Presentation on theme: "1 HIV Drug Resistance Training Module 9: A Systems Approach to Laboratory Quality."— Presentation transcript:
1 HIV Drug Resistance Training Module 9: A Systems Approach to Laboratory Quality
2 Topics What is a Lab Quality System? Components of a Lab Quality System Quality is Everyone’s Responsibility
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 what is a lab quality system? What is quality? What is a lab quality system?
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 Discussion – Dining Out: A Quality Experience Think about your expectations for quality. What might you expect for a quality experience at a restaurant?
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 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 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 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 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 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 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 quality is everyone’s responsibility Who is responsible for quality? Why is a quality system important to genotyping?
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 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 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?