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The COLA Quality Management Systems Program

The COLA Quality Management Systems Program. Introduction. COLA Quality Management Systems Program An ISO 15189:2003 Accreditation Program. Global community standards. We are all part of a global economy Standards and management of quality apply world-wide

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The COLA Quality Management Systems Program

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  1. The COLA Quality Management Systems Program

  2. Introduction COLA Quality Management Systems Program An ISO 15189:2003 Accreditation Program

  3. Global community standards • We are all part of a global economy • Standards and management of quality apply world-wide • International & domestic operations to achieve and maintain accepted levels of quality • Uniform standards across borders with a minimum of confusion and concern over quality

  4. ISO: International Organization for Standardization A world-wide federation of national standards bodies using ISO technical committees • Define standards for quality management systems • ISO 9000 series = fundamentals and vocabulary • ISO 9000:2000 = requirements for QMS • Origins in manufacturing organizations with manufacturing terminology

  5. ISO: Growth from manufacturing to medical Medicine realized the advantages of applying quality management system practices to laboratory operations

  6. ISO: Growth from manufacturing to medical ISO technical committee sought to • Standardize & interpret the ISO 9000 into language more familiar to healthcare organizations • Retain the core essence of the ISO 9000 quality principles ISO 15189:2003: Particular Requirements for Quality and Competence in Medical Laboratories

  7. Quality System Essentials Foundation of the COLA QMS accreditation program is the concept of Quality System Essentials (QSE) • Essential components of quality • Defines all aspects of the laboratory operation • Basis of compliance with regulations

  8. Quality System Essentials • QSEs are the “Infrastructure for Quality Management’s Procedure Manual” • Management sets policies and designs processes for each QSE • Both management and staff follow procedures in the QSEs • QSEs are everyone’s responsibilities

  9. The 12 Quality System Essentials • Organization • Process Control • Personnel • Assessments • Equipment • Documents & Records • Facilities and Safety • Purchasing & Inventory • Occurrence Management • Information Management • Customer Satisfaction & Service • Process Improvement

  10. Workflow Analysis: Path of Workflow • Operational aspect defines how a particular service or product is provided • Sequence of activities from the initiation of a request through the provision of laboratory products or services

  11. CLSI GP26 Preanalytic Analytic Postanalytic Test Ordering Specimen Collection Transport Receipt/Processing Testing Results Review and Follow-Up Interpretation Result Reporting and Archiving  Specimen Management

  12. Quality Management System: Laboratory Model

  13. The COLA QMS Accreditation Program: Epilogue Goals of QMS Accreditation Program • Built-in standards of quality • Continuous systems for quality assessment, improvement, and feedback • Maintenance of Quality Standards Resulting in • Enhances patient care • Integrated Incident Management • Optimized operational efficiency

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