Laboratory Strengthening Gloria Young BD Biosciences

Transcription

1 Laboratory Strengthening y g g Gloria Young BD Biosciences

2 Lessons Learned from Establishing CD4 Testing Capability in Resource-Limited Countries Background Why Lab Strengthening BD s experience What works and why -2-

3 Background HIV is the major focus in international healthcare programs in the Developing World Funding is not currently the limiting factor in providing access to universal ARV treatment access Insufficient access to health services in developing countries is a more fundamental factor impacting expanded treatment Among health services, laboratory capacity and access to diagnostic testing are particularly deficient; often non-existent in rural settings Diagnostic testing and access to treatment are also essential to success of HIV prevention efforts -3-

4 Challenges in Implementing CD4 Testing #1 Limited laboratory experience/capability to produce reliable and accurate results Poor blood collection practices Few technical laboratory staff with adequate training in even basic knowledge and skills across all levels from management to bench testing Hierarchical structures limiting changes in practice Lack of integration across healthcare support #2 Affordable CD4 testing ti was not the 1 o barrier to delivering i ARV therapy BUT poor results reduce confidence in diagnostic testing #3 Laboratory services need to be accessible to the patient population in need of ARV -4-

5 Fundamental Building Blocks for a Successful Lab Strengthening g Program Build Alliances to Develop Local Capacity & Ownership Plan Strategically Network Laboratories Develop Leaders Develop Human resources Introduce New Technology Ensure Quality Improve Infrastructure & Maintain it -5-

6 Build Healthcare Capacity Good Laboratory Practices (GLP) Training Over 662 trainings in 60 countries with 6002 people trained CD4 Testing FACSCount, FACSCalibur, FACSCanto Blood Draw Safe Injection Quality Control Practices in TB Essentials of Laboratory Management EQA and Reference Range Support Partnerships with Leading Healthcare Educators and Sponsors -6-

7 Training Collaborators Clinton Health Access Initiative American Society of Clinical Pathology (ASCP) CDC / Global AIDS Program Infectious Diseases Institute-Uganda World Health Organization Caribbean Epidemiology Centre (CAREC) UNAIDS United Nations Development Programme (UNDP) National Institutes of Health Pasteur Institute Medecins Sans Frontieres (MSF) University of Medicine and Dentistry, New Jersey (UMDNJ) African Medical and Research Foundation (AMREF) in Tanzania National AIDS Control Organization (NACO) in India Dermatology and STDs (NCHADS) in Cambodia National AIDS Control Program (NACP) in Ghana Chantal Biya Foundation Merieux Foundation Pharmaccess Japan International Cooperation Agency (JICA) Armed Forces Research Institute t of Medical Sciences -7-

8 Agenda Time Day 1 Day 2 Day 3 9:30 10:00 Welcome, Introduction and Blood Collection using BD FACSCount Troubleshooting Review Vacutainer tube 10:00 11:00 Introduction to CD4 and Flow Cytometry 11:00 12:00 CD4 Solution using BD FACSCount 12:00 1:00 Instrument Start up and sample and control preparation using the SOP Blood Collection (Demo) and hands-on practice Instrument Maintenance using the SOP Making your own SOP for the laboratory (exercise) BD FACSCount Troubleshooting exercises Lab practice and SD, CV calculation External QC review on QASI samples 1:00 1:30 Lunch Lunch Lunch 1:30 3:00 Quality Assurance and FACSCount Quality Control including LJ graphs Lab Practice and troubleshooting exercise Conclude, Test, Evaluations 3:00-4:30 Lab: Running QC and Laboratory Management Samples on the BD FACSCount 4:30 5:30 Levy Jennings Exercise and Pediatric %CD4 Exercise Laboratory Management -8-

9 Activity is Ongoing -9-

10 Overview - PEPFAR Agreement Focus on laboratory strengthening to address HIV and TB Built on strength & learnings from GLP program A 5-year Program valued at up to $18M 1:1 matching - BD:PEPFAR -10-

11 Background - PEPFAR Agreement BD established a Public Private partnership (PPP) with OGAC in 2007 Supports 8 African countries through collaborations with in-country partners (CDC, ASCP, ASM, CF, and FIND) Utilizes BD associate assistance, globally BD employees selected as volunteers External commitment by BD valued at $9M BD personnel time and contributions BD receives no government funding Establish Work Plans from MoH & CDC visits Training Technical & non-technical support Emphasis placed on HIV/CD4 and TB -11-

12 Three Goals Goal 1: Improve quality of laboratory diagnostics critical to management of HIV/AIDS patients. Establish Country Operational Plans (COPs) with MOH Recruit and deploy short and long-term BD volunteers Implement EQA programs Goal 2: Implement short-term improvements in quality of existing TB diagnostic capacity. Roll out EQA for TB smears in 7 countries Increase availability of TB trainers in collaboration with American Society of Microbiology (ASM) Goal 3: Increase access to TB culture in accordance with new World Health Organization (WHO) guidelines for liquid culture use in HIV patients. -12-

13 Scale-up of the BD/PEPFAR Lab Strengtening Program Coun nt Year Total Number of Training Sessions Countries Impacted New Training Topics -13-

14 Uganda Status Current Laboratory Quality Management Pilot Co-taught with 4 other local partners 96 laboratory workers trained 75 Labs enrolled in NEQAS 51 returned results 35% 88% Pre- to Post-Test Results Overall 30% improvement in EQA performance 9 Ugandan trainers learned teachback skills Monitoring 2011 Preparing Nat l mentors -14-

15 Thank you BD