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-centric. It stores and manages patients’ data and their test results. An LIS system includes patient-centric features such as:
Tracking, storing, and managing a patient’s demographics and associated sample information
Managing clinical tests performed on samples and their outcomes
Generating compliant patient reports
LIMS, on the other hand, is sample-centric i.e. the main focus revolves around lab workflow around a sample or a batch of samples. It is a comprehensive software tool used for centrally managing a laboratory’s operational workflows, eliminating data silos, and optimally utilizing available resources. The data it processes or analyzes includes large batches of complex sample data from drug trials, biological testing, water treatment facilities, etc. A LIMS offers numerous advantages to regulated sectors such as cannabis, clinical diagnostics and research, food and beverage, and environmental testing labs. These advantages encompass the secure consolidation of data into a unified repository, effortless interfacing with analytical equipment, and the automated generation of test reports or certificates of analysis (CoAs). Consequently, LIMS have garnered extensive adoption spanning a diverse range of industries.
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
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
Staff Management: Scheduling staff training, sending timely alerts prior to training, and managing staff competency Document Management: Managing documents, such as standard operating procedures (SOPs) and manuals, along with their version history Quality Control: Managing QC samples and their test results and validating each test run by comparing the test results of QC samples with the test samples, thus supporting the identification of analytical errors
What is the difference between an LIS & a LIMS?
The crucial distinction lies in the existence of LIS for overseeing diagnostic testing, as opposed to LIMS intended for various other testing purposes.
LIS (Laboratory Information System):
LIS stands for Laboratory Information System. It is primarily used in clinical laboratories, such as those in hospitals and healthcare facilities.
The main purpose of an LIS is to manage and store clinical and medical data related to patient samples, tests, and results. It helps in tracking patient information, test requests, and test results.
LIS systems are designed to ensure the accuracy and integrity of patient data, enable efficient sample tracking, automate test ordering and result reporting, and facilitate communication among healthcare professionals.
They often include features such as sample accessioning, test scheduling, result reporting, quality control, and interfacing with other healthcare information systems such as Electronic Health Records (EHRs), Hospital Information System (HIS), and Electronic Medical Record (EMR).
LIMS (Laboratory Information Management System):
LIMS stands for Laboratory Information Management System. It is used in various types of laboratories, including biobanks, diagnostics, research, pharmaceutical, analytical, and industrial labs.
The primary purpose of a LIMS is to manage and track laboratory samples, tests, data, and resources. It helps in organizing and automating laboratory workflows and data management.
LIMS systems are designed to handle a wide range of laboratory processes, including staff management, inventory management, quality control processes, data analysis, and experiment management.
They often include functionality such as sample tracking and chain of custody, sample storage management, test management, instrument integration, data capture and analysis, report generation, and compliance with regulatory standards.
Difference between LIS vs LIMS Capabilities: Fast Facts
Patient-centric; for processing and reporting data of individual patients such as in a clinical diagnostic lab
Sample-centric; reporting large batches of samples at a time, rather than a single input
Type of Laboratories
Clinical labs, hospitals, veterinary clinics, toxicology clinics, reference labs, public health, and other healthcare facilities
Water, environmental, food & beverage, oil & gas, petrochemical, agricultural, pharmaceutical, quality assurance, clinical labs, biobanks, and more
Regulatory Bodies and Standards
CLIA, HIPAA, CAP
ISO 17025, GMP, 21 CFR11, GLP, HIPAA, and many more
Distinction aside, as technology advances, the two systems are becoming increasingly similar. In the next section, we will delve into these shared similarities.
Are there any crossover features common to both?
Today, LIS has evolved from more than just managing patient information. An LIS can manage the testing results and sample details associated with a patient. Similar to LIMS, an LIS can now import data from instruments, software, local databases, 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 patients’ sample management, are now offering comprehensive auditing for patient testing similar to LIS. Recording patient samples with a 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.
There is an undeniable extensive convergence of features between LIMS and LIS. LIMS, in its capacity, serves to efficiently manage biobanks, clinical trials, and veterinary diagnostic lab workflows, in addition to fulfilling other laboratory requirements. It is worth noting that the functionalities of such a LIMS may often exhibit striking resemblances to those found in an LIS. Both systems share the ability to store patient demographic data, record clinical test results, and facilitate the interpretation of these results.
This convergence underscores the inherent adaptability of LIMS, enabling them to seamlessly accommodate a wide spectrum of workflows and effectively address the day-to-day challenges encountered in laboratory operations.
To summarize, LIS and LIMS have started infringing upon each other’s 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 workflows across a lab, right from sample tracking to results reporting.
Which one is better for my lab, LIS or LIMS?
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.
Conclusion: LIS vs LIMS Capabilities
The distinction between LIS and LIMS boils down to the fact that an LIS is patient-centric and is designed for clinical diagnostic testing. In contrast, a LIMS is sample-centric and is meant for labs in a myriad of other industries, such as food or chemical manufacturing, environmental monitoring, and commercial non-clinical testing, to name a few, in addition to clinical diagnostics, pharma, research and biobanking. Differences between LIS and LIMS exist in workflows, support for industry standards and regulations, and the cost of the two systems. Having said that, the two systems are evolving fast to borrow from each other. LIS has undergone significant development, expanding its role beyond patient information management to include the capability to import data from various sources, mirroring the functionality of a LIMS. Likewise, contemporary LIMS systems meticulously record patient samples and associated metadata along with custodians for each sample, ensuring a complete chain of custody, which is a crucial aspect also found in LIS. The future of LIS and LIMS? While the differences between the two must be understood, with all the advances in cloud computing and the advent of modern cloud-based LIMS, the two approaches, viz., patient-centric and sample-centric, can be supported with a single system.