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

3. Today’s Presentation LLSG profile Implementation Plan Outline Quality System Essentials Review: Where are we? Outline the next steps

4. London Laboratory Services Group Joint venture between LHSC and SJHC Pathology and Laboratory Medicine Program 9 disciplines 55 laboratories 4 campuses 500 employees

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

6. Why Quality Management System? QMP-LS: Quality Management Program – Laboratory Services; Ontario Laboratory Accreditation (OLA) Consistent with international trends and laboratory science We are committed to providing the highest level of care to the patient

7. How to Implement a Quality Management System?

8. LLSG Implementation Plan Quality Coordinator Discipline Task Teams Quality Team Develop Policies GAP analysis Map Processes Write procedures Quality Manual Communicate/Educate/Train Audit Accreditation

9. 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

10. QSE: Documents and Records Document Management System - create - identify - change - approve - file - distribute - archive

11. Hierarchy of Documents Policy Process Procedures Forms What to do How to do it How it happens Records

12. Policy Development Quality Policies - QSE’s - Map OLA requirements - Policy statement - Responsibility - Supporting statements - Supporting processes Operational Policies - included in procedures

13. POLICY STATEMENT: PURPOSE: This policy provides the direction for the processes and procedures to…. RESPONSIBILITY (use those that apply) Program Leader/Discipline Leader/Section Head is responsible for Lab Manager is responsible for Technical Specialist/Coordinator is responsible for Staff members are responsible for Other: The following sections are derived from the OLA requirements. They determine the supporting statements for the policy. There should be one section and related statement for the major categories defined in the requirements. Make a broad statement about the Laboratory's intentions for the sections below. References:  NCCLS document HS1-A Vol.22, No.13- A Quality System Model for Health Care; Approved Guideline  QMP-LS- Ontario Laboratory Accreditation Requirements  Others: Supporting Documents List the processes that support this policy: SECTIONSUPPORTING STATEMENTS

14. Process Mapping Address the path of workflow Describe how things happen here Flow Charts or Tables

15. What Happens (List the steps) Who’s responsible Procedure (or another Process) Results 1) 2) 3)

16. Procedure Development Identified from process mapping Templates developed based on NCCLS guidelines Used for analytical and non analytical procedures

17. PURPOSEThis procedure gives instructions…… POLICY EQUIPMENT MATERIALS SPECIMEN SPECIAL SAFETY QUALITY CONTROL PROCEDURE LIMITATIONS INTERPRETATION CALCULATIONS REFERENCE RANGE RESULTS REPORTING REFERENCES RELATED DOCUMENTS APPENDICES NB: SECTIONS NOT APPLICABLE TO A GIVEN DOCUMENT ARE DELETED FROM THAT DOCUMENT

19. Procedures Accessible Up to date User friendly- accurate, easy to follow

20. QSE: Process Control Laboratory processes and procedures Validation Establishing Reference Intervals Quality Control Internal and External QA Method Comparability Accreditation

21. QSE: Occurrence Management Quality Control: Corrective Action External and Internal Quality Assurance Turn Around Time (TAT) delay Discrepant Results Corrected Results Specimen Rejection Criteria

22. QSE: Information Management Results Reporting Release of Results Computer Procedures Change Approval Computer QA Computer Security Computer Validation

23. QSE: Purchasing and Inventory Inventory Control System External Services Purchasing Documents Material Resources

24. QSE: Safety Safety Officer, Safety Committee Safety Manual Audit and Inspections Reporting Incidents, Accidents, Illness Training Personnel Responsibilities

25. QSE: Facilities Location and design Environmental Conditions Access Communication Systems Storage Computer Environment

26. QSE: Equipment Equipment selection, calibration, verification, validation Inventory Equipment operation maintenance and records Defective Equipment

27. QSE: Personnel Job Description and Qualifications Training Competence Continuing Education Personnel Records Performance Appraisal

28. QSE: Organization License Mission Statement Accreditation Organizational Structure Resource Allocation Referral Laboratories

29. QSE: Assessment Quality Indicators Internal Audits Management Review

30. QSE: Process Improvement Quality Improvement Activities Occurrence management Problem Solving

31. QSE: Service and Satisfaction Customer Satisfaction (Complaints) Internal and external

32. Where are We? Quality Team Quality policies developed Processes identified/mapped Procedures written Document Management System Quality Manual Web site for referral labs

33. Where are We? Discipline Task Teams GAP analysis Processes mapped Procedures written Revisit requirements and close GAP

34. What’s Next? Quality Team to continue to address QSE Discipline Task Teams to complete sections of OLA requirements Educate and train staff Perform self assessment

35. Celebrate Success!

36. Resource Material ISO documents: 9001:2000 15189  NCCLS documents: GP26-A GP22-A HS1- A  QMP-LS- OLA Consensus Requirements