1. The COLA Quality Management Systems Program

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

3. 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. 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. 5 ISO: Growth from manufacturing to medical Medicine realized the advantages of applying quality management system practices to laboratory operations

6. 6 ISO technical committee sought to 1.Standardize & interpret the ISO 9000 into language more familiar to healthcare organizations 2.Retain the core essence of the ISO 9000 quality principles ISO 15189:2003: Particular Requirements for Quality and Competence in Medical Laboratories ISO: Growth from manufacturing to medical

7. 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. 8 Quality System Essentials QSEs are the Infrastructure for Quality Managements Procedure Manual Management sets policies and designs processes for each QSE Both management and staff follow procedures in the QSEs QSEs are everyones responsibilities

9. 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. 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. 11 Preanalytic Analytic Postanalytic Testing Results Review and Follow-Up Interpretation Result Reporting and Archiving Specimen Management CLSI GP26 Test Ordering Specimen Collection Transport Receipt/Processing

12. 12 Quality Management System: Laboratory Model

13. 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