October 01, 2016
Laboratory Information System (LIS) and Laboratory Information Management System (LIMS) are two very popular informatics tools, which are fairly easily confused. While the two are related, their purposes are entirely different. Here are the striking differences between the two:
LIS is patient based. It stores and manages patients' data and their test results. A LIS system includes patient-centric features such as:
LIMS, on the other hand, is a comprehensive software tool used for centralizing laboratory's operational workflows and is sample centric rather than patient centric. The data it processes or analyzes includes large batches of complex sample data from drug trials*, biological testing, water treatment facilities etc. Some of the laboratory workflows that a LIMS manages are:
Sample Management: Sample accessioning, storage, chain of custody, test and result management, report generation, and disposal
Subject Management: Patient data entry, data masking, maintaining demographic details and report generation
Test Management: Test registration, result entry and report
Study Management: Projects and research data management
Billing Management: Client profiling and billing
Request Management: Request handling, approval and processing
User Management: User profiles, role based user access rights and data security
Lab Inventory: Stock management of chemicals, reagents, and consumables
Instrument Management: Instrument calibration, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Kits Management: Multiple operating centers, kit preparation, shipping and tracking
Storage Management: Freezer quality control, location management and tracking
Audit Trail: Record of the series of activities performed on a sample
Today, LIS has evolved from more than just managing patient information. LISes manage the testing results and sample details associated with a patient. Similar to LIMS, LIS can now import data from instruments and other sources. Newer LIS systems can even track sample location and report testing status, allowing more flexible workflows from a clinical lab's perspective.
Likewise, LIMS systems which were historically limited to patient sample management, are now offering comprehensive auditing for patient testing similar to LIS. Recording patient samples with full chain of custody is important in LIS for tracking the level of access rights (read/write permissions) to a patient's record. This is now implemented in LIMS systems as well because users are not only interested in who reads a record, but also who changes or deletes it.
Billing management, a feature of a LIS system–especially in private healthcare systems– is finding its way into a LIMS system. Billing and CRM (Customer Relationship Management) modules help manage and streamline accounting and patient information.
To summarize, LIS and LIMS have started infringing upon each others dominion to outperform and serve several markets at a time. Their distinct features and functionality are being unified. A LIMS system delivers a confluence of functionality between a traditional LIS, handling patient data, and a traditional LIMS, managing work flows across a lab, right from sample tracking to results reporting.
If you are a pathology, clinical lab, veterinary clinic or a hospital dealing with patient-centric ("subjects" and "specimens") data, opt for a LIS system. An LIS must satisfy the reporting and auditing needs of hospital accreditation agencies, Health Insurance Portability and Accountability Act of 1996 (HIPAA), and Clinical Laboratory Improvement Amendments of 1988 (CLIA), the United States federal regulatory standards) guidelines.
If you are a large facility handling large data sets --group-centric, we are talking about inputs of large batches of samples at a time-- rather than a single input, LIMS is a better option. LIMS is used by many private and commercial organizations such as environmental, pharmaceutical, research, food and beverages, manufacturing, mining, pharmaceutical and petrochemical works. A LIMS system needs to satisfy good laboratory practice (GLP) and 21 CFR Part 11 (the US FDA’s compliance rules for electronic records) guidelines.
When you talk about price, LIS is more cost effective than LIMS, easier to implement, and can be tweaked according to a lab's requirement. Traditional LIMS software is expensive and difficult to implement since different labs have different/specific requirements and versions. With significant advances happening in cloud computing, development efforts are shrinking and flexible payment options are being offered, labs can easily opt for a Cloud-Based LIMS as an alternative to LIS.
*Clinical drug trials is not a part of LIS.