A Quality Management System

1. A Quality Management System Viki Massey Quality Coordinator A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London

2. Objectives • Quality Management System -What • Why • Goals/Benefits • Structure • Ontario Laboratory Accreditation (OLA) • Implementation Plan • Accreditation Process

3. What is a Quality Management System • ISO 9000 defines a QMS as: “ Management system to direct and control an organization with regard to quality”

4. Why Quality Management System? • QMP-LS: Quality Management Program – Laboratory Services; Ontario Laboratory Accreditation • Consistent with international trends and laboratory science • Providing the highest level of care to the patient

5. LPTP to OLA • 1974 -Laboratory Proficiency Testing Program (LPTP) • 1992-1994- Laboratory Review Quality Improvement Model • 2000- Quality Management Program-Laboratory Services (QMP-LS) • Ontario Laboratory Accreditation (OLA)

6. Ontario Laboratory Accreditation • Mandatory for all Ontario laboratories • Peer accreditation • Based on a process approach • Review of policies and processes • Standards of practice

7. Building Blocks of OLA • ISO 9000; ISO 17025; ISO 15189 • NCCLS- A Quality System Model for Health Care • Ontario Law • Generally accepted standards of laboratory practice

8. The Benefits of a QMS • Encourages active and effective leadership • Involves and empowers staff • Staff will clearly understand their responsibilities • Ensures consistency • Focuses on root cause of problems

9. Goal of a Quality Management System For the laboratory : • to operate efficiently and effectively, meeting regulatory requirements • to be managed with the interests of the patient • to ensure that everyone understands who is responsible for doing what, when, why,where and how • to continually strive for improvement

10. Stated Simply: • Say what you do (document) • Do what you say • Standardize, standardize, standardize • Measure and monitor those things that are important to your customer • Focus on the process • Assess

11. Structure for a Quality system Quality System Essentials Organization Personnel Equipment Purchasing/Inventory Process Control Documents/Records Occurrence Mgmt Internal Assessment Process Improvement Service and Satisfaction Facilities and Safety Information Management Path of Workflow Pre-Analytic Analytic Post-Analytic Info Mgmt Quality system essentials apply to all operations in the path of workflow

12. LLSG Implementation Plan • Quality Coordinator • Discipline Task Teams • Quality Team • Policies drafted • GAP analysis • Mapping Processes • Quality Manual • Communication/Education/Training • Audit • Accreditation

13. Accreditation Process • Institution • Meet Essential Requirements (614) • Meet Good Practice Recommendations (66) • Submit Quality Manual • QMPLS • Review Quality Manual • Appoint Accreditation Team • Accreditation Team • Interview • Observe • Check list of requirements • Assess compliance • Recommend accreditation

14. Summary • Need an organized plan to implement QMS • Use OLA requirements to develop QMS • Develop Quality Manual addressing QSE • Operationalize Quality Manual • Prepare for accreditation assessment visit

15. Additional Information • Can be found at these Web Sites: • www.qmpls.org • www.lhsc.on.ca/lab/qmanage/qmsys.htm