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

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

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.
3

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

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.
5

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

Why Quality?
Wellvalidated assays
Test Site
Quality
Accurate,
Reliable
Testing
7

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
8

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.
9

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

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

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

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?
13

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

Who is responsible for quality?
Why is a quality system important to genotyping?
15

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

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
17

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?
18