developers.
To a degree, the term “LIS” today has more to do with the branding of vendors that focus on clinical markets than it does with information technology. Potential customers who spent their career using an LIS recognize the term, so calling an application an LIS simplifies the marketing message.
Trends driving clinical LIMS adoption
Whatever branding a vendor uses, clinical LIMS platforms have become essential to healthcare laboratory operations. Supporting positive patient outcomes is still central to a lab’s mission. Healthcare labs are still patient-centric. However, several trends over the past twenty years have made the capabilities of a LIMS more relevant to medical testing.
Industry consolidation
Independent hospitals have been swallowed up in mergers and acquisitions to create hospital systems. With hundreds or thousands of beds, these systems rely on core laboratories to quickly turn around high volumes of clinical, toxicological, and other tests.
Similarly, the rise of contract laboratories has allowed small hospitals, clinics, and independent physicians to outsource testing and benefit from more efficient third parties. These contract clinical diagnostic labs must quickly process and test the hundreds of specimens they receive daily.
LIMS platforms are better positioned than LIS applications to serve large hospital systems and contract laboratories. A LIMS already has the codebase to support high-volume, high-throughput operations and multi-location organizational structures.
New clinical testing technologies and practices
Advances in nuclear imaging, mass spectrometry, molecular diagnostics, and other technologies have introduced new tools for physicians to diagnose their patients. These advanced technologies involve complex workflows and generate considerably more data than traditional wet chemistry analysis.
As genomic testing plays an increasing role in healthcare, the amount of data laboratories must handle is growing exponentially. The promise of personalized or precision medicine should dramatically improve patient outcomes by delivering therapies tailored to each patient’s genetic profile.
Again, LIMS platforms are well-positioned to meet this trend. Already used in research laboratories and other use cases where complex test methods generate large data volumes, a LIMS can help healthcare laboratories transition from one-for-many treatments to one-for-one treatments.
LIS or LIMS: What’s best for clinical use cases?
As healthcare laboratories make the LIS vs. LIMS comparison, the critical question is whether a vendor offers a full-featured solution that supports the lab’s future.
A traditional patient-centric LIS may support how the lab has worked in the past, but the software can’t evolve without the underlying capabilities of a LIMS platform.
A clinical LIMS solution, on the other hand, benefits from its robust multi-industry codebase. A healthcare laboratory can add new capabilities to its LIMS through simple configuration changes, avoiding costly software development.
A clinical LIMS solution offers the configurability, flexibility, and scalability healthcare labs need in an era of rapid change.
Before the COVID-19 pandemic, for example, LabLynx offered LIMS solutions tailored for clinical diagnostics labs and for molecular diagnostics labs. As the pandemic intensified, our clinical customers purchased molecular diagnostics systems to accelerate COVID-19 testing in their communities. We activated the molecular diagnostics capabilities in their LabLynx LIMS solution by applying a simple configuration change. Labs quickly integrated their new testing capabilities within the system they already knew to ramp up testing throughput.
ELab LIMS for Healthcare: Combining the best LIS and LIMS capabilities
From our creation of the first true browser-based LIMS more than 20 years ago, LabLynx LIMS solutions have helped laboratories in every industry improve testing performance, productivity, and compliance.
ELab LIMS for Healthcare leverages our cloud-based platform to securely manage every aspect of patient-centric laboratory operations with capabilities that include:
Specimen management
Whether your lab uses traditional single-specimen methods, batch processing, or sample pooling, ELab LIMS for Healthcare associates specimen information, test data, and results with patient records.
Privacy, security, and compliance
End-to-end encryption and role-based access controls ensure patient information remains private and secure. Auditable records, traceability, and other features streamline compliance audits to meet the requirements of HIPAA, CLIA, and other healthcare regulations.
Integrations
ELab LIMS for Healthcare solutions can unify a laboratory’s instruments and systems, turning its LIMS into the central information hub for everything the lab does. Integrations with electronic health record (EHR) systems improve data security and facilitate communications with laboratory stakeholders.
LabLynx’s ELab LIMS for Healthcare combines the characteristics of a LIS with the flexible, scalable capabilities of a LIMS. Contact LabLynx to learn how ELab LIMS for Healthcare can prepare your lab for the future of clinical testing.
