1. 1 HIV Drug Resistance Training Module 9: A Systems Approach to Laboratory Quality

2. 2 Topics  What is a Lab Quality System?  Components of a Lab Quality System  Quality is Everyone’s Responsibility

3. 3 Objectives  Explain the systems approach to lab quality and its benefits  Identify the essential elements of a lab quality system and how they apply to HIVDR genotyping.  Recognize key factors that may compromise the quality of HIVDR genotyping.  Describe your responsibilities in preventing and detecting errors before, during, and after testing.

4. 4 what is a lab quality system? What is quality? What is a lab quality system?

5. 5 What Is “Quality?”  The ability of a product or service to satisfy stated or implied needs of a specific customer  Achieved by conforming to established requirements and standards.

6. 6 Discussion – Dining Out: A Quality Experience  Think about your expectations for quality.  What might you expect for a quality experience at a restaurant?

7. 7 Why Quality?

8. 8 A Systems Approach to Quality  Considers all components within a system  Identifies the connection and relationship (e.g., cause and effect) among the components Example: the human body system A headache may be caused by disorder of other components in the system

9. 9 Definition of A Lab Quality System  The organizational structure, responsibilities, processes, procedures, and resources for implementing quality management of the laboratory or testing site.  In other words… all activities which contribute to quality of tests, directly or indirectly.

10. 10 Benefits of a Quality System Monitors all parts of the testing system Detects and reduces errors Improves consistency among testing sites Helps contain costs Benefits

11. 11 components of a lab quality system What are the components of a lab quality system? How do these components interact to cause/avoid problems?

12. 12 A Systems Approach to Laboratory Quality Organization Stock Management SOPs, Documents & Records Process Improvement Process Improvement Personnel Quality Control Occurrence Management Specimen Management Equipment Data Management Assessment Safety & Waste Management

13. 13 Small Group Activity  Situation: Imagine that a lab has found positive PCR in the negative control and lots of background in many sequences (indicating some systemic contaminant is present).  Work in small groups. For each quality component, determine: –How might this component be related to the problem? –What the lab could do to prevent this problem from happening again?

14. 14 A Systems Approach to Laboratory Quality Organization Stock Management SOP, Documents & Records Process Improvement Process Improvement Personnel Quality Control Occurrence Management Specimen Management Equipment Data Management Assessment Safety & Waste Management

15. 15 quality is everyone’s responsibility Who is responsible for quality? Why is a quality system important to genotyping?

16. 16 Who Is Responsible for Quality?  Laboratory management and program staff establish quality assurance procedures.  Test site personnel implement the quality assurance procedures. EVERYONE!

17. 17 Why is Quality System Important to HIVDR Genotype Testing?  Ensures that quality is the foundation of everything we do  Sets the standard for level of quality  Meets/exceeds customer expectations  Provides a way to prevent, detect and correct problems  Becomes the core of a monitoring, evaluation, & improvement system  Reduces costs

18. 18 Summary  What are the essential elements of a lab quality system for HIVDR genotyping, and what do we need to do to make sure that they are in place systematically?