# Presentation: 446095

## Module 5: Assuring the Quality of HIV Rapid Testing

- A Systems Approach to Quality

## Learning Objectives

- At the end of this module, you will be able to:
- Explain the systems approach to lab quality and its benefits
- Identify the essential elements of a lab quality system and how they apply to HIV rapid testing
- Recognize key factors that may compromise the quality of HIV rapid testing
- Describe your responsibilities in preventing and detecting errors before, during, and after testing

## Content Overview

- The approach we take to achieve quality
- Essential elements of a lab quality system
- Quality assurance procedures at the HIV rapid testing site
- How you can contribute to quality before, during, and after testing

## 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.

## Discussion –   Dining Out: A Quality Experience

- Think about your expectations for quality.
- What might you expect for a quality experience at a restaurant?

## Why Quality?

**Test Site**
** ****Quality**

**Accurate, **
**Reliable**
**Testing**

**Quality in **
**All Aspects **
**of Health Care**

## 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

## 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.

## Benefits of a Quality System

- Monitors all parts of the testing system
- Detect and reduce errors
- Improve consistency between testing sites
- Help contain costs

## The Lab Quality System

## Organization

**A culture **
**committed **
**to quality**

**Quality policy **
**& standards**

**Clearly defined**
**roles**
** ****& accountability**

**Sufficient**
**resources**

## Personnel

**Retention**

**Human resource**
**planning**

**Hiring**

**Performance**
**management**

**Training**

**Supervision**

## Equipment

**Maintenance,**
**service & repair**

**Selection**

**Acquisition**

**Installation &**
**initial calibration**

**Troubleshooting**

**Disposition**

## Purchasing and Inventory

**Inventory**
**management**

**Procurement**

**Receiving**

**Storage**

**Record**
**keeping**

## Process Control

**Standard **
**operating**
**procedures**

**Specimen**
**management**

**Quality**
**control**

## Documents and Records

**Document**
**storage/retrieval**

**Standardized**
**forms**

**Document**
**destruction**

**Document**
**distribution **

**Document**
**approval**

## Information Management

**Information**
**flow**

**Data collection**
**& management**

**Computer**
**skills**

**Patient privacy &**
**confidentiality**

## Occurrence Management

**Written **
**procedures for**
**addressing errors **

**Corrective**
**actions**

**Occurrence**
**records**

**Occurrence**
**reporting**

## Assessment

**Internal audit **
**or self**
**evaluation**

**Improvement**
**measures**

**External**
**Quality**
**Assessment**

## Process Improvement

**On-going**
**data**
**collection**

**Improvement**
**measures**

## Customer Service

**Monitoring **
**Customer**
**satisfaction**

**Process **
**improvement**

**Rewards**

## Facilities and Safety

**Testing and**
**storage**
**areas**

**Safety practice**

**Safety **
**procedures**
**& records**

## The Lab Quality System

## Activity: Are You “Positive” or “Negative?”

- Peel a statement off the ball
- Read out loud your statement to the group
- Based on the statement, go to:
- The Positive Circle or
- The Negative Circle

- Participants take turns tossing the cabbage ball.  When you catch the ball,

## Who Is Responsible for Quality?

- Laboratory management _and_ program staff establish quality assurance procedures.
- Test site personnel implement the quality assurance procedures.

**EVERYONE!**

## Quality Assurance vs. Quality Control

|  | Quality Assurance | Quality      Control |
| --- | --- | --- |
| Definition | Activities to ensure process are adequate for a system to achieve its objectives | Activities to evaluate a product or work result |
| Examples | Establish standard procedures for sample collection
Define criteria for acceptable samples | Analyze known QC sample to determine if a test is valid
Decide if a sample is acceptable for testing |

## The Quality Assurance Cycle

**The Quality Assurance Cycle**

- Pre-Testing

- Testing

- Post-Testing

** ****Data and Lab Management**
**Safety**
**Customer Service**

- Patient/Client Prep
- Sample Collection

- Sample Receipt and Accessioning

- Sample Transport

- Quality Control

- Record Keeping

- Reporting

- Personnel Competency
- Test Evaluations

- Testing

## Why Do Errors Occur? 

- Some causes include:
- Individual responsibilities unclear
- No written procedures
- Written procedures not followed
- Training is not done or not completed
- Checks not done for transcription errors
- Test kits not stored properly
- QC, EQA  not performed
- Equipment not properly maintained
- Errors can occur throughout the testing process

## Pre-testing Errors

- Examples include:
- Specimen mislabeled or unlabeled
- Specimen stored inappropriately before testing
- Specimen transported inappropriately
- Test kits stored inappropriately

## Preventing and Detecting Errors – Before Testing

- Check storage and room temperature
- Select an appropriate testing workspace
- Check inventory and expiration dates
- Review testing procedures
- Record pertinent information, and label test device
- Collect appropriate specimen

## Testing Errors

- Examples include:
- Country algorithm not followed
- Incorrect timing of test
- Results reported when control results invalid
- Improper measurements of specimen or reagents
- Reagents stored inappropriately or used after expiration date
- Dilution and pipetting errors
- Incorrect reagents used

## Preventing and Detecting Errors – During Testing

- Perform and review Quality Control (QC)
- Follow safety precautions
- Conduct test according to written procedures
- Correctly interpret test results

## Post-testing Errors

- Examples include:
- Transcription error in reporting
- Report illegible
- Report sent to the wrong location
- Information system not maintained

## Preventing and Detecting Errors – After testing

- Re-check patient/client identifier
- Write legibly
- Clean up and dispose of contaminated waste
- Package EQA specimens for re-testing, if needed

## Why is Quality System Important to HIV Rapid Testing? 

- Ensures that quality is the foundation of everything we do
- Sets the standard for level of quality
- Meets/exceeds customer expectations
- Provides means to prevent, detect and correct problems
- Becomes the core of a monitoring,  evaluation, & improvement system
- Reduces costs

***Even the simplest Rapid Test is not foolproof***

## Summary

- Why do errors occur?
- What are some common errors that might occur with HIV rapid testing?
- Where is QA applied in a PMTCT or VCT testing site?
- What are some steps to take before, during, and after testing to assure the quality of results?
- Describe the impact that errors will have on the patient/client.