[Manufacture of DNA chips in a laboratory for internal use: legislation and quality assurance]. / Fabrication de puces à ADN par un laboratoire pour sa propre utilisation: réglementation et assurance qualité

Manufacturing and using DNA chips in a laboratory, while respecting legality and good practices, require a review of the regulatory framework and relevant documentation for implementing a quality assurance system. Using DNA chips, either as a research tool, or as an in vitro diagnostic medical device, does not come within the same regulations: none in the first case, and european directive 98/79/CE in the second one. It is the same for research practice, for which the law to be enforced has been primarily conditioned to ethics, while carrying out medical analyses has been framed in France by the GBEA. The regulatory approach laid down in the GBEA is a first step for implementing a quality assurance system, but this must be extended to the manufacturing process of DNA chips. International standards (ISO 9001: 2000, ISO/IEC 15189...) provide documentation to meet this last requirement, but also enable one to carry on the quality approach up to the certification of the laboratory or its accreditation.

Technologies for implementation of quality assurance in the clinical laboratory.

To face the rapid evolution of the clinical laboratory activity from sample analysis towards an in-vitro diagnostic network, a Total Quality Management system must be implemented by laboratory professionals. Technological advances make it possible to introduce new tools and techniques for many issues surrounding the analytical process, as has happened for analysis automation and laboratory management. Preanalytical steps should benefit from extended traceability, using new identification devices such as electronic labels. This may promote the improvement of sample handling in this phase, such as during transportation or centrifugation. Another field is the expansion of metrology. Many factors can now easily be controlled in the clinical laboratory. New reliable automated systems are available to evaluate the performance of pipetting devices. Autonomous miniaturized recorders and probes connected to monitoring softwares allow traceable temperature monitoring. In this paper, some examples are presented to illustrate how technical solutions can support the implementation of Quality Assurance in the clinical laboratory.

New tools for laboratory design and management.

The clinical laboratory is changing from a place of activity based on sample analysis to an in vitro diagnostic network. To convince our team, partners, and administrators, we need new comprehensive tools to define a strategy with limited risk of failure or conflicts. Specific quality goals should be established before choosing automated tools for sample handling, analytical systems, laboratory information systems, communication systems, or advanced technologies. A system approach maps and simplifies the process, based more on a functional study than on classical disciplines. A customer-supplier approach establishes the requirements between partners either inside or outside the laboratory. The quality system must be a management tool, linking samples, tasks, information, and documents. Quantitative simulation modeling explores different automation alternatives and their impact on laboratory workflow. Finally, integration of results in interactive semirealistic simulation tools for laboratory design or reengineering can be used as communications tools to involve laboratory professionals in the change of their practice.