Clinical laboratories play a critical role in diagnosing a disease, notify of its threat, and help to take safety actions to curb its exposure. In addition to this, 70 percent of the medical decisions are based on lab results, thus indicating an essential role of laboratories in today’s healthcare system.
With rising number of lab tests touching 14 billion annually, there’s a vast requirement for laboratories across the country, and with this a need for its effective internal management.
This can be achieved with LIMS (Laboratory Information Management System) that can help to manage labs efficiently, because its capable of sample tracking, resource planning, and handling all facets of laboratory informatics.
3 Benefits of Developing Laboratory Information Management Software
1. Lab Automation
Laboratory information management system increases productivity and effectiveness by automating all manual tasks, thus making it an asset for laboratories.
LIMS is capable of integrating laboratory instruments such as DNA sequencers, RT-PCR machines, GC-MS, etc., and it automates them, thereby eliminating manual data entry. LIMS integration also decreases transcriptional errors, that may slow down lab processes and operational efficiency.
Further, LIMS helps to schedule instrument calibration automatically, thus decreasing downtime problems. Additionally, LIMS provides workflow automation, thereby enhancing productivity of lab processes.
2. Data Centralization
Collecting, recording, examining, and processing samples is a long and complex process. Without the right technology and tools, huge amount of data storage is challenging for diagnostic centers and laboratories.
LIMS helps to overcome these issues, and makes it easier to track data, and reduce the amount of time to record it. This system makes the process of analyzing and storing data simple, thereby centralizing all data.
LIMS allows lab technicians and staff to enter detailed information of samples they’re working on, this includes batch material, inspection number, time, date, testing location, and any other additional data, which further aids in data centralization.
3. Inventory Management
Every lab needs to manage large inventory supplies, inventory management is essential for continuity of lab operations. LIMS is best suited to handle supplies and reagents for labs. It can track supplies and expiration dates of reagents and red flag about contaminated inventories.
Further, laboratory information management system has the ability to keep accurate details of storage location of supplies, this is important if reagents are aliquoted, and there are several boxes of inventories.
Through inventory management records, staff can prevent running out of vital supplies at the last moment, and avoid the need to wait for its delivery. Additionally, LIMS allows labs to manage invoices and quotes received via supplies as well.
9 Key Features of Laboratory Information Management Software
1. Compliance Management
LIMS is the backbone of any laboratory, hence it needs to meet both compliance and QA (Quality Assurance), along with technology needs for a lab.
Large industries, diagnostic centers, and hospitals manage, process, scrutinize, test, and track large number of samples, hence they are required to meet regulatory compliant requirements.
Compliance requirements include –
a. cGLP (Current Good Laboratory Practices)
b. cGMP (Current Good Manufacturing Practices)
c. FDA 21 CFR Part 11 – a guideline for electronic signatures and records
d. GCLP (Good Clinical Laboratory Practices)
e. HTA (Health Technology Assessment)
Laboratory information management system is capable of handling sample and experiment data. In addition, LIMS consist of functionalities to import, create, and export varied types of lab data such as regulatory files, safety protocols, reports, sample details, supplies, etc.
An ideal LIMS encompasses the ability to index and upload document of any file format, size, offer text search; change and export to formats such as PDF/word, or add attachments in a file.
3. Data Storage and Management
LIMS solution makes the process of collecting, processing, and analyzing data simple, and stores it in one place, thus making it accessible for lab staff.
LIMS is designed such that it can keep a track of sample storage throughout its lab cycle, for example LIMS trails storage hierarchy of a lab sample as – sample>position>box>rack>shelf>freezer>room.
Lab staff can rely on LIMS to locate accurately where samples and data are stored, including inventories, thereby boosting efficiency, productivity, and management of lab operations. Data is restricted to only authorized users, and LIMS assures that it adheres to all compliance protocols for data safety.
4. Chain of Custody
Chain of custody (COC) is needed in labs that handle drugs of abuse, forensics, clinical, environmental, and DNA testing, along with labs that want to ensure reliability of reported results. Additionally, laboratories that are bound to legal and regulatory directives, enforced by the US Government require a COC for all the samples.
Test or lab samples under the chain of custody has volumes of paper documents maintained manually by the administrative staff. LIMS development and regulatory standards for e-records are established for replacing manual documentation in labs. LIMS solution provides a flexible and secure database connectivity to build a protected electronic system, and to handle custody of records.
5. Equipment and Inventory Management
Inventory management is a cumbersome, yet crucial process for lab staff. Inventory management feature of LIMS helps to automate the process of organizing supplies, thus making it less tiresome.
LIMS works as a central administrative panel for measuring, controlling, and recording inventories, and certain process facilitated by it are –
a. Barcoding and labelling of samples, test tubes, and materials
b. Lab stock management
d. Automated reporting and tracking of inventories
e. Inventory auditing and accounting
f. Providing real time status of supplies
6. Workflow Management
LIMS is used to streamline lab workflow by auto assigning day-to-day tasks to staff, indicating sample location, and providing search text results. Further, LIMS can be programmed to recommend equipment and instruments for lab processes as well.
Data security feature in LIMS prevents cyberattacks or breaches, thus ensuring uninterrupted workflows. Additionally, LIMS offers insights to data that was assessed, along with a time stamp. This type of audit is difficult to achieve without a LIMS solution.
Coordination and communication of sample testing is facilitated by LIMS solution and prevents errors by doing so, thereby improving workflow in labs.
7. Sample Tracking
This feature automates the process of tracking samples as they move from one department to the next. By assigning unique identifiers to samples, LIMS creates a digital trail which eliminates human errors.
For post test samples, its essential to have an up-to-date protocol, and LIMS ensures that correct protocols are followed from current SOP module.
With LIMS, protocols can be updated with new versions and older ones can be eliminated. Sample tracking feature encompasses processes such as registration of new samples, tracking operations/tests, process verification, and sample data organization.
8. Integration of Lab Instruments
Lab instruments that are usually integrated with LIMS are titrators, AA analyzers, particle counters, HPLC, DNA sequencers, balancers, etc. Integrations save time for lab staff or researchers, as they no longer have to do manual cutting / transcription / pasting of data from instruments. This also enhances user satisfaction and greater adoption of laboratory information management system solution.
Furthermore, instrument integrations is a key area in informatics projects that easily contributes to cost and time overruns, if an effective technique isn’t followed. These techniques include site survey for instruments, prioritizing instruments, scheduling instrument integration in the first phase of project, etc.
9. Reporting and Analytics
Reports are a way to generate and catalogue data, deduce outcomes from it, and state analysis. LIMS generates various kinds of reports such as –
a. Analytical Reports: This combines lab units such as tests conducted, samples registered, and TAT (Turnaround Time).
b. Operational Reports: This includes reports on canceled results, approved tests, completed tests, inventory reports, and lab performance results.
c. Financial Reports: This includes physicians’ revenues, bill settlements, daily collections, and pending bills; helps to keep a track of all daily expenses and income.
Guide to Laboratory Information Management Software (LIMS) Development
1. Assess Needs and Product Requirements
While developing software, a PRD (Product Requirements Document) is created to state clear and detailed description of needs of a software product. PRDs are written by project managers, in which aspects such as product description/name, target audience, and its benefits are mentioned.
Consider following a top-down approach for writing a PDR, starting with the vision to be accomplished. PRD is associated with the waterfall development methodology, but whichever methodology is used, a PRD is always helpful. Aspects to include in a PRD are objective, release, features, user design and flow, analytics, and future work.
Furthermore, assessing needs before software development helps to proactively address gaps in project timeline. It also helps to find the best solution to development issues, thus preventing any compromise on project development.
2. Planning and Research
LIMS development planning and research provides a clear roadmap for development team, and averts confusion during its creation. A software development plan depicts teams’ structure, task assignments, roles, and responsibilities.
Moreover, it provides estimates for development cost and duration of work, which has to be backed up with reasoning and circumstances. To note that first estimates cannot give 100 percent accuracy, hence it needs to be revised as per situations.
During planning, take into account bottlenecks and dead-ends on projects, which leads to delays and more expenses. The research phase involves market research, competitors’ details, and shortlisting the target audience. Consider conducting research before planning out the entire software development process in-depth.
3. Partner With a Software Development Company
Make a list of software development requirements and steps, so a development company is able to comprehend and decide what approach is needed. This helps to note what an in-house team will be able to provide versus what IT project outsourcing can offer.
Further, consider partnering with a company that can offer diversity, expertise, and a range of skillsets. It is recommended to invest in an outsourced development team that knows how to work well together and with others.
Check out portfolios and interact with varied software development companies, before shortlisting one of them. Ensure to note strengths and weaknesses of the shortlisted outsourced company, so it’s easier to work around hinderances.
4. Define Technology Stack
Choosing the technology stack for laboratory information management system development depends on budget and the LIMS module structure. Additionally, it is based on in-lab infrastructure limitations, systems to be included, and functionalities.
An ideal technology stack for LIMS development can be –
a. API integrations for lab instrument, software, and equipment.
b. SQL driven database
c. Cloud for storage and backup
d. Frameworks such as .NET as its reliable, fast, and powerful.
5. Testing, Launch, and Maintenance
Post development stage, test software for its functionality, features, and seamless working. Testing also helps to detect major faults and bugs, and developers can fix it before final launch.
Maintenance is another crucial aspect of software development, as it assures smooth operation after launch. Developers are tasked with regular software updates, fixing bugs, attaining to consumer queries, and adding new features as per market/user demands.
Pivotal Challenges of LIMS Development
Incorporation of any new software, instrument, or system brings with it certain challenges, including LIMS. One of the key challenges for lab staff is to switch from manual work to automation which is offered by laboratory information management system.
The staff needs to be trained in order to get a hang of a new system. Moving on, there’s always a risk of data loss due to any natural calamity or breaches. Hence, this challenge can be overcome by building a robust data backup and storage plan.
Compromise of data integrity is another hurdle, which can take place during data migration. There are chances of data duplication, manual errors, and other anomalies if data integrity is hampered.
These challenges can be overcome through adequate configuration of LIMS and upfront planning. Additionally, LIMS can be developed to identify and prevent redundancy and duplication of data too.
Connect with a great team of experts from Arkenea, who will help you to develop an efficient LIMS that fulfills all your laboratory needs.
If you’re looking for something other than LIMS, then Arkenea provides a range of custom healthcare software development, third-party integrations, AI development, and much more for your healthcare organization.