HIV Drug Resistance Training

1. HIV Drug Resistance Training Module 2: The WHO Lab Network

2. Topics • Purpose and Goals of the WHO HIVDR Lab Network • Structure of the Network • Standards and Accreditation

3. Objectives • Describe the purpose and goals of the WHO laboratory network. • Describe the structure of the network. • Describe the role and responsibilities of specialized labs, regional labs, and national labs. • Describe the role of the DR working group.

4. purpose and goals of the who lab network Why is there a need for a lab network? What can we accomplish through a HIVDR network?

5. Why the Need for a Network? • Importance of preventing drug resistance • Importance of maintaining effectiveness of standard first-and second-line ART regimens

6. Why the Need for a Network? • Lack of common standards  less reliable results • Shortage of lab infrastructure  less access to testing • Cost and complexity of testing  need for shared resources

7. Goals of the Network • Access to quality-assured, accredited genotyping lab services • Guidance for accurate collection, handling, shipment, storage, and testing of HIVDR specimens • Support and training

8. structure of the network What are the different types of labs in the network? What are the roles and responsibilities of specialized labs, regional labs, and national labs?

9. Laboratory Network Structure for HIV DR testing WHO Global Regional National National strategy for the collection, handling, storage, and shipment of HIVDR surveillance and monitoring specimens

10. HIVDR Laboratory Network, Dec. 2008

11. How many NDRLs and Where? • In countries performing Surveillance and/or Monitoring Surveys • With approval of Ministry of Health • Where resources are available and not better spent elsewhere (e.g. drug supply, CD4, viral load labs) • If one genotyping lab is not enough to meet demand, or distance from collection sites too great, two or more labs may be needed

12. Discussion • Why is there a need for a lab network? • What can we accomplish through a HIVDR network? • What network labs are available to assist you? • What plans are in place for the future?

13. standards and accreditation What standards has WHO set for HIVDR labs in the network? How does a lab become accredited?

14. Standards • Specimen Types • Plasma • Serum • Dried fluid spots • Specimen Processing • Quality Assurance

15. Ministry of Health/National HIVDR committee designation National strategy for HIVDR prevention, surveillance and monitoring in place Minimal infrastructure for HIVDR genotyping Pass a WHO recognized Proficiency Panel Test within one year of assessment Accreditation for National HIVDR Laboratories: Mandatory Criteria

16. Minimal Infrastructure for HIVDR Genotyping • Separation of work areas, with workflow plan consistent with molecular diagnostic work • relevant anti-contamination laboratory spaces for PCR • Adequate equipment • Adequate laboratory and office space available and used efficiently • Electrical power backup • Reliable and well-documented specimen logistics and storage procedures and capacity • SOPs in place covering all aspects of laboratory procedures

17. Accreditation for National HIVDR Laboratories: Additional Criteria Each lab must attain a score of 85 points to be accredited

18. Continued WHO Accreditation Candidate lab Once only Accredited Not accredited Re-assessment (< 2 years) Approved Annual Re-assessment Not approved Only after consideration by advisory group Suspended

19. Discussion • What standards has WHO set for HIVDR labs in the network? • How does a lab become accredited?

20. Reflection • What do we need to do to get a national lab accredited—or will we use a regional lab?

21. Summary • Purpose and Goals of the WHO Lab Network • Structure of the Network • Standards and Accreditation