Laboratory Software Systems: What You Need to Know to Make an Informed Decision

Laboratories are big business. The global clinical laboratory service market is estimated to be worth about $200 billion and is predicted to reach approximately $290 billion by 2028. Later in this article, we will look at the key drivers of this growth and what they can tell us about the future of lab software. 

Types of Laboratory Software Systems

Laboratory software terminology can be confusing. Sometimes definitions are unclear or change over time. For example, laboratory information systems (LIS) and laboratory management information systems (LIMS) used to refer to very different concepts, but today their meanings overlap and some people use them interchangeably. Or, to take another example, the term lab management software can be used as a synonym for laboratory information system, but can also be used more broadly, to refer to any software used by a laboratory. 

Taking it even a step further, we call our system an “Operating Platform” because it goes beyond the basic tenets of LIS or LIMS systems and serves as an end-to-end enterprise-grade software solution for all medical laboratories. 

The LigoLab LIS & RCM Operating Platform includes modules for AP, CP, MDx, RCM, and Direct-to-Consumer, all on a silo-free integrated platform that supports every role, every department, and every case, enabling laboratories to differentiate themselves in the marketplace, scale their operations, and become more profitable.

In this article, we will use lab software systems and laboratory management software to refer to all software used in a laboratory environment, and we will define commonly used systems below while also highlighting some of the many aspects that allow LigoLab to stand out amongst the competition.

Laboratory Information System (LIS)

Laboratory information systems are the most common software suites that one will usually see in a lab. Traditionally, an LIS brings all parts of a lab under one software umbrella and establishes and maintains one centralized database for all laboratory departments and processes.  As such, it is responsible for a laboratory’s data collection, management, and reporting needs. This also allows it to manage lab process workflows.  

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Because an LIS is usually the central repository of all data relating to patients and their samples, it needs to effectively operate within the guidelines of CAP (College of American Pathologists), CLIA, (Clinical Laboratory Improvement Amendments), HIPAA (Health Insurance Portability and Accountability Act), and other regulatory agencies to mitigate compliance concerns and avoid penalties. 

Some of the processes managed by LIS software include:

• Collection of patient demographic data (age, gender, ethnicity, blood type, etc.)
• Tracking of specimens and test results for individual patients, including pool testing capabilities
• Order tracking
• Quality control
• Diagnosis and treatment recommendations
• Interoperability with instrumentation
• Interfacing with third parties including physicians and insurance companies
• Data analysis and reporting, including audit capabilities
  

With automated and electronic workflow queues, the modern LIS has rendered paper-based records and legacy IT systems obsolete, resulting in fewer errors, faster processing times, lower human resources costs, and increased scalability.  

With LigoLab’s all-in-one platform, users are freed from restrictions like paper forms and siloed systems that prevent maximized interoperability and efficiency. With one united software infrastructure, end-to-end data integrity is ensured. 

Laboratory Data Management System Reporting

‍Reporting has become an increasingly important component of laboratory information software. Third-party payers are increasingly demanding that laboratories interface with them through their automated electronic portals, and the best LIS solutions come pre-loaded with common, customizable templates. It is worth noting that this is another area where definitions blur; reporting and communicating with billing services can also be thought of as the province of revenue cycle management (RCM) discussed below.

The LigoLab platform comes equipped with a powerful reporting engine that makes every element of reporting templates - for both LIS and RCM operations - completely customizable. For a closer look at examples of report templates produced by the platform, we invite you to take advantage of our free download of lab report templates to see how these templates can add value for your customers. 

Laboratory Information Systems Vendors

The LIS market in the U.S. amounts to almost $2 billion and is predicted to grow at 6.5 percent per year over the next decade. Most LIS vendors are responding to laboratories’ demand for information technology to support higher productivity, reduced costs, fewer errors, and better data management and analysis. These needs are compounded by external pressure on laboratories to provide seamless integration with third parties such as public health agencies, payers, physicians, and billing services. Labs using legacy systems that lack functionality (modules and features) and prevent scalability are at a definite disadvantage, whereas labs that embrace future-ready and scalable systems can quickly adapt to the changing marketplace. 

Laboratory Information Management Software (LIMS)

The difference between a laboratory information system (LIS) and a laboratory information management system (LIMS) is often unclear.  While they share many features, like centralized workflows, tracking of samples, analysis and diagnostic functionality, and real-time data access, they have key differences.

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LIS vs. LIMS: What is the Difference?‍

One of the biggest differences is that LIS solutions are usually focused on individual patient records, whereas LIMS solutions are more sample-oriented and focused on a laboratory's operational workflows.

To expand on the above, an LIS is focused on patient data storage and management in addition to lab test results. It is generally optimized to cater primarily to individual needs, such as the patient’s healthcare provider or the patient him or herself, although it is also capable of managing clinical tests and generating reports. On the other hand, a LIMS is more suited for commercial settings. It processes and analyzes big data in large batches such as complex sample data generated from drug trials, biological testing, and others.

LIS and LIMS often have different end-users. LIS software is generally designed for pathology and clinical laboratories, veterinary clinics, and hospitals. LIMS will often be used in commercial settings such as pharmaceutical labs, manufacturing plants, and water treatment or food and beverage testing facilities.   

An LIS is usually more cost-effective than a LIMS. Furthermore, the best LIS software is easy to implement and adjust to a particular lab’s needs when compared with a LIMS. The latter often comes with more complex implementation protocols.

Notwithstanding the above, the distinctions between LIS and LIMS are blurring and some people use the terms interchangeably.  

Types of LIMS‍

A LIMS should offer data insights to a variety of stakeholders in an organization, assisting with decisions regarding maintenance, operations, and product development. A modern LIMS often comes with ISO 17025 compliance standards, good laboratory practice (GLP), and 21 CFR Part 11 (the U.S. FDA’s compliance rules for electronic records) guidelines in place.

Other Lab Management Software

Revenue Cycle Management (RCM)‍

Revenue cycle management (RCM) software is designed to facilitate revenue collection from patient/provider/insurance firms, and manage all related processes. The RCM software market has been growing rapidly, from just over $80 billion in the U.S. in 2016 to $120 billion today, with future growth predicted to be approximately 12 percent per year.

By digitizing and automating several processes, including collecting patient insurance information with their demographic data, charge capture, coding, claim submission, and payment collections, modern RCM software solutions significantly improve revenue collection. With increasing complexity in the claims reimbursement process, rising demands from third-party payers for digitalization and improved efficiency, and the move toward value-based reimbursements, RCM software is an essential component of an efficient and productive laboratory.

A deeply integrated system like the LigoLab LIS and RCM Operating Platform provides users with several advantages including real-time verification, eligibility, and scrubbing components, automated ICD and CPT coding, and automated client billing. This translates into fewer denials and less audit risk, more collected revenue, and more profitability. 

Scientific Data Management Systems (SDMS)‍

Classified as a Laboratory Data Management System software (or Laboratory Data Analysis Software), SDMS helps capture, catalog, and archive the data that is generated by various types of laboratory instruments and applications. While SDMS can represent an efficient solution for handling unstructured data, it is also designed to handle structured, and semi-structured data as well, including PDF files, images, instrument data, and spreadsheets. It is this ability to handle unstructured, heterogeneous data that sets it apart from a typical LIMS, which deals mostly with homogenous data. 

SDMS also integrates lab-generated data with administrative information, such as standard operating procedures and safety documents, in easily searchable indices housed in a central database. Also, SDMS can be leveraged to enhance research productivity via collaboration efforts between various departments/organizations.

Computerized Maintenance Management System (CMMS)‍

The most crucial factor for maintenance managers and departments is reliable uptime. A CMMS (also known, confusingly, as a CMMIS, or computerized maintenance management information system) helps laboratories optimize performance against this key metric by scheduling, managing, and reporting on maintenance operations. Central to the functionality of a CMMS is its database, which organizes information about an organization’s assets, equipment, materials, and other resources. 

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A robust audit trail and a specimen tracking and management module are examples of CMMS functionality that exists within the LigoLab platform. This enables users to track every entity and activity with user permission and visibility control, and each specimen with a unique identifier that ensures the chain of custody and security of the specimen, virtually eliminating lost or misplaced orders.     

The Future of Laboratory Software Systems

There are two parts to an analysis of the future of lab software: the future of the laboratory service market itself and the outlook for software systems that laboratories use. 

Concerning the former, growth is driven by a rise in infectious diseases and associated new strains of viruses (as we’ve seen with Covid-19), an aging population, increasing awareness of preventative health measures, the increased importance of disease surveillance and screening, and the steady advancement of consumerism with patients becoming more active in their healthcare.  

One way to take advantage of this growth is by embracing new technology that draws laboratories closer to patients. An example of this is TestDirectly, a flexible web-based patient engagement portal that replaces paper forms and manual processes with a user-friendly electronic workflow that empowers patients by directly connecting them with laboratories for convenient, safe, fast, and accurate direct-to-consumer testing.  

While the factors listed above will not drive exponential growth in the developed world, most of which is already reasonably well-served with laboratory resources, they can likely be counted upon to drive further significant incremental growth. That growth in itself generates more demand for the software that laboratories need.

That said, the lab software market is growing more quickly than the laboratory service market.  Like many industries, clinical and anatomic pathology labs are going through an IT revolution. Their work is especially data-intensive and there are significant rewards to effectively using and reporting on laboratory data and significant penalties resulting from data errors. Partners, including, especially, third-party payers like insurance companies, are increasingly demanding that reporting be automated, digital, and according to their unique specifications. 

A final factor fueling laboratory software system growth is that there are so many laboratories that still rely too heavily on paper-based or legacy software data collection and management.  They will need to upgrade to survive. In other words, IT solutions featuring digitalization and automation are no longer desirable add-ons but a necessity to not only support the complex day-to-day operations of a modern clinical lab but also to provide scalability to foster future expansion in operations. The use of such software has a direct correlation with enhanced lab efficiency and productivity.