LIS & LIMS Functionality Overlap to Meet Diverse Needs

The terms Laboratory information system (LIS) and laboratory information management system (LIMS) are sometimes used interchangeably; although the two overlap, they were designed to support different laboratory types and functionality. LISs are traditionally systems that support clinical and patient-centric specimens. LIMSs were historically designed to support sample-centric laboratory requirements, such as clinical research or other nonclinical laboratory settings. Today, functionality of the two systems overlaps to the extent that you may have some confusion over which system is best suited for your laboratory.

What Is an LIS?

An LIS records, manages, and stores patient testing data for clinical and pathology laboratories, including receiving test orders, sending orders to laboratory analyzers, tracking orders and results, and transmitting results from a searchable database. The LIS can include decision support rules that guide workflow, outreach tools, data mining capabilities, and point-of-care testing support. The LIS allows the laboratory to actively contribute to determination of patient health status and development of treatments.

Who Needs an LIS?

An LIS is typically implemented in hospital, clinical, public health, veterinary, or toxicology laboratories. The LIS can be considered a “best-of-breed,” solely focused on laboratory function, or it can be included as a module in an enterprise-wide electronic health record (EHR). An enterprise-wide system is typically designed for large hospital organizations and is typically selected for its system-wide standardization and data access and to decrease the need for interfacing with other systems.

Examples of LIS Functionality
Audit of system use
Barcode handling
Billing support/CPT codes
Data mining (administrative reporting)
Integration with other information systems and lab analyzers
Quality assurance and control
Medical necessity checking
Patient management and data tracking
Result reporting to providers
Rules-based decision support
Support for point-of-care, molecular, and genetic testing
Test ordering and specimen tracking
Workload management

 

What Is a LIMS?

The LIMS was originally developed for use in environmental, research, or commercial analysis such as testing for pharmaceutical, food and beverage, environmental, cannabis, petrochemical, metals, manufacturing, quality assurance, etc. Today’s LIMS functionality includes sample management, assay data management, data mining, data analysis, and the integration of electronic laboratory notebooks (ELNs). In standard LIMS workflow, samples and customer data are accessioned in the laboratory and barcoded; then the LIMS tracks chain of custody (COC), sample location, and other relevant sample information such as freeze-thaw cycles. The LIMS tracks a large volume of specimens through the testing process and through a cascade of analytical procedures. A LIMS helps users manage test results, calculations performed related to testing, quality control associated with the sample, equipment utilized, and inventory. The COC tracks sample-handling steps as required by various regulatory bodies (e.g., Department of Transportation (DOT), Environmental Protection Agency (EPA), Food and Drug Administration (FDA)). A detailed COC is required in many laboratories that handle environmental or forensic testing. Many LIMSs have stability modules that track stability testing that determines how the quality of a drug varies with time under the influence of a variety of environmental factors (e.g., temperature, humidity, light).

Like the LIS, the LIMS of today is required to be more adaptable to individual environments because it is used in so many different industries. Some of today’s LIMSs have added what is considered traditional LIS functionality, such as support for case-centric clinical specimens and patient data management.

Examples of LIMS Functionality
Audit trail management
Automation and integration
Bar code handling
Chain of custody
Compliance
Customer relationship management
Data capture and reduction
Document management
Environmental monitoring
Instrument calibration and maintenance
Inventory, storage, and equipment management
Invoicing and sales
Method management
Personnel and workload management
Project management
Quality assurance and control
SOP enforcement
Study management
Test reporting/certificate of analysis
Time tracking and performance assessment
Worklist assignment and prioritization

 

The Main Difference Between the LIS & LIMS

In the past, it was easier to discern whether your laboratory needed a LIMS or an LIS. Today, as functionality crosses the two systems, the lines are more blurred. The biggest distinction is that an LIS was developed to take care of individual patient records, whereas a LIMS was designed for batch testing, often in cases where individual patient identities are unimportant.

Overlap & Differences

With evolving technologies and ever-changing needs, LISs are incorporating features they may not have had traditionally. Currently, both LISs and LIMSs support data tracking, instrument interfaces, and workflow efficacy. Both an LIS and a LIMS can help a laboratory manager set up calibration date reminders and maintenance schedules for analyzers or instruments to support testing accuracy.

The LIS and LIMS overlap such that distinctions have become harder to make, but their overall initial purpose for development remains the same. The good news is that after determining if your facility is patient-centric or sample-centric, consider that many features in both an LIS and LIMS accompany the traditional functionality of the other. For example, the environmental testing that is traditionally performed by the LIMS can be handled in some LISs. And the LIMS can track instrument calibrations and other LIS-like features.

LIMS & LIS Comparison 1
 LIMSLIS
Traditional UseSample-based process; report data related to batches of samplesPatient-based; for processing and reporting data for individual patients in a clinical setting
Regulatory and Accreditation Bodies
  • FDA Title 21 CFR Part 11
  • GLP
  • ISO 17025
  • CLIA, The Joint Commission
  • CAP, COLA
  • HIPAA
Competitive NicheGroup-centric settings (batches and samples) for anonymous research-specific laboratory dataPatient-centric settings (subjects and specimens) in clinical labs
Laboratory TypesEnvironmental, research, or commercial analysis such as pharmaceutical, food and beverage, petrochemical, metals, manufacturing, quality assurance, biology labs, water treatment facilitiesClinical labs, physician’s office labs, veterinary clinics, hospitals, toxicology and pain clinics, reference labs, anatomic pathology, public health, and other healthcare facilities
OverlapAdopting case-centric information management typically reserved for an LISAdopting specimen tracking, batch-testing options typically reserved for a LIMS
Deployment Both the LIS and LIMS are offered as hosted or SaaS options.

 

Part of the confusion is that certain terms, such as “clinical” or “workflow” are used to mean different things when discussing the two systems. “Clinical” in the LIS refers to treatment of patients; whereas “clinical” in the LIMS is usually referring to clinical trials related to testing new treatments. For workflow, there are information system differences based on the different testing paths of laboratories: patient versus research study.

Determining the Best Fit for Your Lab

In summary, today’s LISs and LIMSs encroach on each other’s territory to garner greater market space and meet the needs of more laboratory types. Their distinct features and functionality overlap. Some LIMSs can handle patient data and manage clinical workflows while some LISs have the flexibility to handle batch testing and specimen tracking. If you are in a hospital, anatomic pathology, veterinary, or clinical laboratory managing patient-centric data, opt for an LIS. If you are in a facility handling large group-centric data sets, the logical choice is to look at a LIMS.

Reference

  1. Metrick G, What is the difference between a LIMS and a LIS? Scientific Computing World. Accessed at: www.scientific-computing.com/analysis-opinion/what-difference-between-lims-and-lis