QASI perspective on POC EQA

Transcription

1 QASI perspective on POC EQA QASI: QUALITY ASSESSMENT AND STANDARDIZATION OF IMMUNOLOGICAL MEASURES FOR HIV/AIDS East Africa QA POCT Consultation T Blake Ball, MSc, PhD Public Health Agency of Canada

2 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)

3 INTERNATIONAL QUALITY ASSESSMENT PROGRAM FOR CD4 ENUMERATION User name: Password: Login Forgot your login information? Click here to contact the administrator. DISTRIBUTION OF QUALITY CONTROL SAMPLES QASI 3 times /year DATA COLLECTED ONLINE DATA ANALYSIS PERFORMANCE REPORT ASSISTANCE WITH REMEDIAL ACTION

4 4 Does participation in EQA matter? CIQAP data, Bergeron et al, Cytometry 2009

5 FUNDING Not sustainable - 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 2013, significant funding challenges. -New Models needed. Sustainability.

6 CD4 EQA MATERIAL - Commercial stabilized whole blood product (Hi and Lo CD4 panel R&D Diagnostics $25USD). Use fresh HIV+ blood for domestic version of program. - R&D: 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. - Internal CDN domestic program (CIQAP) utilises whole blood from HIV+ subjects and controls (Contract with local HIV clinicians/hiv care sites) - Need for Regional or In-country provider (caveat: CD4 is unique)

7 Informatics/Connectivity - Web based Data Entry Portal: 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, results, M&E) - Multilanguage interface (En/Fr/Sp/etc) -Currently QASI is evaluating collaboration with One World Accuracy -Informatics is a moving target, but does hard-wired equipment QC capture all things necessary for QA?

8 QASI IN PARTICIPATING LABORATORIES (~500 more as Science Architect with 1WA) 64 PARTICIPATING COUNTRIES 25 NATIONAL COORDINATING CENTRES

9 TWO-LEVEL STRUCTURE QASI ADMINISTRATOR NATIONAL (Regional) LABORATORY COORDINATING CENTRE PERIPHERAL LABORATORIES SINGLE LABORATORIES

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11 Tunisia Morocco Senegal Cape Verde Liberia Burkina Faso Cote D Ivoire Nigeria Cameroon Ethiopia Congo Democratic Republic of the Congo Uganda Kenya Rwanda Tanzania Zambia Malawi Zimbabwe Botswana Lesotho Swaziland

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

13 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

14 PHASE I SKILLS TRANSFER WORKSHOP Train-The-Trainers EQA MANAGEMENT CD4 TECHNOLOGY INFORMATICS 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

15 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

16 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/m&e

17 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

18 PHASE III IMPLEMENTATION OF NATIONAL QUALITY ASSESSMENT PROGRAM (challenges) Type of QC testing material Fresh/Stabilised/Made/Purchased Frequency of EQA survey cycles ISO vs what is feasible Database application Web based vs cloud (connectivity) Funding How to insure EQA/QA while new tests/platforms being rolled out

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

20 20 Participants using PIMA technology in the QASI Program Total Number of Participants Participants using PIMA

21 QASI Collaboration with OneWorld Accuracy 1WA provides logistic support and ship QASI samples to participants and collect data QASI analyze data, provide remedial action where needed March/April 2015 Tanzania (167 participants) Swaziland (65 participants)

22 POC Lessons learned (challenges): 22 Need for buy-in/commitment from right in- Country partners. Government led consensus building (who are the partners?) Participant/clinician sensitization, need to see value for quality management in patient care (how can we convince funders EQA saves lives - or $$?) Culture of quality at working sites (already burdened front line workers) Role of National Lab EQA providers, or EQA trainers ( simple logistics vs capacity building?)

23 23 Involvement of QA providers/funders/implementators/country partners at a start of roll-out (co-ordination possible at outset?). Connectivity/data collection also required for non-equipment based EQA reporting (systemic evaluation of process?) Sustainability only likely achievable via incountry/region capacity (Who pays?) EQA is really only a small part of QA (are all pieces already in place?)

24 24 QASI team: Dr. Adrienne Meyers Dr. Tamsir Diallo Margot Plews Syeda Rahman Linda Ares