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Custom Laboratory Information System

Features, Architecture, Costs

Since 2005 in healthcare IT, ScienceSoft builds robust, regulatory-compliant systems to optimize the operations of clinical, pathology, public health, veterinary, and other medical labs.

Custom Laboratory Information System (LIS)
Custom Laboratory Information System (LIS)

Contributor

Gala Batsishcha

Healthcare IT Consultant, ScienceSoft

A laboratory information system is needed to manage and automate test and patient-related processes in the laboratory setting, including data entry and exchange, sample tracking, QC assurance, inventory monitoring, equipment maintenance, and more.

Note: Most often, LIS software (laboratory information system) is focused on patient-focused processes, such as test ordering, while a LIMS (laboratory information management system) supports research workflows and has more sample-centered capabilities. However, the borders between the two are not strict, and a LIMS can be used in clinical laboratories.

A custom LIS is usually chosen by organizations that need to cover diverse lab operations (e.g., sample management and equipment management), ensure interoperability with different back-office and external systems, automate the capture of test data from multiple equipment types, and more. A custom solution also allows businesses to benefit from advanced ML/AI-driven features, including automated test result interpretation and what-if modeling.

  • Implementation time: 6 to 18+ months.
  • Common integrations: EHR/EMR, a healthcare information exchange portal (HIE), a quality management system (QMS), laboratory instruments, molecular diagnostic platforms, Point-of-Care testing devices.
  • Costs: $100,000$800,000+, depending on the solution's complexity. Answer a few questions about your business needs, and our consultants will provide you with a custom quote.

Key Capabilities of a Laboratory Information System

Interoperability with other systems

  • Bidirectional data exchange between LIS and EHR/EMR, HIE, billing software, and other enterprise systems.
  • Support of the required data formats (e.g., XML, JSON) and data exchange protocols (e.g., HL7, ASTM).
  • Automated transfer of test results to LIS from lab instruments (e.g., HPLC, GC-MS, LC-MS) and molecular diagnostic platforms (e.g., PCR, NGS).
  • Commands and requests to lab instruments (e.g., calibration requests).
  • Tools for communication between patients, laboratory staff, healthcare providers and other parties (e.g., internal messaging systems).
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Sample management

  • Generating barcodes and printing labels.
  • Real-time sample logging with the help of barcode scanners.
  • Tracking sample locations, storage conditions (e.g., temperature, humidity) and expiration dates.
  • Linking samples to the relevant tests (including linking multiple tests to one sample or multiple samples to one test).
  • Manual and rule-based updates on sample status.
  • Disposal management (e.g., maintaining records of sample disposal methods and dates).
  • Real-time notifications to staff (e.g., on result availability, process discrepancies).
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Testing management

  • Test order entry via different options (as an H7 message from EHR/EMR; by uploading CSV, via web portal, XML and custom entry).
  • Customizable templates for electronic requisition forms, collection lists, test reports.
  • Automated interpretation of test results.
  • Test validation capabilities (e.g., ability to accept, re-run, reject a test, order additional tests and send the relevant notifications).
  • Rule-based test routing to specific instruments or reference labs.
  • Automated generation of test result reports with delivery to the relevant parties.
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Patient data management

  • Aggregating non-clinical patient information (e.g., name, age, sex, address, data of birth, contact info, insurance details, patient consent information).
  • Accumulating medical history data (e.g., previous test results, diagnoses, allergies, medications, clinical notes).
  • Automated linking of test results to patient profiles.
  • Manual and rule-based patient data updates with automated notifications to the staff.
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Quality control management

  • Comparing test results against the set validation criteria from lab standards, internal protocols, and regulatory requirements.
  • Comparing QC samples with actual test samples.
  • Documenting, tracking and validating corrective and preventive actions (CAPA).
  • Alerts on out-of-control results.
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Workflow management

  • Capabilities for creating customized workflows in line with SOPs (e.g., adding sample-specific tasks, assigning required inputs for certain steps, providing prompts) without the need for any custom programming.
  • Scheduling and task assignment based on staff skills and availability.
  • Tools for patient appointment scheduling.
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Inventory and supply chain management

  • Tools for inventory and equipment cataloging.
  • Real-time tracking of laboratory supplies and sending out-of-stock and expiration alerts.
  • Automated inventory reordering.
  • What-if modeling for simulating procurement strategies.
  • Automated generation of purchase orders.
  • Order tracking from placement to delivery.
  • Supplier performance evaluation (e.g., based on delivery time, material quality).
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Compliance and security management

In line with CLIA, HIPAA, and other regulations

  • Mechanisms for sensitive data protection (e.g., data masking and encryption, two-factor authentication, role-based access).
  • Centralized storage of regulatory documents, including SOPs and quality manuals.
  • Automated logging of all system activities (e.g., user actions, equipment usage, data modifications).
  • Regulation-specific capabilities (e.g., automated quality checks to ensure compliance with CLIA).
  • Process-specific compliance checklists.
  • Automated generation of reports for regulatory bodies in compliant formats (e.g., for FDA, CAP, CMS).
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Equipment management

  • Continuous monitoring of equipment status and availability.
  • Automated scheduling of equipment maintenance and calibration based on data from equipment logs, manufacturer recommendations, and internal protocols.
  • Predictive equipment maintenance.
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Billing management and patient portals

  • Service catalog with service descriptions, turnaround times, and pricing.
  • Automated quote and invoice generation based on provided services.
  • Payment processing via integrated payment gateways.
  • Order placement, status updates, and access to test results for patients.
  • Feedback gathering tools (e.g., patient surveys).
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  • Monitoring lab operational KPIs (e.g., turnaround time, cost per test).
  • Data segmentation (e.g., costs per test type, suppliers by performance).
  • Identifying root causes of inefficiencies and errors (e.g., deviation from QC standards due to improper instrument calibration).
  • Predictive analytics and what-if modeling (e.g., to forecast inventory demand).
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Sample Architecture for a Laboratory Information System

According to Medical Laboratory Observer, 65% of medical labs use a laboratory information system integrated with other enterprise software like EHR/EMR and HIS. 33% of respondents use a standalone LIS. 78% of organizations integrate their LIS with an analytics solution.

Below, ScienceSoft’s solution architects provide a sample architecture of an LIS that features sample- and patient-focused workflows and integrates with a variety of enterprise softwar and external systems.

Architecture for LIS

Enterprise software (e.g., EHR/EMR, a practice management system, an HIE portal) is usually integrated via APIs and can have a shared interface with an LIS for submitting test orders and receiving results.

Lab instruments (e.g., HPLC, GC-MS, LC-MS), are often integrated via middleware – an intermediate software layer that unifies data management mechanisms for different instruments.

An LIS is typically integrated with an analytics solution that gathers a variety of lab management data and uses it for calculating lab performance metrics, identifying trends, forecasting and what-if modeling.

LIS backend features an operational database with a database management system and a metadata catalog. The backend processes requests from LIS users (e.g., for sample labeling and registration, workflow creation, quality control setup) and powers all actions and workflows such as sample tracking, test results interpretation, QC checks, inventory reordering, and more. Some actions such as automated test result interpretation can be powered by the ML/AI engine.

LIS user interface provides lab staff with convenient access to tools for receiving test results, tracking lab operations, interacting with the involved parties (e.g., patients, clinicians), and more.

The integrated patient portal with billing functionality streamlines appointment scheduling, test ordering and result delivery, patient-hospital communication, and other related processes.

The data governance and security framework features mechanisms for data masking and encryption, multi-factor authentication, role-based access, data backup and recovery, and more. These measures ensure data integrity, security, and privacy in line with such data protection regulations as HIPAA and GDPR.

Laboratory Information System Development: Key Steps

LIS software development is an optimal choice when an organization needs custom capabilities to cover multiple lab operations, unique sample handling procedures, integration with diverse back-office and external systems, complex analytics features like ML/AI-driven test result interpretation, and more. With 19 years of experience in custom healthcare software development, ScienceSoft provides a brief outline of key steps for successful LIS implementation.

1.

Business analysis and requirement engineering

At this step, business analysts conduct Q&A sessions with the organizations’ management and target LIS users (lab managers, technicians, researchers) to understand their requirements for the LIS. The experts find out what operations the solution should cover, what software the organization uses, and what data exchange processes are to be established between the future LIS and other systems (e.g., test ordering from ERP, test result delivery to a patient portal). The analysts also elicit the types of user roles and their challenges.

At this stage, it is determined what capabilities of the future solution will ensure its compliance with regulations (e.g., HIPAA, CLIA). All the details gathered by business analysts are used to create the list of functional and non-functional software requirements.

ScienceSoft

ScienceSoft

2.

Integrations and architecture design

During this stage, solution architects decide on optimal ways to integrate the LIS with the required software and instruments. For instance, to integrate LIS with multiple instruments with differences in their protocols, formats, or interfaces, it is best to opt for middleware that acts as an intermediary between the instruments and LIS. With such an approach, it is possible to centralize data management processes and integrate varied instruments according to the same pattern.

The design team plans the architectural components that will support the outlined workflows and chooses an optimal tech stack to power the solution. The specialists compare suitable techs and pick the ones that can satisfy LIS scalability, availability, and performance requirements at the best cost-to-benefit ratio. When designing the solution’s architecture, the architects also consider the existing IT environment of the organization. For example, if most data sources for integration are Azure-based, the specialists may consider Microsoft tools for LIS development as this will simplify integration and help avoid costs related to purchasing services and products of other providers.

ScienceSoft

ScienceSoft

3.

Design of security and data governance frameworks

Security engineers design a comprehensive security and data governance system in line with regulatory and internal requirements. For example, they plan the implementation of multi-factor authentication, role-based user access, and data encryption at rest and in transit, which are crucial for achieving compliance with HIPPA. To ensure complete data accountability and traceability, the experts design mechanisms of audit trail processes. For example, they define events that are to be logged (e.g., record creation, user logins) and choose immutable storage options for audit logs, digital signatures, and other relevant data (e.g., write-once storage, blockchain-based storage). The specialists also plan capabilities for data backup and recovery to prevent data loss and ensure uninterrupted operations in case of emergencies.

ScienceSoft

ScienceSoft

4.

UX/UI design

UX designers create solution workflows tailored to specific user roles. For example, quality assurance specialists are likely to benefit from visual alerts on SOP deviations with capabilities for generating the relevant report just by clicking the button in the notification window. For lab managers, the experts may consider no-code capabilities that enable the creation of new workflows by dragging and dropping widgets with procedures, procedure-specific tasks, relevant steps, etc.

UI designers focus on making the solution easy-to-navigate and user-friendly. For instance, they can create color-coded indicators for delays and issues in the sample processing journey. They can also audit the systems the organization already has in use and reuse similar colors, buttons and other familiar visual elements in the LIS to facilitate user adoption.

ScienceSoft

ScienceSoft

5.

Development and testing

In most cases, developers and testers work in parallel. This helps promote efficient collaboration between team members and fix arising issues early on.

At ScienceSoft, we always try to find ways to optimize development time and costs and have a set of best practices to achieve this without sacrificing quality. One of such best practices is utilizing cloud services of reputable providers. Thanks to their ready-made components for data storage and low-code development options, they allow for 2-20x faster software development. We often go for DevOps implementation and feasible QA automation, which help us cut development costs for the clients by up to 78%.

Senior Solution & Integration Architect, ScienceSoft

6.

Deployment and support

The experts integrate the LIS with the necessary systems and monitor solution performance to detect and fix any remaining issues. They also provide the organization with comprehensive software documentation (e.g., maintenance guides, instructions on API usage) to support smooth software maintenance and evolution.

ScienceSoft

ScienceSoft

What makes ScienceSoft different

We achieve project success no matter what

ScienceSoft does not pass mere project administration off as project management, which, unfortunately, often happens on the market. We practice real project management, achieving project success for our clients no matter what.

See how we do it

How Much Does It Cost to Develop a Custom Laboratory Information System?

The cost of custom LIS software development may range from $100,000 to $800,000+. The major cost factors include the scope of LIS capabilities, the need for real-time and ML/AI-powered workflows, and presence of complementary modules like a customer portal and a billing system.

A basic solution

$100,000–$150,000

  • Sample and patient management capabilities (e.g., test status tracking, patient profiles).
  • Integration with 1-2 core systems like EHR/EMR and HIE.
  • KPI monitoring (e.g., turnaround time, billable tests) and BI reporting.
  • Real-time capabilities (e.g., for sample status updates).

A solution of medium complexity

$150,000–$300,000

  • Inventory management capabilities in addition to sample and patient management.
  • Integration with 3-4 systems, including middleware for lab instrument integration.
  • Barcode labeling.
  • A patient portal for up to 5,000 users.
  • Rule-based and ML/AI-powered forecasts (e.g., of turnaround time).

An advanced solution

$300,000–$800,000+

  • Covers all lab operations, including equipment, quality management, supply chain management.
  • Integration with multiple systems, including QMS and clinical decision support systems.
  • A patient portal for more than 5,000 users.
  • A billing system.
  • ML/AI-powered test result interpretation.

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