QASI QUALITY ASSESSMENT AND STANDARDIZATION OF IMMUNOLOGICAL MEASURES FOR HIV/AIDS

Transcription

1 QASI QUALITY ASSESSMENT AND STANDARDIZATION OF IMMUNOLOGICAL MEASURES FOR HIV/AIDS National Laboratory for HIV Immunology National HIV & Retrovirology Laboratories Public Health Agency of Canada

2 INTERNATIONAL QUALITY ASSESSMENT PROGRAM FOR CD4 ENUMERATION DISTRIBUTION OF QUALITY CONTROL SAMPLES QASI 3 times /year DATA COLLECTED ONLINE DATA ANALYSIS PERFORMANCE REPORT ASSISTANCE WITH REMEDIAL ACTION

3 HISTORY QASI 1996 International AIDS Conference in Vancouver (Canada) John Fahey[Fogarty Institute (USA)] - financial support John Bradley [Flinders Medical School(Australia]) & Francis Mandy, [Health Canada] technical support The first QASI survey took place in 1997 (Ottawa, Canada)

4 FUNDING HISTORY - In 2000, QASI financed by Health Canada alone - Since 2002, WHO, CDC, Clinton Foundation involved with technology transfer , WHO financed EQAP for African, American and other WHO regions -Since 2011, QASI financed by Public Health Agency of Canada -Operations moved from Ottawa to Winnipeg 2012

5 QA MATERIAL - Commercial stabilized whole blood product - Non-infectious, Validated stability across conditions - Compatible with various processing methods and instrumentation based on extensive in-house testing - Each panel run on every instrument (FacsCount, Haematology analyzer, Guava, FacsCalibur, FC500, Canto, PIMA, CyFlow, Presto, Navios) prior to shipment

6 QASI - DATABASE - 3 levels of access - Participant, Coordinating Centre, Supporting Organization - Helps build local capacity for implementing independent national/regional QA programs - Allows monitoring activities - current submission status - enrollment of new laboratories - reported results - Multilanguage interface (En/Fr/Sp)

7 TWO-LEVEL STRUCTURE QASI ADMINISTRATOR NATIONAL LABORATORY COORDINATING CENTRE PERIPHERAL LABORATORIES SINGLE LABORATORIES

8 QASI IN PARTICIPATING LABORATORIES 48 PARTICIPATING COUNTRIES 24 COORDINATING CENTRES

9 QASI African Participants 2015 BURKINA FASO COTE D IVOIRE CAMEROON CAPE VERDE DR CONGO LESOTHO LIBERIA MALAWI MOROCCO MOZAMBIQUE REPUBLIC of CONGO SENEGAL SWAZILAND TANZANIA TUNISIA UGANDA ZAMBIA ZIMBABWE

10 QASI DEVELOPS LOCAL CAPACITIES SO THE NATIONAL LABORATORY CAN INDEPENDENTLY MANAGE THE CD4 QUALITY ASSESSMENT PROGRAM

11 HOW? PHASE 1 TRAINING FOR LABORATORIES RESPONSIBLE FOR QUALITY CONTROL ( COORDINATING CENTRES ) Train the Trainers PHASE II SKILLS DEVELOPMENT THROUGH ACTIVE PARTICIPATION IN QASI MANAGEMENT Redistribution of QA material, collection/oversight of peripheral laboratories (access to database), assist with troubleshooting/remedial action, develop QC guidelines PHASE III IMPLEMENTATION OF THE NATIONAL QUALITY ASSESSMENT PROGRAM IN CONJUNCTION WITH QASI TO FACILITATE THE TRANSITION TO INDEPENDENCE select material/tools to assess performance select platform to analyse data/produce reports

12 PHASE I SKILLS TRANSFER WORKSHOP Train-The-Trainers EQA MANAGEMENT CD4 TECHNOLOGY LYMPHO-SITE DATABASE QC MATERIAL DISTRIBUTION PROBLEM INVESTIGATION SPECIFIC TO QC MATERIAL AND TECHNOLOGIES INTERNAL QUALITY CONTROL MEASURES - INSTRUMENTAL, PROCEDURAL, ANALYTICAL - ADAPTED TO CD4 PLATFORMS AND TECHNIQUES IN USE REMEDIAL ACTION - FOLLOW UP WITH CORRECTIVE MEASURES

13 WORKSHOP LOGISTIC Identify EQA team 2 WEEKS (TECHNICAL AND MANAGEMENT) LOCATION (CANADA IF POSSIBLE) NUMBER OF PARTICIPANTS (MIN 2, MAX 4) WHO SHOULD PARTICIPATE? - INDIVIDUALS WITH ADEQUATE TECHNICAL BACKGROUND ( HANDS-ON) AND CAPACITY TO TRAIN - QC/EQA MANAGER CANADA PROVIDES ADVANCED TRAINING FREE OF CHARGE (TRAVEL/ACCOMMODATION NOT INCLUDED)

14 PHASE II SKILLS DEVELOPMENT THROUGH ACTIVE PARTICIPATION IN QASI MANAGEMENT THE NATIONAL QASI COORDINATOR = FRONT LINE CONTACT CENTER FOR THE PARTICIPATING LABORATORIES FIRST LINE MANAGEMENT BETWEEN PARTICIPANTS AND NATIONAL EQA MANAGER

15 PHASE II SKILLS DEVELOPMENT THROUGH ACTIVE PARTICIPATION IN QASI MANAGEMENT Redistribute QC samples 3X/year Respect timeline (dates, data submission deadline) Monitor data submission Assist with: - problem investigation - remedial action - implementation of corrective measures and follow-up Distribute performance report

16 PHASE III IMPLEMENTATION OF NATIONAL QUALITY ASSESSMENT PROGRAM 01/02 03/04 05/06 07/08 09/10 11/12 Year 1 QASI QASI QASI Year 2 QASI QASI QASI QASI NTL QAP NTL QAP Year 3 NTL QAP QASI NTL QAP QASI NTL QAP

17 PHASE III IMPLEMENTATION OF NATIONAL QUALITY ASSESSMENT PROGRAM Type of QC testing material Frequency of EQA survey cycles Database Software Application Funding

18 QASI PoC Devices Supported end of 2014 Africa Guava 27 (2.1%) CyFlow 24 (3.8%) Presto 9 (0.8%) PIMA 584 (56.5%)

19 19 Participants using PIMA technology in the QASI Program Total Number of Participants Participants using PIMA

20 QASI African Participants 2015 PIMA Instruments BURKINA FASO COTE D IVOIRE CAMEROON (98%) DR CONGO LESOTHO (100%) LIBERIA (94%) MALAWI (100%) MOZAMBIQUE (70%) REPUBLIC of CONGO SENEGAL SWAZILAND (100%) TANZANIA UGANDA ZAMBIA ZIMBABWE (100%)

21 QASI Collaboration with OneWorld Accuracy Pilot: 1WA ship QASI samples to participants and collect data submissions on web interface QASI analyze data, provide remedial action where needed March/April 2015 Tanzania (167 participants) Swaziland (65 participants)

22 22 QASI team: Dr. Adrienne Meyers Dr. Tamsir Diallo Margot Plews Syeda Rahman Linda Ares