ISO 15189 accreditation provides a solid framework for quality and technical competence, thereby significantly improving laboratory patient care by establishing comprehensive standards that medical laboratories should meet. Navigate BioPharma Services, Inc.’s recent accreditation by the College of American Pathologists (CAP) under the ISO 15189 standard is a testament to its commitment to enhancing patient safety and minimizing risks. The CAP 15189SM Accreditation Program is designed to complement the existing Clinical Laboratory Improvement Amendments (CLIA)-based Laboratory Accreditation Program. It focuses on optimizing laboratory processes, improving quality standards, reducing institutional errors, managing risks, and controlling costs, thereby elevating the overall patient experience.
Every laboratory seeking ISO 15189 accreditation must undergo a rigorous assessment process that includes evaluating technical competence, management systems, and continual improvement practices. As highlighted by Vipul Trivedi, MD FCAP and Chair of the CAP 15189 Committee, the ISO 15189 standard encourages laboratories to continuously improve their care through risk assessment and process enhancement. Shannon Sykes, Head of Quality at Navigate BioPharma, added that achieving ISO 15189:2012 accreditation emphasizes their dedication to quality and excellence in patient care. By adhering to these strict standards, laboratories can ensure their processes are not only efficient but also reliable, which directly contributes to better patient outcomes.
Continuous Improvement and Risk Management
ISO 15189 accreditation establishes a robust framework that ensures quality and technical competence in medical laboratories, greatly enhancing patient care through stringent standards. Navigate BioPharma Services, Inc. recently received accreditation from the College of American Pathologists (CAP) under the ISO 15189 standard, underscoring its commitment to patient safety and risk minimization. The CAP 15189SM Accreditation Program complements the existing CLIA-based Laboratory Accreditation Program by focusing on process optimization, quality improvement, error reduction, risk management, and cost control—all contributing to superior patient care.
For a laboratory to achieve ISO 15189 accreditation, it must undergo a detailed assessment that covers technical competence, management systems, and practices for continuous improvement. Dr. Vipul Trivedi, Chair of the CAP 15189 Committee, emphasized that ISO 15189 encourages ongoing improvements in care through risk assessment and process enhancements. Shannon Sykes, Head of Quality at Navigate BioPharma, pointed out that attaining ISO 15189:2012 accreditation highlights their commitment to high standards and excellence in patient care. Adhering to these rigorous standards ensures that laboratories’ processes are efficient and reliable, leading to better patient outcomes.
