How do I Know if My Laboratory has Outgrown its LIS System?
July 6, 2023
All one needs to do is spend one day in a medical laboratory to quickly understand the important role that a laboratory information system (LIS) plays while supporting a lab’s technical operations. In basic terms, a lab information system records and stores patient and specimen data while also tracking the specimen through every stage of testing. A LIS in the laboratory organization drives productivity and efficiency and also generates and distributes lab reports to a lab’s customers.
Be it a high-volume full-service clinical laboratory, a growing pathology group, or a molecular diagnostics start-up lab, the importance of LIS software cannot be overstated. But what happens when a lab and the industry begin to evolve and expand?
In most cases, legacy LIS systems and homegrown pathology lab software solutions aren’t built with flexibility and scale in mind, and inadequate laboratory software systems can quickly become a barrier to business success.
The best LIS software doesn’t have a shelf life and laboratory information system companies that understand this offer flexible and comprehensive laboratory information system software that adapts and scales as the lab does, enabling the business to reach its full potential faster.
Note: Laboratory Information Systems, known as LIS or LIS systems, and Laboratory Information Management Systems, known as LIMS or LIMS systems, are two types of laboratory management software solutions that often are used interchangeably even though they are built to support different types of labs.
Tips for Evaluating Your Laboratory Information System
Identifying if a lab has outgrown its LIS system from within can be challenging, but it's vitally important in terms of efficient operations and overall growth. As LIS system vendors with nearly 20 years of industry experience, and having replaced legacy systems in over 200 laboratory facilities, we’re acutely aware of the struggles that labs with inadequate lab informatics go through. That’s why we’ve compiled a list of examples that may indicate that it’s time for your lab to upgrade its LIS software.
Is Your Lab Experiencing Any of These LIS Pathology Issues?
Difficulty in Adapting to Changes
If your LIS system is struggling to keep pace with changes to your laboratory workflow, it might be a sign that you've outgrown the LIS software. Your lab information system should be flexible and able to adapt to new tests, regulatory changes, and updated laboratory workflows. It also should allow for your staff to make changes via configuration to enhance workflow efficiency. LIS vendors typically charge thousands of dollars for a simple change that can take weeks and even months to deliver, and sometimes they even fail to deliver the requested change. If you frequently request customizations from your LIS vendor thanks to limitations in configuration, it's probably time to look for a more agile and flexible laboratory information system software.
Bottlenecks in Laboratory Workflow
Operational efficiency is paramount in any laboratory setting. If your LIS system causes delays due to slow processing times, data entry errors, or convoluted workflows that require more labor due to insufficient workflow support from your lab informatics system, it could be a sign that your LIS is holding you back. A modern laboratory information management system should streamline operations, support rules and automation, and enable medical laboratory technologists to work smarter, not harder by erasing the need for external systems and most manual processes (Excel, log sheets, etc.).
Costly Manual Workarounds
A fully-featured LIS system that supports rules and automation can help take pressure off a lab’s staffing requirements, an especially important consideration these days with labs across the country struggling with the cost to acquire and retain qualified personnel. Are manual workarounds eating up too much of your lab’s FTE time? If yes, it might be a good time to call on other LIS software vendors and learn more about how modern labs are leveraging this automation to keep expenses and compliance in check.
An effective LIS system should seamlessly integrate with your other key software systems, including Electronic Health Record (EHR) systems, laboratory billing software, government agencies, and lab instrumentation. If your laboratory information system software can't effectively communicate with these systems easily and quickly, it might be causing unnecessary manual work and a loss of business while increasing the risk of errors and wasting valuable tech time.
Limited Reporting Capabilities
As your clinical lab or pathology group grows, so does the need for detailed, robust statistical and productivity reporting. If your LIS system is unable to provide the reports you need to run a successful operation or makes it difficult to access and analyze your data, or if it takes staff days rather than minutes to put together monthly, quarterly, and annual reports - you've likely outgrown it. A sophisticated laboratory information system offers customizable reporting and lab analytics to support data-driven decision-making.
Custom personalized report templates that reflect your customers’ preferences for design and delivery are no longer “nice to haves.” Instead, they’ve quickly become the norm and not having the capability to easily modify and adapt lab reports to meet customer needs will reflect negatively on your business. If your vendor is charging you $5,000-10,000 for every time you need to modify your reports, this makes your practice or lab growth unsustainable. Modern laboratory information systems empower your team to make these changes easily and at no additional cost.
Inadequate Support for Future Growth
If your LIS system cannot scale to meet your lab's growth plans, it's a clear sign you've outgrown it. Whether you're planning to expand your test menu, increase your testing volume, or open new locations, a modern lab information system with advanced features will support this growth, not restrict it.
Antiquated and legacy laboratory information systems were designed to meet the needs of the time they were created, but today’s advanced lab environment demands much more from these LIS systems. When labs are tied to legacy LIS systems, they often experience an artificial ceiling of growth with multiple challenges that hinder scaling, performance, and potential.
Not Compliant with Regulatory Standards
Regulatory compliance is a critical aspect of laboratory operations. If your LIS system struggles to meet the latest regulatory requirements for organizations like CAP (College of American Pathologists) and CLIA (Clinical Laboratory Improvement Amendments), it's time for an upgrade. The best LIS software not only meets the current standards but can also quickly pivot to handle and standardize new workflows to meet new regulations as well.
As an example, LigoLab Informatics Platform not only automates and standardizes procedures, but it also offers compliance-conscious workflows and reports, ad hoc data query capabilities, and compliance verification at every stage, thereby ensuring that its lab partners have the tools to operate within regulatory guidelines at all times.
To maintain compliance with regulatory standards and prepare for audits, here are tips for medical laboratories to follow, be it with LigoLab or with another lab management system:
- Follow Regional Guidelines: Each region has specific guidelines and regulatory bodies in the United States. These guidelines include standards for test performance, personnel qualifications, quality assurance, quality control, and proficiency testing.
- Documentation: All procedures and protocols should be documented with a robust and searchable audit trail that logs every activity. This includes everything from specimen collection and processing to reporting of results for audits and inspections. This documentation should be kept up-to-date and readily available for review.
- Training: Staff should be adequately trained and their competency should be assessed regularly. Training should cover both technical procedures and regulatory requirements with a dedicated training environment set up within the lab information system by the LIS provider.
- Quality Control and Assurance: Regular quality control (QC) checks should be performed on all equipment, reagents, and procedures. Quality assurance (QA) processes should also be in place to monitor the overall quality of the laboratory's work and flag out-of-range values. With a modern LIS system, QA and QC processes can be tracked within the system, removing the need to manually track reagent lot numbers and expiration dates outside of the LIS via Excel or log sheets.
- Validation and Calibration: All new equipment and tests should be properly validated before they are used for patient samples. Equipment should also be calibrated regularly according to the manufacturer's instructions. The best pathology lab reporting software helps laboratory personnel manage all validation by maintaining calibration and maintenance schedules.
- Safety: Laboratories should follow safety guidelines to protect patients, employees, and the environment. This includes proper handling and disposal of biohazardous materials, use of personal protective equipment, and regular safety training. A modern LIS system with an embedded specimen tracking system assures this level of safety.
- Privacy and Confidentiality: Patient data must be handled by following privacy laws, such as the Health Insurance Portability and Accountability Act (HIPAA) in the U.S. This includes secure storage and transmission of data and data guarding while providing patients with access to their information. Modern LIS systems are designed with the latest data security measures, including user authentication and access controls, encryption, and audit trails to track both access and any changes to the data.
- Regular Audits and Inspections: Regular self-audits should be conducted to ensure ongoing compliance. In addition, laboratories should be prepared for unannounced inspections by regulatory bodies.
- Continual Improvement - Lastly, laboratories should strive for continual improvement. This includes regularly reviewing and updating procedures, addressing any issues or non-compliances identified during audits or inspections, and staying up-to-date with new guidelines and best practices. An advanced lab information system can help in this regard by providing comprehensive data analytics capabilities.
A few other things to consider on this topic:
First, some laboratory information systems come equipped with rule engines that can check for potential compliance issues before processing orders or reporting results.
Second, modern LIS systems can interface with other systems such as electronic health records (EHRs), billing systems, and regional or national health information exchanges, helping to ensure that data is shared securely and appropriately while still complying with interoperability requirements.
And third, these are general tips and the specific requirements for compliance may vary depending on the region and the specific type of laboratory (clinical, research, etc.). It's crucial to have a deep understanding of the applicable laws and regulations in your specific area and field.
By ensuring data integrity, maintaining high standards of quality control, enabling robust reporting capabilities, and providing advanced analytics, a modern LIS system can play a critical role in maintaining regulatory compliance in a laboratory setting. However, it's essential to remember that a laboratory information system is just a tool and the ultimate responsibility for regulatory compliance still lies with the laboratory's personnel.
Lack of Cloud and Mobile Support
A modern medical laboratory information system should allow for both on-premises and cloud deployments. If your LIS system does not, it may limit your ability to access critical data, scale easily, meet your strategic goals, or leverage the benefits of automatic LIS software updates and offsite data backup.
High Total Cost of Ownership
If your LIS system requires frequent costly updates and nickel and dimes you on modules, users, upgrades, and features, that’s a red flag, and so are excessive vendor customization fees and timelines, expensive maintenance fees, and requirements for you to have an in-house IT team to manage it. Clinical laboratory management with a modern LIS system should provide high value at a reasonable total cost of ownership. If any of these issues mentioned resonate with you, it might be time to consider a lab information system upgrade. A modern and flexible laboratory information system solution like LigoLab Informatics Platform could revolutionize your lab operations, streamline workflows, improve reporting, and support your laboratory's growth now and in the future.
How Will I Know if the New LIS System I’m Evaluating is Truly an Upgrade?
Just like no two medical labs are alike, the same goes for laboratory information systems and the LIS software vendors that produce them. Since that’s the case, here are tips on how one can tell if the medical LIS under evaluation is truly an upgrade from what’s in place currently.
A Comprehensive LIS System
Choosing the right lab information management system at this stage is critical, and the last thing you want to do is to select a LIS system that lacks features and growth potential. Advanced LIS systems that include all the embedded modules integral to long-term laboratory success are available and affordable. When evaluating various laboratory software systems, be sure to ask if the following elements are included in the LIS solution you’re investigating:
- Rule Engine
- Automation Engine
- Integration Engine
- Specimen Tracking
- Billing Management
- Patient Engagement
- Outreach (Ordering, Reporting, Supply Ordering, Tracking)
- Document Scanning
- Sendout Management
- Business Intelligence
- Customer Service Management
With LigoLab, all these modules and applications work in synergy to provide a holistic solution tailored to the multifaceted needs of modern clinical and reference laboratories and pathology groups.
LIS System Services and Support
Once you’ve determined if the LIS system is comprehensive, you’ll next want to learn about the LIS vendor’s approach to LIS customer service and support. This is especially important because in many cases LIS software support can result in unexpected or hidden costs for the need to add seats and modules as the lab evolves. The last thing you want to do is upgrade your medical LIS without having a complete understanding of any costs that may adversely affect the growth of your business.
To optimize laboratory workflow management, you’ll want the software’s support team to be an ally, one that’s available 24/7 for critical issues and that also provides unlimited support and training during normal business hours.
A Commitment to Independent Laboratories
You can make the case that independent clinical laboratories and pathology groups are underserved in the healthcare industry, so upgrading to a LIS system backed by a company that is keenly aware of the distinct requirements and hurdles faced by independent labs is a big plus.
At LigoLab, we’re committed and exclusively focused on the success of our independent laboratory clients. Our nearly 20 years of experience and best practices in this space give us a profound understanding of the unique market dynamics at play and what today’s independent labs need to scale efficiently.