Functional Requirements – Local LIS

F-001

Patient management

Essential

Unique patient identifier, critical for traceability.

OpenELIS Global has a comprehensive patient management solution that seamlessly integrates with the broader healthcare information ecosystems. Users can quickly add new patients locally with the detailed patient records then immediately submitted to the centralized client registry. Additionally, the system allows healthcare professionals to search for existing patients within that registry and accurately import demographic details to local OpenELIS instances, while supporting the automatic import of patient information from orders sent by the EMR system, streamlining workflow, and reducing duplicate data entry.

F-002

Sample management

Essential

Traceability is essential for all analyses.

OpenELIS Global features fully user-configurable sample types that empower laboratories to tailor the system to their unique operational needs. The platform supports end-to-end interoperability by importing sample data from EMR systems via the FHIR API, ensuring that detailed information—such as collection dates, times and who collected it —is accurately captured. In addition, the system incorporates a comprehensive workflow for handling sample non-conformity, including sample rejection. When a sample is flagged as non-compliant, an immediate alert is generated, prompting a redraw to minimize delays in diagnosis and treatment, and help to avoid manual steps in clinical workflows.

F-003

Analysis management

Essential

Laboratory operational base.

OpenELIS Global supports detailed analysis management features, with out-of-the-box management for basic workflows and complex workflows like Pathology and Cytology. All workflows have been tested and utilized in practice.

OpenELIS features a unique rule builder for both reflex test algorithms and calculated values for tests. This allows these complex analyses to be managed by the end user through the user interface, and makes OpenELIS Global one of the most flexible, user configurable options available. 

F-004

Results management

Essential

Key to reliability of generated data.

OpenELIS Global supports a comprehensive results entry system that accommodates everything from simple numeric and select-list inputs to the complex algorithms and workflows required for specialized fields such as Cytology or Pathology. Beyond capturing routine test results, the system offers fully configurable tests, allowing laboratories to define test algorithms, establish reflex tests, and configure calculated values directly within an intuitive user interface. This level of customization empowers lab managers and administrators to tailor every aspect of the testing process to reflect their unique procedures and quality control standards, ensuring that even the most sophisticated diagnostic processes are accurately and efficiently managed. Through its flexible, user-driven design, OpenELIS Global not only meets the diverse reporting needs of modern laboratories but also enhances overall workflow efficiency and clinical precision.

F-005

Quality control

Essential

Guarantee reliability of results.

All workflows have built in quality control workflows, including options for technical rejection at any point in the workflow. All results have a biological validation step before the release of any results. Tests can also be referred to reference laboratories for QA / QC from within the interface. 

OpenELIS supports all reference ranges: normal range, reporting range, valid ranges, and informs the user when the entered value is outside the normal range. 

F-006

Inventory management

Essential

Essential for business continuity.

OpenELIS Global uses connectivity to Odoo to provide a fully featured inventory management system. Precise inventory control is essential for timely and accurate medical testing in a clinical laboratory. Odoo's inventory management functionality is tailored to address these needs by enabling labs to monitor crucial supplies in real time, such as reagents, test kits, consumables, and equipment. With automated replenishment, barcode scanning, batch tracking, and real-time stock alerts, the system ensures that every item is accurately logged from receipt to expiration, supporting rigorous quality control standards that clinical environments demand.

Furthermore, Odoo’s seamless integration with existing procurement, maintenance, and compliance reporting systems creates a unified ecosystem that enhances workflow continuity and regulatory adherence in the laboratory setting. For example, automated reordering processes help ensure that critical test reagents and consumables are always available, minimizing downtime and disruptions in testing operations. Detailed inventory analytics and reporting empower lab managers to make informed, data-driven decisions regarding resource allocation and cost optimization, ultimately contributing to improved operational efficiency and patient outcomes.

F-008

Security and Privacy

Essential

Legal and ethical obligation.

OpenELIS Global has undergone rigorous evaluation and testing to ensure the highest levels of data security, adherence to privacy regulations and standards, and configurable role-based user roles for compartmentalizing access to sensitive information.

OpenELIS Global has undergone rigorous penetration testing and source code scanning to ensure that there are no vulnerabilities in the system, and it can be installed in the most sensitive of locations. All software is currently supported with regular security patches for any published or reported vulnerabilities. OpenELIS can be deployed in accordance with all local regulations, including compliance to HIPPA regulations, and all ISO requirements for security. We have also worked with many countries to ensure that all software is compliant with local privacy regulations, and all data is stored securely.

OpenELIS also has integration with OAUTH2 and SAML single sign on methods with our Keycloak compatibility, with all data secured through point-to-point encryption with the servers using SSL secure encrypted communication.   

We allow customized user configuration by role and by lab unit. For example, someone could be given a “reception” role in Biochemistry where they would only be able to register biochemistry tests and view only the tests and panels relevant to only their lab section, making order entry easier and enhancing customized, role-based lab workflows. Also, for privacy, someone with the “Results Entry” role for Hematology would not be able to see any Virology results with their view limited to only Hematology results to limit access to sensitive patient information. 

F-009

Traceability

Essential

Mandatory for audits and compliance.

OpenELIS Global has a full audit trail for all transactions within the LIS system, allowing full traceability for every action taken. Furthermore, there are full logs for every transaction through the API available in an audit trail for the system back end. This allows for complete traceability of workflow and actions to support audits and verify compliance. 

F-010

User management

Essential

Security and internal governance.

OpenELIS has sophisticated user management features. Users can be assigned roles that specify functionality that each user has access to, as well as the ability to be assigned to specific lab units (e.g. Hematology or Molecular Biology) to make the workflows easier by filtering unneeded options or information and enhancing patient privacy. 

Single sign-on is also available through all SAML and OAUTH2 providers, allowing OpenELIS to be integrated into centralized identity management systems. 

F-011

Workflow management

Important

Optimization of the internal process.

OpenELIS Global has robust Administrator options to empower laboratory managers to customize workflow processes. Through an intuitive design, administrators can tailor every step of the system, from sample reception and analysis prioritization to quality control and final reporting, to mirror the established procedures within their labs. This flexibility ensures that the software conforms seamlessly to existing operational flows, reducing the learning curve for new users and allowing teams to integrate digital processes without disrupting their familiar methodologies.

Moreover, the customizable workflows in OpenELIS Global help streamline data collection and reporting, significantly reducing the administrative burden on staff. Automated data capture, real-time validation, and integrated reporting features work together to minimize manual data entry and error-prone processes. By aligning digital workflows with real-world laboratory practices, the system not only improves data accuracy and quality but also boosts overall operational efficiency, enabling lab personnel to focus more on critical diagnostic tasks. 

F-012

Equipment management

Important

Direct impact on test quality.

Odoo's maintenance module in a clinical laboratory offers robust tools for managing equipment, like lab analyzers, with precision and ease. Laboratories can schedule preventative and corrective maintenance tasks, such as calibrations, cleaning cycles, and diagnostics checks, using an intuitive calendar and workflow system that assigns tasks to the appropriate technicians. This proactive scheduling minimizes downtime and enhances accuracy, ensuring sensitive instruments continuously operate at peak performance. The module's dashboard and automated alerts streamline maintenance workflows, allowing lab managers to oversee equipment status in real time while reducing administrative overhead.

Using a lab analyzer as an example, the maintenance module simplifies complex equipment management by directly integrating service history and performance tracking into one unified platform. The system not only stores detailed maintenance records and calibration logs for each analyzer but also ties these records to inventory management, ensuring that essential spare parts and calibration reagents are available when needed. By providing a transparent, data-driven view of equipment performance and maintenance schedules, Odoo's solution helps clinical laboratories adhere to rigorous quality standards, reduce manual data entry, and improve medical test results.

F-013

Document management

Important

Facilitates administrative and quality management.

OpenELIS Global enhances laboratory workflows by allowing users to attach a wide range of digital files, such as scanned documents, images, and supplementary reports, to laboratory orders. These attachments are seamlessly stored on the central server, ensuring that all relevant documentation is securely archived and can be easily retrieved and reviewed at any time. This capability not only streamlines record-keeping and supports regulatory compliance but also enhances clinical decision-making by providing instant access to all pertinent data associated with each lab order.

F-016

Management of PLC interfaces

Important

Reduce the risk of human error.

OpenELIS Global does not currently support PLC interfaces, meaning it lacks the built-in functionality to directly communicate with automated equipment controllers commonly used in some laboratory environments. However, as part of this project's scope, we will conduct a comprehensive evaluation to determine how to incorporate this critical capability. This will involve assessing the technical and integration requirements, exploring potential modifications to the existing architecture, and consulting with industry experts to ensure that any new functionality aligns with the system's design and the operational demands of advanced clinical laboratories.

F-018

Personalization

Optional

Adaptation according to local preferences.

OpenELIS Global offers a highly configurable platform that empowers laboratories to tailor the system to their unique operational and branding needs. Users configurability is also critical for adaptation, where users can be assigned to specific lab roles to streamline their workflow. 

The administrator interface enables labs to customize the user interface and reports by adding custom logos, color schemes, and relevant information. This ensures that every digital interaction and printed document aligns perfectly with the lab’s identity. In addition, the system supports the upload of a lab manager's digital signature, allowing secure e-signing of results to enhance authenticity and regulatory compliance. 

F-019

Multilingual support

Important

Relevant in the multilingual context of the DRC.

OpenELIS Global boasts a broad international user base, with thousands of users comfortably operating the system in French. Its architecture is built with multilingual capabilities at its core, enabling labs to swiftly adapt the user interface, reports, and notifications to any language with minimal effort. This flexibility ensures that institutions in various linguistic regions can localize their experience easily, guaranteeing that language is never a barrier to efficient data management and communication within the laboratory environment.

F-020

Audit and traceability

Essential

Mandatory criterion for certification and compliance.

OpenELIS Global is engineered with a robust audit trail that meticulously records every transaction within the LIS, ensuring full traceability for every action taken. Every event—from user-initiated changes to automated system processes—is logged in comprehensive detail, creating an unequivocal record that supports strict compliance measures and thorough internal reviews. Additionally, the system extends this rigorous logging to the back end by capturing every API transaction, providing a complete, end-to-end audit trail across all platform levels. This extensive documentation facilitates rapid troubleshooting and security analysis. This fosters a culture of accountability and transparency throughout the laboratory network, ensuring that every data modification is fully traceable and auditable.