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What are the Different Stages Involved in Developing Custom Software for Laboratory Data Management?

Posted in Healthcare Software

Last Updated | April 6, 2022

Overview: Different Stages Involved in Developing Custom Software for Laboratory Data Management?

Are you implementing a new lab management system? Do you fear that the system might mess up your current workflow?

Changing your lab management system might seem painful, but not as painful as staying stuck to the one that does not meet your needs.

Your laboratory might find it intimidating to turn to a new system, even if your existing workflow involves compiling spreadsheets.

But, did you know (no matter how many times reviewed) about 90% of spreadsheets contain errors?

You cannot afford these inevitable errors when the lives of millions of people are at risk.

Consider this recent research on COVID-19 tests: in the US alone, close to 880 million Covid-19 tests have been performed on January 24, 2022. That’s a huge amount of data for laboratories to store!

With millions of test results flowing into your lab data management systems, spreadsheets alone do not cut it.

You need an automated solution that supports efficient workflow and leaves no room for errors.

Luckily, a laboratory information management system (LIMS) offers you just what your workflow needs and promises efficiency and quality across lab management activities.

With the use of a custom-built lab information management system, there is so much your organization can accomplish. You can keep your data organized, automate workflows, record and store detailed data, and a lot more.

To develop a customized information management system for your lab, there is a simple 9 step process you need to follow and you will end up building great software.

However, before you learn about developing the software, you need to first go over the basics of what a laboratory management system is.

What is a Laboratory Information Management System?

A laboratory information management system (LIMS), often referred to as a laboratory information system or laboratory management system is a software solution used for managing samples and sample-related data.

LIMS software is built with features to support modern laboratory operations. Its key features include flexible architecture, data tracking and workflow support, and integrated interfaces, to count a few. These features have evolved the system over the years- from simple sample tracking to an advanced enterprise management tool that supports various aspects of laboratory management.

Using LIMS, you can harness it to streamline the management of instruments, data, validation, sample, resources, communication, and security. The major purpose of LIMS is to improve productivity and quality across your laboratory.

However, when you develop the system, the scope and depth of the laboratory management system depend on how you carry out implementation. Though most LIMS software come with modules for workflow and summary data management, some of them go beyond to offer more functionalities.

If you want to yield maximum ROI (return on investment) from the implementation, you must invest in a custom laboratory information management system.

Why Is a Custom Laboratory Information Management System Important?

Developing a custom system puts everything in your hands, allowing you to plan every step wisely and as per your requirements.

A custom laboratory management system is packed with lots of tools you can benefit from:

  • Smooth management for lab data: samples, tests, instruments, standards, and more
  • Creation of analysis reports
  • A solid framework for lab workflows and much more.

In addition to these features, you have the flexibility to request the vendor to add more tools to your custom LIMS software. You can also ask for HIPAA compliance for software development and get their support to achieve interoperability with other data systems through medical device integration.

All this and more is possible with custom LIMS software, and to develop such software, all you need to do is follow this 9 step process.

9 Easy Steps to Developing Custom Laboratory Information Management System

Step 1: Evaluation and Selection

The first process in developing LIMS software is the evaluation of all the potential systems and selecting the one that’s best for your lab.

Your evaluation will depend on various factors:

  • Your budget
  • Structure of LIMS modules
  • Limitations and opportunities of in-lab infrastructure
  • What you envision of system objectives
  • Laboratory functionalities you need
  • Systems and modules you want to include and more.

Even after you factor in these points, purchasing LIMS might still be confusing.

Although most systems will meet some or all your requirements, they also have some frills that might look exciting but do not add much value.

So, take your time during the decision-making process and evaluate every aspect- of your lab structure and the LIMS software. There is no need to make a hasty choice which could waste time and money. In fact, it is reasonable to take some weeks and search for the software that best fits your criterion.

While you evaluate any LIMS software, make sure the potential vendor is able to provide you with the following:

  • A demo of the system to let you explore key features you need in the software
  • References from their existing or past LIMS users (i.e. labs)
  • Professional team to customize any feature for your laboratory
  • Sandbox and features outside the production environment
  • A price quote for initial implementation costs and yearly licensing fee

Step 2: Review and Amendment to the Contracts

As you select LIMS software for your lab, the next thing you need to do is get down to brass tacks with the provider. You must turn the price quote you got in the first step into a signed contract. Until you feel the interests of your lab are presented appropriately, take time to review and amend the contracts as many times as you need.

Plus, you must get the legal and scientific content in the contracts reviewed by the experts. Make sure all parties (your lab, the vendor, and other stakeholders) are content and satisfied with this business agreement.

At a minimum, your contracts or business agreement should have the following in place:

  • Licensing: Granted on per user basis
  • Implementation with some customizations needed for your lab. Make sure the costs and timelines for the customizations are also detailed in the contract

Step 3: Evaluation of LIMS Implementation Costs

LIMS software comes with a price tag. Before you move on to the next step, evaluate LIMS implementation costs and make sure to develop a realistic budget for it.

The cost of LIMS is based on factors which include:

  • Software licenses for LIMS, database, and instruments
  • Optional modules such as stability, instrument interfacing, and instrument calibration
  • Hardware including infrastructure (servers and routers) and peripherals (mobile devices, laptops, barcode printers, and readers)
  • Implementation, customization, training, and support services

However, not all of these factors are associated with all LIMS software.

For example, SaaS software does not generally require cost for peripheral devices, and an open-source LIMS would not include licensing costs.

The actual cost of the software depends on the type you choose- traditional, on-premises, or cloud-based system, the number of users, and your needs and requirements.

So, do consider these factors when you evaluate the costs.

Step 4: Gather All Requirements Related to LIMS Functionality

Once all the contracts are signed, you can expect a lot of meetings with the vendor. In those meetings, your lab will detail its requirements for the LIMS.

All LIMS software have “out of the box” features, so you will need to see if those features meet your requirements, as they are, or you need configuration or customization to the software to serve your purpose.

At this stage, to learn about your configuration needs, you must get down to the nitty-gritty of your lab testing workflow and ask the following questions at every step of it:

  • What are the tangible actions of the lab at this step?
  • If it applies, how each sample can be tracked in the software during this step?
  • What data is LIMS supposed to provide to help the user?
  • What data is LIMS going to capture at this step?

Getting answers to these questions is quite a time-consuming process as you need to ask these questions during every step of the workflow.

It is rare for labs to find all ready-to-go answers to every workflow that may occur in the LIMS software. So, you can take as much time as you need to clarify as many concerns as you have.

Another essential approach you need to consider during the requirements gathering process is a minimal viable product (MVP). This approach implies the initial product you get developed contains quintessential features. Anything you deem “nice to have” can be added in the next phase.

This way, each step of the implementation becomes clear and easy to perform.

Step 5: Develop the Details of LIMS Functionality Specific to Your Lab Needs

Any functionality that does not meet your requirements will need customizations. Generally, the configuration team develops customization on its own, and then it demonstrates the features to the lab for feedback.

The development process of LIMS functionality is almost iterative in most cases. After the vendor team develops the functionalities, they give a demo to the lab, and then the lab refines requirements.

This will consume a lot of time, but relax.

3 to 4 weeks is a perfectly reasonable amount of time you can spend on configuration. At this step, you need to be picky to make sure you get what you need. That’s because unless the LIMS is up to what you need, the implementation is never going to completely succeed.

It is also crucial for your lab to provide specific requirements to the configuration team because the more detailed requirements you provide in step 3, the faster and more accurate the configuration will be.

Explicit explanation of everything and providing examples is always the best way your lab can provide details to the vendor.

Also, do not get distracted by the features not included in the MVP. Developing a complex LIMS software in one go as your first software is challenging and not easy for new users to get hang of.

However, by launching an MVP before the final system launch, you can get users learn a few basic features and use a focused system for some time. As they get the hang of basic system, you can add more features which will be easy for them to digest.

Step 6: Training and Testing

When your vendor tells you the system is fully ready, it is time to train and test multiple end-users in your lab and fully test the system. This testing process is known as “User Acceptance Testing.”

During this process, you are likely to find some bugs within your LIMS system that your developers need to tweak. Make sure you own this “User Acceptance Testing” process. However, the configuration team can aid you wherever possible by providing hands-on tutorials or preparing the documentation for training.

While testing the system, the best practice is to train as many users as possible.

Remember: it is unlikely for configuration specialists to predict perfectly the scenarios your lab users might run into after the implementation. Therefore, all you can be sure of is carrying out robust testing which is the key to developing a robust final system.

Step 7: Software Verification of the LIMS

Now you have tested the system. The next step is the formal verification of the system. Here the decision depends on the regulatory requirements of your lab.

Although developers and users always do appropriate testing of the system during the 4 and 5 steps, this step of formal system verification is the next level testing process.

This formal verification process consists of four stages:

  • Mapping out a pre-specified verification plan for software
  • Documenting the specific requirements of the system
  • Performing separate test cases to determine if the system meets each requirement
  • Putting together and documenting all test cases in the form of a final summary report

Although any entity (your lab, developers, or a third party) can perform this verification, the best option is the technical team that has configured the system for your lab. Since they know everything about feature customization, they will be the fastest and perhaps the most cost-effective option for formal verification.

This process validation is not for testing what may occur in the software; instead, it is to demonstrate all components of the testing process are fully integrated.

In order to validate the system, take a representative sample (inconclusive and invalid samples) to run it through the full workflow and make sure the sample testing process works as expected and gives anticipated outcomes for each sample.

Step 8: Go-Live Deployment of the LIMS

Once you test and validate the system, it is time to roll it out to all lab users. Your lab should have a detailed go-live plan containing the date to go live with the system. Make sure to loop everyone in and keep them aware of the go-live plan.

In your go-live plan, you should include:

  • Deployment date and time
  • The date for getting started with the LIMS
  • The deployment team
  • Locking out the users from any current system during the deployment process
  • Whether the data will be backed up before system deployment
  • If sample data needs to be re-run to ensure the success of deployment in the production environment
  • Whether you need to verify the data was not affected by the deployment of new LIMS software

Step 9: Update the Functionality of LIMS According to New Requirements

Until now, you have probably been working on the MVP system (in case you followed that approach.) Now is the time to evaluate nice-to-have features you wanted to add to the system.

For this iterative process, you simply need to repeat steps from 3 to 7.

When you decide to include more features to your system, deem answering the following questions:

  • Which features will make sense to be bundled in a single deployment?
  • Which new features do you want to add?
  • When do you exactly plan to develop and add new features? (Before you add more features, allow lab users to use LIMS for a particular amount of time and provide feedback.)
  • Whom do you want to manage the development? (Do you have resources (i.e. budget) left from the initial MVP development to spend on LIMS developers for this purpose?)
  • Do additional features require any new licensing?

To Sum Up

With technology becoming a phenomenon in the world, efficiency is no longer a need but a necessity. This applies to laboratory workflows too.

During the times like the widespread pandemic, laboratories are being used more than ever for testing and storing samples.

This means there is an increasing need for the lab workflow to be efficient to cater to the soaring testing needs.

If you want to achieve efficiency in managing lab workflow, the best option is to get custom software developed for your lab data management. The more customized the software you develop, the more you will be able to harness this technology to get your job done much more efficiently.

So, to fully achieve what LIMS technology promises, you must take your time and plan each step of the development process carefully to build a system that serves current and all future purposes of your lab.

FAQs:

What is data management in Lab?

Data management is the practice of collecting, storing, managing and using data securely and inexpensively. Data management in the lab helps to optimize the use of data in accordance with policy and regulation.

The practice of data management is wider in scope and involves:

  • Creating, accessing, and updating data
  • Storing data across multiple on-premise and cloud systems
  • Providing availability and disaster recovery
  • Ensuring privacy and security of data

Why are LIMS software used for laboratory data management?

LIMS software caters to various laboratory needs to define, automate, and enforce standard lab workflows.

Laboratories use LIMS software for lab data management to store samples and associated data, track sample sequence, integrate instruments to eliminate prescription errors and prevent data loss.

What is the difference between Cerner vs Epic EHR?

Cerner and Epic are the top healthcare IT companies that offer EHR (electronic health record) software or healthcare software development services. Their EHR systems are the most recognized data integration solutions for healthcare.

To answer your question about the difference between them, let’s quickly go over Cerner Vs Epic pros and cons:

  • Both EHRs (Epic and Cerner) need the help of healthcare compliance consultants to become HIPAA compliance solutions and meet regulatory needs.
  • Epic provides EHR service to help you accomplish long-term IT goals
  • Some users consider Epic to have a better UI design in healthcare than Cerner. However, Epic interoperability feature is relatively weaker than Cerner.
  • Cerner is somewhat economical and offers better customer service than Epic.
  • Users may find Epic interface more friendly than Cerner, but Cerner is a complete software with better reporting tools.
  • In the comparison of Cerner, Epic integration is often criticized for not being up to mark.
  • With Cerner HL7 integration and other built-in tools, data sharing from Cerner to other systems becomes easier.

What are HL7 messages examples, and what are they used for?

HL7 messages are different types of data sharing structures associated with “a trigger event”. The trigger event can be defined as an event that occurs to a patient in a healthcare setting. For instance, a patient is admitted or discharged from a healthcare facility.

Some of the most common HL7 message formats include ADT (Admission, Discharge, and Transfer) and ACK (General Acknowledgment). Through HL7 integration, this data in the form of HL7 messages are shared with other healthcare providers or disparate health data systems.

How do I understand the difference between HL7 vs FHIR?

HL7 (Health Level Seven) and FHIR (Fast Healthcare Interoperability Resources) are international standards developed to achieve interoperability among disparate medical diagnostic software and EHR data integration systems. These standards are committed to improving data sharing as the volume of data collection grows. However, they have different applications in healthcare organizations.

HL7 V2 (version 2) standards allow hospitals and medical practices to communicate clinical and administrative data with other systems. On the other hand, FHIR standards are more promising in nature and support universal interoperability. They connect mobile devices, wearables, and applications to leverage information without being affected by internet ambiguity.

What are electronic health records?

Electronic health records (EHRs) are an essential documentation of our health. They follow us throughout our lives.

EHRs are stored in hospitals and consist of 10 components of medical records in a hospital. These components include identification information, patient medical and medication history, and more to help medical professionals understand a patient’s health and anything else that improves care outcomes.

Although there are many EHRs, the most promising ones are developed by the best healthcare mobile app development company, such as Allscripts professional EHR by Allscripts software development company or Epic EHR by Epic.

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