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.qmpls.org - www.lhsc.on.ca/lab/qmanage/qmsys.htm www.lhsc.on.ca/lab/qmanage/qmsys.htm