1. 1 Overview of Quality Management Systems Workshop Module 1 1

2. 2 Workshop Goals By the end of this workshop you will be able to: Discuss all processes and components within a Laboratory Quality Management System. Interpret an Assessment Report and write a Gap Analysis based on the report. Implement Quality Control policies into their laboratory daily procedures and responsibilities. Implement International Best Laboratory Practices into their daily laboratory activities. 2

3. 3 Ground Rules / Expectations Group decides the ground rules and their individual expectations for this workshop!

4. 4 What to Expect From This Workshop This workshop will be: Prescriptive – Of the activities/tasks/good practices that you can perform in your own laboratories Interactive – An opportunity to discuss, interact, and share experiences with fellow laboratorians; i.e. learn from each other’s experiences

5. 5 Workshop Expectations ASCP Expectations: Motivated laboratory professionals who are interested in implementing good laboratory practices Attendance and full participation in all sessions Asking questions and sharing experiences Completion of all prescribed course activities Nightly homework assignments are integral to full participation in the course

6. 6 ASCP Expectations: Upon returning to work, participant will facilitate: – Implementation of the Improvement Project they developed during this workshop – Sharing of workshop information with staff and colleagues through staff and other documented meetings Workshop Expectations

7. 7 What Part of Laboratory Management are You Most Comfortable Doing? Developing strategies for using effective communication skills in management duties and responsibilities. Motivating staff to follow Good Lab Practices (not what they may see demonstrated on the job). Using various managerial styles to motivate and delegate tasks and responsibilities to laboratory staff. Role-modeling Good Lab Practices. Other??

8. 8 What Part of Laboratory Management are You Most Un-Comfortable Doing? Developing strategies for using effective communication skills in management duties and responsibilities. Motivating staff to follow Good Lab Practices (not what they may see demonstrated on the job). Using various managerial styles to motivate and delegate tasks and responsibilities to laboratory staff. Role-modeling Good Lab Practices. Other??

9. 9 Modules Included in this Workshop Module 1: Overview of Quality Management Systems (QMS) Workshop Module 2: Introduction to Quality Assurance and Quality Control Module 3: Assessment Reports and Gap Analysis Module 4: Assuring the Quality of Laboratory Testing 9

10. 10 Modules Included in this Workshop Module 5: BioStatistics: Measures of Central Tendency & Variance in the Medical Laboratory Setting Module 6: QC Basic Rules, Charts and Interpretation of Results Module 7: Micropipette Use and Calibration Check Module 8: The Art of Management and Delegation 10

11. 11 How and Why to develop a working Quality Manual How to interpret Assessment Reports and write a Gap Analysis Plan of Action Levey-Jennings chart construction and applicability in the lab Interpretation of L J chart results and possible causes for biases/shifts, trends, other Rule violations Care, Maintenance, Calibration Check of Pipettes 11 Activities Included in this Workshop

12. 12 Agenda Schedule Facilitators will present a Module followed by an activity which allows participants the opportunity to practice using the information in small / large groups There will be 2 Tea Breaks and a lunch break each day There will be dedicated time for questions and comments each day 12

13. 13 Summary After this presentation participants can explain: – What to expect in terms of workshop goals. What questions do you have? 13