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

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

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

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

5. 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

6. How to Implement a Quality Management System?

7. 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

8. 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

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

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

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

12. 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: 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: 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. SECTION SUPPORTING STATEMENTS

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

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

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

16. PURPOSE This 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

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

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

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

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

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

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

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

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

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

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

28. QSE: Assessment • Quality Indicators • Internal Audits • Management Review

29. QSE: Process Improvement • Quality Improvement Activities • Occurrence management • Problem Solving

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

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

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

33. 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

34. Celebrate Success!

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