The Board of Directors Resolution RDC 786/2023, of the National Health Surveillance Agency (ANVISA), imposes rigorous quality standards for clinical laboratories, with a special focus on sample traceability and patient safety. In this scenario, the Greiner Bio-One eTrack system emerges as a transformative solution, designed to elevate laboratory management to new levels of excellence.
This article explores how Greiner Bio-One eTrack drives compliance with RDC 786/2023, highlighting its benefits and the positive impact it brings to clinical laboratories.
Robust Traceability: The Foundation of Security and Trust
RDC 786/2023 requires impeccable traceability of biological samples. Greiner Bio-One eTrack responds to this challenge with a robust and advanced system that offers:
- Accurate Identification at Collection: The system captures critical sample data at the time of collection, including patient name, date of birth (or age), material type and date/time of collection. This ensures unambiguous identification, minimizing the risk of errors.
- Continuous Pre-Analytical Tracking: eTrack monitors each step of the pre-analytical process, recording who performed the activity, when and with which materials. This total visibility promotes continuous traceability, essential for process safety and quality.
- Detailed Reports: The system generates comprehensive reports that facilitate auditing, identification of areas for improvement and informed decision-making. The ability to demonstrate compliance easily and accurately is one of the system's great differentiators.
With an estimated pre-analytical traceability coverage of 90-95%, Greiner Bio-One eTrack positions itself as a leader in sample management, overcoming the challenges imposed by RDC 786/2023.
Accurate Data and Intelligent Integration
The Greiner Bio-One eTrack not only tracks samples, but also generates valuable data for reporting quality. It offers:
- Detailed Data Capture: The system stores essential information about the laboratory, the professional responsible and the materials used, facilitating the identification and correction of problems.
- Integration with LIS Systems: Integration with LIS systems enhances the generation of complete and consistent reports, ensuring that all relevant information is accessible and reliable.
The ability to manage and integrate accurate and reliable data is one of the main advantages of Greiner Bio-One eTrack, enabling laboratories to achieve RDC 786/2023 compliance efficiently and effectively, achieving 70-80% coverage.
Operational Efficiency and Risk Reduction
The impact of Greiner Bio-One eTrack goes beyond traceability, transforming laboratory operations:
- Significant Error Reduction: Automating identification and tracking reduces the risk of mix-ups and transcription errors, representing an 80-90% reduction in potential errors.
- Flow Optimization: The system streamlines the collection and recording process, resulting in a 20-40% improvement in laboratory efficiency. This allows teams to focus on more complex and strategic tasks.
- Simplified Compliance: eTrack simplifies compliance with RDC 786/2023, facilitating audits and reducing the risk of non-conformities.
Smart Integration and Flexibility
The flexibility of the Greiner Bio-One eTrack is another key factor for success:
- Integration with LIS and Other Systems: The system integrates with other systems, creating a connected ecosystem that improves the flow of information.
- Adaptability: Greiner Bio-One eTrack adapts to different workflows and the particularities of each laboratory, allowing for efficient and seamless implementation.
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