Bika Health, an Open Surce Laboratory Information Management System (LIMS) for health care laboratories

Introduction

Supporting the formalisation of the laboratory workflow and analysis methodologies through SOPs, LIMS allows the implementation of Quality Assurance and Control (QA/QC) mechanisms to ensure consistency, accuracy, reproducibility and integrity of analysis results and procedures. Two big problems with LIMS acquisition are high monetary cost due to license fees, and lack of access to the system source code, making it difficult to adapt it to the real local needs in the laboratory. In fact, it prevents small health centres and those which do not have sufficient financial resources from implementing LIMS. Bika Health is an Open Source LIMS which aims to address these shortcomings, for the application of QA mechanisms to no longer be exclusive to larger centres.

LIMS: Beyond management system

The prevailing view of LIMS is of software capable of managing samples and laboratory analysis, as well as control mechanisms to monitor and track the processes and agents who participate in these workflows: from sample reception through to publication of analytical results.

This simplified view equates LIMS to traditional business management tools, but designed to resolve laboratory specific requirements. This approach led, for many years, to the use of a wide spectrum software tools, often unrelated to the idiosyncrasies of laboratory work. The use of database management systems (DBMS) conceived for domestic and personal use as well as software used for spreadsheet creation, are still prevalent in small laboratories and those with limited financial resources.

The reality is that LIMS goes far beyond this perception and is indispensable for meeting many international standards and mechanisms for quality control management. Compliance with such regulations and standards ensures consistency, accuracy, reproducibility and integrity of the results and the methods used to produce them. This is unavoidable, and important in clinical and health laboratories.

Some examples of standards and regulations applicable to LIMS are: ISO/IEC 17025, ISO 9000/9001, ISO/TS 16949, Good Automated Laboratory Practice (GALP); and for health care LIMS specifically: ISO 15189, 21 CFR Part 11 and Clinical Laboratory Improvement Amendments (CLIA). The implementation of Quality Assurance (QA) and Quality Control (QC) policies are key factors addressed by LIMS.

Thus, a LIMS is not only a system for sample and analysis management, it sets the framework in which all laboratory work processes will take place, for the activities, services and products generated by the laboratory to conform to standards and quality criteria required by legislation and certification bodies.

LIMS Implementation

LIMS implementation is not a trivial process, and requires the involvement of key people from the laboratory from the start. Comprehensive analysis of the laboratory workflow, formalisation of routines, needs assessment and requirements definition are elements that precede implementation. Thorough knowledge of the laboratory and its peculiarities is essential for success of LIMS implementation and use. This first analysis and design phase is crucial and requires a significant effort from both the laboratory and the development team. The information generated during initial A&D serves to produce a design and functional specification document on which the entire development will be based. Omitting it will see the the delivery of a system poorly fitted to laboratory needs, and lab staff are likely to experience the system as adding to their work instead of as a tool making it easier.

In the next stage, active development, the LIMS team incorporates the additional features identified, and parametrise the system based on the design document drawn up earlier. Regular communication between the development team leader and key people in the lab is a fundamental aspect here: small deviations from the functional specification are uncovered and must be resolved to ensure all work is completed 'first time right'. Agile programming techniques are good to manage these modifications, encouraging regular testing and adjustment of functionality as the team progresses developing the new features.

Finally, the LIMS is deployed in a pre-production environment, to be used as acceptance testing platform by laboratory staff. After final adjustments, the validated system is deployed in a production environment. The test platform remains in place for training purposes.

The human and economic factors

The different stages of development and implementation highlight the importance of the human factor. It cannot be ignored and is an intrinsic part of the entire implementation project: motivation and involvement of laboratory personnel and the development team are essential.

Currently, most systems on the market require the laboratory to pay licensing fees (with annual renewals) that cannot be afforded by many. The licensing cost has to be added to those associated with professional product development and implementation services.

Proprietary systems also do not provide access to the system source code. A LIMS should be understood as a dynamic system, it evolves and adapts while the laboratory incorporates new analytical techniques, changes the focus of the services offered or adapts to new market needs and regulations. Restricted access to the source code requires the laboratory to depend on the manufacturer of the system, locked in without the ability to manage or customise the system, nor form a team for its maintenance and support. In addition, the laboratory has no control over system functionality and how it manages data internally. The laboratory loses the freedom to understand and manage a central part of their business model.

Unfortunately economic constraints and the use of proprietary licenses have most severe implications in small laboratories. This problem is especially important in the health centres providing local services in emerging economies.

While the expenditure on these human factors can be considered an investment in knowledge and an opportunity for the development of local economies, license fees and proprietary software use also hinder a return investment to society. A clear example can be found in the training centres for future health care laboratory professionals, it is not uncommon to find training centres that do not have LIMS because of the cost of acquisition, implementation and maintenance. This directly affects the education of students who will enter the labour market as laboratory professionals without knowledge about using such systems nor the aspects of Quality Assurance and Quality Control.

Bika Health LIMS and Open Source Project

Bika Health forms part of the Bika LIMS open source project, established as an alternative to proprietary LIMS. The Bika LIMS project comprises a family of open source and web-based applications, each aimed at a different laboratory discipline: Bika LIMS, Bika Health, Bika Epid, Bika Wine and Interlab. Bika Health is the Bika LIMS branch developed specifically for health care laboratories, with patient samples and clinical cases the central elements in the lab workflow.. More than 60,000 free downloads of Bika LIMS gave the project traction and rise to an active community of developers and users.

The development and maintenance of Bika Health source code takes place under the stewardship of the Bika Health Foundation, a non-profit organisation in South Africa with global membership. The Foundation has as its most important objective ensuring the Bika Health intellectual property and source code remain available as Free and Open Source (FOSS).

Bika Health provides a competitive advantage over proprietary LIMS, not only through saving licensing costs, but because the design and development team gets to focus all efforts and resources on implementing a custom-made LIMS, responding to specific laboratory needs. The Open Source nature of Bika Health allows the laboratory to take complete control of the system, without vendor lock-in, even transferring maintenance and support to inhouse teams. In addition, laboratories benefit from improvements aggregated from world-wide contributions by the Bika Open Source community. The continued development by project participants, sponsored by fee-paying clients, and the debate generated by users on community forums, ensure a high quality best-of-breed system with constant growth in new features and enhancements.

Bika Health is a robust LIMS that can be adapted and implemented in any laboratory, from those of small size to large research and clinic laboratories. It doesn't require external databases and is independent of infrastructure. On OSS, no web server, database or operating system license fees required.

Bika Health has been implemented in various laboratories around the world: Caribbean Public Health Agency (CARPHA), the Sri Lanka Medical Research Institute and commercial labs soon to be announced.

Conclusions

systems in many laboratories, with particular relevance on small laboratories with limited financial resources. This is particularly disturbing in health laboratories, where the deficit implies an added difficulty for compliance with laws and standards, and the establishment of quality policies. This can have a direct impact on the diagnosis and treatment of the patient.

Bika Health is an Open Source LIMS of high quality, designed specifically for health laboratories and cost saving in mind. Bika Health complies with regulations, standards and quality policies. Thanks to its Open Source model, the laboratory has full control of the system, being able to adapt to new needs independently.