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HIV Drug Resistance Training Module 2: The WHO Lab Network Topics Purpose and Goals of the WHO HIVDR Lab Network Structure of the Network Standards and Accreditation Objectives Describe the purpose and goals of the WHO laboratory network. Describe the structure of the network.

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hiv drug resistance training

HIV Drug Resistance Training

Module 2:

The WHO Lab Network

topics
Topics
  • Purpose and Goals of the WHO HIVDR Lab Network
  • Structure of the Network
  • Standards and Accreditation
objectives
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.
purpose and goals of the who lab network
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?

why the need for a network
Why the Need for a Network?
  • Importance of preventing drug resistance
  • Importance of maintaining effectiveness of standard first-and second-line ART regimens
why the need for a network6
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
goals of the network
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
structure of the network
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?

laboratory network structure for hiv dr testing
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

how many ndrls and where
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
discussion
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?
standards and accreditation
standards and accreditation

What standards has WHO set for HIVDR labs in the network?

How does a lab become accredited?

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

Accreditation for National HIVDR Laboratories: Mandatory Criteria
minimal infrastructure for hivdr genotyping
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
accreditation for national hivdr laboratories additional criteria
Accreditation for National HIVDR Laboratories: Additional Criteria

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

continued who accreditation
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

discussion19
Discussion
  • What standards has WHO set for HIVDR labs in the network?
  • How does a lab become accredited?
reflection
Reflection
  • What do we need to do to get a national lab accredited—or will we use a regional lab?
summary
Summary
  • Purpose and Goals of the WHO Lab Network
  • Structure of the Network
  • Standards and Accreditation