HIV Drug Resistance Training by zwftoTP

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									HIV Drug Resistance Training




         Module 2:
         The WHO Lab Network



                               1
                   Topics

 Purpose and Goals of the WHO HIVDR Lab
  Network
 Structure of the Network
 Standards and Accreditation




                                           2
                   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.




                                                        3
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?




                                                  4
        Why the Need for a Network?

   Importance of preventing drug resistance
   Importance of maintaining effectiveness of
    standard first-and second-line ART regimens




                                                  5
      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




                                                     6
           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




                                                     7
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?




                                                                        8
           Laboratory Network Structure
                for HIV DR testing

                                       Advisory              WHO
                                        Group
Global




                                  Specialized Lab
                                     (SDRL)
Regional




                               Regional HIV DR Lab
                                     (RDRL)

                         National HIV DR Lab (NDRL)
National




             National strategy for the collection, handling, storage, and
             shipment of HIVDR surveillance and monitoring specimens
                                                                            9
HIVDR Laboratory Network, Dec. 2008




                                      10
      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


                                                   11
                  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?




                                                   12
standards and accreditation

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




                                                            13
                          Standards

   Specimen Types
    – Plasma
    – Serum
    – Dried fluid spots
   Specimen Processing
   Quality Assurance




                                      14
    Accreditation for National HIVDR
    Laboratories: Mandatory Criteria

 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




                                                 15
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
                                                              16
      Accreditation for National HIVDR
      Laboratories: Additional Criteria
Criterion                                                     Points
1. Adequate laboratory facilities and infrastructure           30
2. Adequate personnel expertise                                24
3. The institution guarantees a sustainable laboratory work     8
4. Laboratory experience in genotyping                         20
5. Use of Standard Operation Procedures                        18
TOTAL SCORE                                                    100

  Each lab must attain a score of 85 points to be accredited




                                                                       17
   Continued WHO Accreditation

                    Candidate lab




                                                               Once only
    Accredited                             Not accredited


                                             Re-assessment
                 Approved                     (< 2 years)


   Annual
Re-assessment
                            Not approved
                                            Only after
                                            consideration by
                                            advisory group
                            Suspended                                 18
                 Discussion

 What standards has WHO set for HIVDR labs in
  the network?
 How does a lab become accredited?




                                                 19
                    Reflection

   What do we need to do to get a national lab
    accredited—or will we use a regional lab?




                                                  20
                   Summary

   Purpose and Goals of the WHO Lab Network
   Structure of the Network
   Standards and Accreditation




                                               21

								
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