Seminar #6

Lessons learnt from a large scale implementation of the Xpert MTB/RIF TB program in South Africa

National Health Laboratory Service

No invitations necessary; open to all conference registrants

Saturday, 3 December 
13:00 – 17:00
CTICC room location: 2.61-2.63

TARGET AUDIENCE:
TB Programme managers, Medical Technologist, Laboratory Service Managers, Clinicians and Ministries of Health.

SEMINAR DESCRIPTION:

The Xpert MTB/RIF TB program was initiated at the request of the Honorable Minister of Health of South Africa, Dr Aaron Motsoaledi, in early 2011, following the World Health Organization’s strong recommendation published in December 2010 which stated that “the new automated DNA test for TB be used as the initial diagnostic test in individuals suspected of MDR‐TB or HIV/TB”. In essence this comprises the majority of those with presumptive TB in South Africa. All instruments were interfaced to the National Health Laboratory Service (NHLS) Laboratory Information System (LIS) allowing for data collection and Troubleshooting.

Since 2011, 314 Xpert MTB/RIF instruments of varying sizes (GX4: 115; GX16:190; GX48: 1; GX80:9) have been placed in 211 sites – both urban and rural settings, by the National Priority Programmes (NPP) of the NHLS and the National Department of Health (NDoH). The programme was further expanded to directly support the screening for TB and HIV in high risk populations; correctional services and in peri-mining communities.

Going forward, it is essential to perform monitoring and evaluation of a National Xpert MTB/RIF TB Program to assist in gauging the performance of the program within a country, and furthermore, within different settings of a country (i.e. rural versus urban). To assist in improving the program, certain quality assurance tools need to be implemented; such as an External Quality Assurance (EQA) program and review of assay errors and instrument utilization through remote monitoring and use of operational dashboards.

The main aim of this seminar is for South Africa to share their lessons learnt from their implementation of a large-scale national Xpert MTB/RIF TB program. These lessons will be addressed through a broad scope of activities including; Implementation Challenges, Quality Assurance, Clinical Studies, Specimen Types (Pulmonary and Extra-pulmonary), Monitoring & Evaluation, Linkage-to-Care as well as the upcoming plans for the new Ultra assay and software upgrades from Cepheid.

SESSION LEARNING OBJECTIVES:

  • At the end of the session participants will have an understanding of Quality Assurance needed for Xpert, Monitoring tools for program performance and training requirements.

SESSION SPEAKERS:

Puleng Marokane, National GeneXpert Project Manager at the National Priority Programs (NPP), National Health Laboratory service (NHLS), South Africa
Puleng Marokane is the National GeneXpert Project Manager at the National Health Laboratory service(NHLS), South Africa. She is responsible for supporting all NHLS GeneXpert laboratories across all 9 province in the country and maintaining relationships with key partners. She qualified as medical technologist with a Btech degree. She has acquired a lot of experience working on molecular diagnosis platforms and has worked as application specialist at IVD commercial company specialising in Nucleic acid testing, she worked as a Research Laboratory Coordinator for a Non-Govermental Organisation and as expert trainer on the national GeneXpert roll out program.

Dr Leigh Berrie,  Head of Grants and Special Programss for the National Priority (NPP) of the National Health Laboratory Service (NHLS), South Africa
Dr Leigh Berrie is currently the Head of Grants and Special Programs for the National Priority Programs of the National Health Laboratory Service, South Africa, where she leads a team in the implementation and monitoring of National HIV and TB laboratory programs in the public health sector. In addition, she is the Chief Operations Officer for the NHLS-EQUIP program run through Wits Health Consortium which is involved with scale-up of access to HIV viral load monitoring in Africa. Her research efforts have included evaluation of new technologies for TB, HIV viral load monitoring and Early Infant Diagnosis which can be supported by various publications and conference presentations. She has 14 years of expertise with various commercial molecular diagnostic laboratory technologies available for HIV and TB, and 7 years of experience in the public health sector and working with National TB and HIV programs. She is currently a committee member of the National Task team for Improvement of HIV and TB services in the Department of Correctional Services and Chairs the Lab and Infection Control Working Group of this Task Team.

Prof. Lesley Scott, Associate Professor in the department of Molecular Medicine and Haematology and overseas Research and Development in molecular diagnostics with the National Priority Programs of the National Health Laboratory Service (NHLS), South Africa
Prof Lesley Scott is an Associate Professor in the department of Molecular Medicine and Haematology and overseas Research and Development in molecular diagnostics with the National Priority Program of the National Health Laboratory Service.  She specialises in design, development, evaluation, implementation and quality management of new molecular diagnostics for HIV and tuberculosis for disease diagnosis and monitoring to impact on global health with a special focus on resource limited settings.

Mrs Sylvia Ntsimane, GeneXpert Clinical Trainer at National Priority Programs of the National Health Laboratory Service (NHLS), South Africa
Sylvia Ntsimane is the clinical trainer at the National Priority Program, National Health Laboratory Service.  Sylvia has a BTech degree in Community Nursing with Technikon North West and has been practicing nursing for more than 27 years. Sylvia is responsible for training and supporting nurses and doctors across all 9 Provinces in South Africa on the GeneXpert Xpert MTB/Rif test and the new TB clinical algorithm.

Priyesh Bhoora, Systems Coordinator at Cepheid, South Africa
Priyesh Bhoora is a qualified as Biomedical Technologist and registered with HPCSA in Microbiology in ’98. He has 8yrs experience in a Microbiology Pathology lab followed by 9yrs experience in Commercial IVD Company, initially as an Application Specialist to Automated ID/AST instruments and progressing up to Project Management function. He is currently with Cepheid as systems coordinator, initially for RemoteXpert implementation and currently as Global Product Support Specialist for global rollout of the Cepheid C360 software

Lynsey Stewart-Isherwood, mHealth Program Manager and Medical Scientist at National Priority Programs (NPP), National Health Laboratory Service (NHLS), South Africa
Lynsey Isherwood is the mHealth Program Manager and Medical Scientist at National Priority Programs, National Health Laboratory Service. Lynsey is also a Technical Specialist to EQUIP, tasked to scale-up viral load testing in 17 African countries. Lynsey collaborates with the National Department of Health, provincial departments of health and NGO’s, in the design and implementation of mHealth projects (e.g. miLINC, Treat-TB and SmartLinc). Lynsey’s TA role within EQUIP includes liaising with in-country partners to devise suitable and innovative solutions for pre- and post-analytics for viral load testing.

Andani Phaswana, Program Manager (Correctional Services), National Priority Programs, National Health Laboratory Service (NHLS)
Andani  Phaswana obtained his national diploma in medical technology and has specialised in Clinical Pathology. He  started working in the Department of Health, then went and opened a private pathology laboratory in Mpumalanga where he serviced the private doctors in the Nkangala district for 5 years before joining the National Health Laboratory Service(NHLS) in 2004 as a laboratory manager and later as a client liaison officer. He joined the National Priority Programs of the NHLS in 2014 where he  was instrumental in the setting up of the GeneXpert laboratories in 7 correctional centres in South Africa. Up to this day his role is making sure that the correctional services’ hospitals and clinics receive the best of pathological services in the land.