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Published on: December 12, 2011
[Impact of the analitycal quality for the infectious serology]
1Laboratorios LICON S.A., Subdirección de Línea, Sistemas de Control de la Calidad. Tlalnepantla, Estado de México, México.
Abstract:
The application of quality and its scope have diversified. From this perspective, quality assurance applied to analytical tests (performed in clinical laboratories or blood banks) for the detection of infectious markers is one of the concepts that has gained strength in the last 10 years. The official Mexican standards require ensuring the quality of the published results and for their compliance it is recommended the use of international guides and guidelines that describe good practices that can be applied when carrying out this activity, without losing sight of the fact that everything related to quality assurance must be supported by the implementation of a quality management system. Thus, by using materials selected correctly and in accordance with official regulatory requirements, a good statistical analysis and the appropriate tools, the quality assurance of the analytical phase of the laboratory process in the screening of infectious markers can bring great benefits to the emission of clinically useful results by monitoring indicators and applying the necessary corrective actions, in order to reduce the risk of unfavorable results for patients and donors.
Insights
Quality assurance in clinical laboratory testing for infectious markers is crucial for reliable results. Implementing robust quality management systems and adhering to international guidelines ensures accurate detection and patient safety.
Area of Science:
- Clinical Laboratory Science
- Medical Diagnostics
- Public Health
Context:
- The scope of quality assurance has expanded significantly, particularly in analytical testing for infectious disease markers within clinical laboratories and blood banks.
- Official Mexican standards mandate the assurance of result quality for these tests.
- International guidelines for good practices are recommended for compliance.
Purpose:
- To highlight the importance and application of quality assurance in the analytical phase of infectious marker screening.
- To emphasize the integration of quality management systems with regulatory requirements and international best practices.
- To underscore the benefits of robust quality assurance in clinical laboratory diagnostics.
Summary:
- Quality assurance in infectious marker testing involves meticulous material selection, statistical analysis, and appropriate tools, all within a comprehensive quality management system.
- Adherence to official standards and international guidelines is essential for ensuring the reliability of laboratory results.
- Monitoring key indicators and implementing corrective actions are vital for reducing risks associated with diagnostic testing.
Impact:
- Enhances the reliability and clinical utility of results from infectious marker screening.
- Reduces the risk of adverse outcomes for patients and blood donors.
- Promotes a higher standard of care in clinical laboratories and blood banking services through systematic quality management.
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