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LISemus - Laboratory Information System

License: GPL v3 Project Status: Documentation Phase

This repository contains the design, technical specifications, and functional requirements for the LISemus (Laboratory Information System) project. The system is designed to manage complex laboratory workflows, from patient registration to diagnostic reporting and specialized services.

Overview

LISemus is an open-source Laboratory Information System (LIS) designed to support modern clinical laboratories, with particular attention to healthcare facilities operating in low-resource contexts.

The project aims to improve the quality, traceability, safety, and efficiency of laboratory diagnostic workflows by providing a modular, interoperable, and standards-oriented software platform.

LISemus is conceived as a progressive and sustainable system: it starts from a Minimum Viable Product (MVP) focused on the essential end-to-end diagnostic workflow and evolves through additional modules and functional extensions.

Vision

Our vision is to make reliable laboratory diagnostics more accessible through an open-source, sustainable, and adaptable LIS platform.

LISemus is intended to help laboratories move from paper-based or fragmented workflows to structured digital processes, supporting better clinical decisions, safer patient care, and stronger laboratory governance.

Mission

The mission of LISemus is to provide a modern, open-source LIS that helps clinical laboratories:

  • manage patient requests, samples, examinations, results, and reports;
  • ensure end-to-end traceability of the diagnostic process;
  • reduce transcription errors and data loss;
  • support standardized and high-quality reporting;
  • improve interoperability with hospital systems and laboratory analyzers;
  • promote compliance with internationally recognized laboratory quality principles, including ISO 15189;
  • remain sustainable and adaptable in different healthcare environments.

Key Principles

LISemus is based on the following principles:

  • Open source by design
  • Modular and incremental development
  • MVP-first approach
  • API-first architecture
  • Interoperability with healthcare systems
  • Traceability and auditability
  • Security and privacy by design
  • Support for low-resource and mission hospital contexts

Project Scope

The initial scope focuses on the core laboratory workflow:

  1. Patient acceptance and test requests
  2. Sample collection
  3. Pre-analytical sample management
  4. Core analytical areas
  5. Technical and clinical validation
  6. Reporting
  7. Report management
  8. Data governance, security, and audit trail

Additional laboratory domains and advanced features are planned as post-MVP extensions.

Technology Stack

The reference architecture currently includes:

  • Backend: Django / Django REST Framework
  • Frontend: Vue.js / Quasar Framework
  • Database: PostgreSQL
  • Interoperability: OpenHIM and healthcare standards such as HL7 / FHIR
  • Deployment: Linux, Nginx, Gunicorn/Uvicorn
  • Versioning: Git / GitHub

Current Status

LISemus is currently in the analysis, architectural definition, and functional specification phase.

The documentation structure includes progressive levels, from vision and architecture to operational domains, software requirements, modules, and product-level specifications.

Documentation Roadmap (LIS Series)

The project documentation is structured into five main series (LIS 1 to LIS 5). The current status is as follows:

Document ID Description Status Reference
LIS 1 System Architecture & High-Level Design Baselined Frozen
LIS 2 Data Model & Schema Specifications Baselined Frozen
LIS 3 Functional Requirements Mapping (rev. 4.1) Baselined Frozen
LIS 4 Technical Implementation Specs In Progress Phased
LIS 5 Integration & Quality Assurance Plan In Progress Phased

MVP & Phased Development Strategy

The project follows an MVP (Minimum Viable Product) methodology. Functional requirements documented in LIS 4 and LIS 5 are being developed in stages based on the priority matrix defined in LIS 3.

1. Core Functionalities (MVP Scope)

Focuses on essential features required for the system's initial launch. This includes:

  • Patient Intake: Basic registration and ID management.
  • Order Management: Request validation and tracking.
  • Reporting: Core diagnostic workflows and result delivery.

2. Extended Functionalities (Post-MVP)

Advanced features designed to optimize and scale the system, including:

  • Advanced Integration: High-level synchronization with external HIS/EMR systems.
  • Specialized Domains: Comprehensive modules for specific areas (e.g., Blood Bank/Transfusional Services - Ambito 21).
  • Audit & Resiliency: Advanced audit trails and system-wide data protection.

Note

Technical documentation is currently in Italian to ensure clinical precision and alignment with local healthcare regulations. English translations are part of our roadmap and will be released alongside the first stable modules.

About

Open-source Laboratory Information System for modern clinical laboratories, focused on traceability, interoperability, ISO 15189-oriented workflows, and low-resource healthcare contexts.

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