LIS vs LIMS

There is often some confusion in the use of the terms Laboratory Information System (LIS) and Laboratory Information Management System (LIMS), and a temptation to use the terms interchangeably. Generally, the term LIS refers to systems used to manage clinical diagnostic testing within a hospital or healthcare environment. LIMS on the other hand refers to systems used in other analytical testing environments, for example those associated with pharmaceutical, food or chemical manufacturing, environmental control and commercial non-clinical testing organizations.

LIS

When comparing LIS vs LIMS the traditional differences cited are that LIS are patient centric with an emphasis on keeping personally identifiable information secure. This was formalized with the HIPAA requirements introduced in the USA in 1996. LIS store and manage patients' data and test results. LIS system software typically includes features such as:

• Patient demographic information including name, Date of Birth, ethnicity and blood type – key data that allows accurate interpretation of test results and diagnosis of conditions
• Tracking of patient samples and associated test results
• A historic record of clinical diagnosis, treatment and patient outcomes
• Integration of high throughput clinical analyzers
• Integration with numerous other health-based informatics systems, potentially using protocols such as HL7

LIMS

By contrast LIMS are sample centric. They have always been focused on efficiently managing a laboratory’s workflows usually, but not always, in batch-oriented environments. LIMS support organizations working to standards and regulations such as ISO/IEC 17025 setting out the competence requirements for testing and calibration, Good Manufacturing Practice (GMP) a code a practices controlling the manufacture of certain products like food and pharmaceuticals, and FDA 21 CFR Part 11 governing the use of electronic records and electronic signatures. A LIMS typically includes features such as:

• Batch tracking and management in addition to individual sample tracking
• Workflow management that ensures lab practices are adhered to
• Management of multiple specifications for product quality checking
• Laboratory management functionality such as Instrument calibration and staff competency management
• Integration with analytical instruments and instrument systems from simple balances to complex data systems
• Integration with other business systems such as Enterprise Resource Planning (ERP) Systems and Manufacturing Execution Systems (MES)

LIS vs LIMS

LIMS provide many benefits to regulated industries such as pharmaceutical, food and water. However, these benefits, including secure storage of data in a single repository, seamless integration with analytical instruments, and automated management reporting and creation Certificates of Analysis, mean that LIMS have been widely adopted across a broad spectrum of industries. LIMS provide support for going paperless, making the paperless laboratory a real possibility.

Without doubt there is a broad overlap of functionality between LIMS and LIS. Biobank management, clinical trial management and veterinary diagnostic systems, all of which are typically implemented using a LIMS, are examples of where functionality may seem the same or very similar to LIS. All may contain patient demographic data and record the results of clinical testing and some sort of clinical interpretation of the results. However, these applications are usually based on LIMS. This is symptomatic of the inherent flexibility of LIMS that allows them to support a wide range of applications

Modern LIS vs LIMS Capabilities

Unfortunately, there is no hard and fast definition of the terms LIS and LIMS; which is used may depend on an individual’s background and can vary, for example, from country to country. The important distinction is that there are Laboratory Informatics Systems designed specifically for managing diagnostic testing (LIS) and Laboratory Informatics Systems for other types of testing (LIMS). While there are many similarities there are also important differences that mean they are not interchangeable. It is important that these differences are understood. They range from workflows and support for industry standards and regulations through to cost.

Current LIS/LIMS solutions cope with the needs of Clinical and Non-clinical markets. LIMS show a significant difference, however. Because each industry they serve is different most LIMS providers create industry specific variants of their software in order to meet those specific needs. Autoscribe Informatics LIMS solutions are different. All our starter systems are based on exactly the same software. No software code is changed, instead changes to the workflows are made using our unique graphical configuration tools. This makes maintaining and updating your LIMS easy, support straight forward (even for screens you configure yourself) and reduces the total lifetime costs of your LIMS.