HIV Rapid Testing quality Improvement Initiative – Using Innovative Approaches for Achieving the RIGHT First 90s
Centers for Disease Control and Prevention
No invitations necessary; open to all conference registrants
Sunday 4 December
8:00 – 12:00
CTICC room location: 2.64-2.66
Laboratory professionals, Program managers, medical technicians/Scientists, Implementing partners, quality assurance officers
The rapid expansion of HIV testing and counseling services has been driven by the implementation of HIV rapid diagnostic tests (RDT) performed by either health care workers or lay providers, the increasing need for HIV services, and the increased provision and demonstrated effectiveness of antiretroviral drugs to treat persons living with HIV and prevent further transmission (e.g. prevention of mother-to-child transmission (PMTCT), discordant couples, etc.). Considerable effort and resources have focused on expanding and decentralizing HIV Testing Services (HTS), Prevention of HIV Mother to Child Transmission (PMTCT) programs and HIV care and treatment services.
However, complementary quality assurance systems for HIV rapid diagnostic tests have not been adequately prioritized or implemented. WHO has supported the use of HIV rapid diagnostic tests, including their use by specifically trained and supervised lay providers, as part of the recommended testing algorithms and the scale-up of provider-initiated HIV testing and counseling (PITC) in health facilities. The WHO 2016 Consolidated Guidelines on the Use of Antiretroviral for the Treatment and Prevention of HIV Infection (Consolidated ARV Guidelines) now recommends ART initiation based solely on the result of the HIV rapid tests for certain populations. In the area of “Test and Start”, increasing the access to accurate and reliable HIV test result is critical in order to meet the UNAIDS targets of diagnosing 90% of HIV infected persons by 2020, therefore there is an urgent need to strengthen country capacity for robust continuous quality improvement processes.
Considering a comprehensive package of quality activities, countries have adopted the WHO concept of the Quality Assurance Cycle – A continuum of integrated planned activities that supports and promotes effective rapid HIV testing – to ensure the accuracy and reliability of HIV test results.
Several countries have prioritized key activities such as 1) developing guidelines and policies on quality assurance, 2) establishing a certification program for testers and testing sites using innovative tools and approaches, Scaling up their proficiency testing program and increasing the used of standardized testing logbook and finally strengthening their capacity to ensure the quality of test kits.
In this session, countries will present their experience on this new approach, from conceptualization to implementation, will share best practices and challenges encountered.
SESSION LEARNING OBJECTIVES:
- To promote the importance of well-established continuous quality improvement processes which take into consideration planning, implementation and sustainability phases to meet global targets and guarantee a great impact.
Dr Moses Sakala. University Teaching Hospital, Department of Pathology and Microbiology. Head of Zambia National Quality Assurance Program.
Dr Moses Sakala is an immunologist heading the Zambia National Quality Assurance program. Over the past two years his focus has been on improving the quality of HIV test results obtaining in the testing sites around the country through the RTQII program. His major research interests include the use of immunological therapy for both infectious and non-infectious diseases.
Mr. Clement Udedi. Malawi AIDS Counselling and Resource Organization. Head of Programs
Mr. Clement Udedi holds Bachelor of Science in Nursing, a Master’s Degree in Business Administration, Diploma in Computer Studies and certificates in advanced health care management. He has more than 7 years’ experience in management of Health, HIV and AIDS related projects. Currently he is working as Head of Programs with Malawi AIDS Counseling and Resource Organization
Dr. Joyce Wamicwe. NASCOP – Ministry of Health. Medical Doctor/Epidemiologist
Dr. Wamicwe is a medical doctor with post-graduate training in Applied Epidemiology under the Field Epidemiology and Laboratory Training Program (FELTP) – Kenya. Her goal is to pursue a vibrant and fulfilling medical career with emphasis on preventive medicine so as to contribute towards achieving greater good for humankind. Currently, she is the team lead in the Strategic Information Unit at NASCOP – Ministry of Health and have also been acting HIV Testing Services Manager for the last two years.
Dr. Bienvenu Etogo Ondigui. Ministry of Public Health, Cameroon. Head of Laboratory Services.
Dr. Etogo is a Medical Doctor (2000) with a Master in Immuno-haematology and Blood Transfusion (2004) and later got a specialization in Clinical Biology (2012) from Yaoundé I University Cameroon and Université Libre de Bruxelles (ULB) Belgium respectively. He has worked in the field of HIV and AIDS for over fifteen years. This includes, clinical diagnosis of patients in emergency unit of Central Hospital Yaoundé, blood safety in the largest blood transfusion centre of the country in the same structure, capacity building of health personnel and students of the High Institute of Medical Technology Yaoundé, Cameroon. He has over fifteen years of experience in the management of a working team as Head of blood bank, of a clinical laboratory and of a district hospital. He is also trained in Quality Management System and certified as internal auditor. As a MoH official, he is used to developing project proposals and to coordinating health programs. He is currently working in the Ministry of Public Health Cameroon as the Head of Laboratory Services. The Laboratory Service oversees the regulation and development of clinical laboratories in the country in order to ensure that the best practices are being delivered to the population.
Mr. Douglas Chiwara. NIP. Quality Manager NIP
Mr. Chiwra is a Medical Laboratory Scientist with 16 years of extensive working experience in the Medical Laboratory environment. In addition to an Honors Degree in Medical Laboratory Sciences from the University of Zimbabwe, Douglas holds a Bachelor of Technology Degree in Quality Management from the University of South Africa and a Graduate Certificate in Global Point of Care Testing from Flinders University in Australia. It is noteworthy to mention that Douglas is the first International student to complete a post-graduate qualification in Point of Care Testing from the Flinders University in 2014. For the past 7 years, Douglas has occupied various management level positions at the Namibia Institute of Pathology (NIP) where he has been employed since 2003. NIP is a state owned enterprise that runs a total of 40 Medical laboratories in Namibia and provides pathology testing services to all public health facilities in the country. Currently, Douglas is the Quality Manager at NIP and leads the implementation of a Quality System for the HIV RT programme in Namibia. In this capacity, Douglas is responsible for managing HIV RT tester and site certification processes as well as the ongoing monitoring of testers’ competences and sites performances. In addition to this, Douglas is responsible for the in-country roll-out of the SLMTA program. Since 2008, Douglas has contributed immensely to the implementation of Quality Management Systems in the NIP network of laboratories. This led to the achievement of International Accreditation by a number of Laboratories to ISO 15189. Douglas is driven by an immense passion for Quality Management and Point of Care Testing.
Dr Adrian J Puren, Centre for HIV and STIs, National Institute for Communicable Diseases
Dr. Adrian Puren heads the HIV Sero-Molecular laboratory in the Centre and has experience in the implementation of various serological and molecular methods and platforms for research e.g. HIV vaccine trial endpoints, surveillance e.g. HIV incidence and routine diagnostics. Dr. Puren heads a team that provides support to the South African National Department of Health in the implementation of HIV rapid testing quality assurance. The Unit supports laboratory-based evaluations and selection of HIV rapid test devices and post-market surveillance of devices. In addition, the Unit through a PEPFAR grant actively trains on the quality assurance of HIV rapid testing at facility level and has implemented a monitoring and evaluation programme viz., the Stepwise Process Implementation of HIV Rapid Test Quality Improvement Initiative (SPI RTQII) to assess programmatic effectiveness. The Unit also contributes to policies related to HIV testing and counselling and POCT.
Mr. Franklin Kitheka. Kenya National Public Health Laboratory Services (NPHLS). RTQII Manager
Mr. Kitekha holds a Bachelor’s degree in Medical Laboratory Sciences as well as several Diplomas in Medical Laboratory and Quality Assurance related field. He is a registered Medical Laboratory Scientist with 25 years’ experience in the field of Medical Laboratory Science in the public sector, having worked for the Ministry of Health in Kenya. Mr. Kitheka has worked in Public Health Microbiology as well as HIV Laboratory Program. Stationed at the Division of National Public Health Laboratory Services (NPHLS), he served as the National HIV Serology Proficiency Testing Scheme Coordinator. He has immensely contributed in the roll out as well as the scale up of the national HIV Testing Quality Assurance Program. Currently, he is the Manager for the HIV Rapid Testing Quality Improvement Initiative (RTQII) for Kenya and spearheading the roll out of this initiative.
Dr. Christine Watera. Uganda Virus Research Institute (UVRI). HIV Serology Quality Assurance and Quality Control (QA/QC) Project Coordinator
Public Health Specialist for over 15 years with vast experience in HIV program management, operational research in additional to general clinical practice. She has coordinated and led teams with a mix of skills and background for effective program and project implementation, working with Ministry of Health leadership and other partners. Between 1999-2010, she served as the Project Leader for several project funded by the British Medical Research Council. Since 2010, she is the Program Manager for several PEPFAR-funded initiatives through a co-operative agreements with the Centers for Disease Control and Prevention (CDC). The goal of these projects is to strengthen surveillance, epidemiology and conduct operational research to inform the delivery of cost-effective, evidence-based, and innovative interventions. Dr Watera is a board member of the Uganda Medical Association, and she is member of several technical working group the National HIV Drug Resistance Technical Working group and the National Technical Working Group for the Uganda Population HIV Impact Assessment Results from her work have influenced national policy and she has contributed to over 20 publications in peer reviewed journals. She is a good communicator with excellent public speaking skills, able to work in multicultural and multinational settings.
Khumbo Ng’ona Namachapa. Malawi Ministry of Health, Department of HIV and AIDS. HIV Testing Services officer
Khumbo holds a Bachelor of Science in Nursing, has more than 5 years’ experience in HIV and AIDS policy development and management as well as health management. Currently working as HIV Testing Services Officer at Department of HIV and AIDS
Dr Peris Urasa – Tanzania. Ministry of Health Community Development, Gender, Elderly and Children. National Coordinator for HIV Testing and Counselling Services
Dr Peris Urasa is a Public Health Specialist who has worked for the National AIDS Control Programme of the Ministry of Health, Community Development, Gender Elderly and Children in Tanzania since 2003, is currently as the National Coordinator for HIV Testing and Counselling services. Before that, she was the Regional AIDS Control Coordinator for a region in the Northern part of Tanzania. She holds an Advance Diploma in Clinical Medicine from the Kilimanjaro Christian Medical Collage and a Master Degree in Public Health from the same College. She is the Local Principal Investigator of the Provider Initiated HIV Testing and Counseling Collaborative Quality Improvement – in Tanzania, project in collaboration with the Centres for Disease Control- Tanzania and ICAP Columbia University.
MS. Amanda Mohlala. National Institute for Communicable Diseases. QA/QI Project Manager
A qualified Medical Technologist with a BTech Degree in Pharmaceutical Sciences and Project Management qualifications. Currently studying towards a Post Graduate Diploma in Public Health. Has more than 10 years of combined management, clinical research and training experience in Quality management Systems. Primary role is the implementation of Quality Assurance and Quality Improvement activities for Point of Care testing at government health facilities in all nine provinces of South Africa. This includes acquiring resources, training of health care workers and coordinating the efforts of team members and stakeholders or consultants to ensure implementation of QA activities at facility level. Responsible for directing and managing Quality Assurance and Quality Improvement as well as monitoring and evaluating the implementation of the QA program in support of the National Department of Health HIV Testing Services (HTS) program as part of the continuum of care and treatment.
Mr. Joseph Ndekha. Malawi Aids Counseling and Resource Organization. RTQII Project Coordinator
Mr. Ndekha holds Bachelor of Science degree in Biology, Diploma in Biomedical Sciences (Medical Laboratory Technology). He possess 5 years working experience in HIV related laboratory work and 2 years of Management of HIV Program.
Mr. Busari Olusegun. Centre for Integrated Health Programs (CIHP). Nigeria. Associate Director and Head of Laboratory Services
Mr Olusegun is currently responsible for the provision of leadership, technical oversight and strategic direction in implementation of the laboratory program and system strengthening, Biosafety, Waste management, Safe Injection and Blood Safety. He holds a Fellow of the Medical Laboratory Sciences Council of Nigeria (FMLSCN) in Medical Virology, a Master’s of Science degree in Medical Microbiology and Parasitology. He has over16 year’s extensive experience in the Medical Microbiology, Virology and Biotechnology Laboratories; and track record of managing increasingly larger and complex programmes and projects in the public healthcare regulation and developmental sector. He is a member of the African Society of Laboratory Medicine (ASLM) and American Society of Microbiology (ASM).
Mr. Habtamu Asrat. Ethiopia Public Health Institute (EPHI). RTQII coordinator
Mr Habtamu Asrat has a Master of Science in Clinical laboratory sciences with specialty of diagnostic and public health microbiology and a Bachelor of Science in Medical laboratory technology. He has 15 years’ work experience in different health institutions (public, private and NGOs). Since March 2011, he works in EPHI as an Associate Researcher and Quality Officer position and he is currently the focal person of the HIV Rapid Testing Quality Improvement Initiative in Ethiopia. He provides mentoring, supervision, assessment and conduct training sessions for laboratories services across Ethiopia. Contributed to the development of multiple guidelines and manuals and also organized meetings and workshops. He is also involved in various operational research project of public health interest.
Ms. Rose Akide. Uganda Virus Research Institute. Quality Officer
Experienced and successful laboratory scientist with over 10 years’ experience in building high-performing research teams, spearheading operational research and impacting public health. Seasoned in managing quality assurance and quality control (QA/QC) laboratory activities in internationally accredited research laboratories and managing national External Quality Assurance schemes.
Ms. Priscila Sigala Mosoke. Global Health Systems Solutions Cameroon. Laboratory quality assurance officer and RTQII Coordinator
Ms. Mosoke has a Bachelor of Science in Biochemistry (1997) and Masters of Science in Virology (1999) from Obafemi Awolowo University Ile Ife and University of Ibadan Nigeria respectively. She has worked in the field of HIV and AIDS for over fourteen years. This includes, isolation of HIV from HIV infected peripheral blood mononuclear cells for antiviral effect of medicinal plants, capacity building of health personnel and HIV quality Corps volunteers on the HIV rapid test quality assurance cycle and community sensitization on HIV prevention and care. She has over thirteen years of experience in the management of development project as a project assistant, project coordinator, program coordinator and branch manager of non-governmental international and national organizations. The QA and RTQII program organizes training for health personnel and HIV quality corps volunteer on HIV rapid testing and laboratory quality assurance and carries out external quality assessment for trained sites through site visit, and HIV proficiency testing.
Dr Eliangiringa Amos Kaale. Organization: Health Links Initiative (HLI), Tanzania. Senior Program Associate
Dr Kaale is a Professor in Medicine Quality Assurance at the School of Pharmacy and has more than 16 years of working experience in the health system of in Tanzania, Rwanda, Botswana, Afghanistan, Zambia and Ethiopia. His research work is in the development and validation of analytical methods, inter-laboratory cross validation studies. He is the East African Community (EAC) External Quality Assurance coordinator for medicine testing laboratory involving more than 20 labs organized within the framework of the EAC-PTB project “Establishment of a Quality Infrastructure for the pharmaceutical sector”. Dr Kaale is a member of an Expert Panel for the United States Pharmacopeia Convention (USP) Review of Surveillance and Screening Technologies for the Quality Assurance of Medicines. He is the current hair for National Technical Committee for registration of Human Medicines and TFDA and National Technical committee for pharmaceutical Standards at Tanzania Bureau of Standards. Recently, he was appointed into the National Committee to oversee the implementation of the strategies to improve local pharmaceutical production in Tanzania. He is a member of the Technical Working Group for Medicine Regulatory Capacity Building in Africa of NEPAD Africa and has recently been nominated as technical expert to represent the East African Community Regional Medicines Regulation Harmonization Initiative (RHI) as ICH members of the E11(R1) EWG on Clinical Investigation of Medicinal Products in the Pediatric Population. He is a member of the Scientific Advisory Board Serenus Biotherapeutics, an emerging biotechnology company in San Francisco, California. He currently serves as the Senior Program Associate with Health Links Initiative (HLI), a locally established NGO, overseeing an efforts to improve quality of HIV rapid testing initiative in four target regions.