HIV Drug Resistance Training Module 2: The WHO Lab Network Topics Purpose and Goals of the WHO HIVDR Lab Network Structure of the Network
Download ReportTranscript HIV Drug Resistance Training Module 2: The WHO Lab Network Topics Purpose and Goals of the WHO HIVDR Lab Network Structure of the Network
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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