Specification & Quantification of Laboratory Equipment and HIV ...
Transcript of Specification & Quantification of Laboratory Equipment and HIV ...
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Vincent Habiyambere & Paula Fernandes
WHO AMDS, Sep 2014
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• Tests for each tiered network level defined
• Importance of standardization recognized
Maputo 2008
• TWG 1 Goal: Standardization and case studies
• TWG 2 Goal: Specifications to facilitate (a) procurement HIV
diagnostic tests in adults and children (b) monitor treatment
outcomes in patients on ART
Geneva 2008 (AMDS/EHT meeting)
• Tool revised from meeting outcomes
• Released Jan 2014
Geneva 2012 (AMDS/EHT meeting)
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ASLM
CDC
CHAI
CPS
Crown Agents
FIND
Global Fund
GSSHealth
SCMS
STB
UNDP
UNICEF
USAID
USAID/Deliver, JSI
USAID/SIAPS, MSH
WHO/HIV/TAC
WHO/HIV/TCO (AMDS)
WHO AFRO
WHO/EHT/DLT
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Enable purchasers and suppliers to understand end user requirements;
Provide detailed specifications to improve procurement;
Itemize commodities by test;
Approximate quantities of commodities by test;
List required and optional accessories;
List other relevant data e.g. shelf life, installation.
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Buyers, logisticians and
national program officers
•Develop correct specifications
•List required accessories
•List optional accessories
• Identify installation and
training requirements
• Identify quality standards
Staff responsible for laboratory
logistics, supply chain
management, service planning
and scale-up
•Determine appropriate
laboratory network level
• Identify required additional
equipment
•Determine required quantities
• Identify shipping and storage
conditions
•Approximate shelf-life
Laboratory managers,
supervisors and technical staff
• Identify suitable equipment
for the laboratory network
level
•Determine need for
equipment installation,
training, calibration and
regular servicing
•Understand equipment
operating conditions
•Recognize required quality
standards
• Identify items required by test
to assist in work flow
planning
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Training of laboratory, program and logistics managers – approx. 60
All 5 ROs and Country Offices
Positive feedback from procurement staff
Useful input for updates
Surveys planned
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Table re-organization and additional information on tests required
RDTs/EIAs not updated in January 2014 edition
Technologies obsolete or removed from WHO and GF lists for quality issues
New technologies WHO PQ’d and/or included on the GF/other partner lists
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New technologies added
Obsolete technologies removed
Catalogue numbers, shelf life, storage conditions, accessories updated
Performance characteristics for NA-based test analyzers and CD4 enumerating instruments significantly expanded
Division of Section I adapted
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Current version Name of analyzer
Catalog number
Description
Pre-installation requirements & Operating conditions
Items supplied with analyzer & Required accessories & Optional accessories
Throughput
Installation & Training
Maintenance/calibration
URL
2014 revision Name of analyzer
Name of test
Catalog number
Description
Pre-installation requirements & Operating conditions
Items supplied with analyzer & Required accessories & Optional accessories
Turnaround time & Capacity per run
Throughput
Sample needed and stability
Sample preparation and protocol complexity
Reagent stability and storage requirements
Cost/test & Cost/instrument
Installation & Training
Maintenance/calibration
Internal QC & External QA
URL
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New technologies (PQ & partner lists) ◦ 31 added (more pq’d items expected)
◦ 26 deleted
Test table revision ◦ Specimen type, Eligibility Criteria, Regulatory Status
◦ No. of tests, UN hazard code deleted
Revised structure of specification tables ◦ Columns “Manufacturer”, “Price range” added
Separated RDTs and EIAs
Alphabetical order by technology, not manufacturer
Updates: catalog nos., shelf life, storage conditions,
accessories, items required to perform test
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Price range of lab commodities
Overall input on the draft which will be circulated for review before publication (technical and non-technical)
Contact information (to ensure tool info is up to date)
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Joint publication Possible online version Dissemination through workshops and field
visit (actively collect feedback as the tool is used)