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

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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.

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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?

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Why the Need for a Network?

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

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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  resources need for shared

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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

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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?

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Laboratory Network Structure for HIV DR testing

Advisory Group Specialized Lab (SDRL) Regional HIV DR Lab (RDRL) WHO National HIV DR Lab (NDRL) National strategy for the collection, handling, storage, and shipment of HIVDR surveillance and monitoring specimens

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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

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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?

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standards and accreditation

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

How does a lab become accredited?

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Standards

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

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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

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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

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Accreditation for National HIVDR Laboratories: Additional Criteria Criterion

1. Adequate laboratory facilities and infrastructure 2. Adequate personnel expertise 3. The institution guarantees a sustainable laboratory work 4. Laboratory experience in genotyping 5. Use of Standard Operation Procedures

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

30 24 8 20 18

100 17

Continued WHO Accreditation

Candidate lab Accredited Approved Not accredited Re-assessment (< 2 years) Annual Re-assessment Not approved Suspended Only after consideration by advisory group

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Discussion

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

How does a lab become accredited?

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Reflection

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

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Summary

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

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