Clinical diagnostic laboratories generate tons of clinical data on a daily basis. This data is the engine of the healthcare industry as it provides clinicians with the critical information that they need for decision-making. Clinical data fuels the discovery of disease-specific biomarkers and novel drugs and also provides the tools needed for personalized healthcare which is the future of modern medicine. Given the centrality of their role in the healthcare system, clinical diagnostic labs should always function at optimal levels.
As the healthcare industry evolves, clinical diagnostic laboratories are presented with requests for unique and diverse tests that require the shortest possible turnaround time. All the while, these laboratories have to abide by regulatory compliance, such as HIPAA, EU GDPR, HITECH, CLIA, and applicable ISO standards among others. This can be difficult to achieve without having efficient informatics support from a Laboratory Information Management System (LIMS) in place.
The global demand for LIMS has increased exponentially in the last couple of years. This has been fuelled by increased awareness of automation, increased demands for meeting regulatory compliance, higher R&D budgets, as well as increased adoption of software in laboratories. It is therefore not a surprise that LIMS vendors have also begun to flood the market and customers are almost spoilt for choice. While that is a positive thing for the industry, clinical diagnostics laboratories can easily get lost at sea when choosing a medical and healthcare LIMS that will serve their needs.
There’s no one-size-fits-all when it comes to medical and healthcare LIMS. Hence, it is important to be aware of what to look for when zeroing in on a cloud-based laboratory information management system for your clinical diagnostics laboratory. This blog highlights the important considerations to have in mind in this journey.
Offline Versus Online Model
The first thing to be clear about is the difference between an offline versus an online medical and healthcare LIMS for clinical research. An offline model is what was used historically and refers to a standalone or on-premise LIMS. This kind of LIMS has numerous setbacks and consequently, it is now fading out in favor of online LIMS.
An online model is a LIMS solution that is cloud-hosted. It offers several benefits such as remote and round-the-clock access, automatic updates, enhanced security, and economies of scale among others. When choosing a medical and healthcare LIMS, it’s always important to consider the benefits of an online LIMS against those of an offline LIMS.
There are a number of functionality requirements that you should also have in mind when buying the right LIMS for your laboratory. We have discussed some key considerations for a medical and healthcare LIMS, also known as clinical LIMS or medical laboratory management software, in the next section.
It should be able to manage samples from the time they are received in the laboratory up to the point of disposal. This includes managing patient consent as well as the sample metadata.
It should be able to deliver test results and invoices to physicians and patients in real-time via physician and patient portals respectively. Medical tests are usually urgent and having this capability built into a LIMS will improve diagnosis and treatment outcomes.
Support compliance with regulatory standards
Clinical diagnostics laboratories have to comply with a number of regulatory requirements, including HIPAA, EU GDPR, CLIA, ISO 15189:2012, GCP, and 21 CFR Part 11. The ideal Medical and Healthcare LIMS software should support compliance with all these requirements.
Support instrument and software integration
It should support instrument and software integration to enable the laboratory to handle growing data volumes. This minimizes the chances of data redundancies and transcription errors while optimizing efficiency.
Safeguard protected health information (PHI)
It should be highly secure to ensure that PHI is never breached. This preempts the need for enhanced security features such as passwords, two-factor authentication, role-based access to users, and data encryption among others.
24/7 Support System
The clinical diagnostics team might need help from time to time; they might need support to fix technical issues or configure the product per their new testing requirements. With teams that work remotely and from different parts of the world, it is important to have round-the-clock support from the LIMS vendor to prevent unnecessary delays.
That said, you will need to understand the unique needs of your laboratory based on your volumes, workflows, staff capabilities, and available resources before you settle on LIMS software.
Why Choose CloudLIMS’ Medical and Healthcare LIMS?
CloudLIMS offers a purpose-built, scalable, SaaS LIMS that’s uniquely designed to meet the needs of clinical diagnostic laboratories. It helps laboratories automate processes swiftly and provides functionality for end-to-end sample and data management. It offers remote access from anywhere and at any time. It also supports compliance with the full range of regulatory standards. Contact us today to discover if this is the LIMS for your laboratory.