# Presentation: 461054

## Applying Quality System Concepts to HIV Rapid Testing

## CDC/WHO HIV Rapid Test Quality System WorkshopJohannesburg, South Africa  

- May 2-3, 2004

## Background

- Framework developed using Quality System essentials
- Workgroup composed of representatives from African countries, WHO, CDC, met in Johannesburg
- Draft will be circulated broadly for additional input
- Published by CDC and WHO

## The Quality System

**Information Management**

## Organization and ManagementRecommendations

- Establish a national quality system
- national office of quality assurance
-  identify a national quality assurance manager
- identification of a multisectorial working team  (avoids vertical assessments)
- Extend system to all tiers (central, regional, district) of the network - all service providers at all levels

## Organization and ManagementRecommendations, cont.

- Establish national policies for use of HIV rapid testing
- Develop strategic plan for HIV rapid testing, including training and implementation
- Support and maintain continuous monitoring and improvement system

## Personnel – TrainingRecommendations

- Standardized training must be provided for
- All staff performing HIV testing must be trained (pre-service and in-service)
- Individuals providing monitoring or oversight for testing site
- Trainers
- Program staff

## Personnel – CompetencyRecommendations

- Initial and on-going competency evaluation is required for all staff performing testing
- Continual mentoring

## Quality Control Recommendations

- QC material (other than kit) must be used
- Develop within country, standardize

## Quality ControlRecommendations, cont.

- Run a positive and negative, when possible low positive:
- At least weekly
- New operator
- New lot or shipment
- Environmental factors
- Corrective action

## External Quality Assessment

- Components:
- On-site monitoring or assessment
- Re-testing
- Proficiency testing

## EQA - Current Practice

- Relies heavily on retesting
- 10% is a common practice (DBS or serum)
- Delay in identification of problems
- Lack of capacity at national reference laboratory for re-testing, analysis, etc.
- On-site monitoring varies by country
- Some capacity for proficiency testing
- Lack of national oversight, analysis and feedback.

## Statistics

| Volume
(Per Site) | 
  1%* error |  
  5%* error |   Re-testing
  Feasibility |
| --- | --- | --- | --- |
| Very low
50 spec |  re-test 48
    (96%) | re-test 31
     (62%) | 
      No |
| Low
500 spec | re-test 225
    (45%) | re-test  56
     (11%) | 
 Possible |
| High
5000 spec | re-test 290
    (5.8%)      | re-test 59
     (1.2%) | 
      Yes |

***95% Confidence**

## Re-testing – EQARecommendations

- Use re-testing to establish competence of new staff or new site
- On-going re-testing must be based upon statistical considerations
- Outcome of re-testing must be analyzed for effective and timely feedback
- Determine cost-effectiveness
- Corrective action if problems identified

## External Quality AssessmentRecommendations

- Place emphasis on on-site assessment (minimum EQA requirement)
- All aspects of quality system (records and documents, storage, inventories, testing, etc.)
- On-site observation of testing with known specimens (proficiency panels)

## External Quality AssessmentRecommendations

- On-site monitoring, continued:
- On-site observation of testing of clients (instructional visit, not punitive)
- Use of standard checklist
- Assessment to occur quarterly
- Take corrective actions for identified problems

## Next Steps for Guidelines

- Workgroup to complete final draft of guidelines by July 30, 2004
- Official clearances
- Available on website
- Publication and distribution

## Next Steps within Region

- Continued development and implementation of country  plans incorporating all elements of the quality system
- Promote, monitor, and support the use of guidelines  (WHO and other partners)