1. Quality Management Systems are All About Client Service and Satisfaction Customer Requirements Customer Satisfaction Input  Output PRODUCT Answer to Question 1!

2. The Quality Hierarchy TQM QUALITY MANAGEMENT QUALITY SYSTEM coordinated QUALITY ASSURANCE planned/systematic QUALITY CONTROL operational techniques Efficiency Operating Excellence Baldridge Quality Award World Class Quality Effectiveness Regulatory compliance Answer to Question 2! We do the blue…but we want the gold

3. Quality Management System QSE 1 : Organization QSE 2 : Document & Record QSE 3 : Purchasing & Inventory QSE 4 : Occurrence Mgm QSE 5 : Equipment QSE 6 : Personnel QSE 7 : Process Control QSE 8 : Assessment QSE 9 : Process Improvement QSE 10 : Information Mgm QSE 11 : Service & Satisfaction QSE 12 : Facility & Safety

4. Quality manual (Policy, Process, Procedures) On the 12 QSEs Policy: What we want to do Process: How to do it Procedure : What to do Emphasize education & staff awareness

5. Document across the Path of Workflow Pre-analytical  Analytical  Post-analytical Collection ManualMethod ValidationResults Reporting Specimen TransportSources of ErrorResponsiveness Quality Management Systems Answer to Question 4!

6. How QMS Relates to OLA

7. OLA has 11 sections with multiple questions in each section (See OLA Requirements Handout): I. Organizational Structure, Personnel Policies and Training, and Laboratory Management II. Quality Management System III. Physical Facilities IV. Equipment, Reagents and Supplies V. Pre-analytical Process VI. Analytical Process VII. Quality Assurance VIII Post-analytical Process (Reporting) IX. Laboratory Information System X. Safety XI. Point-of-Care Testing OLA Requirement Answer to Question 5!

8. I.Organizational Structure, Personnel Policies and Training, and Laboratory Management – Human Resources II.Quality Management System - Organization, Process Improvement, Documents and Records, Occurrence Management, Purchasing & Inventory III.Physical Facilities – Facilities and Safety IV.Equipment, Reagents and Supplies – Equipment, Purchasing & Inventory V. Pre-analytical Process – Information Management, Process Control Relating our Quality Management System Essentials to OLA’S Requirements…

9. VI. Analytical Process – Process Control VII. Quality Assurance – Process Control, Assessment VIII Post-analytical Process (Reporting) – Information Management, Service and Satisfaction IX. Laboratory Information System – Information Mgm X. Safety – Facilities and Safety Relating the QSEs to OLA…

10. It is essential for us to design, not fully implement a QMS for the first round Essential to meet requirements for safety and care of patients and employees Essential for us to meet requirements for the protection of patient and employee rights Essential for us to meet requirements for appropriate, accurate, timely and reliable laboratory results Essential for us to do this for legal requirement And more …about the OLA requirements

11. 1. Assessment 2. Documents and Records 3. Equipment 4. Facilities and Safety 5. Human Resources 6. Information Management 7. Occurrence Management 8. Organization 9. Process Control 10. Process Improvement 11. Purchasing and Inventory 12. Service and Satisfaction We need to operationalize these now – in every lab Pre-analytical  Analytical  Post-analytical